Applicators for robotic-assisted surgery

Abstract

The present disclosure relates to a laparoscopic applicator for administering a substance, such as a hemostatic agent, at a selected site using a surgical robotic arm, the laparoscopic applicator comprising a delivery tube and an applicator tip connected to a distal end of the delivery tube, the applicator tip configured to be controllably operated by the robotic arm near a gripping area in the axial extension of the delivery tube, the gripping area having an outer periphery transverse to an axis and including a shaped apex area such that the applicator tip is configured to be clamped and spatially manipulated by the robotic arm.

Description

[Technical field]

[0001] The present disclosure relates to an applicator, and more particularly to a laparoscopic applicator for administering a medical substance or fluid at a selected site using a surgical robotic arm. The present invention further relates to a laparoscopic applicator tip for a laparoscopic applicator, a kit of parts comprising said applicator tip, and / or a kit of parts comprising said applicator. [Background technology]

[0002] Robotic systems are increasingly used in surgery, particularly in minimally invasive surgical procedures, to avoid the more invasive techniques of traditional open surgery. Robotic systems comprise several robotic arms to which medical devices are attached, and the robotic arms and medical devices are controlled and steered by the surgeon from a console via control devices such as joysticks and foot pedals. Thus, the robotic arms replace the surgeon's hands at the surgical site, and the surgeon instead views the surgical site via a display device that is positioned remotely from the patient and shows a three-dimensional view of the surgical site.

[0003] Similar to traditional open surgery techniques where an assistant provides the necessary medical devices to a physically present surgeon, in robotic surgery an assistant is positioned near the robotic arm to provide the necessary medical devices to the arm. For example, the assistant can replace medical devices on the robotic arm and can provide medical fluids either directly as medical devices to the robotic arm or via applicator tubes that are introduced into the body through a trocar port.

[0004] Surgical hemostatic agents as well as other medical fluids and pastes are conventionally administered to a target site by the use of a manually operated syringe that contains the paste in the syringe barrel. However, for minimally invasive surgical procedures, the target site is not directly accessible to the syringe cannula. Thus, to administer the paste to a target site in a body cavity, an elongated applicator tube pre-filled with the paste is typically introduced into the body through a trocar port. The insertion of the elongated applicator tube is performed at the trocar port and is therefore not visible to the surgeon performing the minimally invasive surgical procedure, as the surgeon's field of vision is limited to a display device showing the internal target site in high resolution. Thus, the insertion of the applicator tube as well as the administration of the paste from the applicator tube are typically performed by the surgeon's assistant via the surgeon's word of mouth. As a result, the administration of the paste using currently available systems is not directly controlled by the surgeon.

[0005] U.S. Patent No. 9,636,177 discloses a robotic arm equipped with a hemostatic applicator comprising a catheter and a syringe filled with a hemostatic agent that is expelled from the catheter to the surgical site when the surgeon presses a button that activates the syringe plunger.

[0006] US Patent Application Publication No. 2012 / 0289894 discloses a suction / irrigation device for laparoscopic surgery with a tip that is graspable by a robotic tool. The liquid / vacuum supply to the device is delivered from a remotely located valve unit that includes a valve that is located outside and remote from the surgical field. The device is thus adapted for irrigation with free-flowing fluids, such as liquids and gases, from a remote source.

[0007] EP1915950 discloses a suction applicator in which a distal applicator tip can be moved via a cable extending to a proximal hand handle. Similarly, U.S. Patent Application Publication No. 2009 / 171332 discloses a distal applicator tip that can be moved by a cable. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 9,636,177 [Patent Document 2] US Patent Application Publication No. 2012 / 0289894 [Patent Document 3] EP1915950 [Patent Document 4] US Patent Application Publication No. 2009 / 171332 Summary of the Invention [Problem to be solved by the invention]

