WO2018078589A1 - Compression anastomosis device and mechanism for positioning and connecting same - Google Patents

Compression anastomosis device and mechanism for positioning and connecting same Download PDF

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Publication number
WO2018078589A1
WO2018078589A1 PCT/IB2017/056702 IB2017056702W WO2018078589A1 WO 2018078589 A1 WO2018078589 A1 WO 2018078589A1 IB 2017056702 W IB2017056702 W IB 2017056702W WO 2018078589 A1 WO2018078589 A1 WO 2018078589A1
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WO
WIPO (PCT)
Prior art keywords
rod
coupling
male coupling
conical
female coupling
Prior art date
Application number
PCT/IB2017/056702
Other languages
Spanish (es)
French (fr)
Inventor
Cristóbal Adolfo ABELLO MUNARRIZ
Original Assignee
Abello Munarriz Cristobal Adolfo
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Publication date
Application filed by Abello Munarriz Cristobal Adolfo filed Critical Abello Munarriz Cristobal Adolfo
Publication of WO2018078589A1 publication Critical patent/WO2018078589A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound

Definitions

  • the present invention relates to devices for anastomosis of tubular ducts, and with mechanisms for inserting and connecting said devices.
  • the present invention relates to devices for anastomosis of tubular organs, such as, esophagus, stomach, and intestines.
  • the prior art discloses devices for anastomosis of hollow anatomical structures, such as intestines, stomach and esophagus, such as those disclosed in US 8,709,025 B2 and US 6,030,392.
  • US 8,709,025 B2 discloses a device for anastomosis of tubular organs, such as intestines, stomach, esophagus, etc., wherein the tubular organ to which the anastomosis is to be made has two ends separated by a gap.
  • the device comprises an inner ring and an outer ring, the outer ring is made of an elastic material; wherein each ring is sewn to a separate tubular organ end. The ends of each separate tubular organ are sewn to the outer surface of a ring.
  • the outer ring surrounds the tubular organ, then the outer ring and the end of the tubular organ to which it is sewn are turned so that the tubular organ is connected within the outer ring. Then, the outer ring and the inner ring, and the adventitia of the ends of the tubular organ attached to the rings are assembled.
  • the inner ring has an upper portion used for anastomosis, a middle section used for connection, and a low section used for insertion. The diameter of the middle section is smaller than the diameter of the lower section, and the upper section. He
  • the outer ring has holes in its periphery in which the suture is anchored by gluing a section of tubular organ.
  • the outer ring has a prominent ring towards the center.
  • the prominent ring is coupled with the middle section of the inner ring.
  • the lower section of the inner ring used for insertion includes beards that prevent the inner and outer rings from separating after they have been connected.
  • US 8,709,025 B2 requires an invasive operation to be installed, for example, in the case of an anastomosis of an esophagus, it is carried out around the esophagus in which the thyroid gland, the carotid artery, the vocal cords and the trachea, which must be manipulated to execute the anastomosis.
  • document US 2009/0012543 Al discloses a device for anastomosis of two parts of blood vessels, or for anastomosis of two parts of tubular organs.
  • the device includes a first attachable unit and a second attachable unit.
  • Each unit is connected to a part of the blood vessel, in addition, the attachable units are connected to each other.
  • Each attachable unit has a through hole that defines a longitudinal axis.
  • each unit has a receiving unit that grabs the blood vessel, the receiving unit includes a surface with sharp projections that penetrate the walls of the blood vessel without piercing it.
  • the attachable units are preferably manufactured in titanium or in another partially or completely resorbable material.
  • the first attachable unit is cylindrical, and has a rear section, and a front section of a diameter larger than the rear section. The surface with sharp projections is arranged on the inside of the rear section.
  • axial extensions are arranged in the first unit, for example, tabs.
  • the second unit is also cylindrical, and has at its front edge, guides in which the axial extensions of the first unit are inserted.
  • the device of US 2009/0012543 for anastomosis of tubular organs is installed by an invasive operation.
  • the walls of the tubular organ there is a risk that the walls will weaken and cause an injury to the organ.
  • the organ is a intestine
  • the lesion in the wall of the intestine can become an intestinal ischemia and later a peritonitis.
  • the state of the art discloses devices for anastomosis of tubular organs that need invasive operations, for example in the case of an esophageal anastomosis, where incisions are made in the neck and must make their way between important anatomical parts, such as the Thyroid gland, jugular artery, vocal cords, and trachea to make the anastomosis of the esophagus.
  • incisions are made in the neck and must make their way between important anatomical parts, such as the Thyroid gland, jugular artery, vocal cords, and trachea to make the anastomosis of the esophagus.
  • they need to be attached to the walls of the tubular organs by sutures or sharp projections that can weaken said walls.
  • the present invention corresponds to a device for compression anastomosis, and a mechanism for positioning and connecting the device.
  • the device comprises a female coupling with a through conical housing that communicates its distal end with its proximal end, where the smaller diameter of the through conical housing is located towards the proximal end; and a male coupling with a conical protuberance, which has its largest diameter at the distal end, and which includes a through hole that communicates its distal end with its proximal end.
  • the conical protuberance is operatively coupled to the through conical housing of the female coupling.
  • the mechanism comprises two malleable stems one with a distal end connected to the female coupling and the other with a proximal end connected to the male coupling of the device. Also, the mechanism can conform to the first rigid rod with a first radially arranged end, the first end is connected to the female coupling, and the second rigid rod with a first radially arranged end, the first end is connected to the male coupling.
  • the second rigid rod is connected to the first rigid rod by means of an axis that is located in the medial zone of each rod.
  • the mechanism and the device make it possible to make the anastomosis of an esophagus of a neonate by introducing one of the couplings with one of the malleable stems through the mouth of the neonate, and introducing the other coupling with the other stem through an incision made in the stomach of the neonate, thus, avoiding making invasive incisions in the neck and thorax.
  • FIG. 1 corresponds to a cross-section of a male coupling (4) and a female coupling (5) in one embodiment of a device for compression anastomosis.
  • FIG. 2 corresponds to a cross-section of a male coupling (4) and a female coupling (5) when they are already coupled in an embodiment of a device for compression anastomosis, forming areas of total ischemia (A), partial ischemia ( B) and non ischemia (C).
  • A total ischemia
  • B partial ischemia
  • C non ischemia
  • FIG. 3 corresponds to a detailed view of a procedure of anastomosis of the esophagus of a newborn, showing a modality of a device for compression anastomosis, and a mechanism for positioning and connecting the device.
  • FIG. 4 corresponds to a side view of an embodiment of the mechanism for positioning and connecting a compression anastomosis device having malleable stems.
  • FIG. 5 corresponds to an embodiment of the mechanism for positioning and connecting a compression anastomosis device where the stems of the mechanism for positioning and connecting a compression anastomosis device are arranged inside sleeves.
  • FIG. 6 corresponds to a modality of the mechanism for positioning and connecting a compression anastomosis device that has rigid stems.
  • the present invention corresponds to a device for compression anastomosis (hereinafter device), and a mechanism for positioning and connecting a device for compression anastomosis (hereinafter mechanism).
  • the device for compression anastomosis comprising:
  • proximal means a near point according to a reference.
  • distal means a remote point according to a reference.
  • a tubular organ eg esophagus, intestines, stomach, etc.
  • the head is taken as a reference, with the points closest to the head being proximal and the points away from the head being distal.
  • the device serves to make the compression anastomosis of a duct (1) which can be a tubular organ (e.g. esophagus, intestines, stomach, etc.), or a synthetic duct (e.g. hoses, ducts, etc.).
  • a duct which can be a tubular organ (e.g. esophagus, intestines, stomach, etc.), or a synthetic duct (e.g. hoses, ducts, etc.).
  • the conduit (1) has a proximal connection (2), a distal connection (3) and a wide gap that separates the proximal connection (2) and the distal connection (3).
  • a gap is an irregular breakage or opening between two objects.
  • the proximal connection (2) of the conduit (1) is connected to the distal end of the female coupling (5), and the proximal end of the male coupling (4) is connected to a distal connection (3) of the duct (1).
  • the proximal connection (2) is communicated with the distal connection (3) of the conduit (1), thus closing the wide gap that separates the proximal connection (2) and the distal connection (3).
  • the male coupling (4) consists of two parts along its longitudinal axis.
  • the first part (8) of the male coupling (4) consists of a cylindrical section located at the distal end of the male coupling (4)
  • the second part (9) of the male coupling (4) consists of a conical protuberance (7) that extends axially from the first part, between the medial and proximal region of the male coupling (4).
  • the male coupling (4) has as its only section a conical protuberance (7).
  • the first part (8) of the male coupling (4) the cylindrical section may have a length between 3mm and 10mm, between 3mm and 4mm, between 5mm and 6mm, between 7mm and 8mm, between 8mm and 9mm.
  • the second part (9) of the male coupling (4) the conical protuberance (7) can have a length between 3mm and 10mm, between 3mm and 4mm, between 5mm and 6mm, between 7mm and 8mm, between 8mm and 9mm.
  • the cone angle of the conical protrusion (7) of the male coupling (4) may be 5 or 30 °, between 5 ° and 10 °, between 10 ° and 15 °, between 15 ° and 20 °, between 20 ° and 25 °, between 25 ° and 30 °.
  • the external diameter of the male coupling (4) can be between 4mm and 30mm, between 4mm and 6mm, between 6mm and 8mm, between 8mm and 12mm, between 12mm and 15mm, between 15mm and 18mm, between 18mm and 20mm.
  • the conical protuberance (7) of the male coupling (4) has a stepped outer surface (10).
  • stepped form is a change of section on a surface.
  • a stepped shape may be a 90 ° section change; a section change with groove with chamfer-shaped edges; a spike-shaped section change; a change of section in circular form; a change of section in semicircular form and combinations of the previous ones.
  • a spike shape can be a triangular, or trapezoidal section with angles less than 90 °.
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) when connected to the through conical housing (6) of the female coupling (5) forms a bolt coupling system and tube that uses an interference fit.
  • the bolt and tube coupling system uses friction between two parts without the use of an additional fixing element.
  • the stepped shape (10) favors the bolt and tube coupling system.
  • the steps of the stepped surface (10) are deformed plastically, and thus, strengthen the interference fit of the conical protuberance (7) and the conical through housing (6).
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a spike shape.
  • the spike shape is the shape where more plastic deformation is achieved in the steps, which improves the coupling between the male coupling (4) and the female coupling (5)
  • the stepped form (10) of the conical protuberance (7) of the male coupling (4) has a step located at its proximal end.
  • the stepped form (10) of the conical protuberance (7) of the male coupling (4) has two steps.
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has between three and five steps.
  • ischemia pressure is the force necessary to obstruct blood flow through tissue.
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a circular section change.
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a semicircular section change.
  • the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a groove section change with chamfered edges.
  • the circular, semicircular and chamfered edges in the stepped form (10) have the purpose of facilitating the force that must be applied to couple the male coupling (4) and the female coupling (5).
  • the stepped form (10) of the conical protuberance (7) of the male coupling (4) has four steps.
  • One step has a semicircular section and the others have a triangular section.
  • the step with semicircular section is located at the proximal end of the male coupling (4).
  • the step with semicircular section in the proximal end allows to reduce the force necessary to couple the male coupling (4) to the female coupling (5).
  • the remaining three steps They will have a spike shape and will give more resistance so that the male coupling does not separate
  • the edges of the male coupling (4) and the female coupling (5) are rounded and / or chamfered.
  • Roundings and chamfers are used to reduce the risk of perforation or laceration to the tubular organ.
  • the female coupling (5) is cylindrical in shape.
  • the cylindrical shape makes it easier to insert and move the female coupling (5) into the duct (1).
  • the external diameter of the female coupling (5) can be between 5mm and 30mm, between 5mm and 8mm, between 8mm and 12mm, between 12mm and 15mm, between 15m and 18mm, between 18mm and 25mm, between 25mm and 30mm.
  • the female coupling (5) has a conical through housing (6).
  • the angle of taper of the conical housing of the female coupling (5) may be between 6 and 35 °, between 6 and 12 °, between 12 ° and 17 °, between 18 ° and 22 °, between 22 ° and 28 °, between 28 ° and 35 °.
  • the through conical housing (6) the female coupling (5) has a rough internal surface.
  • the through conical housing (6) the female coupling (5) has concentric grooves axially distributed on its inner surface.
  • the through conical housing (6) the female coupling (5) has concentric grooves axially distributed on its inner surface.
  • the conical protuberance (7) of the male coupling (4) has a smooth surface.
  • the shape of the internal surface with grooves of the conical through housing (6) of the female coupling (5), as well as the stepped shape (10) serve to improve the interference fit.
  • the conical angle of the conical protuberance (7) of the male coupling (4) is not the same, as the conic angle of the through conical housing (6) of the female coupling (5).
  • the difference in these conicity angles generates a contact pressure gradient between the male coupling (4) and the coupling female (5) over the duct (1).
  • the contact pressure gradient decreases in the distal direction of the duct (1).
  • the contact pressure gradient that occurs at the proximal end of the male coupling (4) and at the distal end of the Female coupling (5) generates in the duct tissue (1) a total ischemia (A).
  • Ischemia (C) is not generated in the distal region of the male coupling (4) and proximal of the female coupling (5).
  • the contact pressure is sufficient to achieve total ischemia (A).
  • Total ischemia (A) cuts off the blood flow to this area of the duct (1), which occurs after approximately eight hours, tissue necrosis.
  • the contact pressure is sufficient to achieve a partial ischemia (B).
  • partial ischemia (B) a process of scarring and tissue sealing is promoted, and therefore the union of the proximal connection (2) with the distal connection (3) of the duct (1).
  • the female coupling (5) and the male coupling (4) are made of a biocompatible material.
  • biocompatible material shall be understood as a material that complies with ISO-10993: "Biological Evaluation of Medical Devices”.
