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WO2025083309A1 - Dispositif d'extrusion intracorporel pour l'application de bio-encres, d'hydrogels ou de fluides en chirurgie laparoscopique - Google Patents

Dispositif d'extrusion intracorporel pour l'application de bio-encres, d'hydrogels ou de fluides en chirurgie laparoscopique Download PDF

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Publication number
WO2025083309A1
WO2025083309A1 PCT/ES2024/070626 ES2024070626W WO2025083309A1 WO 2025083309 A1 WO2025083309 A1 WO 2025083309A1 ES 2024070626 W ES2024070626 W ES 2024070626W WO 2025083309 A1 WO2025083309 A1 WO 2025083309A1
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WO
WIPO (PCT)
Prior art keywords
reservoir
nozzle
extruder
head
coupled
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/ES2024/070626
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English (en)
Spanish (es)
Inventor
Isabel ANDIA ORTIZ
Ane Miren ITURREGUI DEL POZO
Ines JAUREGUI MONASTERIO
Cristina DEL AMO MATEOS
Rubén García Fernández
David LECUMBERRI CASTAÑOS
Jose Luis BLANCO BRUNED
Francisco José ÁLVAREZ DÍAZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Administracion General de la Comunidad Autonoma de Euskadi
Original Assignee
Administracion General de la Comunidad Autonoma de Euskadi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Publication of WO2025083309A1 publication Critical patent/WO2025083309A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/20—Apparatus for additive manufacturing; Details thereof or accessories therefor
    • B29C64/205—Means for applying layers
    • B29C64/209—Heads; Nozzles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/118—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using filamentary material being melted, e.g. fused deposition modelling [FDM]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y30/00—Apparatus for additive manufacturing; Details thereof or accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0007—Special media to be introduced, removed or treated introduced into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media

Definitions

  • Intracorporeal extruder device for the application of bioinks, hydrogels or fluids in laparoscopic surgery
  • the present invention pertains to the technical field of minimally invasive (MIS) or laparoscopic surgery, and more specifically, to the technical field of applying bioinks in this type of surgery.
  • the object of the present invention is an intracorporeal extruder device for the in situ application of fluids, hydrogels, or bioinks in minimally invasive or laparoscopic surgery, with manual applicators, which can be motorized or assisted by a surgical robot.
  • Laparoscopy is a frequently used surgical technique that allows viewing of the pelvic-abdominal cavity with the aid of an optical lens, always under aseptic or sterile conditions.
  • Light is transmitted through an optical fiber to illuminate the cavity, while images of the interior are observed with a camera connected to the same lens.
  • the same method also allows for surgical interventions, which is why it is also considered a minimally invasive surgical system, the goal of which is to cure or correct diseases.
  • the device used is called a laparoscopic tower.
  • Sterile surgical instruments enter the body through a small incision, usually between 0.5 and 1.5 centimeters, or through an access port called a trocar, to maintain aseptic procedure.
  • Procedures such as cholecystectomy (removal of the gallbladder), hiatal hernia surgery, partial or total nephrectomy (removal of the kidney), pyeloplasty (an operation to resolve pyelourethral stricture) or hysterectomy (removal of the uterus or cervix) have achieved very high rates of substitution to laparoscopic surgery, however, other procedures have not achieved the expected levels of implementation.
  • 3D vision allows the surgeon to work with great precision and reliability.
  • the surgeon does not operate directly on the patient, but rather sits at a console where he or she handles forceps and can achieve up to tenfold magnification.
  • this technology facilitates surgeon access to complicated anatomy, improves visualization of anatomical landmarks and tissue planes. It also eliminates physiological tremors or involuntary movements, as well as postural fatigue after long hours of surgery.
  • both conventional and robotic laparoscopic surgery offer advantages for the patient, as small incisions are used, resulting in a shorter postoperative period, less bleeding, less pain, and a lower risk of complications, including those resulting from contamination or failure to properly control the asepsis of the procedure.
  • patients return to their daily lives more quickly, which leads to better management of hospital resources.
  • the instruments conventionally used in minimally invasive surgery comprise three main elements: a handle to maneuver the device, a long, straight shaft to reach the operating area, and an end effector to operate, which usually contains a clamp or a cutting, pulling, dissecting, etc. mechanism.