[0009] To further improve robotic-assisted surgery, medical devices adapted to be controlled by a robotic arm and thus directly controlled by a surgeon are desired. In particular, there is a demand for devices that can be controlled by a robotic arm with greater accuracy, precision, and intuitive tactile control, so that the reproduced remote motion of the robotic arm simulates to a greater extent the interaction of a surgeon. Furthermore, there is a demand for having a medical device that provides feedback to the surgeon, for example, regarding the amount of paste available in an elongated applicator tube. [Means for solving the problem]

[0010] The present disclosure relates to an applicator that is particularly suitable for robotic assisted surgery. In particular, the present disclosure provides an applicator that is suitable for insertion into a trocar port and has an applicator tip, and orientation and / or actuation of the applicator is actuated via the distal end or applicator tip of the inserted applicator. Thus, the applicator can be steered and actuated via the applicator tip, and is therefore particularly suitable for being steered and actuated by a robotic arm that interacts with the distal end / tip of the applicator, for example, within the abdominal cavity during a medical procedure at a surgical site, where the applicator is configured for intraperitoneal delivery of a medical substance. The medical substance can be a medical fluid, a medical paste, and / or a medical powder.

[0011] Replacing the movements of an actual human hand with a robotic arm controlled by computer software facilitates highly accurate and controlled movements. Thus, a laparoscopic applicator spatially steered by a robotic arm can be more precisely controlled, as well as more reliable with reduced risk of accidental movements that may be critical during surgery. Thus, for example, a laparoscopic applicator for administering a medical substance using a robotic arm can administer the substance more accurately and reliably at a selected site. Specifically, a robotically steered applicator for administering a hemostatic agent substance at a selected site can result in bleeding being stopped more efficiently.

[0012] Because robotic arms and fingers thus have limited tactile feedback and design compared to a human hand, the means for steering and / or actuating the distal end / tip of the applicator can be advantageously adapted to the robotic arms / fingers to increase the safety, precision, and reliability of the applicator.

[0013] Applicators and applicator tips Thus, the present disclosure may generally relate to applicators whose orientation and / or actuation can be precisely and reliably controlled by a robotic arm with constrained design and haptic feedback. Specifically, the present disclosure relates generally to applicators having an applicator tip configured to be controllably operated by a robotic arm such that only the tip needs to be accessible and visible to the robotic arm.

[0014] A first aspect of the present disclosure is a laparoscopic applicator for administering or withdrawing a substance, such as a substance including a hemostatic agent, at a selected site using a surgical robotic arm, comprising: - a delivery tube for holding the substance; - an applicator tip connected to a distal end of a delivery tube, - to be spatially navigated by a robotic arm; and / or - controllably releasing the substance from the delivery tube by the robotic arm or controllably drawing the substance from the selected site into the delivery tube. an applicator tip comprising: The present invention relates to a laparoscopic applicator comprising:

[0015] Preferably, the applicator tip is configured to be controllably operated by a robotic arm, either by the tip being spatially maneuvered by the robotic arm and / or by the tip being configured to expel / retract substance by the robotic arm.

[0016] The spatial steering of the applicator tip by the robot arm can be obtained by the robot arm physically contacting the applicator tip. To ensure accurate and reliable spatial steering, the applicator tip is advantageously configured to be gripped by the robot arm such that at least two opposing contact points are obtained, thereby providing a stable and robust contact. For example, the applicator tip can be configured to be gripped by the robot arm in the manner of tweezers with a gripping direction parallel to the longitudinal axis of the applicator and tip and to the material flow direction. The tweezers jaws are thus gripping or clamping around a cross section or circumference transverse to the axis of the applicator tip. This is obtained in particular when the applicator tip comprises a gripping area configured to be gripped and spatially steered by the robot arm in the axial extension of the delivery tube, the gripping area having a cross section or circumference shape transverse to the axis, which shape is stable and robust in particular towards the gripping forces of the robot, in particular towards the stronger non-tactile gripping forces of the robot. Advantageously, the gripping area has a cross-sectional or circumferential shape with a contoured area such that at least a part of the shape of the top essentially matches the gripping part of the robot arm, thereby obtaining a more efficient contact area and contact surface. Typically, the gripping of the robot arm is a jaw gripping, and the shape of the top can be correspondingly oval or triangular.