  • Some materials are: Polyaryl ether ketone (PAEK), polyether ether ketone (PEEK), high density polyethylene (HDPE), Ultra High Molecular Weight Polyethylene (UHMWPE), polymethylmethacrylate (PMMA), Polysulfones (PSU), Polyetherimide (PEI), polyphenylsulfone (PPSU) and polyphenylene sulfide (PPS, for its acronym in English) its acronym in English), Commercially Pure Titanium (ASTM F67), Titanium alloys ASTM B265 (standard specification of titanium and titanium in the form of a band, sheet and plate) and AISI 316L Stainless Steel, Acrylonitrile butadiene styrene (ABS) in English) medical grade, polycarbonate, polyamide, polyester, polyvinylchloride (PVC), absorbable materials such as polyprop
  • the male coupling (4) and the female coupling (5) are made of Acrylonitrile Butadiene Styrene (ABS), or an acrylic material.
  • ABS Acrylonitrile Butadiene Styrene
  • the male coupling (4) and the female coupling (5) can be manufactured by 3D printing, preferably high definition, or rapid prototyping.
  • the material of the male coupling (4) and the female coupling (5) is selected from PAEK, PEEK, Polysulfones (PSU), Polyetherimide (PEI). ), polyphenylsulfone (PPSU) and polyphenylene sulfide (PPS).
  • the male coupling (4) and the female coupling (5) can be manufactured by plastic injection, machining (eg milling, turning), die cutting, molding (e.g. broken molding) and combinations of the above
  • the female coupling (5) has a first magnet (11) located in its proximal region.
  • the male coupling (4) has a second magnet (12) located in its medial region.
  • the first magnet (11) and the second magnet (12) have opposite polarity, thus, the magnets generate a force that attracts the male coupling (4) to the female coupling (5).
  • the first magnet (11) of the female coupling (5) and the second magnet (12) of the male coupling (4) are in the form of a washer.
  • the male coupling (4) and the female coupling (5) are made of a magnetizable material.
  • the male coupling (4) and the female coupling (5) are magnetized with opposite polarities to generate attraction between them.
  • the male coupling (4) and the coupling Female (5) can be made of ferromagnetic stainless steel, magnetizable titanium, and magnetizable biocompatible materials.
  • the first magnet (11) of the male coupling (4) and the second magnet (12) of the female coupling (5) are selected from alnico, flexible, ceramic, super magnets, earth magnets rare, temporary magnets and natural magnets.
  • the male coupling (4) and the female coupling (5) have a heating means.
  • the heating medium increases the temperature of the male coupling (4) and the female coupling (5) when the proximal connection (2) and the distal connection (3) are found.
  • the heating of the male coupling (4) and the female coupling (5) melts the ends of the proximal connection (2) and the distal connection (3).
  • the melted ends of the proximal connection (2) and the distal connection (3) are joined by fusion.
  • fusion fusion will be understood when similar or different materials are heated so that a physical and / or chemical bond between said materials occurs.
  • the heating means may be an electrical resistor, inductors, graphite electrodes and a combination thereof.
  • an eyelet is located at the proximal end of the female coupling (5), a thread is connected to the eyelet.
  • the wire extends from the female coupling (5) to the proximal mouth of the duct (1).
  • the thread allows the female coupling (5) and the male coupling (4) to be recovered after the anastomosis of the duct, pulling the thread and removing both parts through the proximal mouth of the duct (1).
  • the first rod (14) pushes in the distal direction the female coupling (5) in the middle of the proximal connection (2)
  • the second rod (15) pushes in the proximal direction the male coupling (4) in the middle of the distal connection (3) thus connecting the male coupling (4) and the female coupling (5).
  • the first rod (14) and the second rod (15) are malleable.
  • the malleable stems serve to give better control of the male coupling (4) and female coupling (5) and are better molded to the tubular organs.
  • a malleable rod is a cylinder, wire or bar with a rigidity that allows it to be folded with the hands.
  • the conduit (1) is an esophagus, a bowel, colon, or stomach.
  • the proximal connection (2) belongs to a section of the conduit (1) comprised from the wide gap to the mouth of the proximal end.
  • the mouth of the proximal end of the canal (1) may be the mouth of a person.
  • the distal connection (3) belongs to a section of the duct (1) comprised from the wide gap to the incision of the distal end.
  • the mouth of the distal end may be an incision in the stomach of the person.
  • the first rod (14) is connected to the female coupling (5) at the distal end of the first rod (14).
  • the second rod (15) is connected to the male coupling (4) at the proximal end of the second rod (15).
  • the first rod (14) pushes the female coupling (5) through the duct (1), from the duct mouth (1) to the proximal connection (2) where the gap is located.
  • the second rod (15) pushes the male coupling (4) through the duct (1), from the incision in the stomach to the distal connection (3), where the gap is located.
  • the first rod (14) and the second rod (15) exert a force that plastically deforms the conical protuberance (7) of the male coupling (4) against the through conical housing (6) of the female coupling (5), and in turn generates the pressure gradient described above, thereby completing the anastomosis of the duct (1).
  • a first guide (16) is inserted at the distal end of the first rod (14) which is inserted into the through conical housing (6) of the female coupling (5) ; and at the proximal end of the second rod (15) is located a second guide (17) that is inserted into the through hole (29) of the male coupling (4).
  • the female coupling (5) is connected to the first rod (14) by means of an adhesive (18).
  • the second rod (15) is connected by means of an adhesive (18) to the male coupling (4).
  • the adhesive (18) must be soft, for example, a pressure sensitive adhesive.
  • the adhesives can be acrylics (Ethyl Cyanoacrylate, Alkoxyethyl Cyanoacrylate, polyacrylates), epoxides, polyurethanes, hydrogels, silicone gel, silicone, modified and anaerobic silanes, phenolic resin adhesives, polyamides, heat cured rubber adhesives, unsaturated polyester , hotmelts, solvent based adhesives, water based adhesives, contact adhesives, dispersion adhesives, plastisol adhesives, pressure adhesives (PSA) and adhesive waxes.
  • acrylics Ethyl Cyanoacrylate, Alkoxyethyl Cyanoacrylate, polyacrylates
  • epoxides polyurethanes
  • hydrogels silicone gel
  • silicone modified and anaerobic silanes
  • phenolic resin adhesives polyamides
  • heat cured rubber adhesives unsaturated polyester
  • hotmelts solvent based adhesives
  • solvent based adhesives water based adhesives
  • contact adhesives dis
  • the first rod (14) has a plunger (19) at the distal end.
  • the second rod (15) has a plunger (19) at the proximal end.
  • a plunger is a piece that moves inside a duct and serves to facilitate the thrust of an object.
  • the piston (19) of each rod has a paraboloid shape.
  • Each paraboloid has its vertex pointed towards the medial zone of the stem where the plunger (19) is located.
  • the paraboloid has a flat face opposite its vertex.
  • the first cylindrical guide (16) protrudes from the flat face of the piston (19) of the first rod (14).
  • the second cylindrical guide (17) protrudes from the flat face of the plunger (19) of the second rod (15).
  • the plunger (19) is cylindrical in shape.
  • the plunger (19) may have a circular, oval, elliptical, oblong and cross-sectional cross-section.
  • the plunger (19) and the first rod (14) are two different parts.
  • the piston (19) and the second rod (15) are two different pieces.
  • the plunger (19) and the first rod (14) are joined by welding.
  • the piston (19) and the second rod (15) are joined by welding
  • the piston (19) and the first rod (14) can be joined by adhesives, threaded fasteners (e.g. bolts, screws, prisoners and studs), rivets, nails, by interference.
  • the piston (19) and the second rod (15) can be joined by the same means.
  • a plunger (19) and the first rod (14) form a monolithic body.
  • a plunger (19) and the second rod (15) form a monolithic body.
  • the first rod (14) has a plunger (19) at the distal end.
  • the plunger (19) is connected by means of an adhesive (18) at its distal end with the female coupling (5).
  • the second rod (15) has a plunger (19) at the proximal end.
  • the plunger (19) is connected by means of an adhesive (18) at its proximal end with the male coupling (4).
  • the first rod (14) has a plunger (19) at the distal end. From the piston (19) the first cylindrical guide (16) of the first rod (14) protrudes at the distal end.
  • the first cylindrical guide (16) of the first rod (14) is connected to the female coupling (5).
  • the second rod (15) has a plunger (19) at the proximal end. From the piston (19) a second cylindrical guide (17) of the second rod (15) protrudes at the proximal end. The second cylindrical guide (17) of the second rod (15) is connected to the male coupling (4).
  • first cylindrical guide (16) of the first rod (14) is rigid.
  • second cylindrical guide (17) of the second rod (15) is rigid.
  • first cylindrical guide (16) of the first rod (14) is malleable.
  • second cylindrical guide (17) of the second rod (15) is malleable
  • the first cylindrical guide (16) and the second cylindrical guide (17) have a diameter smaller than the internal diameter of the through hole (29) of the male coupling (4) and the smaller diameter of the through conical coupling (6) of the female coupling (5).
  • the diameter of the first cylindrical guide (16) and the diameter of the second cylindrical guide (17) have a tolerance that results in an interference fit.
  • the tolerance of the diameters of the first cylindrical guide (16) and the second cylindrical guide (17) can be, for example, from -0.06 mm and +0 mm for diameters from 0 mm to 3 mm, -0.07 mm and +0.001 mm for diameters from 6 mm to 10 mm, -0.08 mm and +0.001 mm for diameters from 6 mm to 10 mm.
  • the first rod (14) can be guided by the tubular organ without the need for a jacket.
  • the second rod (15) can be guided by the tubular organ without the need for a jacket. Referring to FIG. 5, in another embodiment of the invention, the first rod
  • first rod (14) and the second rod (15) have a rectangular section change along the entire longitudinal axis.
  • the change of rectangular section serves to decrease the weight of the first rod (14) and the second rod (15).
  • the change of rectangular section favors the malleability of the first rod (14) and the second rod (15).
  • the first rod (14) has a first support plate (22) located at its proximal end.
  • the second rod (15) has a second support plate (23) located at its distal end.
  • the support plate serves to support the fingers. Also, the support plate facilitates the pushing of the rod through the conduit (1).
  • the first rod (14) has a first end (24) arranged radially, the first end (24) is connected to the female coupling (5), and;
  • the second rod (15) has a first end (25) arranged radially, the first end (25) is connected to the male coupling (4),
  • the second rod (15) is connected to the first rod (14) by means of an axis (26) that is located in the medial zone of each rod;
  • the shaft (26) allows the first rod (14) to move radially with respect to the second rod (15).
  • the first rod (14) and the second rod (15) are rigid.
  • an incision is made near the proximal connection (2) of the duct (1).
  • an incision is made near the distal connection (3) of the duct (1).
  • the incision of the proximal connection (2) serves as input for the first rod (14).
  • the incision of the distal connection (3) serves as an input for the second stem (15).
  • the first rod (14) pushes in the distal direction the female coupling (5) in the middle of the proximal connection (2).
  • the second rod (15) pushes in the proximal direction the male coupling (4) in the middle of the distal connection (3) thus connecting the male coupling (4) and the female coupling (5).
  • the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of an adhesive (18).
  • the second rod (15) is connected to the male coupling (4) at the first end (25) by means of an adhesive (18).
  • the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of an adhesive (18).
  • the second rod (14) is connected to the male coupling (4) at the first distal end (24) by means of the second cylindrical guide (17).
  • the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of the first cylindrical guide (16).
  • the second rod (15) is connected to the male coupling (4) at the first end (25) by means of the second cylindrical guide (17).
  • the use of the first cylindrical guide (16) and the second cylindrical guide (17) serves to have greater control over the male coupling (4) and the female coupling (5).
  • the first rigid rod (14) has a grip handle at the second end (27).
  • the second rigid rod (15) has a grip handle at the second end (28).
  • the first rigid rod (14) has a curved grip handle at its second end (27).
  • the second rigid rod (15) has a curved grip handle at its second end (28).
  • the curved grip handle serves to improve the grip and ergonomics of the first rod (14) and the second rod (15).
  • the curved shape of the grip handle has a semicircular section with a radius greater than 100mm.
  • the curved shape of the grip handle may be a truncated elliptical section, truncated oval, parabolic, conical, truncated, hyperbolic, truncated horseshoe and combinations of the foregoing.
  • the first rigid rod (14) has at its second end (27) a ring for a finger.
  • the second rigid rod (15) has at its second end (28) a ring for one finger. The rings improve the grip and ergonomics of the first rod (14) and the second rod (15).
  • the first rod (14) is formed of:
  • first diagonal section connected to the first prismatic section and located at the opposite end of the first protuberance, where the first diagonal section is the medial region of the first stem (14); Y a first grip handle connected to the first diagonal section, the first grip handle is located at the second end (27) of the first rod (14);
  • the second rod (15) consists of:
  • the second grip handle is located at the second end (28) of the second rod
  • the first rod (14) and the second rod (15) have a hole in their medial region, in the holes a fixing means is provided that secures the first rod (14) and second rod (15 ).
  • the fixing means can be rivets, screws, pins, studs and combinations thereof.
  • the first rigid rod (14) and the second rigid rod (15) can be cylindrical.
  • first rod (14) and the second rod (15) are square, rectangular, triangular, elliptical, polygonal, oblong and combinations of the foregoing.
  • the first rod (14) and the second rod (15) have a length between 10mm and 10mm. Preferably, they have a length between 100mm and 300mm. In one embodiment of the invention, the first rod (14) and the second rod (15) are made of 304 stainless steel.
  • the first rod (14) and the second rod (15) may be of a biocompatible material, for example, 316 stainless steel, 316 Lvm stainless steel, Titanium T ⁇ 6A14V Grade 5, Titanium T ⁇ 6A14V ELI Grade 23.
  • Example 1 Device for compression anastomosis of the esophagus of a newborn and mechanism to position and connect the device.
  • a device for compression anastomosis and a mechanism (13) were designed and constructed to position and connect the device.
  • the device was used for anastomosis of the esophagus of a newborn, the device consisted of the following parts:
  • the mechanism (13) has the following parts:
  • the piston (19), the first rod (14) and the first cylindrical guide (16) form a monolithic body and are made of 304 stainless steel.
  • the piston (19), the second rod (15) and the second cylindrical guide (17) form a monolithic body and are made of 304 stainless steel.
  • Example 2 Mechanism with shirts to position and connect a device for compression anastomosis.
  • Example 3 In the third example the device was used for the anastomosis of a bowel.
  • the separated parts of the intestine are in parallel, the mechanism (13) enters through a small incision that is made to each intestine laterally. Then join them.