  • the rigid, thin instruments used in MI severely limit surgeon dexterity due to the loss of wrist joint and the restriction posed by the small incision size.
  • the number of degrees of freedom (DOF) is limited from six in open surgery to four in MI, as shown in Fig. 1 : pivoting about the incision in two perpendicular planes 20 and 30, translation 40, and axial rotation 50.
  • the surgeon has to deal with the fulcrum effect: the reversal of the handle's movements at the end effector due to the pivot point created by the trocar in the abdominal wall.
  • Robotic devices such as the da Vinci® Robotic System (Intuitive Surgical Inc., Sunnyvale, CA, USA, https://www.intuitive.com/en-us/products-and-services/da-vinci, last visited 10-10-2023), have the ability to decrease the fulcrum effect and improve surgeon dexterity by providing two additional DOFs to the robotic arm’s end effector using the so-called EndoWrist mechanism.
  • Instrument handles are the primary physical interface for the surgeon.
  • tissue engineering or tissue regeneration a combination of scaffolds, cells, and biologically active molecules to create functional tissues that restore, maintain, and improve damaged tissues or organs
  • biomaterial printing a combination of scaffolds, cells, and biologically active molecules to create functional tissues that restore, maintain, and improve damaged tissues or organs
  • in situ bioprinting is an emerging technique in which biomaterials, loaded with cells and growth factors, are deposited directly at the site of an injury or anatomical defect, enabling tissue regeneration in a precise and controlled manner.
  • the extruded biomaterials can be hydrogels or more advanced composites, such as cell-laden hydrogels.
  • These hydrogels can also be doped with bioactive molecules, such as cytokines or growth factors, allowing their therapeutic effects to be customized based on the patient's clinical needs.
  • a specifically doped hydrogel can provide anti-inflammatory, angiogenic, or anabolic effects, provided it is applied under sterile conditions to properly activate tissue repair mechanisms.
  • advanced therapies which entails greater regulatory complexity and requires ensuring the confinement of the construct to the therapeutic target.
  • 3-D Tissue Engineering is currently a field open to new developments and requires significant advances in biomaterials, biomedical engineering and design and Scaffold/construct manufacturing.
  • the broader impact of intracorporeal tissue engineering is the ability to deliver solutions to tissues wherever they are located deep within body cavities in a minimally invasive manner, following rigorous quality control procedures that ensure procedural asepsis.
  • Intracorporeal tissue engineering is a modern approach to the problem of tissue regeneration, which would leverage modern robotics and tissue engineering manufacturing technologies to provide patient benefits without the morbidity associated with invasive surgeries, using medical devices for the sequential intracorporeal application of different types of biomaterials (hydrogels, cell-laden hydrogels, hydrogels doped with distinct cytokine configurations) with high anatomical precision while maintaining asepsis (patient safety).
  • biomaterials hydrogels, cell-laden hydrogels, hydrogels doped with distinct cytokine configurations
  • Document ES2194936 describes a handheld instrument for laparoscopic surgery, which includes electrocautery and additional physiological fluid irrigation/evacuation capabilities during laparoscopic surgery.
  • This device refers to a combined laser and electrocautery instrument.
  • the surgical instrument consists of a housing. which has an outlet opening for the passage of evacuated fluid that has been aspirated from a body cavity and which has an inlet opening for the passage of irrigation fluid.
  • the housing contains a first internal conduit communicating with the outlet opening, and a second internal conduit communicating with the inlet opening.
  • Document ES2526294 describes a handheld laparoscopic medical device with a detachable tip, which provides one or more additional degrees of freedom at the instrument tip. It also includes suction/irrigation tools for fluids or other aqueous solutions.
  • Document EP3030171 B1 describes a manual injection device for minimally invasive procedures, comprising a needle, initially protected in a sheath, which, with the aid of a plunger, allows drugs to be injected into a target tissue or organ. This device would allow extracorporeal injection of the drug, reaching the injection site under the surgeon's control. It also describes the adaptation of the sheath to contain the syringe, with an internal adapter that allows the plunger to be actuated from outside the patient.
  • Document US7867222B1 describes a manual instrument for endoscopic surgical insertion and application of liquid, gel, and similar material.
  • This endoscopic instrument includes an inner elongated portion that fits into the hole of an outer elongated instrument.
