Flexible multi-articulated cartridge with flexible stapling line for endoscopic staplers (manually or electrically actuated) used in video and robotic thoracic surgery

Abstract

Multi-articulated cartridge for endoscopic surgical stapler (mechanically or electrically actuated) with integrated tissue cutting system using an electric field. It allows video or robotic surgery with the creation of stapling lines with a sharp curve (not possible with currently available devices) and automatic cauterisation of the transected tissue, preventing bleeding. Ideal for parenchyma-sparing lung surgeries and for patients at high risk of bleeding. The device features a completely new constructive concept inspired by nature, by means of observation of centipedes and millipedes. The device is very promising for use in uniportal surgeries and natural orifice surgery (NOTES).

Description

FLEXIBLE MULTI-ARTICULATED LOAD WITH FLEXIBLE STAPLING LINE FOR ENDOSCOPIC STAPLERS (MANUAL OR ELECTRIC) USED IN VIDEO AND ROBOT-BASED THORACIC SURGERIES. DESCRIPTIVE REPORT FIELD OF INVENTION

[0001] The present invention features a load for an endoscopic surgical stapler capable of stapling with sharp curves, enabling lung surgery to remove nodules or lesions while preserving tissue. It is ideal for removing benign lesions and lung metastases.

[0002] It also has an electric field cutting system, enabling the cauterization of tissues close to the stapling lines and reducing the chances of bleeding. PREVIOUS EVENTS

[0003] When searching the Patentscope (WIPO) and Espacenet databases for the terms "multi-articulated surgical stapler," "multi-articulated staples unit for surgical stapler," and "surgical stapler with electric scalpel to cut the tissue," we found no records that include multi-articulated surgical loads, multi-articulated surgical staplers, stapler loads with a cutting mechanism based on the application of an electric field, or surgical stapler loads with staple line articulation mechanisms based on metal wire traction, as described in this application. However, we found the following records that mention loads with articulated support rods:

[0004] There is a record titled ARTICULATING CURVED CUTTER STAPLER

[0005] KR20080021527A • 2008-03-07 • ETHICON ENDO SURGERY INC [US]

[0006] Earliest priority: 2003-12-30 • Earliest publication: 2007-02-22. This record describes a stapler with an articulated tip; however, in this model, the articulation is single and the staple line cannot be curved. It does not use an electric field to cut the stapled fabric, which is done mechanically with a cold knife.

[0007] In record 20190298350 "METHODS FOR CONTROLLING A SURGICALLY POWERED DRUM HAVING SEPARATE ROTATING CLOSING AND FIRING SYSTEMS"

[0008] US - 10 / 3 / 2019 Ethicon LLC, the described device does not have a multi-joint load, only a load-bearing rod with a single joint. The staple line cannot be curved by the surgeon. The staple line is cut with a cold knife and does not use an electric field to cut tissue.

[0009] In the registration WO / 2023 / 175468SURGICAL STAPLER CARTRIDGE WITH INTEGRATED RFID FEATURE WO - 21.09.2023 Applicant CILAG GMBH INTERNATIONAL, the stapler load joint is not mentioned. Only the stapler rod is articulated with a single joint. The staple line is cut by a cold knife and not by an electric field.

[0010] Registration WO / 2013 / 043717 STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK

[0011] WO - 03 / 28 / 2013 Applicant ETHICON ENDO-SURGERY, INC., does not address the articulation of the load. It only addresses the refill cartridge with a stapler. The cutting of the stapled tissue is performed by a mechanical process; it does not use an electric field for cutting.

[0012] In the registration WO / 2019 / 186466SURGICALLY CARTRIDGE WITH CAM-DRIVED ASSEMBLY BY TRIGGER ELEMENT THAT HAS A FABRIC CUTTING CHARACTERISTIC ON BOARD WO - 03.10.2019 Applicant ETHICON LLC, do not deal with the articulation of the stapler load. Only the cutting line of the stapling that is carried out mechanically by a cold knife and not by an electric field.

[0013] In the registration WO / 2019 / 079171 SURGICAL HYPOTHERMIC LINEAR STAPLES AND METHODS OF USE WO - 25.04.2019 Applicant ETHICON, INC. We found that the stapling device cools the tissues to be stapled to minimize bleeding, but there is no mention of the application of an electric field for tissue cutting.