  • the mechanism (13) consists of the following parts.
  • the first rigid rod (14) and the first cylindrical guide (15) form a monolithic body and are made of 304 stainless steel.
  • the second rigid rod (14) and the second cylindrical guide (16) form a monolithic body and are made of 304 stainless steel.

Abstract

The invention relates to a compression anastomosis device, and to a mechanism for positioning and connecting the device. The device comprises: a female coupling having a conical through-housing that extends from the distal end to the proximal end, the smaller diameter of the conical through-housing being located towards the proximal end; and a male coupling having a conical protrusion with the greater diameter thereof at the distal end, and including a through-opening that extends from the distal end to the proximal end. The conical protrusion is operatively coupled to the conical through-housing of the female coupling. In turn, the mechanism comprises two flexible rods, one having a distal end connected to the female coupling and the other having a proximal end connected to the male coupling of the device. In addition, the mechanism can be formed by a first rigid rod having a radially disposed first end, wherein the first end is connected to the female coupling, and a second rigid rod having a radially disposed first end, wherein the first end is connected to the male coupling. The second rigid rod is connected to the first rigid rod by means of a shaft located in the medial zone of each rod.

Description

DISPOSITIVO PARA ANASTOMOSIS POR COMPRESIÓN Y MECANISMO PARA POSICIONAR Y CONECTAR EL MISMO  DEVICE FOR COMPRESSION AND MECHANISM ANASTOMOSIS TO POSITION AND CONNECT THE SAME
Campo de la invención Field of the Invention
La presente invención se relaciona con dispositivos para anastomosis de conductos tubulares, y con mecanismos para insertar y conectar dichos dispositivos. Particularmente, la presente invención se relaciona con dispositivos para anastomosis de órganos tubulares, tales como, esófago, estómago, e intestinos. The present invention relates to devices for anastomosis of tubular ducts, and with mechanisms for inserting and connecting said devices. Particularly, the present invention relates to devices for anastomosis of tubular organs, such as, esophagus, stomach, and intestines.
Descripción del estado de la técnica Description of the state of the art
El estado de la técnica divulga dispositivos para anastomosis de estructuras anatómicas huecas, tales como intestinos, estómago y esófago, como por ejemplo los divulgados en los documentos US 8,709,025 B2 y US 6,030,392. The prior art discloses devices for anastomosis of hollow anatomical structures, such as intestines, stomach and esophagus, such as those disclosed in US 8,709,025 B2 and US 6,030,392.
El documento US 8,709,025 B2 divulga un dispositivo para anastomosis de órganos tubulares, como intestinos, estómago, esófago, etc., en donde el órgano tubular al cual se le quiere hacer la anastomosis tiene dos extremos separados por una brecha. El dispositivo comprende un anillo interno y un anillo externo, el anillo externo es de un material elástico; en donde cada anillo es cosido a un extremo de órgano tubular separado. Los extremos de cada órgano tubular separado se cosen a la superficie exterior de un anillo. Para la anastomosis, el anillo externo rodea el órgano tubular, luego se voltean el anillo externo y el extremo del órgano tubular al cual está cosido, de manera que el órgano tubular quede conectado dentro del anillo externo. Luego, el anillo externo y el anillo interno, y la adventicia de los extremos de órgano tubular pegados a los anillos son ensamblados. El anillo interno tiene una porción superior usada para la anastomosis, una sección media usada para conexión, y una sección baj a usada para inserción. El diámetro de la sección media es menor que el diámetro de la sección baja, y la sección superior. El anillo externo tiene en su periferia agujeros en los cuales se ancla la sutura al pegar una sección de órgano tubular. US 8,709,025 B2 discloses a device for anastomosis of tubular organs, such as intestines, stomach, esophagus, etc., wherein the tubular organ to which the anastomosis is to be made has two ends separated by a gap. The device comprises an inner ring and an outer ring, the outer ring is made of an elastic material; wherein each ring is sewn to a separate tubular organ end. The ends of each separate tubular organ are sewn to the outer surface of a ring. For the anastomosis, the outer ring surrounds the tubular organ, then the outer ring and the end of the tubular organ to which it is sewn are turned so that the tubular organ is connected within the outer ring. Then, the outer ring and the inner ring, and the adventitia of the ends of the tubular organ attached to the rings are assembled. The inner ring has an upper portion used for anastomosis, a middle section used for connection, and a low section used for insertion. The diameter of the middle section is smaller than the diameter of the lower section, and the upper section. He The outer ring has holes in its periphery in which the suture is anchored by gluing a section of tubular organ.
También, el anillo externo tiene un anillo prominente hacia el centro. El anillo prominente se acopla con la sección media del anillo interno. Además, la sección baja del anillo interno usada para inserción incluye barbas que evitan que los anillos interior y exterior se separen luego de haber sido conectados. El documento divulga, que luego de la anastomosis, el anillo interno y el anillo externo se desacoplan del órgano tubular en aproximadamente diez días. En anastomosis de intestinos, los anillos son evacuados por el ano del paciente. Also, the outer ring has a prominent ring towards the center. The prominent ring is coupled with the middle section of the inner ring. In addition, the lower section of the inner ring used for insertion includes beards that prevent the inner and outer rings from separating after they have been connected. The document discloses that after the anastomosis, the inner ring and the outer ring are decoupled from the tubular organ in approximately ten days. In bowel anastomosis, the rings are evacuated through the patient's anus.
El documento US 8,709,025 B2 requiere una operación invasiva para ser instalado, por ejemplo, en el caso de una anastomosis de un esófago se lleva a cabo alrededor del esófago en el cual se encuentran la glándula tiroidea, la arteria carótida, las cuerdas vocales y la tráquea, las cuales deben ser manipuladas para ejecutar la anastomosis. US 8,709,025 B2 requires an invasive operation to be installed, for example, in the case of an anastomosis of an esophagus, it is carried out around the esophagus in which the thyroid gland, the carotid artery, the vocal cords and the trachea, which must be manipulated to execute the anastomosis.
Por otro lado, el documento US 2009/0012543 Al divulga un dispositivo para anastomosis de dos partes de vasos sanguíneos, o para anastomosis de dos partes de órganos tubulares. El dispositivo incluye una primera unidad acoplable y segunda unidad acoplable. Cada unidad se conecta a una parte del vaso sanguíneo, además, las unidades acoplables se conectan entre sí. Cada unidad acoplable tiene un agujero pasante que define un eje longitudinal. Adicionalmente, cada unidad tiene una unidad receptora que agarra el vaso sanguíneo, la unidad receptora incluye una superficie con proyecciones filosas que penetran las paredes del vaso sanguíneo sin traspasarlo. On the other hand, document US 2009/0012543 Al discloses a device for anastomosis of two parts of blood vessels, or for anastomosis of two parts of tubular organs. The device includes a first attachable unit and a second attachable unit. Each unit is connected to a part of the blood vessel, in addition, the attachable units are connected to each other. Each attachable unit has a through hole that defines a longitudinal axis. Additionally, each unit has a receiving unit that grabs the blood vessel, the receiving unit includes a surface with sharp projections that penetrate the walls of the blood vessel without piercing it.
También, el documento indica que las unidades acoplables se fabrican preferiblemente en titanio o en otro material parcialmente, o completamente reabsorbible. La primera unidad acoplable es cilindrica, y tiene una sección trasera, y una sección frontal de un diámetro mayor que la sección trasera. En la cara interna de la sección trasera se dispone la superficie con proyecciones filosas. Para conectar las unidades acoplables entre sí, se disponen extensiones axiales en la primera unidad, por ejemplo, lengüetas. Por su parte, la segunda unidad, también es cilindrica, y tiene en su borde frontal, guías en las cuales se insertan las extensiones axiales de la primera unidad. Also, the document indicates that the attachable units are preferably manufactured in titanium or in another partially or completely resorbable material. The first attachable unit is cylindrical, and has a rear section, and a front section of a diameter larger than the rear section. The surface with sharp projections is arranged on the inside of the rear section. To connect the attachable units to each other, axial extensions are arranged in the first unit, for example, tabs. For its part, The second unit is also cylindrical, and has at its front edge, guides in which the axial extensions of the first unit are inserted.
Con base en lo anterior, se puede notar que el dispositivo del documento US 2009/0012543 para anastomosis de órganos tubulares es instalado mediante una operación invasiva. Por otro lado, al penetrar las paredes del órgano tubular, existe el riesgo que las paredes se debiliten y generen una lesión en el órgano. En el caso que el órgano es un intestino, la lesión en la pared del intestino puede llegar a transformarse en una isquemia intestinal y más adelante en una peritonitis. Based on the foregoing, it can be noted that the device of US 2009/0012543 for anastomosis of tubular organs is installed by an invasive operation. On the other hand, when penetrating the walls of the tubular organ, there is a risk that the walls will weaken and cause an injury to the organ. In the case that the organ is a intestine, the lesion in the wall of the intestine can become an intestinal ischemia and later a peritonitis.
Por lo tanto, el estado de la técnica divulga dispositivos para anastomosis de órganos tubulares que necesitan operaciones invasivas, por ejemplo en el caso de anastomosis de esófago, en donde se hacen incisiones en el cuello y deben abrirse paso entre partes anatómicas importantes, como la glándula tiroidea, la arteria yugular, cuerdas vocales, y la tráquea para hacer la anastomosis de esófago. Además, necesitan ser unidos a las paredes de los órganos tubulares mediante suturas o proyecciones filosas que pueden debilitar dichas paredes. Therefore, the state of the art discloses devices for anastomosis of tubular organs that need invasive operations, for example in the case of an esophageal anastomosis, where incisions are made in the neck and must make their way between important anatomical parts, such as the Thyroid gland, jugular artery, vocal cords, and trachea to make the anastomosis of the esophagus. In addition, they need to be attached to the walls of the tubular organs by sutures or sharp projections that can weaken said walls.
Breve descripción de la invención Brief Description of the Invention
La presente invención corresponde a un dispositivo para anastomosis por compresión, y a un mecanismo para posicionar y conectar el dispositivo. El dispositivo comprende un acople hembra con un alojamiento cónico pasante que comunica su extremo distal con su extremo proximal, donde el diámetro menor del alojamiento cónico pasante se ubica hacia el extremo proximal; y un acople macho con una protuberancia cónica, que tiene su diámetro mayor en el extremo distal, y que incluye una perforación pasante que comunica su extremo distal con su extremo proximal. La protuberancia cónica se acopla operacionalmente al alojamiento cónico pasante del acople hembra. Por su parte, el mecanismo comprende a dos vástagos maleables uno con un extremo distal conectado al acople hembra y el otro con un extremo proximal conectado al acople macho del dispositivo. También, el mecanismo puede conformarse del primer vástago rígido con un primer extremo dispuesto radialmente, el primer extremo se conecta al acople hembra, y el segundo vástago rígido con un primer extremo dispuesto radialmente, el primer extremo se conecta al acople macho. El segundo vástago rígido se conecta al primer vástago rígido mediante un eje que se ubica en la zona medial de cada vástago. En una modalidad de la invención, el mecanismo y el dispositivo permiten hacer la anastomosis de un esófago de un neonato introduciendo uno de los acoples con uno de los vástagos maleables a través de la boca del neonato, e introduciendo el otro acople con el otro vástago a través de una incisión hecha en el estómago del neonato, así, evitando hacer incisiones invasivas en el cuello y tórax. The present invention corresponds to a device for compression anastomosis, and a mechanism for positioning and connecting the device. The device comprises a female coupling with a through conical housing that communicates its distal end with its proximal end, where the smaller diameter of the through conical housing is located towards the proximal end; and a male coupling with a conical protuberance, which has its largest diameter at the distal end, and which includes a through hole that communicates its distal end with its proximal end. The conical protuberance is operatively coupled to the through conical housing of the female coupling. For its part, the mechanism comprises two malleable stems one with a distal end connected to the female coupling and the other with a proximal end connected to the male coupling of the device. Also, the mechanism can conform to the first rigid rod with a first radially arranged end, the first end is connected to the female coupling, and the second rigid rod with a first radially arranged end, the first end is connected to the male coupling. The second rigid rod is connected to the first rigid rod by means of an axis that is located in the medial zone of each rod. In one embodiment of the invention, the mechanism and the device make it possible to make the anastomosis of an esophagus of a neonate by introducing one of the couplings with one of the malleable stems through the mouth of the neonate, and introducing the other coupling with the other stem through an incision made in the stomach of the neonate, thus, avoiding making invasive incisions in the neck and thorax.
Breve descripción de las figuras Brief description of the figures
La FIG.1 corresponde a un corte transversal de un acople macho (4) y un acople hembra (5) en una modalidad de un dispositivo para anastomosis por compresión. FIG. 1 corresponds to a cross-section of a male coupling (4) and a female coupling (5) in one embodiment of a device for compression anastomosis.
La FIG.2 corresponde a un corte transversal de un acople macho (4) y un acople hembra (5) cuando ya están acoplados en una modalidad de un dispositivo para anastomosis por compresión, formando áreas de isquemia total (A), isquemia parcial (B)y no isquemia (C). FIG. 2 corresponds to a cross-section of a male coupling (4) and a female coupling (5) when they are already coupled in an embodiment of a device for compression anastomosis, forming areas of total ischemia (A), partial ischemia ( B) and non ischemia (C).
La FIG.3 corresponde a vista de detalle de un procedimiento de anastomosis del esófago de un neonato, mostrando una modalidad de un dispositivo para anastomosis por compresión, y un mecanismo para posicionar y conectar el dispositivo. FIG. 3 corresponds to a detailed view of a procedure of anastomosis of the esophagus of a newborn, showing a modality of a device for compression anastomosis, and a mechanism for positioning and connecting the device.
La FIG.4 corresponde a una vista lateral de una modalidad del mecanismo para posicionar y conectar un dispositivo de anastomosis por compresión que tiene vástagos maleables. La FIG.5 corresponde a una modalidad del mecanismo para posicionar y conectar un dispositivo de anastomosis por compresión donde los vástagos del mecanismo para posicionar y conectar un dispositivo de anastomosis por compresión se disponen dentro de camisas. FIG. 4 corresponds to a side view of an embodiment of the mechanism for positioning and connecting a compression anastomosis device having malleable stems. FIG. 5 corresponds to an embodiment of the mechanism for positioning and connecting a compression anastomosis device where the stems of the mechanism for positioning and connecting a compression anastomosis device are arranged inside sleeves.