  • the outer elongated instrument includes a slot through which a surgical blade can be placed, allowing it to be pulled to roll the material inside the instrument.
  • the instrument member may include a bag that allows the collection of resected tissue.
  • the outer instrument connecting member includes an articulated end portion that can be moved to deflect the end portion of the inner instrument.
  • Different nozzles can be adapted to allow the injection and/or suction of fluids and/or hydrogels from outside the patient through the entire device, by connecting a syringe or other injection and/or aspiration system to the external part of the injector.
  • a syringe or other injection and/or aspiration system to connect to the external part of the injector.
  • the positioning of the end of the injector in the three spatial planes is performed manually by the surgeon, as well as the actuation of the plunger for the injection/aspiration of the fluid.
  • the document further describes the presence of a head attached to a hollow flexible dispensing tube, a hollow applicator body, and a hollow inner shaft with a rubber gasket sealing device.
  • LIS2021085469 describes a hand-held device with external drive and intracorporeal application thanks to a long shaft.
  • the device described could be coupled to a robotic arm, allowing the robot to precisely position the injector tip in the three spatial planes.
  • the plunger is actuated for biomaterial injection by the robot from the outside or extracorporeally.
  • Externally driven devices offer the following advantages: easy refilling and access, a wide range of injectable volumes (from a few milliliters to hundreds), and a long injector length (between 250 and 500 millimeters).
  • devices with internal drive have the following disadvantages: refilling is hampered by the surgical technique and limited by the available useful sections, maximum loads of 1 to 2 milliliters using standard tanks. However, they have the advantage of having a low dead volume and low resistive load (short extruder length).
  • the intracorporeal extruder device for in situ application in laparoscopic surgery object of the present invention, combines tissue engineering with robotic assistance in laparoscopic surgery and is directly applicable in the field of intracorporeal tissue engineering.
  • the device combines the advantages of internal drive and intracorporeal application, which are not found in any other device in the prior art.
  • the patient benefits from minimally invasive surgery, eliminating the need to use donor tissue for some types of surgeries, the limitations of donor availability, and the risk of rejection and/or infection that accompanies tissue donation.
  • an intracorporeal extruder device for applying bioinks in laparoscopic surgery.
  • the device comprises:
  • a reservoir with open ends, arranged in the central channel, at the first end of the body, intended to store a fluid, hydrogel or bioink to be dispensed,
  • an extruder such as a plunger, coupled to an open end of the reservoir, opposite the first end of the body, to exert pressure on the fluid contained in the reservoir,
  • a drive shaft configured to act on the extruder, on one side opposite the reservoir, arranged longitudinally along the central channel of the body, and exiting from it at its second end, so that it can be manipulated by a professional or by a robotic arm, and
  • the device allows for the separation of therapeutic components (bioinks) from mechanical components (e.g., the extruder and drive shaft), maintaining sterile or aseptic conditions during surgery.
  • Asepsis or sterility are defined as conditions that prevent the entry of pathogens during surgical procedures.
  • Bioinks are materials composed of biomaterials and/or living cells.
  • the biomaterial can be, for example, a biopolymer gel that acts as a molecular scaffold to promote cell growth, hydrogels, cell-laden hydrogels, hydrogels doped with different cytokine configurations, etc.
  • a specifically doped hydrogel can provide anti-inflammatory, angiogenic, or anabolic effects, provided it is applied under sterile conditions to properly activate tissue repair mechanisms.
  • Bioinks must possess specific properties, such as viscosity, specific for bioprinting and suitable for the transport of living cells.
  • the crucial properties of a high-performance bioink are related to its viscosity and the flow of the material through conductive systems, which determine the generation of resistive forces. These forces, which generate high pressures, are key elements in providing a viable solution for the application of bioinks in laparoscopic surgery.
  • the arrangement of the device's various elements, and particularly the reservoir, maintains a separation between the extruder and the bioink, ensuring extrusion under sterile conditions. Furthermore, the device is easily refilled according to the surgical procedure's needs, maintaining the barrier (asepsis) between the biological (bioink) and purely mechanical elements of the device.
  • the reservoir is thermostatically controlled according to the requirements of the hydrogel or bioink. That is, it comprises a thermostat that allows its temperature to be automatically regulated.