[0017] Accordingly, a first related aspect of the present disclosure is a laparoscopic applicator for administering a substance, such as a substance including a hemostatic agent, at a selected site using a surgical robotic arm, comprising: - a delivery tube; - an applicator tip connected to a distal end of a delivery tube, the applicator tip being configured to be controllably moved by a robotic arm in the vicinity of a gripping area in an axial extension of the delivery tube, the gripping area having an outer periphery transverse to an axis and with a shaped apex area such that the applicator tip is configured to be clamped and spatially steered by the robotic arm; The present invention relates to a laparoscopic applicator comprising:

[0018] Moreover, to ensure easy, accurate and reliable spatial steering, the delivery tube is advantageously configured to be flexible and deformable, and configured to be mechanically stress-free or stress-relieved upon deformation associated with tip steering. The spatial evacuation of the substance is determined primarily by the orientation of the distal end of the delivery tube and / or the orientation of the applicator tip. A flexible orientation of the distal end / applicator tip can be obtained by a partially deformable applicator, for example, at least a portion of the delivery tube is stretchable and / or flexible. Thus, the delivery tube may comprise a deformable section. Additionally or alternatively, the delivery tube may comprise an energy dissipating material and / or a material with a lower modulus of elasticity, such that the accumulation of tension in the delivery tube is reduced or eliminated. To facilitate that the delivery tube can be easily introduced or inserted and directed from the environment to the target site while being spatially maneuvered with both minimal tension buildup to and at the target site within the body cavity, the applicator advantageously further comprises an insertion guide for at least temporarily supporting the mechanically deformable and soft delivery tube during insertion. The temporary or interim mechanical support may be in the form of a partially supporting frame or a retractable frame.

[0019] The distal end of the tube / applicator tip is preferably steered by a robotic arm during laparoscopic surgery so that the surgeon can orient and position the distal end / tip by use of the robotic arm. To reduce the risk of the robotic arm squeezing, breaking, or twisting the applicator during manipulation, the applicator may include a surface area adapted for safe interaction with the robotic arm. For example, the applicator may include a rigid section that is less deformable and therefore specifically palpable and adapted for safe manipulation by the robotic arm. The rigid section may be provided on the delivery tube and / or the applicator tip. The release of the substance is preferably controlled by the robotic arm on-site during laparoscopic surgery. Thus, the applicator may comprise at least one actuator adapted for safe interaction with the robotic arm, such as an actuator configured to be actuated by a specific pressure height and / or by a specific pressure orientation that can be applied via the robotic arm. The actuator may alternatively be actuated by pulling or rotating the actuator. Thus, the release of the substance may be actuated by the robotic arm on-site and thus by the surgeon controlling the robotic arm. Alternatively, release of the substance may be actuated remotely from the target site, for example actuated by an assistant.

[0020] Advantageously, the delivery tube of the applicator is configured to hold the substance under pressure, or to hold the pressurized substance at least immediately prior to the substance being expelled. This can provide for more accurate and reliable expulsion of the substance at a determined site and at a determined time. For example, this has the advantage that the substance can be expelled from the delivery tube by simple interaction with the applicator tip, without any significant time delay.

[0021] Accordingly, a related aspect of the present disclosure is a laparoscopic applicator for administering or withdrawing a substance, such as a substance including a hemostatic agent, at a selected site using a surgical robotic arm, the applicator comprising: - a delivery tube configured to hold a substance under pressure; - an applicator tip connected to a distal end of the delivery tube, the applicator tip configured to controllably expel the substance from the delivery tube by a robotic arm; The present invention relates to a laparoscopic applicator comprising:

[0022] Thus, depending on the form of the substance to be pressurized, the distal end of the delivery tube may include one or more flow control elements, such as a valve adapted to allow the substance to be contained and pressurized within the delivery tube. Alternatively or additionally, the delivery tube may be dimensioned such that the substance may be pressurized due to existing capillary forces. Capillary forces may be defined as the pressure drop that occurs over the length of the delivery tube. Thus, the delivery tube, and in particular the applicator tip, is advantageously dimensioned and / or configured to include one or more flow control elements to hold the substance under pressure or configured to hold a pressurized substance.