La FIG.6 corresponde a una modalidad del mecanismo para posicionar y conectar un dispositivo de anastomosis por compresión que tiene vástagos rígidos. FIG. 6 corresponds to a modality of the mechanism for positioning and connecting a compression anastomosis device that has rigid stems.
Descripción detallada La presente invención corresponde a un dispositivo para anastomosis por compresión (en adelante dispositivo), y un mecanismo para posicionar y conectar un dispositivo para anastomosis por compresión (en adelante mecanismo). Detailed description The present invention corresponds to a device for compression anastomosis (hereinafter device), and a mechanism for positioning and connecting a device for compression anastomosis (hereinafter mechanism).
Haciendo referencia a la FIG. l, el dispositivo para anastomosis por compresión, que comprende: Referring to FIG. l, the device for compression anastomosis, comprising:
un acople hembra (5) con un alojamiento cónico pasante (6) que comunica su extremo distal con su extremo proximal, donde el diámetro menor del alojamiento cónico pasante (6) se ubica hacia el extremo proximal; y un acople macho (4) con una protuberancia cónica (7), que tiene su diámetro mayor en el extremo distal, y que incluye una perforación pasante a female coupling (5) with a through conical housing (6) that communicates its distal end with its proximal end, where the smaller diameter of the through conical housing (6) is located towards the proximal end; and a male coupling (4) with a conical protuberance (7), which has its largest diameter at the distal end, and which includes a through hole
(29) que comunica su extremo distal con su extremo proximal; (29) that communicates its distal end with its proximal end;
donde la protuberancia cónica del acople macho (4) se acopla operacionalmente al alojamiento cónico pasante (6) del acople hembra (5). La perforación pasante (29) sirve para permitir el paso de sólidos y fluidos (v.g. aire, fluidos corporales, alimentos, heces y combinaciones de los anteriores). Para efectos de interpretación de la presente invención, proximal significa un punto cercano de acuerdo a una referencia. Del mismo modo, distal significa un punto alejado de acuerdo a una referencia. Por ejemplo, en el caso de la anastomosis de un órgano tubular (v.g. esófago, intestinos, estómago, etc.), se toma como referencia la cabeza, siendo proximales los puntos más cercanos a la cabeza y distales los puntos alejados de la cabeza. where the conical protuberance of the male coupling (4) is operatively coupled to the through conical housing (6) of the female coupling (5). The through hole (29) serves to allow the passage of solids and fluids (eg air, body fluids, food, feces and combinations of the above). For purposes of interpretation of the present invention, proximal means a near point according to a reference. Similarly, distal means a remote point according to a reference. For example, in the case of anastomosis of a tubular organ (eg esophagus, intestines, stomach, etc.), the head is taken as a reference, with the points closest to the head being proximal and the points away from the head being distal.
El dispositivo sirve para hacer la anastomosis por compresión de un conducto (1) que puede ser, un órgano tubular (v.g. esófago, intestinos, estómago, etc.), o un conducto sintético (v.g. mangueras, ductos, etc.). The device serves to make the compression anastomosis of a duct (1) which can be a tubular organ (e.g. esophagus, intestines, stomach, etc.), or a synthetic duct (e.g. hoses, ducts, etc.).
El conducto (1) tiene una conexión proximal (2), una conexión distal (3) y una brecha ancha que separa la conexión proximal (2) y la conexión distal (3). The conduit (1) has a proximal connection (2), a distal connection (3) and a wide gap that separates the proximal connection (2) and the distal connection (3).
Se entenderá para efectos de interpretación que una brecha es una rotura o abertura irregular entre dos objetos. It will be understood for purposes of interpretation that a gap is an irregular breakage or opening between two objects.
Haciendo referencia a la FIG. l y al FIG.2, la conexión proximal (2) del conducto (1) se conecta con el extremo distal del acople hembra (5), y el extremo proximal del acople macho (4) se conecta a una conexión distal (3) del conducto (1). Al conectar el acople hembra (5) y el acople macho (4) se comunica la conexión proximal (2) con la conexión distal (3) del conducto (1), cerrando así la brecha ancha que separa la conexión proximal (2) y la conexión distal (3). Referring to FIG. l and FIG. 2, the proximal connection (2) of the conduit (1) is connected to the distal end of the female coupling (5), and the proximal end of the male coupling (4) is connected to a distal connection (3) of the duct (1). When connecting the female coupling (5) and the male coupling (4), the proximal connection (2) is communicated with the distal connection (3) of the conduit (1), thus closing the wide gap that separates the proximal connection (2) and the distal connection (3).
En la modalidad preferida de la invención, el acople macho (4) consta de dos partes a lo largo de su eje longitudinal. La primera parte (8) del acople macho (4) consta una sección cilindrica ubicada en el extremo distal del acople macho (4), la segunda parte (9) del acople macho (4) consta de una protuberancia cónica (7) que se extiende axialmente desde la primera parte, entre la región medial y proximal del acople macho (4). In the preferred embodiment of the invention, the male coupling (4) consists of two parts along its longitudinal axis. The first part (8) of the male coupling (4) consists of a cylindrical section located at the distal end of the male coupling (4), the second part (9) of the male coupling (4) consists of a conical protuberance (7) that extends axially from the first part, between the medial and proximal region of the male coupling (4).
En otra modalidad de la invención, el acople macho (4) tiene como única sección una protuberancia cónica (7). In another embodiment of the invention, the male coupling (4) has as its only section a conical protuberance (7).
En modalidades preferidas de la invención, la primera parte (8) del acople macho (4) la sección cilindrica puede tener longitud entre 3mm y 10mm, entre 3mm y 4mm, entre 5mm y 6mm, entre 7mm y 8mm, entre 8mm y 9mm. Del mismo modo, la segunda parte (9) del acople macho (4) la protuberancia cónica (7) puede tener longitud entre 3mm y 10mm, entre 3mm y 4mm, entre 5mm y 6mm, entre 7mm y 8mm, entre 8mm y 9mm. In preferred embodiments of the invention, the first part (8) of the male coupling (4) the cylindrical section may have a length between 3mm and 10mm, between 3mm and 4mm, between 5mm and 6mm, between 7mm and 8mm, between 8mm and 9mm. Similarly, the second part (9) of the male coupling (4) the conical protuberance (7) can have a length between 3mm and 10mm, between 3mm and 4mm, between 5mm and 6mm, between 7mm and 8mm, between 8mm and 9mm.
En una modalidad de la invención, el ángulo de conicidad de la protuberancia cónica (7) del acople macho (4) puede ser entre 5o y 30°, entre 5o y 10°, entre 10° y 15°, entre 15° y 20°, entre 20° y 25°, entre 25° y 30°. El diámetro externo del acople macho (4) puede ser entre 4mm y 30mm, entre 4mm y 6mm, entre 6mm y 8mm, entre 8mm y 12mm, entre 12mm y 15mm, entre 15mm y 18mm, entre 18mm y 20mm. In one embodiment of the invention, the cone angle of the conical protrusion (7) of the male coupling (4) may be 5 or 30 °, between 5 ° and 10 °, between 10 ° and 15 °, between 15 ° and 20 °, between 20 ° and 25 °, between 25 ° and 30 °. The external diameter of the male coupling (4) can be between 4mm and 30mm, between 4mm and 6mm, between 6mm and 8mm, between 8mm and 12mm, between 12mm and 15mm, between 15mm and 18mm, between 18mm and 20mm.
Haciendo referencia a la FIG.2, en una modalidad de la invención, la protuberancia cónica (7) del acople macho (4) tiene una superficie externa escalonada (10). Referring to FIG. 2, in one embodiment of the invention, the conical protuberance (7) of the male coupling (4) has a stepped outer surface (10).
Se entenderá en la presente invención que forma escalonada es un cambio de sección en una superficie. Una forma escalonada puede ser un cambio de sección a 90°; un cambio de sección con ranura con bordes en forma de chaflán; un cambio de sección con forma de espiga; un cambio de sección en forma circular; un cambio de sección en forma semicircular y combinaciones de los anteriores. Por ejemplo, una forma de espiga, puede ser una sección triangular, o trapezoidal con ángulos menores a 90 °. Haciendo referencia a la FIG.2, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) al conectarse con el alojamiento cónico pasante (6) del acople hembra (5) forma un sistema de acoplamiento perno y tubo que utiliza un ajuste de interferencia. El sistema de acoplamiento perno y tubo usa la fricción entre dos partes sin el uso de un elemento de fijación adicional. It will be understood in the present invention that stepped form is a change of section on a surface. A stepped shape may be a 90 ° section change; a section change with groove with chamfer-shaped edges; a spike-shaped section change; a change of section in circular form; a change of section in semicircular form and combinations of the previous ones. For example, a spike shape can be a triangular, or trapezoidal section with angles less than 90 °. Referring to FIG. 2, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) when connected to the through conical housing (6) of the female coupling (5) forms a bolt coupling system and tube that uses an interference fit. The bolt and tube coupling system uses friction between two parts without the use of an additional fixing element.
La forma escalonada (10) favorece el sistema de acoplamiento perno y tubo. Los escalones de la superficie escalonada (10) se deforman plásticamente, y así, fortalecen el ajuste por interferencia de la protuberancia cónica (7) y el alojamiento cónico pasante (6). The stepped shape (10) favors the bolt and tube coupling system. The steps of the stepped surface (10) are deformed plastically, and thus, strengthen the interference fit of the conical protuberance (7) and the conical through housing (6).
En una modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene forma de espiga. La forma espiga es la forma donde se logra más deformación plástica en los escalones, lo cual mejora el acoplamiento entre el acople macho (4) y el acople hembra (5) In one embodiment of the invention, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a spike shape. The spike shape is the shape where more plastic deformation is achieved in the steps, which improves the coupling between the male coupling (4) and the female coupling (5)
En una modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene un escalón ubicado en su extremo proximal. In one embodiment of the invention, the stepped form (10) of the conical protuberance (7) of the male coupling (4) has a step located at its proximal end.
En otra modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene dos escalones. In another embodiment of the invention, the stepped form (10) of the conical protuberance (7) of the male coupling (4) has two steps.
En otra modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene entre tres y cinco escalones. In another embodiment of the invention, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has between three and five steps.
La cantidad de escalones afecta el ajuste por interferencia, entre más escalones el ajuste por interferencia mejora. Del mismo modo, Entre más escalones sean usados su fabricación será más compleja. Por lo que se debe valorar la complejidad de la acción de compresión en el órgano tubular para decidir cuantos escalones son necesarios. Para valorar la complejidad de la acción de compresión se puede tener en cuenta propiedades mecánicas del órgano tubular (v.g. dureza, rigidez, elasticidad, presión de isquemia), espesor de la pared, entre otros. The number of steps affects the interference adjustment, the more steps the interference adjustment improves. In the same way, the more steps are used, the manufacturing will be more complex. Therefore, the complexity of the compression action in the tubular organ must be assessed to decide how many steps are necessary. For To assess the complexity of the compression action, mechanical properties of the tubular organ can be taken into account (eg hardness, stiffness, elasticity, ischemia pressure), wall thickness, among others.
Se entenderá en la presente invención que presión de isquemia es la fuerza necesaria para obstruir el flujo sanguíneo a través del tejido. It will be understood in the present invention that ischemia pressure is the force necessary to obstruct blood flow through tissue.
En otra modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene un cambio de sección circular. In another embodiment of the invention, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a circular section change.
En otra modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene un cambio de sección semicircular. In another embodiment of the invention, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a semicircular section change.
En otra modalidad de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene un cambio de sección de ranura con bordes achaflanados. In another embodiment of the invention, the stepped shape (10) of the conical protuberance (7) of the male coupling (4) has a groove section change with chamfered edges.
Las formas circulares, semicirculares y con bordes achaflanados en la forma escalonada (10) tiene como propósito facilitar la fuerza que hay que realizar para acoplar el acople macho (4) y el acople hembra (5). The circular, semicircular and chamfered edges in the stepped form (10) have the purpose of facilitating the force that must be applied to couple the male coupling (4) and the female coupling (5).
En la modalidad preferida de la invención, la forma escalonada (10) de la protuberancia cónica (7) del acople macho (4) tiene cuatro escalones. Un escalón tiene una sección semicircular y los demás tienen una sección triangular. Preferiblemente, el escalón con sección semicircular se ubica en el extremo proximal del acople macho (4). El escalón con sección semicircular en el extremo proximal permite disminuir la fuerza necesaria para acoplar el acople macho (4) al acople hembra (5). Los tres escalones restantes tendrán forma de espiga y darán más resistencia para que no se separen el acople machoIn the preferred embodiment of the invention, the stepped form (10) of the conical protuberance (7) of the male coupling (4) has four steps. One step has a semicircular section and the others have a triangular section. Preferably, the step with semicircular section is located at the proximal end of the male coupling (4). The step with semicircular section in the proximal end allows to reduce the force necessary to couple the male coupling (4) to the female coupling (5). The remaining three steps They will have a spike shape and will give more resistance so that the male coupling does not separate
(4) y el acople hembra (5). (4) and the female coupling (5).
En una modalidad de la invención, las aristas del acople macho (4) y el acople hembra (5) son redondeadas y/o achaflanadas. In one embodiment of the invention, the edges of the male coupling (4) and the female coupling (5) are rounded and / or chamfered.
Los redondeos y lo chaflanes se usan para que disminuir el riesgo de perforación o laceración al órgano tubular. Roundings and chamfers are used to reduce the risk of perforation or laceration to the tubular organ.
Haciendo referencia a la FIG.2, en una modalidad de la invención, el acople hembra (5) es de forma cilindrica. La forma cilindrica permite que sea más fácil introducir y mover el acople hembra (5) dentro del conducto (1). El diámetro externo del acople hembra (5) puede ser entre 5mm y 30mm, entre 5mm y 8mm, entre 8mm y 12mm, entre 12mm y 15mm, entre 15m y 18mm, entre 18mm y 25mm, entre 25mm y 30mm. Referring to FIG. 2, in one embodiment of the invention, the female coupling (5) is cylindrical in shape. The cylindrical shape makes it easier to insert and move the female coupling (5) into the duct (1). The external diameter of the female coupling (5) can be between 5mm and 30mm, between 5mm and 8mm, between 8mm and 12mm, between 12mm and 15mm, between 15m and 18mm, between 18mm and 25mm, between 25mm and 30mm.