  • the head can be of two types: rigid and adjustable/flexible.
  • the head in the event that the head is rigid, it comprises a coupling section to the body and the reservoir, and a nozzle, both with a hollow channel in communication with the reservoir, through which the fluid that exits to the outside circulates.
  • the head coupling region is a threaded region coupleable to the reservoir.
  • the head in which the head is orientable, it comprises, between the coupling section and the nozzle, an articulated section, through which the internal channel runs, which allows the nozzle to be oriented at a desired angle, which facilitates the dispensing of the fluid at an exact point.
  • the articulated section is formed by at least two truncated-cone-shaped pieces that articulate with respect to one another.
  • Each of the truncated-cone pieces comprises a larger base and a smaller base, coupled to each other, the smaller base of one truncated-cone piece being coupled to the larger base of the next truncated-cone piece, wherein the smaller base of a first truncated-cone piece starts from the coupling region and the larger base of a last truncated-cone piece coincides with the base of the nozzle, the interior channel running through said truncated-cone pieces.
  • the articulated section comprises between 4 and 6 truncated conical pieces.
  • the diameter of the larger base of the truncated cone pieces is less than 10 mm.
  • the truncated conical pieces are made of a material selected from medical grade stainless steel, biocompatible resin and biocompatible polymer.
  • the device further comprises a corrugated tube of biocompatible material surrounding the articulated section.
  • the hollow channel through which the fluid circulates is a tube made of flexible inert material, which guarantees sealing and prevents the loss of the extruded fluid or bioink.
  • the tube has a diameter of between 1 and 4 mm, preferably between 2 and 3 mm.
  • the device when the head is of the orientable type, may additionally comprise at least one head drive cable fixed at a first end to the nozzle, and arranged along the body, exiting through the second end of the body.
  • the device may comprise two drive cables fixed to the nozzle and facing each other with respect to a central point thereof.
  • the device comprises four drive cables fixed to the nozzle forming a square, its center being the center of the nozzle.
  • the device may additionally comprise guides that run longitudinally through the articulated section and the body and in which the drive cables are located.
  • the device additionally comprises a forward and reverse impeller coupled to the drive shaft at an end opposite the extruder.
  • the fluid is dispensed, significantly reducing the effort required by the professional to apply the bioink to the desired area.
  • the present invention also relates to a surgical articulated robotic arm, comprising a device as described above, coupled to a terminal of the articulated robotic arm, and comprising at least one of:
  • the object of the present invention allows for the sequential and anatomically accurate extrusion of bioinks, which can be used, for example, to create a three-dimensional "scaffold" over a lesion, on which cells can proliferate and form new tissue.
  • This approach is particularly useful in soft tissue repair and also in complex defects, such as those present in cartilage, bone, or tendon tissue, where the tissue structure must be precisely restored.
  • the device By depositing the bioink layer by layer, the device facilitates the regeneration of the tissue structure in a personalized and minimally invasive manner, reducing recovery time and improving clinical outcomes.
  • intracorporeal extrusion is mentioned, specifically referring to laparoscopic surgery.
  • the device is suitable for laparoscopic surgery, but its characteristics clearly show that it can be used for any other type of intracorporeal surgery requiring bioink extrusion. Therefore, the device of the invention can be applied not only to surgeries performed on the abdominal cavity and its associated organs, but also to other types of surgeries, such as arthroscopic surgeries (surgeries on joints such as the knee, shoulder, etc.) or thoracoscopic surgeries (chest surgery).
  • Figure 1. Shows the degrees of freedom of minimally invasive surgery.
  • Figure 2. Shows a longitudinal section of the device of the invention.
  • Figure 3. Shows a view of the device coupled to an articulated arm.
  • Figure 4.- Shows a detailed section of the device with the rigid head.
  • Figure 5. Shows a section of the rigid head.
  • Figure 6. Shows a detailed section of the device with the articulated head.
  • Figure 7.- Shows a longitudinal section of the articulated head in three different positions.
  • Figure 8.- Shows a detailed view of a truncated cone-shaped piece of the articulated head.
  • Figure 9. Shows a set of cross sections of a truncated cone-shaped part, in which the movement of the head is represented depending on which drive cables are manipulated.