[0014] In the record 2018352212 HYPOTHERMIC CIRCULAR SURGICAL STAPLERS AND METHODS OF USE AU - 25.04.2019 Applicant Ethicon, Inc, the cooling of tissues during stapling is described to prevent bleeding, however, the application of an electric field for tissue cutting is not described. GENERAL DESCRIPTION

[0015] This is a new type of load for endoscopic surgical staplers that has not yet been produced by any manufacturer. It consists of the construction of loads for surgical staplers with multi-articulated segmentation composed of overlapping segments (Figures 1, 2, and 5) that articulate with each other, similar to the body of an earwig.

[0016] This construction modality allows the loads to assume curved shapes not yet achieved with current commercial loads, enabling the surgeon to perform stapling for resection of nodular lung lesions while preserving the lung parenchyma. Ideal for resection of benign lesions, small nodules, and lung metastases.

[0017] When the lever to bend the load is activated (Figure 6, item 17), a micro-gear system attached to the inside of the stapler shaft rotates (Figures 6 and 7, items 9 and 16). This system rotates nanopulleys that simultaneously pull resistant metal wires inside the upper and lower halves of the jaw, arranged along the longitudinal axis and fixed to the tip of the load (Figure 7, item 12), allowing the load to be bent to the right or left side as needed by the surgeon. (Figure 6)

[0018] Each jaw halves (Figures 1 and 2) are composed of a sequence of articulated segments that have two lines of staples on the right and left sides (Figure 1, item 3) (lower part of the load) or lines of figure-8 channels (Figure 2, item 6) (upper part of the jaw), separated by a gutter (upper part of the jaw) (Figure 2 item 5) or a flexible metal blade resistant to high temperatures that connects to a conductive cable that connects to a bipolar electric scalpel generator (Figure 1, item 2) (lower part of the jaw). The two halves are flexible and can be curved with adjustments made on a stapler lever. When the trigger is activated, a central wire located in the lower part of the jaw is pulled, passing through a nanopulley located at the tip of the load with ends fixed to the flexible staple elevator and to the other nanopulley located on the stapler rod (Figure 7.C, item 18) that pulls the flexible staple elevator (Figure 7C, item 15) promoting the release of the staples and the firing of the load stapling the operated tissue. After stapling, the structure is sectioned by applying an electric current to the central blade (Figures 1 and 7C, item 2) which is connected to a bipolar electric scalpel generator through a conductive cable connected to it for this purpose. The other pole of the scalpel. bipolar electric cable connects to the metal channel resistant to high temperatures (Figure 2, Item 5) promoting the closing of the electric arc that promotes the cutting and cauterization of the tissue along the cutting line, minimizing the chances of bleeding in the staple line.

[0019] This construction model is not observed in any of the researched prior art published to date in the aforementioned databases. None of the surgical stapler loads described thus far have multi-joint capabilities such as centipede bodies, cutting devices that use electric current, or bending devices based on the traction of metal wires running through nanopulleys. Table 1: Description of Figures PREFERRED MODALITIES

[0020] A preferred modality involves implementing this load model in lung surgeries performed by video or robot, allowing small lung lesions, benign lesions, or lung metastases to be resected without excessive removal of lung tissue and harm to the health of patients.

[0021] Another preferred modality is the expansion of the use of this type of load for surgeries on other structures such as digestive system surgeries, endoscopic surgeries, bariatric surgeries, urological surgeries, cardiac surgeries and even vascular surgeries.

[0022] The third preferred modality is that the use of this type of loads allows the advancement of surgeries performed through natural orifices (NOTES) and surgeries through uniportal microincisions.

[0023] The last preferred modality is the use of this device in surgeries with a high chance of bleeding, generating the cauterization of the tissues close to the stapling lines, reducing this risk.

Claims

CLAIMS 1. Model of multi-articulated loads for endoscopic surgical staplers, characterized by composing endoscopic stapler loads composed of multiple overlapping segments and articulated with each other, similar to the body of a centipede.

2. Curved stapling system - flexible, characterized by a staple line firing system through a flexible staple elevator pulled to the tip of the load by a resistant central metal cable that passes through a nano pulley at the tip of the load and on the rod in the stapler.

3. Cutting system by application of electric field, characterized by the addition of a flexible temperature-resistant metal blade to one of the halves of the jaw that cuts the tissue after triggering the stapling by the action of electric current that is applied to it by a cable connected to the bipolar electric scalpel generator and the second pole of the scalpel connected to the conductive metal channel in the opposite half of the jaw.

4. Stapler load bending system, characterized by a surgical load that bends through the action of synchronized traction of resistant metal wires that run through the inside of the upper and lower halves of the jaw using a system of micro gears and nano pulleys.

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