En una modalidad el acople hembra (5) cuenta con un alojamiento cónico pasante (6). El ángulo de conicidad del alojamiento cónico del acople hembra (5) puede ser entre 6o y 35°, entre 6o y 12°, entre 12° y 17°, entre 18° y 22°, entre 22° y 28°, entre 28° y 35°. In one embodiment, the female coupling (5) has a conical through housing (6). The angle of taper of the conical housing of the female coupling (5) may be between 6 and 35 °, between 6 and 12 °, between 12 ° and 17 °, between 18 ° and 22 °, between 22 ° and 28 °, between 28 ° and 35 °.
En una modalidad de la invención, el alojamiento cónico pasante (6) del acople hembraIn one embodiment of the invention, the through conical housing (6) of the female coupling
(5) tiene una superficie interna lisa. (5) has a smooth internal surface.
En otra modalidad de la invención, el alojamiento cónico pasante (6) el acople hembra (5) tiene una superficie interna rugosa. En otra modalidad de la invención, el alojamiento cónico pasante (6) el acople hembra (5) tiene en su superficie interna ranuras concéntricas distribuidas axialmente. In another embodiment of the invention, the through conical housing (6) the female coupling (5) has a rough internal surface. In another embodiment of the invention, the through conical housing (6) the female coupling (5) has concentric grooves axially distributed on its inner surface.
En otra modalidad de la invención, el alojamiento cónico pasante (6) el acople hembra (5) tiene en su superficie interna ranuras concéntricas distribuidas axialmente. A la vez, la protuberancia cónica (7) del acople macho (4) tiene una superficie lisa. In another embodiment of the invention, the through conical housing (6) the female coupling (5) has concentric grooves axially distributed on its inner surface. At the same time, the conical protuberance (7) of the male coupling (4) has a smooth surface.
La forma de la superficie interna con ranuras del alojamiento cónico pasante (6) del acople hembra (5), al igual que la forma escalonada (10) sirven para mejorar el ajuste de interferencia. The shape of the internal surface with grooves of the conical through housing (6) of the female coupling (5), as well as the stepped shape (10) serve to improve the interference fit.
Haciendo referencia a la FIG.2, el ángulo de conicidad de la protuberancia cónica (7) del acople macho (4) no es el mismo, que el ángulo de conicidad del alojamiento cónico pasante (6) del acople hembra (5). Cuando la conexión proximal (2) y la conexión distal (3) del conducto (1) se unen por medio del dispositivo, la diferencia de estos ángulos de conicidad genera un gradiente de presión de contacto entre el acople macho (4) y el acople hembra (5) sobre el conducto (1). El gradiente de presión de contacto disminuye en la dirección distal del conducto (1). Referring to FIG. 2, the conical angle of the conical protuberance (7) of the male coupling (4) is not the same, as the conic angle of the through conical housing (6) of the female coupling (5). When the proximal connection (2) and the distal connection (3) of the conduit (1) are joined by means of the device, the difference in these conicity angles generates a contact pressure gradient between the male coupling (4) and the coupling female (5) over the duct (1). The contact pressure gradient decreases in the distal direction of the duct (1).
Haciendo referencia a la FIG. 2, en la anastomosis de órganos tubulares, cuando se acopla el acople macho (4) al acople hembra (5), el gradiente de presión de contacto que se da en el extremo proximal del acople macho (4) y en el extremo distal del acople hembra (5) genera en el tejido del conducto (1) una isquemia total (A);. De la misma manera, una isquemia parcial (B) en la zona de contacto ubicada en la región medial del acople macho (4) y el acople hembra (5) . En la región distal del acople macho (4) y proximal del acople hembra (5) no se genera isquemia (C). En la zona de contacto ubicada en el extremo proximal del acople macho (4), la presión de contacto es suficiente para lograr una isquemia total (A). La isquemia total (A) corta el flujo de sangre hacia esta zona del conducto (1), con lo cual se produce después de aproximadamente ocho horas, necrosis de tejido. Referring to FIG. 2, in the anastomosis of tubular organs, when the male coupling (4) is coupled to the female coupling (5), the contact pressure gradient that occurs at the proximal end of the male coupling (4) and at the distal end of the Female coupling (5) generates in the duct tissue (1) a total ischemia (A). In the same way, a partial ischemia (B) in the contact area located in the medial region of the male coupling (4) and the female coupling (5). Ischemia (C) is not generated in the distal region of the male coupling (4) and proximal of the female coupling (5). In the contact zone located at the proximal end of the male coupling (4), the contact pressure is sufficient to achieve total ischemia (A). Total ischemia (A) cuts off the blood flow to this area of the duct (1), which occurs after approximately eight hours, tissue necrosis.
En la zona de contacto ubicada en la zona medial del acople macho (4), la presión de contacto es suficiente para lograr una isquemia parcial (B). Con la isquemia parcial (B) se promueve un proceso de cicatrización y sellamiento tisular, y por lo tanto la unión de la conexión proximal (2) con la conexión distal (3) del conducto (1). In the contact zone located in the medial zone of the male coupling (4), the contact pressure is sufficient to achieve a partial ischemia (B). With partial ischemia (B), a process of scarring and tissue sealing is promoted, and therefore the union of the proximal connection (2) with the distal connection (3) of the duct (1).
En otra modalidad de la invención, el acople hembra (5) y el acople macho (4) son de un material biocompatible. In another embodiment of the invention, the female coupling (5) and the male coupling (4) are made of a biocompatible material.
Para efectos de interpretación de la presente invención se entenderá por material biocompatible, un material que cumplen con la norma ISO- 10993 : "Biological Evaluation of Medical Devices". Algunos materiales son: Poliariletercetona (PAEK, por sus siglas en inglés), polieteretercetona (PEEK, por sus siglas en inglés), polietileno de alta densidad (HDPE, por sus siglas en inglés), Polietileno de ultra alto peso molecular (UHMWPE), polimetilmetacrilato (PMMA, por sus siglas en inglés), Polisulfonas (PSU, por sus siglas en inglés), Polieterimida (PEI, por sus siglas en inglés), polifenilsulfona (PPSU por sus siglas en ingles) y sulfuro de polifenileno (PPS, por sus siglas en inglés), Titanio Comercialmente Puro (ASTM F67), Aleaciones de titanio ASTM B265 (especificación estándar de titanio y titanio en forma de banda, chapa y placa) y Acero Inoxidable AISI 316L, Acrilonitrilo butadieno estireno (ABS, por sus siglas en inglés) grado médico, policarbonato, poliamida, poliéster, policloruro de vinilo (PVC, por sus siglas en inglés), materiales absorbibles como polipropileno, poliestireno, ácido poliglicólico, polidoxanona, Poliglecaprone, Catgut, Poliglactín 910 y materiales acrílicos. En una modalidad de la invención, el acople macho (4) y el acople hembra (5) son de Acrilonitrilo Butadieno Estireno (ABS, por sus siglas en inglés), o un material acrílico. Por ejemplo, el acople macho (4) y el acople hembra (5) pueden fabricase por impresión 3D, preferiblemente de alta definición, o prototipado rápido. For the purposes of interpreting the present invention, biocompatible material shall be understood as a material that complies with ISO-10993: "Biological Evaluation of Medical Devices". Some materials are: Polyaryl ether ketone (PAEK), polyether ether ketone (PEEK), high density polyethylene (HDPE), Ultra High Molecular Weight Polyethylene (UHMWPE), polymethylmethacrylate (PMMA), Polysulfones (PSU), Polyetherimide (PEI), polyphenylsulfone (PPSU) and polyphenylene sulfide (PPS, for its acronym in English) its acronym in English), Commercially Pure Titanium (ASTM F67), Titanium alloys ASTM B265 (standard specification of titanium and titanium in the form of a band, sheet and plate) and AISI 316L Stainless Steel, Acrylonitrile butadiene styrene (ABS) in English) medical grade, polycarbonate, polyamide, polyester, polyvinylchloride (PVC), absorbable materials such as polypropylene, polystyrene, polyglycolic acid, polidoxanone, Poliglecaprone, Catgut, Polyglactin 910 and acrylic materials. In one embodiment of the invention, the male coupling (4) and the female coupling (5) are made of Acrylonitrile Butadiene Styrene (ABS), or an acrylic material. For example, the male coupling (4) and the female coupling (5) can be manufactured by 3D printing, preferably high definition, or rapid prototyping.
En otra modalidad de la invención, el material del acople macho (4) y el acople hembra (5), se selecciona entre PAEK, PEEK, Polisulfonas (PSU, por sus siglas en inglés), Polieterimida (PEI, por sus siglas en inglés), polifenilsulfona (PPSU por sus siglas en ingles) y sulfuro de polifenileno (PPS, por sus siglas en inglés). In another embodiment of the invention, the material of the male coupling (4) and the female coupling (5) is selected from PAEK, PEEK, Polysulfones (PSU), Polyetherimide (PEI). ), polyphenylsulfone (PPSU) and polyphenylene sulfide (PPS).
En otra modalidad de la invención, el acople macho (4) y el acople hembra (5) pueden ser fabricados por inyección de plástico, mecanizado (v.g. fresado, torneado), troquelado, moldeado (v.gr. roto moldeado) y combinaciones de los anteriores. In another embodiment of the invention, the male coupling (4) and the female coupling (5) can be manufactured by plastic injection, machining (eg milling, turning), die cutting, molding (e.g. broken molding) and combinations of the above
Haciendo referencia en la FIG.2, en una modalidad de invención, el acople hembra (5) tiene un primer imán (11) ubicado en su región proximal. De igual manera, el acople macho (4) tiene un segundo imán (12) ubicado en su región medial. El primer imán (11) y el segundo imán (12) tienen polaridad opuesta, así, los imanes generan una fuerza que atrae el acople macho (4) al acople hembra (5). Referring to FIG. 2, in one embodiment of the invention, the female coupling (5) has a first magnet (11) located in its proximal region. Similarly, the male coupling (4) has a second magnet (12) located in its medial region. The first magnet (11) and the second magnet (12) have opposite polarity, thus, the magnets generate a force that attracts the male coupling (4) to the female coupling (5).
En unamodalidad de la invención, el primer imán (11) del acople hembra (5) y el segundo imán (12) del acople macho (4) tienen forma de arandela. In a modality of the invention, the first magnet (11) of the female coupling (5) and the second magnet (12) of the male coupling (4) are in the form of a washer.
En una modalidad de la invención, el acople macho (4) y el acople hembra (5) son de un material magnetizable. El acople macho (4) y el acople hembra (5) se magnetizan con polaridades opuestas para generar atracción entre ellos. El acople macho (4) y el acople hembra (5) pueden ser de acero inoxidable ferromagnético, titanio magnetizable, y materiales biocompatibles magnetizables. In one embodiment of the invention, the male coupling (4) and the female coupling (5) are made of a magnetizable material. The male coupling (4) and the female coupling (5) are magnetized with opposite polarities to generate attraction between them. The male coupling (4) and the coupling Female (5) can be made of ferromagnetic stainless steel, magnetizable titanium, and magnetizable biocompatible materials.
En otra modalidad de la invención, el primer imán ( 11) del acople macho (4) y el segundo imán (12) del acople hembra (5), se selecciona entre imanes de alnico, flexibles, cerámicos, súper- imanes, de tierras raras, imanes temporales e imanes naturales. In another embodiment of the invention, the first magnet (11) of the male coupling (4) and the second magnet (12) of the female coupling (5) are selected from alnico, flexible, ceramic, super magnets, earth magnets rare, temporary magnets and natural magnets.
En una modalidad de la invención, el acople macho (4) y el acople hembra (5) tienen un medio de calentamiento. El medio de calentamiento aumenta la temperatura del acople macho (4) y el acople hembra (5) cuando se encuentran la conexión proximal (2) y la conexión distal (3). El calentamiento del acople macho (4) y el acople hembra (5) derrite los extremos de la conexión proximal (2) y la conexión distal (3). Los extremos derretidos de la conexión proximal (2) y la conexión distal (3) se unen por fusión. In one embodiment of the invention, the male coupling (4) and the female coupling (5) have a heating means. The heating medium increases the temperature of the male coupling (4) and the female coupling (5) when the proximal connection (2) and the distal connection (3) are found. The heating of the male coupling (4) and the female coupling (5) melts the ends of the proximal connection (2) and the distal connection (3). The melted ends of the proximal connection (2) and the distal connection (3) are joined by fusion.
Para efectos de interpretación de la presente invención se entenderá por unión por fusión, cuando materiales similares o diferentes se calientan de manera que se produce una unión física y/o química entre dichos materiales. For purposes of interpretation of the present invention, fusion fusion will be understood when similar or different materials are heated so that a physical and / or chemical bond between said materials occurs.
En una modalidad de la invención el medio de calentamiento puede ser una resistencia eléctrica, inductores, electrodos de grafito y combinación de estos. In one embodiment of the invention, the heating means may be an electrical resistor, inductors, graphite electrodes and a combination thereof.