  • Figure 10. Shows a detailed view of the device in an embodiment comprising an impeller.
  • the device 1 comprises, firstly, an elongated and hollow body 2, which will be the base of the device 1.
  • the body 2 is therefore essentially cylindrical, and being hollow, defines inside a central channel 3, centred on the longitudinal axis of the body 2, which runs between a first and a second end, open to the outside.
  • the body 2 of the device 1 has a variable length, preferably between 250 and 350 mm (or even longer).
  • a reservoir 4 is arranged in the central channel 3, close to a first end, intended to store a bioink, hydrogel or a fluid to be dispensed.
  • This fluid is of the type used in 3-D Tissue Engineering. Therefore, the reservoir 4 functions as a tank, and comprises open ends, aligned with the longitudinal axis of the body 2.
  • the reservoir 4 allows the separation of the fluid, bioink or hydrogel from the mechanical components of the device 1 , such as the drive shaft 6.
  • the device 1 further comprises a head 7, connected to one of the open ends of the reservoir 4, such that the fluid can pass from the reservoir 4 to the head 7, and from this to the outside, for application at a point of interest.
  • the device also comprises an extruder 5, coupled to the other open end of the reservoir 4, opposite the head 7.
  • the extruder 5 can be an element that exerts pressure on the fluid contained in the reservoir 4, such as a piston, and that compresses it until it is extruded by the head 7.
  • the assembly formed by the reservoir 4 and the extruder 5 is of the syringe type.
  • the device comprises a drive shaft 6, coupled to the extruder 5, on a side opposite to the reservoir 4.
  • the drive shaft 6 is arranged longitudinally along the central channel 3 of the body 2, and extends outside the device 1, so that it can be manipulated by a professional, or coupled to an articulated surgical robotic arm 110, in order to extrude the fluid.
  • the drive shaft 6 can move longitudinally, along the central channel 3 of the body 2 or, alternatively, it can perform a rotational and forward movement along the central channel 3. Thanks to either of the two movements, it is capable of actuating the extruder 5, causing the expulsion of the fluid through the head 7.
  • the device 1, and more specifically the drive shaft 6, may be intended to be coupled to a robotic surgical system 100, specifically to an articulated robotic arm 110, which will be the one that manipulates said drive shaft 6.
  • the device 1 may additionally comprise a variable speed motor, coupled to the drive shaft 6 and connected to the articulated robotic arm 110, which allows it to carry out its translation or rotation-translation movement with respect to the body 2 and the reservoir 4.
  • the motor may comprise a position sensor, which allows the position of the drive shaft 6 to be known at all times. By standardizing the displacement of the drive shaft 6 by section or surface of the reservoir 4, the volume and flow rate of the extruded bioink, hydrogel or fluid can be determined.
  • the motor in addition to controlling the forward and reverse speed of the drive shaft 6, is capable of transmitting said information to the robotic surgical system 100, for the integration of the information on the flow and the extruded volume based on the travel of the motor and the articulated robotic arm 110.
  • the head 7 of the device 1 of the invention can be of two types, rigid or orientable/flexible.
  • the head 7 is rigid and comprises an essentially conical nozzle 8 with a base and a vertex.
  • the head 7 comprises a coupling region 10 to the reservoir 4.
  • this region will preferably be threaded.
  • an internal channel 9 is defined inside the head 7 through which the fluid circulates, and which runs both through the coupling region 10 and through the nozzle 8, through whose vertex the fluid exits to the outside.
  • the threaded coupling region 10 can be adapted to medical fixing and closing mechanisms (medical syringes, luer-lock locking and closing connectors), with a reduced section and length, which considerably minimizes the resistive forces of the fluid or bioink to be used.
  • medical fixing and closing mechanisms medical syringes, luer-lock locking and closing connectors
  • FIG. 5 A detailed longitudinal section of the different areas of the rigid head 7 is shown in Fig. 5.
  • section “e” at the vertex or tip of nozzle 8, with a maximum inner diameter of ID 2 mm and an outer diameter OD> 2.2 mm.
  • the dead volume defined as the internal white space located between the walls of the head 7, is 60 pl. That is, in this case, the dead volume is what is known as the internal channel 9. As explained in the background section of the invention, the dead volume represents the unusable remaining volume after the total fluid discharge has occurred, and which also generates high hydrodynamic resistance. As can be seen, in the case of the present invention, the dead volume is very small.
  • the head 7 is orientable, as shown in Figs. 6 and 7.
  • the head comprises an articulated section 11. This is arranged between the threaded region 10 and the nozzle 8, giving continuity to the inner channel 9.
  • the articulated section 11 comprises a set of frustoconical pieces 12 with a larger base and a smaller base, coupled and articulated with each other.
  • the smaller base of one frustoconical piece 12 couples to the larger base of the next frustoconical piece 12, thus forming an articulated section.
  • the smaller base of the first frustoconical piece 12 starts from the coupling region 10 and the larger base of the last frustoconical piece 12 coincides with the base of the nozzle 8.
  • the diameter of the largest base of the truncated cone-shaped parts 12 must not exceed 10 mm, as they must be the standard size for the trocars through which they are to be introduced into the human body.
  • the largest trocars used have an internal diameter of 11 or 12 mm, so the external diameter of the entire device 1 must be 10 mm.
  • the material of the truncated cone-shaped parts can be medical grade stainless steel (if the device 1 is decided to be durable) or plastic materials (biocompatible resins or polymers) that guarantee a certain degree of structural integrity (for single-use or disposable devices).
  • truncated conical pieces 12 of the articulated section 11 may be protected by an external “corrugated tube” type casing in order to isolate the metallic and/or plastic components of the device 1 from the tissues and organic fluids present in the abdomen.
  • the inner channel 9 that runs through the coupling region 10, the articulated region 11 and the nozzle 8 is a tube made of flexible inert material, biocompatible with the fluid used, such as silicone or any other plastic polymer, which guarantees the sealing of the head 7 and prevents the loss of the extruded fluid or bioink.
  • the tube has a diameter between 3 and 4 mm, and ideally should not be less than 2 mm, since greater limitations in diameter would entail the generation of high resistive pressures to the passage of the biomaterial flow through this tube, which would prevent propulsion by the force of gravity.
  • the device 1 of the invention may additionally comprise drive cables 13 of the head 7. These drive cables 13 are fixed at a first end to the nozzle 8. Their second end is accessible from the outside of the device 1, so as to allow its manipulation.
  • the articulated section 11 comprises between 4 and 6 truncated conical pieces 12, which allows the contraction of only one of the drive cables 13 to accumulate an angle variation of about 10° per truncated conical piece 12. That is, if the articulated section 11 comprises four truncated conical pieces, the angular variation of the head 7 will be 40°, while an articulated section 11 of six truncated conical pieces 12 will allow an angle of 60° with a greater degree of incidence on apical defects.
  • a head 7 with a given maximum angle depends on physiological and anatomical variations in the defects in the target organs. For example, a frontal presentation of a defect to be filled by device 1 would only require a maximum angle of inclination of 10 or 20°; however, a more apical or basal defect in an organ such as a kidney would require a greater angle of incidence on the defect. This issue is also limited by the limitation that the entry point into the abdomen (trocar fulcrum) in laparoscopic surgery (LS) imposes on the movement of the instruments, including device 1, and the angle presented with respect to the surgical plane or surgical defect.
  • LS laparoscopic surgery
  • Fig. 8 shows the detail of the truncated conical pieces 12 with the guides 14 for the drive cables 13. Furthermore, these guides 14 are arranged externally on the body 2 and the head 7 so as not to interfere with the reservoir 4 or the extruder 5 in the first, nor with the internal channel 9 in the second.
  • the device 1 comprises a single drive cable 13 which provides the head 7 with a single degree of freedom in one direction.
  • the device 1 comprises two drive cables 13, fixed at opposite points of the nozzle 8 with respect to its center, as shown in Fig. 7. In this way, a degree of freedom is provided to the head 7 in both directions in this case.
  • the central image if none of the drive cables 13 is split, the head 7 does not move. If one of the two drive cables 13 is split and the other is not, the nozzle 8 moves towards the side of the split drive cable 13, as shown in the side images. If both drive cables were split simultaneously, the head 7 would remain unflexed.
  • the device 1 comprises three drive cables 13, preferably arranged at angles of 120° between them with respect to the center of the nozzle 8.
  • the device 1 comprises four drive cables 13, which form angles of 90° with respect to the center of the nozzle 8, such that they face each other two by two at the vertices of a square.