En una modalidad de la invención, en el extremo proximal de acople hembra (5) se ubica un ojal, en el ojal se conecta un hilo. El hilo se extiende desde el acople hembra (5) hasta la boca proximal del conducto (1). El hilo permite recuperar el acople hembra (5) y el acople macho (4) después de la anastomosis del conducto, halando el hilo y extrayendo ambas partes por la boca proximal del conducto (1). Haciendo referencia a la FIG.3, se divulga un mecanismo (13) posicionar y conectar un dispositivo para anastomosis por compresión que comprende: In one embodiment of the invention, an eyelet is located at the proximal end of the female coupling (5), a thread is connected to the eyelet. The wire extends from the female coupling (5) to the proximal mouth of the duct (1). The thread allows the female coupling (5) and the male coupling (4) to be recovered after the anastomosis of the duct, pulling the thread and removing both parts through the proximal mouth of the duct (1). Referring to FIG. 3, a mechanism (13) for positioning and connecting a device for compression anastomosis comprising:
un primer vástago (14) con un extremo distal conectado a un acople hembra (5), el un acople hembra (5) tiene un alojamiento cónico pasante (6) que comunica su extremo distal con su extremo proximal, donde el diámetro menor del alojamiento cónico pasante (6) se ubica hacia el extremo proximal y  A first rod (14) with a distal end connected to a female coupling (5), the one female coupling (5) has a through conical housing (6) that communicates its distal end with its proximal end, where the smaller diameter of the housing conical through (6) is located towards the proximal end and
un segundo vástago (15) con un extremo proximal conectado a un acople macho (4), el acople macho (4) incluye una protuberancia cónica (7), que tiene su diámetro mayor en el extremo distal, y que incluye una perforación pasante (29) que comunica su extremo distal con su extremo proximal. En donde, el primer vástago (14) empuja en la dirección distal el acople hembra (5) en medio de la conexión proximal (2), y el segundo vástago (15) empuja en la dirección proximal el acople macho (4) en medio de la conexión distal (3) conectando así el acople macho (4) y el acople hembra (5).  A second rod (15) with a proximal end connected to a male coupling (4), the male coupling (4) includes a conical protuberance (7), which has its largest diameter at the distal end, and which includes a through hole ( 29) that communicates its distal end with its proximal end. Wherein, the first rod (14) pushes in the distal direction the female coupling (5) in the middle of the proximal connection (2), and the second rod (15) pushes in the proximal direction the male coupling (4) in the middle of the distal connection (3) thus connecting the male coupling (4) and the female coupling (5).
En una modalidad de la invención, el primer vástago (14) y el segundo vástago (15) son maleables. Los vástagos maleables sirven para dar un mejor control del acople macho (4) y acople hembra (5) y se amoldan de mejor manera a los órganos tubulares. In one embodiment of the invention, the first rod (14) and the second rod (15) are malleable. The malleable stems serve to give better control of the male coupling (4) and female coupling (5) and are better molded to the tubular organs.
Se entenderá en el presente invento que un vástago maleable, es un cilindro, alambre o barra con una rigidez que permite ser doblado con las manos. It will be understood in the present invention that a malleable rod is a cylinder, wire or bar with a rigidity that allows it to be folded with the hands.
Haciendo referencia en la FIG.3, en una modalidad de la invención, el conducto (1) es un esófago, un intestino, colon, o estómago. Referring to FIG. 3, in one embodiment of the invention, the conduit (1) is an esophagus, a bowel, colon, or stomach.
En una modalidad de la invención, la conexión proximal (2) pertenece a una sección del conducto (1) comprendida desde la brecha ancha hasta la boca del extremo proximal. Por ejemplo, en el caso de anastomosis de esófago, la boca del extremo proximal del conducto (1) puede ser la boca de una persona. In one embodiment of the invention, the proximal connection (2) belongs to a section of the conduit (1) comprised from the wide gap to the mouth of the proximal end. By For example, in the case of an esophageal anastomosis, the mouth of the proximal end of the canal (1) may be the mouth of a person.
En una modalidad de la invención, la conexión distal (3) pertenece a una sección del conducto (1) comprendida desde la brecha ancha hasta la incisión del extremo distal. Por ejemplo, en el caso de anastomosis de esófago la boca del extremo distal puede ser una incisión en el estómago de la persona. In one embodiment of the invention, the distal connection (3) belongs to a section of the duct (1) comprised from the wide gap to the incision of the distal end. For example, in the case of an esophageal anastomosis, the mouth of the distal end may be an incision in the stomach of the person.
Haciendo referencia a la FIG.3, en una modalidad de la invención, el primer vástago (14) se conecta con el acople hembra (5) en el extremo distal del primer vástago (14). Igualmente, el segundo vástago (15) se conecta con el acople macho (4) en el extremo proximal del segundo vástago (15). Referring to FIG. 3, in one embodiment of the invention, the first rod (14) is connected to the female coupling (5) at the distal end of the first rod (14). Similarly, the second rod (15) is connected to the male coupling (4) at the proximal end of the second rod (15).
El primer vástago (14) empuja el acople hembra (5) a través del conducto (1), desde la boca del conducto (1) hasta la conexión proximal (2) donde se ubica la brecha. Del mismo modo el segundo vástago (15) empuja el acople macho (4) a través del conducto (1), desde la incisión en el estómago hasta la conexión distal (3), donde se ubica la brecha.The first rod (14) pushes the female coupling (5) through the duct (1), from the duct mouth (1) to the proximal connection (2) where the gap is located. Similarly, the second rod (15) pushes the male coupling (4) through the duct (1), from the incision in the stomach to the distal connection (3), where the gap is located.
Cuando se encuentran el acople macho (4) y el acople hembra (5), el primer vástago (14) y el segundo vástago (15) ejercen una fuerza que deforma plásticamente la protuberancia cónica (7) del acople macho (4) contra el alojamiento cónico pasante (6) del acople hembra (5), y a su vez genera el gradiente de presión descrito anteriormente, con lo cual se completa la anastomosis del conducto (1). When the male coupling (4) and the female coupling (5) meet, the first rod (14) and the second rod (15) exert a force that plastically deforms the conical protuberance (7) of the male coupling (4) against the through conical housing (6) of the female coupling (5), and in turn generates the pressure gradient described above, thereby completing the anastomosis of the duct (1).
Haciendo referencia a la FIG.4, en una modalidad de la invención, en el extremo distal del primer vástago (14) se ubica una primera guía (16) que se inserta en el alojamiento cónico pasante (6) del acople hembra (5); y en el extremo proximal del segundo vástago (15) se ubica una segunda guía (17) que se inserta en la perforación pasante (29) del acople macho (4). En una modalidad de la invención, el acople hembra (5) se conecta con el primer vástago (14) por medio de un adhesivo (18). Del mismo modo, el segundo vástago (15) se conecta por medio de un adhesivo (18) al acople macho (4). El adhesivo (18) debe ser suave, por ejemplo, un adhesivo sensible a la presión. Los adhesivos pueden ser acrílicos (Cianoacrilato de Etilo, Cianoacrilato de Alcoxietilo, poliacrilatos), epóxidos, poliuretanos, hidrogeles, gel de silicona, silicona, silanos modificados y anaeróbicos, adhesivos de resina fenólicas, poliamidas, adhesivos de goma curados por calor, poliéster insaturado, hotmelts, adhesivos en base solventes, adhesivos en base agua, adhesivos de contacto, adhesivos de dispersión, adhesivos plastisoles, adhesivos de presión (PSA) y ceras adhesivas. Referring to FIG. 4, in one embodiment of the invention, a first guide (16) is inserted at the distal end of the first rod (14) which is inserted into the through conical housing (6) of the female coupling (5) ; and at the proximal end of the second rod (15) is located a second guide (17) that is inserted into the through hole (29) of the male coupling (4). In one embodiment of the invention, the female coupling (5) is connected to the first rod (14) by means of an adhesive (18). Similarly, the second rod (15) is connected by means of an adhesive (18) to the male coupling (4). The adhesive (18) must be soft, for example, a pressure sensitive adhesive. The adhesives can be acrylics (Ethyl Cyanoacrylate, Alkoxyethyl Cyanoacrylate, polyacrylates), epoxides, polyurethanes, hydrogels, silicone gel, silicone, modified and anaerobic silanes, phenolic resin adhesives, polyamides, heat cured rubber adhesives, unsaturated polyester , hotmelts, solvent based adhesives, water based adhesives, contact adhesives, dispersion adhesives, plastisol adhesives, pressure adhesives (PSA) and adhesive waxes.
En una modalidad de la invención, el primer vástago (14) tiene un émbolo (19) en el extremo distal. Del mismo modo, el segundo vástago (15) tiene un émbolo (19) en el extremo proximal. In one embodiment of the invention, the first rod (14) has a plunger (19) at the distal end. Similarly, the second rod (15) has a plunger (19) at the proximal end.
Para efectos de interpretación de la presente invención se entenderá que un émbolo es una pieza que se mueve por el interior de un conducto y sirve para facilitar el empuje de un objeto. For purposes of interpretation of the present invention, it will be understood that a plunger is a piece that moves inside a duct and serves to facilitate the thrust of an object.
Haciendo referencia en la FIG.4, en una modalidad de la invención, el émbolo (19) de cada vástago tiene una forma de paraboloide. Cada paraboloide tiene su vértice apuntado hacia la zona medial del vástago en donde se ubica el émbolo (19). Por otro lado, el paraboloide tiene una cara plana opuesta a su vértice. De la cara plana del émbolo (19) del primer vástago (14) sobresale la primera guía cilindrica (16). De igual manera, de la cara plana del émbolo (19) del segundo vástago (15) sobresale la segunda guía cilindrica (17). En otra modalidad de la invención, el émbolo (19) es de forma cilindrica. El émbolo (19) puede tener una sección transversal circular, ovalada, elíptica, oblonga y combinaciones de los anteriores. Referring to FIG. 4, in one embodiment of the invention, the piston (19) of each rod has a paraboloid shape. Each paraboloid has its vertex pointed towards the medial zone of the stem where the plunger (19) is located. On the other hand, the paraboloid has a flat face opposite its vertex. The first cylindrical guide (16) protrudes from the flat face of the piston (19) of the first rod (14). Similarly, the second cylindrical guide (17) protrudes from the flat face of the plunger (19) of the second rod (15). In another embodiment of the invention, the plunger (19) is cylindrical in shape. The plunger (19) may have a circular, oval, elliptical, oblong and cross-sectional cross-section.
En una modalidad de la invención, el émbolo ( 19) y el primer vástago (14) son dos piezas diferentes. De la misma manera, el émbolo (19) y el segundo vástago (15) son dos piezas diferentes. In one embodiment of the invention, the plunger (19) and the first rod (14) are two different parts. In the same way, the piston (19) and the second rod (15) are two different pieces.
En una modalidad de la invención, el émbolo (19) y el primer vástago (14) están unidos por medio de soldadura. El émbolo ( 19) y el segundo vástago (15) están unidos por medio de soldadura In one embodiment of the invention, the plunger (19) and the first rod (14) are joined by welding. The piston (19) and the second rod (15) are joined by welding
En otra modalidad de la invención, el émbolo (19) y el primer vástago (14) se pueden unir por adhesivos, sujetadores por roscado (v.g. pernos, tornillos, prisioneros y espárragos), remaches, clavos, por interferencia. De igual manera, el émbolo (19) y el segundo vástago (15) se pueden unir por los mismos medios. In another embodiment of the invention, the piston (19) and the first rod (14) can be joined by adhesives, threaded fasteners (e.g. bolts, screws, prisoners and studs), rivets, nails, by interference. Similarly, the piston (19) and the second rod (15) can be joined by the same means.
En otra modalidad de la invención, un émbolo (19) y el primer vástago (14) forman un cuerpo monolítico. De igual manera, un émbolo (19) y el segundo vástago (15) forman un cuerpo monolítico. In another embodiment of the invention, a plunger (19) and the first rod (14) form a monolithic body. Similarly, a plunger (19) and the second rod (15) form a monolithic body.
En una modalidad de la invención, el primer vástago (14) tiene un émbolo (19) en el extremo distal. El émbolo (19) se conecta por medio de un adhesivo (18) en su extremo distal con el acople hembra (5). El segundo vástago (15) tiene un émbolo (19) en el extremo proximal. El émbolo (19) se conecta por medio de un adhesivo (18) en su extremo proximal con el acople macho (4). Haciendo referencia a la FIG.4, en otra modalidad de la invención, el primer vástago (14) tiene un émbolo (19) en el extremo distal. Del émbolo (19) sobresale la primera guía cilindrica (16) del primer vástago (14) en el extremo distal. La primera guía cilindrica (16) del primer vástago (14) se conecta con el acople hembra (5). El segundo vástago (15) tiene un émbolo (19) en el extremo proximal. Del émbolo (19) sobresale una segunda guía cilindrica (17) del segundo vástago (15) en el extremo proximal. La segunda guía cilindrica (17) del segundo vástago (15) se conecta con el acople macho (4). In one embodiment of the invention, the first rod (14) has a plunger (19) at the distal end. The plunger (19) is connected by means of an adhesive (18) at its distal end with the female coupling (5). The second rod (15) has a plunger (19) at the proximal end. The plunger (19) is connected by means of an adhesive (18) at its proximal end with the male coupling (4). Referring to FIG. 4, in another embodiment of the invention, the first rod (14) has a plunger (19) at the distal end. From the piston (19) the first cylindrical guide (16) of the first rod (14) protrudes at the distal end. The first cylindrical guide (16) of the first rod (14) is connected to the female coupling (5). The second rod (15) has a plunger (19) at the proximal end. From the piston (19) a second cylindrical guide (17) of the second rod (15) protrudes at the proximal end. The second cylindrical guide (17) of the second rod (15) is connected to the male coupling (4).
En una modalidad de la invención, la primera guía cilindrica (16) del primer vástago (14) es rígida. De igual modo, la segunda guía cilindrica (17) del segundo vástago (15) es rígida. In one embodiment of the invention, the first cylindrical guide (16) of the first rod (14) is rigid. Similarly, the second cylindrical guide (17) of the second rod (15) is rigid.
En una modalidad de la invención, la primera guía cilindrica (16) del primer vástago (14) es maleable. De igual modo, la segunda guía cilindrica (17) del segundo vástago (15) es maleable In one embodiment of the invention, the first cylindrical guide (16) of the first rod (14) is malleable. Similarly, the second cylindrical guide (17) of the second rod (15) is malleable
En una modalidad de la invención, la primera guía cilindrica (16) y la segunda guía cilindrica (17) tiene un diámetro menor al diámetro interno de la perforación pasante (29) del acople macho (4) y al diámetro menor del acoplamiento cónico pasante (6) del acople hembra (5). El diámetro de la primera guía cilindrica (16) y el diámetro de la segunda guía cilindrica (17) tienen una tolerancia que da como resultado un ajuste por interferencia. La tolerancia de los diámetros de la primera guía cilindrica (16) y la segunda guía cilindrica (17) puede ser por ejemplo de-0,06 mm y +0 mm para diámetros de 0 mm a 3 mm, -0,07 mm y +0,001 mm para diámetros de 6 mm a 10 mm, -0,08 mm y +0,001 mm para diámetros de 6 mm a 10 mm. In one embodiment of the invention, the first cylindrical guide (16) and the second cylindrical guide (17) have a diameter smaller than the internal diameter of the through hole (29) of the male coupling (4) and the smaller diameter of the through conical coupling (6) of the female coupling (5). The diameter of the first cylindrical guide (16) and the diameter of the second cylindrical guide (17) have a tolerance that results in an interference fit. The tolerance of the diameters of the first cylindrical guide (16) and the second cylindrical guide (17) can be, for example, from -0.06 mm and +0 mm for diameters from 0 mm to 3 mm, -0.07 mm and +0.001 mm for diameters from 6 mm to 10 mm, -0.08 mm and +0.001 mm for diameters from 6 mm to 10 mm.