  • This embodiment allows two degrees of freedom, the possible combinations of fractionated cables with the consequent flexion of the head 7 in the desired direction and angle being shown in Fig. 9.
  • a single drive cable 13 i, i, iii, iv
  • two consecutive drive cables 13 v, vi, vii, viii
  • the subject of the present invention is an articulated surgical robotic arm 110.
  • the subject of the present invention is an articulated surgical robotic arm 110.
  • which is coupled to a terminal with the intracorporeal extruder device 1 for applying fluids, hydrogels or bioinks in laparoscopic surgery of the invention.
  • the device 1 follows the trajectory and orientation supplied by the robot 110 to locate the injection path in space.
  • the robotic arm 110 must have at least 7 degrees of freedom, and also the capacity to control the supplied flow of biomaterial by means of micrometric regulation of the displacement of the drive shaft 6 - extruder 5. This can be achieved, as explained above, with a motor and a coupling/reducer communicated directly to the robotic controller.
  • the drive cables 13 are connected to the robotic arm 110 and by their retraction or relaxation (achieved by the actuation of motors of the robotic arm 110) they rotate the head 7 in the four main axes (embodiments i-iv of Fig. 9) or an intermediate rotation (embodiments v-viii of Fig. 9) between two actuating drive cables 13.
  • Fig. 10 shows a detailed view of the device 1 in another embodiment of the invention, in which it comprises a manually operated forward and reverse impeller 200.
  • the impeller 200 is coupled to the drive shaft 6, at an end opposite to that of the extruder 5.
  • the impeller 200 causes the drive shaft 6 to advance (upper figure) or retreat (lower figure) on the extruder 5 and the reservoir 4.
  • the drive shaft 6 may comprise a threaded region at its end opposite to that coupled to the extruder 5.
  • the coupling may be of the clutch type.
  • the impeller 200 may comprise an ergonomic handle, to facilitate its grip and manipulation. It may also comprise a power module, with a battery, to power a motor that is the one that achieves the advance and retreat of the drive shaft 6.
  • the impeller 200 may also comprise a reducer, to have greater control of the movement of the drive shaft 6.
  • it may comprise a motor rotation inverter, to achieve both the advance and retreat of the drive shaft 6.
  • the impeller 200 may comprise an actuator, such as a button, to change the direction of rotation of the motor and make the drive shaft 6 advance or retreat.
  • the bioink (with or without cells) or hydrogels are prepared in a sterile room (clean room).
  • the bioink is then loaded into the reservoir 4.
  • the reservoir 4 and the extruder 5 form a unit that can be removed from the body 2 of the device.
  • the ink Once the ink has been loaded into the reservoir 4, it is introduced together with the extruder 5 into its position in the central channel 3.
  • the bioink can be applied through the head 7.
  • the assembly is the same, with a final stage of coupling the body 2 and the drive shaft 6 to the robotic arm 110 or the impeller 200.
  • the reservoir 4 is removed. As indicated, this reservoir can be independent or can be coupled to the extruder 5, forming a syringe-type assembly.
  • the reservoir 4 is either filled with the new bioink or replaced with an identical one filled with the new bioink to be applied, maintaining sterility in the operating room.
  • the device 1 is reinserted and the new bioink is applied to the wound. The procedure can be repeated as many times as necessary, always ensuring the sterility of the assembly and making changing and applying the bioink quick and easy.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Manufacturing & Machinery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Optics & Photonics (AREA)
  • Robotics (AREA)
  • Physics & Mathematics (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

Le dispositif (1) comprend un corps (2) allongé et creux, avec un canal central (3) longitudinal ; un réservoir thermostaté (4) destiné à stocker un fluide à distribuer ; un dispositif d'extrusion (5) accouplé au réservoir (4), qui exerce une pression sur le fluide ; un axe d'entraînement (6) accouplé au dispositif d'extrusion (5), disposé longitudinalement le long du canal central (3) du corps (2), et sortant de celui-ci par la seconde extrémité, et une tête (7) présentant une zone d'accouplement (10) avec le réservoir (4), un embout (8) qui part de la zone d'accouplement (10), et un canal intérieur (9) qui s'étend à travers la zone d'accouplement (10) et l'embout (8), la tête (7) pouvant comprendre une section articulée (11) qui permet d'orienter l'embout (8) en vue d'obtenir une plus grande précision de distribution.