En una modalidad de la invención, el primer vástago (14) se puede guiar por el órgano tubular sin necesidad de una camisa. De igual manera, el segundo vástago (15) se puede guiar por el órgano tubular sin necesidad de una camisa. Haciendo referencia de la FIG.5, en otra modalidad de la invención, el primer vástagoIn one embodiment of the invention, the first rod (14) can be guided by the tubular organ without the need for a jacket. Similarly, the second rod (15) can be guided by the tubular organ without the need for a jacket. Referring to FIG. 5, in another embodiment of the invention, the first rod
(14) se dispone dentro de una primera camisa (20). Del mismo modo, el segundo vástago(14) is arranged inside a first shirt (20). Similarly, the second stem
(15) se dispone dentro de una segunda camisa (21). La primera camisa (20) y la segunda camisa (21) sirven para evitar el riesgo del afectar el conducto (1). También, son usadas como guía para el primer vástago (14) y el segundo vástago (15), de este modo se agiliza el acoplamiento del acople macho (4) al acople hembra (5). En unamodalidad de la invención, el primer vástago (14) y el segundo vástago (15) tienen un cambio de sección rectangular por todo el eje longitudinal. El cambio de sección rectangular sirve para disminuir el peso del primer vástago (14) y el segundo vástago (15). También, el cambio de sección rectangular favorece la maleabilidad del primer vástago (14) y el segundo vástago (15). (15) is arranged inside a second shirt (21). The first shirt (20) and the second shirt (21) serve to avoid the risk of affecting the duct (1). Also, they are used as a guide for the first rod (14) and the second rod (15), in this way the coupling of the male coupling (4) to the female coupling (5) is expedited. In a modality of the invention, the first rod (14) and the second rod (15) have a rectangular section change along the entire longitudinal axis. The change of rectangular section serves to decrease the weight of the first rod (14) and the second rod (15). Also, the change of rectangular section favors the malleability of the first rod (14) and the second rod (15).
Haciendo referencia a la FIG.5, en una modalidad de invención el primer vástago (14) tiene una primera placa de soporte (22) ubicada en su extremo proximal. Del mismo modo, el segundo vástago (15) tiene una segunda placa soporte (23) ubicada en su extremo distal. La placa soporte sirve para apoyar los dedos. También, la placa soporte facilita el empuje del vástago por el conducto (1). Referring to FIG. 5, in one embodiment of the invention the first rod (14) has a first support plate (22) located at its proximal end. Similarly, the second rod (15) has a second support plate (23) located at its distal end. The support plate serves to support the fingers. Also, the support plate facilitates the pushing of the rod through the conduit (1).
Haciendo referencia en la FIG.6, en una modalidad de la invención, el mecanismo (13) donde: Referring in FIG. 6, in one embodiment of the invention, the mechanism (13) where:
el primer vástago (14) tiene un primer extremo (24) dispuesto radialmente, el primer extremo (24) se conecta al acople hembra (5), y;  the first rod (14) has a first end (24) arranged radially, the first end (24) is connected to the female coupling (5), and;
el segundo vástago (15) tiene un primer extremo (25) dispuesto radialmente, el primer extremo (25) se conecta al acople macho (4),  the second rod (15) has a first end (25) arranged radially, the first end (25) is connected to the male coupling (4),
en donde, el segundo vástago (15) se conecta al primer vástago (14) mediante un eje (26) que se ubica en la zona medial de cada vástago; el eje (26) permite que el primer vástago (14) se mueva radialmente respecto al segundo vástago (15). En una modalidad de la invención, el primer vástago (14) y el segundo vástago (15) son rígidos. wherein, the second rod (15) is connected to the first rod (14) by means of an axis (26) that is located in the medial zone of each rod; The shaft (26) allows the first rod (14) to move radially with respect to the second rod (15). In one embodiment of the invention, the first rod (14) and the second rod (15) are rigid.
Haciendo referencia a la FIG. 6, en una modalidad de la invención, en el caso de anastomosis de intestino, se realiza una incisión cerca de la conexión proximal (2) del conducto (1). Del mismo modo, se hace una incisión cerca de la conexión distal (3) del conducto (1). La incisión de la conexión proximal (2) sirve de entrada para el primer vástago (14). De igual manera, la incisión de la conexión distal (3) sirve de entrada para el segundo vástago (15). Referring to FIG. 6, in one embodiment of the invention, in the case of intestine anastomosis, an incision is made near the proximal connection (2) of the duct (1). Similarly, an incision is made near the distal connection (3) of the duct (1). The incision of the proximal connection (2) serves as input for the first rod (14). Similarly, the incision of the distal connection (3) serves as an input for the second stem (15).
El primer vástago (14) empuja en la dirección distal el acople hembra (5) en medio de la conexión proximal (2). El segundo vástago (15) empuja en la dirección proximal el acople macho (4) en medio de la conexión distal (3) conectando así el acople macho (4) y el acople hembra (5). The first rod (14) pushes in the distal direction the female coupling (5) in the middle of the proximal connection (2). The second rod (15) pushes in the proximal direction the male coupling (4) in the middle of the distal connection (3) thus connecting the male coupling (4) and the female coupling (5).
Haciendo referencia a la FIG. 6, en una modalidad de la invención, el primer vástago (14) rígido se conecta con el acople hembra (5) en el primer extremo (24) por medio de un adhesivo (18). Del mismo modo, el segundo vástago (15) se conecta al acople macho (4) en el primer extremo (25) por medio de un adhesivo (18). En una modalidad de la invención, el primer vástago (14) rígido se conecta con el acople hembra (5) en el primer extremo (24) por medio de un adhesivo (18). El segundo vástago (14) se conecta al acople macho (4) en el primer extremo (24) distal por medio de la segunda guía cilindrica (17). En la modalidad preferida de la invención, el primer vástago (14) rígido se conecta con el acople hembra (5) en el primer extremo (24) por medio de la primera guía cilindrica (16). Del mismo modo, el segundo vástago (15) se conecta al acople macho (4) en el primer extremo (25) por medio de la segunda guía cilindrica (17). El uso de la primera guía cilindrica (16) y la segunda guía cilindrica (17) sirve para tener un mayor control sobre el acople macho (4) y el acople hembra (5). Referring to FIG. 6, in one embodiment of the invention, the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of an adhesive (18). Similarly, the second rod (15) is connected to the male coupling (4) at the first end (25) by means of an adhesive (18). In one embodiment of the invention, the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of an adhesive (18). The second rod (14) is connected to the male coupling (4) at the first distal end (24) by means of the second cylindrical guide (17). In the preferred embodiment of the invention, the first rigid rod (14) is connected to the female coupling (5) at the first end (24) by means of the first cylindrical guide (16). Similarly, the second rod (15) is connected to the male coupling (4) at the first end (25) by means of the second cylindrical guide (17). The use of the first cylindrical guide (16) and the second cylindrical guide (17) serves to have greater control over the male coupling (4) and the female coupling (5).
En una modalidad de la invención, el primer vástago (14) rígido tiene en el segundo extremo (27) un mango de agarre. Del mismo modo, el segundo vástago (15) rígido tiene en el segundo extremo (28) un mango de agarre. In one embodiment of the invention, the first rigid rod (14) has a grip handle at the second end (27). Similarly, the second rigid rod (15) has a grip handle at the second end (28).
En una modalidad de la invención, el primer vástago (14) rígido tiene en su segundo extremo (27) un mango de agarre en forma curva. Del mismo modo, el segundo vástago (15) rígido tiene en su segundo extremo (28) un mango de agarre en forma curva. El mango de agarre en forma de curva sirve para mejorar el agarre y la ergonomía del primer vástago (14) y el segundo vástago (15). In one embodiment of the invention, the first rigid rod (14) has a curved grip handle at its second end (27). Similarly, the second rigid rod (15) has a curved grip handle at its second end (28). The curved grip handle serves to improve the grip and ergonomics of the first rod (14) and the second rod (15).
En una modalidad de la invención, la forma curva del mango de agarre, tiene una sección semicircular con radio mayor a 100mm. In one embodiment of the invention, the curved shape of the grip handle has a semicircular section with a radius greater than 100mm.
En una modalidad de la invención, la forma curva del mango de agarre, puede ser una sección elíptica truncada, ovalo truncada, parabólica, cónica, truncada, hiperbólica, herradura truncada y combinaciones de las anteriores. In one embodiment of the invention, the curved shape of the grip handle may be a truncated elliptical section, truncated oval, parabolic, conical, truncated, hyperbolic, truncated horseshoe and combinations of the foregoing.
En una modalidad de la invención, el primer vástago (14) rígido tiene en su segundo extremo (27) un anillo para un dedo, Del mismo modo, el segundo vástago (15) rígido tiene en su segundo extremo (28) un anillo para un dedo. Los anillos mejoran el agarre y la ergonomía del primer vástago (14) y el segundo vástago (15). In one embodiment of the invention, the first rigid rod (14) has at its second end (27) a ring for a finger. Similarly, the second rigid rod (15) has at its second end (28) a ring for one finger. The rings improve the grip and ergonomics of the first rod (14) and the second rod (15).
Haciendo referencia a la FIG. 6, en la modalidad preferida de la invención, el primer vástago (14) se conforma de: Referring to FIG. 6, in the preferred embodiment of the invention, the first rod (14) is formed of:
una primera sección prismática con una primera protuberancia localizada en su primer extremo (24);  a first prismatic section with a first protrusion located at its first end (24);
- una primera sección diagonal conectada a la primera sección prismática y ubicada en el extremo opuesto a la primera protuberancia, donde la primera sección diagonal es la región medial de del primer vástago (14); y un primer mango de agarre conectado a la primera sección diagonal, el primer mango de agarre se ubica en el segundo extremo (27) del primer vástago (14); - a first diagonal section connected to the first prismatic section and located at the opposite end of the first protuberance, where the first diagonal section is the medial region of the first stem (14); Y a first grip handle connected to the first diagonal section, the first grip handle is located at the second end (27) of the first rod (14);
Por otro lado, el segundo vástago (15) se conforma de: On the other hand, the second rod (15) consists of:
- una segunda sección prismática con una segunda protuberancia localizada en su primer extremo (25);  - a second prismatic section with a second protrusion located at its first end (25);
una segunda sección diagonal conectada a la segunda sección prismática y ubicada en el extremo opuesto a la segunda protuberancia, donde la segunda sección diagonal es la región medial de del segundo vástago (15); y  a second diagonal section connected to the second prismatic section and located at the opposite end of the second protuberance, where the second diagonal section is the medial region of the second rod (15); Y
un segundo mango de agarre conectado a la sección diagonal, el segundo mango de agarre se ubica en el segundo extremo (28) del segundo vástago a second grip handle connected to the diagonal section, the second grip handle is located at the second end (28) of the second rod
(15); (fifteen);
donde, el eje (26) atraviesa las secciones diagonales de los vástagos (14) y (15).  where, the axis (26) crosses the diagonal sections of the stems (14) and (15).
En una modalidad de la invención, el primer vástago ( 14) y el segundo vástago (15) tienen un orificio en su región medial, en los orificios se dispone un medio de fijación que asegura el primer vástago (14) y segunda vástago (15). El medio de fijación puede ser remaches, tornillos, pines, espárragos y combinaciones de los mismos. In one embodiment of the invention, the first rod (14) and the second rod (15) have a hole in their medial region, in the holes a fixing means is provided that secures the first rod (14) and second rod (15 ). The fixing means can be rivets, screws, pins, studs and combinations thereof.
En una modalidad de la invención, el primer vástago (14) y el segundo vástago (15) rígidos pueden ser cilindricos. In one embodiment of the invention, the first rigid rod (14) and the second rigid rod (15) can be cylindrical.
En otra modalidad de la invención, el primer vástago (14) y el segundo vástago (15) son de sección transversal cuadrada, rectangular, triangular, elíptica, poligonal, oblonga y combinaciones de las anteriores. In another embodiment of the invention, the first rod (14) and the second rod (15) are square, rectangular, triangular, elliptical, polygonal, oblong and combinations of the foregoing.
En una modalidad de la invención, el primer vástago ( 14) y el segundo vástago (15) tienen una longitud entre lOOmm y lOOOmm. Preferiblemente, tienen una longitud entre 100mm y 300mm. En una modalidad de invención el primer vástago (14) y el segundo vástago (15), son de acero inoxidable 304. In one embodiment of the invention, the first rod (14) and the second rod (15) have a length between 10mm and 10mm. Preferably, they have a length between 100mm and 300mm. In one embodiment of the invention, the first rod (14) and the second rod (15) are made of 304 stainless steel.
En otra modalidad de invención el primer vástago (14) y el segundo vástago (15), pueden ser de un material biocompatible, por ejemplo, Acero inoxidable 316, Acero inoxidable 316 Lvm, Titanio TÍ6A14V Grado 5, Titanio TÍ6A14V ELI Grado 23. In another embodiment of the invention, the first rod (14) and the second rod (15) may be of a biocompatible material, for example, 316 stainless steel, 316 Lvm stainless steel, Titanium TÍ6A14V Grade 5, Titanium TÍ6A14V ELI Grade 23.
Ejemplo 1 : Dispositivo para anastomosis por compresión del esófago de un neonato y mecanismo para posicionar y conectar el dispositivo. Example 1: Device for compression anastomosis of the esophagus of a newborn and mechanism to position and connect the device.
Se diseñó y construyó un dispositivo para anastomosis por compresión y un mecanismo (13) para posicionar y conectar el dispositivo. A device for compression anastomosis and a mechanism (13) were designed and constructed to position and connect the device.
En el primer ejemplo el dispositivo se usó para la anastomosis de esófago de un neonato, el dispositivo constaba de los siguientes partes: In the first example the device was used for anastomosis of the esophagus of a newborn, the device consisted of the following parts:
- un acople macho (4) con las siguientes características: - a male coupling (4) with the following characteristics:
longitud máxima: 10mm diámetro externo máximo: 9,68mm - diámetro externo mínimo: 7,67mm diámetro interno: 2mm  maximum length: 10mm maximum external diameter: 9.68mm - minimum external diameter: 7.67mm internal diameter: 2mm
- número de escalones: 4 primer escalón semicircular de extremo proximal: radio 1 mm - number of steps: 4 first semicircular step of proximal end: radius 1 mm
- ángulo del segundo y tercer escalón con sección triangular: 30° - ángulo del cuarto escalón del extremo distal: 45° diámetro máximo del último escalón: 9,68mm - ángulo de conicidad del acople macho (4): 10° - angle of the second and third steps with triangular section: 30 ° - angle of the fourth step of the distal end: 45 ° maximum diameter of the last step: 9.68mm - taper angle of the male coupling (4): 10 °
- material: ABS - material: ABS
- un acople hembra (5) con las siguientes características: - a female coupling (5) with the following characteristics:
longitud máxima: 6,03mm  maximum length: 6.03mm
- diámetro interno máximo: 13,71mm  - maximum internal diameter: 13.71mm
diámetro interno mínimo: 7,20mm  minimum internal diameter: 7.20mm
diámetro externo: 16,99mm  external diameter: 16.99mm
- ángulo de conicidad del acople hembra (5): 15° - taper angle of female coupling (5): 15 °
- material: ABS - material: ABS
El mecanismo (13) tiene las siguientes partes: The mechanism (13) has the following parts:
- un primer vástago (14) maleable con las siguientes características longitud máxima: 400mm  - a malleable first rod (14) with the following characteristics maximum length: 400mm
diámetro en la región medial: 5mm  diameter in the medial region: 5mm
- diámetro primera placa de soporte (22): 10mm  - first support plate diameter (22): 10mm
- espesor primera placa de soporte (22): 10mm  - first support plate thickness (22): 10mm
- un segundo vástago (15) maleable con las siguientes características:  - a second malleable rod (15) with the following characteristics:
longitud máxima: 400mm  maximum length: 400mm
diámetro en la región medial: 5mm  diameter in the medial region: 5mm
- diámetro primera placa de soporte (23): 10mm  - first support plate diameter (23): 10mm
- espesor primera placa de soporte (23): 5mm  - first support plate thickness (23): 5mm
- un émbolo (19) con las siguientes características:  - a piston (19) with the following characteristics:
- longitud: 5mm  - length: 5mm
diámetro: 7mm  diameter: 7mm
- una primera guía cilindrica (16) con las siguientes características diámetro: 7, 19mm - a first cylindrical guide (16) with the following characteristics diameter: 7, 19mm
- longitud: 2mm - length: 2mm
- una segunda guía cilindrica (17) con las siguientes características diámetro: l,99mm - a second cylindrical guide (17) with the following diameter characteristics: l, 99mm
- longitud: 2mm  - length: 2mm
el émbolo ( 19), el primer vástago ( 14) y la primera guía cilindrica (16) conforman un cuerpo monolítico y son de un acero inoxidable 304.  The piston (19), the first rod (14) and the first cylindrical guide (16) form a monolithic body and are made of 304 stainless steel.
el émbolo (19), el segundo vástago (15) y la segunda guía cilindrica (17) conforman un cuerpo monolítico y son de un acero inoxidable 304.  The piston (19), the second rod (15) and the second cylindrical guide (17) form a monolithic body and are made of 304 stainless steel.
Ejemplo 2. Mecanismo con camisas para posicionar y conectar un dispositivo para anastomosis por compresión. Example 2. Mechanism with shirts to position and connect a device for compression anastomosis.
En otro caso de anastomosis de esófago en un neonato, se usó el dispositivo para anastomosis por compresión y el mecanismo (13) del ejemplo anterior, pero además se usó unas camisas guías: In another case of an esophageal anastomosis in a neonate, the compression anastomosis device and the mechanism (13) of the previous example were used, but also guide shirts were used:
- la primera camisa (20) con las siguientes características: - the first shirt (20) with the following characteristics:
diámetro externo: 10mm diámetro interno: 9mm - longitud: 420mm  external diameter: 10mm internal diameter: 9mm - length: 420mm
- la segunda camisa (21) con las siguientes características: - the second shirt (21) with the following characteristics:
diámetro externo: 10mm diámetro interno: 9mm longitud: 420mm  external diameter: 10mm internal diameter: 9mm length: 420mm
Ejemplo 3 En el tercer ejemplo el dispositivo se usó para la anastomosis de un intestino. En el caso de anastomosis de un intestino, las partes separadas del intestino se encuentran en paralelo, el mecanismo (13) entra por una pequeña incisión que se le hace a cada intestino lateralmente. Para luego unirlos. El mecanismo (13) consta de las siguientes partes. Example 3 In the third example the device was used for the anastomosis of a bowel. In the case of an anastomosis of a intestine, the separated parts of the intestine are in parallel, the mechanism (13) enters through a small incision that is made to each intestine laterally. Then join them. The mechanism (13) consists of the following parts.
- un primer vástago (14) rígidos con las siguientes características - a first rigid rod (14) with the following characteristics
longitud máxima: 200mm  maximum length: 200mm
diámetro: 5mm  diameter: 5mm
material: Acero inoxidable 304  material: 304 stainless steel
- un segundo vástago (15) rígidos con las siguientes características:  - a second rigid rod (15) with the following characteristics:
longitud máxima: 200mm  maximum length: 200mm
diámetro: 5mm  diameter: 5mm
material: Acero inoxidable AISI 304  Material: AISI 304 stainless steel
- una primera guía cilindrica (16) con las siguientes características diámetro: 7, 19mm  - a first cylindrical guide (16) with the following diameter characteristics: 7, 19mm
- longitud: 2mm  - length: 2mm
- una segunda guía cilindrica (17) con las siguientes características diámetro: l,99mm  - a second cylindrical guide (17) with the following diameter characteristics: l, 99mm
- longitud: 2mm  - length: 2mm
el primer vástago (14) rígido y la primera guía cilindrica (15) conforman un cuerpo monolítico y son de un acero inoxidable 304.  The first rigid rod (14) and the first cylindrical guide (15) form a monolithic body and are made of 304 stainless steel.
el segundo vástago (14) rígido y la segunda guía cilindrica (16) conforman un cuerpo monolítico y son de un acero inoxidable 304.  the second rigid rod (14) and the second cylindrical guide (16) form a monolithic body and are made of 304 stainless steel.
Se debe entender que la presente invención no se halla limitada a las modalidades descritas e ilustradas, pues como será evidente para una persona versada en el arte, existen variaciones y modificaciones posibles que no se apartan del espíritu de la invención, el cual solo se encuentra definido por las siguientes reivindicaciones. It should be understood that the present invention is not limited to the modalities described and illustrated, since as will be evident to a person versed in art, there are possible variations and modifications that do not depart from the spirit of the invention, which is only found defined by the following claims.

Claims

REIVINDICACIONES
Un dispositivo para anastomosis por compresión, que comprende: A device for compression anastomosis, comprising:
un acople hembra (5) con un alojamiento cónico pasante (6) que comunica su extremo distal con su extremo proximal, donde el diámetro menor del alojamiento cónico pasante (6) se ubica hacia el extremo proximal; y un acople macho (4) con una protuberancia cónica (7), que tiene su diámetro mayor en el extremo distal, y que incluye una perforación pasante (29) que comunica su extremo distal con su extremo proximal;  a female coupling (5) with a through conical housing (6) that communicates its distal end with its proximal end, where the smaller diameter of the through conical housing (6) is located towards the proximal end; and a male coupling (4) with a conical protuberance (7), which has its largest diameter at the distal end, and which includes a through hole (29) that communicates its distal end with its proximal end;
donde la protuberancia cónica del acople macho (4) se acopla operacionalmente al alojamiento cónico pasante (6) del acople hembra (5).  where the conical protuberance of the male coupling (4) is operatively coupled to the through conical housing (6) of the female coupling (5).
2. El dispositivo de la Reivindicación 1, caracterizado porque la protuberancia cónica (7) del acople macho (4) tiene una superficie externa escalonada (10). 2. The device of Claim 1, characterized in that the conical protuberance (7) of the male coupling (4) has a stepped outer surface (10).
3. El dispositivo de la Reivindicación 1, caracterizado porque la protuberancia cónica (7) del acople macho (4) tiene forma de espiga. 3. The device of Claim 1, characterized in that the conical protuberance (7) of the male coupling (4) is shaped like a pin.
4. El dispositivo de la Reivindicación 1, caracterizado porque la protuberancia cónica (7) del acople macho (4) tiene un ángulo de conicidad entre 8o y 15°, y el alojamiento cónico pasante (6) del acople hembra (5) tiene un ángulo de conicidad entre 10° y 30°. 4. The device of Claim 1, characterized in that the conical protuberance (7) of the male coupling (4) has an angle of conicity between 8 or 15 °, and the through conical housing (6) of the female coupling (5) has an angle of conicity between 10 ° and 30 °.
5. Un mecanismo (13) para posicionar y conectar un dispositivo para anastomosis por compresión que comprende: 5. A mechanism (13) for positioning and connecting a device for compression anastomosis comprising:
un primer vástago (14) con un extremo distal conectado a un acople hembra (5), el un acople hembra (5) tiene un alojamiento cónico pasante (6) que comunica su extremo distal con su extremo proximal, donde el diámetro menor del alojamiento cónico pasante (6) se ubica hacia el extremo proximal y  A first rod (14) with a distal end connected to a female coupling (5), the one female coupling (5) has a through conical housing (6) that communicates its distal end with its proximal end, where the smaller diameter of the housing conical through (6) is located towards the proximal end and
un segundo vástago (15) con un extremo proximal conectado a un acople macho (4), el acople macho (4) incluye una protuberancia cónica (7), que tiene su diámetro mayor en el extremo distal, y que incluye una perforación pasante (29) que comunica su extremo distal con su extremo proximal. A second rod (15) with a proximal end connected to a male coupling (4), the male coupling (4) includes a conical protuberance (7), which It has its largest diameter at the distal end, and that includes a through hole (29) that communicates its distal end with its proximal end.
6. El mecanismo de la Reivindicación 5, donde el primer vástago y el segundo vástago son maleables. 6. The mechanism of Claim 5, wherein the first rod and the second rod are malleable.
7. El mecanismo (13) de la Reivindicación 5, caracterizado porque en el extremo distal del primer vástago (14) se ubica una primera guía (16) que se inserta en el alojamiento cónico pasante (6) del acople hembra (5); y en el extremo proximal del segundo vástago (15) se ubica una segunda guía (17) que se inserta en la perforación pasante (29) del acople macho (4). 7. The mechanism (13) of Claim 5, characterized in that at the distal end of the first rod (14) is located a first guide (16) that is inserted into the through conical housing (6) of the female coupling (5); and at the proximal end of the second rod (15) is located a second guide (17) that is inserted into the through hole (29) of the male coupling (4).
8. El mecanismo (13) de la Reivindicación 5, caracterizado porque el extremo distal del primer vástago (14) y en el extremo proximal del segundo vástago (15) tienen un embolo (19). 8. The mechanism (13) of Claim 5, characterized in that the distal end of the first rod (14) and the proximal end of the second rod (15) have a plunger (19).
9. El mecanismo (13) de la Reivindicación 5, en donde el primer vástago (14) se dispone dentro de una primera camisa (20); y el segundo vástago (15) se dispone dentro de una segunda camisa (21). 9. The mechanism (13) of Claim 5, wherein the first rod (14) is disposed within a first sleeve (20); and the second rod (15) is disposed within a second shirt (21).
10. El mecanismo (13) de la reivindicación 5, donde: 10. The mechanism (13) of claim 5, wherein:
el primer vástago (14) tiene un primer extremo (24) dispuesto radialmente, el primer extremo (24) se conecta al acople hembra (5), y;  the first rod (14) has a first end (24) arranged radially, the first end (24) is connected to the female coupling (5), and;
el segundo vástago (15) tiene un primer extremo (25) dispuesto radialmente, el primer extremo (25) se conecta al acople macho (4),  the second rod (15) has a first end (25) arranged radially, the first end (25) is connected to the male coupling (4),
en donde, el segundo vástago (15) se conecta al primer vástago (14) mediante un eje (26) que se ubica en la zona medial de cada vástago. where, the second rod (15) is connected to the first rod (14) by means of an axis (26) that is located in the medial zone of each rod.
PCT/IB2017/056702 2016-10-31 2017-10-27 Compression anastomosis device and mechanism for positioning and connecting same WO2018078589A1 (en)

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CONC2016/0003711 2016-10-31
CO16003711 2016-10-31

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4598712A (en) * 1984-02-16 1986-07-08 Carlo Rebuffat Circular anastomosis
US4907591A (en) * 1988-03-29 1990-03-13 Pfizer Hospital Products Group, Inc. Surgical instrument for establishing compression anastomosis
US4931057A (en) * 1988-03-29 1990-06-05 Pfizer Hospital Products Group, Inc. Compression anastomosis coupling assembly
US6666873B1 (en) * 2002-08-08 2003-12-23 Jack L. Cassell Surgical coupler for joining tubular and hollow organs

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4598712A (en) * 1984-02-16 1986-07-08 Carlo Rebuffat Circular anastomosis
US4907591A (en) * 1988-03-29 1990-03-13 Pfizer Hospital Products Group, Inc. Surgical instrument for establishing compression anastomosis
US4931057A (en) * 1988-03-29 1990-06-05 Pfizer Hospital Products Group, Inc. Compression anastomosis coupling assembly
US6666873B1 (en) * 2002-08-08 2003-12-23 Jack L. Cassell Surgical coupler for joining tubular and hollow organs

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