PCT/ES2024/070626 2023-10-17 2024-10-15 Dispositif d'extrusion intracorporel pour l'application de bio-encres, d'hydrogels ou de fluides en chirurgie laparoscopique Pending WO2025083309A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP202330857 2023-10-17
ES202330857A ES3014435A1 (es) 2023-10-17 2023-10-17 Dispositivo extrusor intracorpóreo para aplicación de biotintas, hidrogeles o fluidos en cirugía laparoscópica

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WO2025083309A1 true WO2025083309A1 (fr) 2025-04-24

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2194936T3 (es) 1990-05-25 2003-12-01 Edward H Phillips Instrumento para cirugia laparoscopia.
US7867222B1 (en) 1995-03-17 2011-01-11 Tilton Jr Eugene B Instrumentation for endoscopic surgical insertion and application of liquid, gel and like material
US20110028991A1 (en) * 2001-06-29 2011-02-03 Intuitive Surgical Operations, Inc. Cardiac Tissue Ablation Instrument with Flexible Wrist
WO2011143577A1 (fr) * 2010-05-13 2011-11-17 Ethicon Endo-Surgery, Inc. Instrument applicateur de cellules thérapeutiques avec pointes modulaires
ES2526294T3 (es) 2010-10-01 2015-01-09 Microline Surgical, Inc. Dispositivo médico de laparoscopia con punta desacoplable
WO2017143355A2 (fr) * 2016-01-20 2017-08-24 Sunp Biotech, Llc Tête de fabrication de cellules/substances biologiques à entraînement par vis direct destinée à l'assemblage de constructions de tissu en 3d
EP3030171B1 (fr) 2013-08-08 2017-11-01 Global Bio Therapeutics, Inc. Dispositif d'injection pour interventions peu invasives
US20210007778A1 (en) * 2017-04-02 2021-01-14 Mazor Robotics Ltd. Three dimensional robotic bioprinter
US20210085469A1 (en) 2016-05-12 2021-03-25 University Of Notre Dame Du Lac Additive Manufacturing Device For Biomaterials

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766157A (en) * 1995-03-17 1998-06-16 Tilton, Jr.; Eugene B. Instrumentation for surgical endoscopic insertion and application of liquid and gel material
ES2353484B1 (es) * 2010-09-30 2011-10-07 Aleaciones De Metales Sinterizados, S.A. Brazo robotizable para cirugía laparoscópica.
CN214926900U (zh) * 2021-07-12 2021-11-30 老河口市维杰电子材料有限公司 基于压力式的可调节出胶量的硅胶挤出机

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2194936T3 (es) 1990-05-25 2003-12-01 Edward H Phillips Instrumento para cirugia laparoscopia.
US7867222B1 (en) 1995-03-17 2011-01-11 Tilton Jr Eugene B Instrumentation for endoscopic surgical insertion and application of liquid, gel and like material
US20110028991A1 (en) * 2001-06-29 2011-02-03 Intuitive Surgical Operations, Inc. Cardiac Tissue Ablation Instrument with Flexible Wrist
WO2011143577A1 (fr) * 2010-05-13 2011-11-17 Ethicon Endo-Surgery, Inc. Instrument applicateur de cellules thérapeutiques avec pointes modulaires
ES2526294T3 (es) 2010-10-01 2015-01-09 Microline Surgical, Inc. Dispositivo médico de laparoscopia con punta desacoplable
EP3030171B1 (fr) 2013-08-08 2017-11-01 Global Bio Therapeutics, Inc. Dispositif d'injection pour interventions peu invasives
WO2017143355A2 (fr) * 2016-01-20 2017-08-24 Sunp Biotech, Llc Tête de fabrication de cellules/substances biologiques à entraînement par vis direct destinée à l'assemblage de constructions de tissu en 3d
US20210085469A1 (en) 2016-05-12 2021-03-25 University Of Notre Dame Du Lac Additive Manufacturing Device For Biomaterials
US20210007778A1 (en) * 2017-04-02 2021-01-14 Mazor Robotics Ltd. Three dimensional robotic bioprinter

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