[0023] A second aspect of the present disclosure is a laparoscopic applicator tip for connection to a laparoscopic delivery tube for holding a substance, such as a substance including a hemostatic agent, comprising: - at least one valve configured to release the substance from the delivery tube when opened; at least one actuator configured to open / close at least one valve; The present invention relates to a laparoscopic applicator tip comprising:

[0024] The applicator tip can be removably attached to the distal end of the delivery tube, which allows the tip to be reused while the delivery tube (possibly including a fluid or pressure source, as further described below) is discarded. Thus, the delivery tube, the applicator tip, and / or the fluid source can be disposable and / or configured for one-time use. Alternatively, the applicator tip can be an integral part of the delivery tube, such that the delivery tube and the applicator tip are a single unit. In an embodiment, the applicator tip only refers to the distal end of the delivery tube. The applicator tip can include a rigid section configured to be gripped by a robotic arm. The applicator tip can further include an adjustable nozzle for adjusting the dispense rate and / or dispense angle of the substance. The applicator tip can further include a pressure sensor, such as a resistive membrane pressure sensor, to sense the pressure applied to the actuator (e.g., by the robotic arm). In this case, the applicator tip preferably further includes a pressure indicator lamp for indicating the pressure applied to the at least one actuator.

[0025] Parts Kit An applicator according to the present disclosure may be provided as a part in a kit of parts for laparoscopic procedures, in particular a kit of parts suitable for robotic assisted surgery. Optionally, the applicator may be provided as a separate part of the kit, such as a delivery tube and applicator tip, which when assembled form an applicator according to the first aspect.

[0026] The kit may optionally further comprise one or more substance reservoirs for loading or filling the delivery tube prior to use. For example, the substance reservoir may be a syringe configured to be filled with a substance and configured to form a fluid connection to a delivery tube of the applicator, such as a distal opening of the delivery tube.

[0027] To reduce the number of parts and simplify assembly, a kit of parts may include an applicator and a pressure source that are easily assembled and configured to deliver a substance under pressure when assembled. For example, the pressure source may be a gas cartridge configured to form a fluid connection to a delivery tube of the applicator, such as a proximal opening of the delivery tube.

[0028] To further simplify assembly, one or more pressure sources may be integrated into the applicator, for example, a pressure source may be integrated into the delivery tube in the form of a spring located at the proximal end, where spring energy is pre-stored and / or stored upon loading the delivery tube with the substance.

[0029] A third aspect of the present disclosure relates to a kit of parts comprising an applicator according to the first aspect or an applicator tip according to the second aspect, one or more pressure sources, and optionally one or more substance reservoirs. For example, the substance reservoirs can be one or more syringes configured to be filled with a substance and configured to form a fluid connection to a delivery tube, such as a distal opening of the delivery tube. An embodiment relates to a kit of parts comprising an applicator according to the first aspect, one or more pressure sources, and optionally a syringe configured to be filled with a substance.

[0030] A kit of parts has the advantage that all parts can be assembled and operated manually and that all parts are disposable after use and adapted for single use.

[0031] Alternatively, the kit of parts may include parts adapted for multiple uses to obtain a more renewable and sustainable applicator design, for example the applicator may be assembled into a reusable unit or carrier that may include a pressure source in the form of a reusable piston or motor.

[0032] The kit of parts may further comprise a drive unit for holding the parts, i.e. the applicator and a pressure source.

[0033] A fourth aspect of the present disclosure is - a laparoscopic applicator according to a first aspect, - a drive unit, - at least one fluid source for holding a fluid, in fluid communication with the delivery tube; and / or - at least one pressure source, such as a motor, configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube; A drive unit for holding the The present invention relates to a kit of parts comprising:

[0034] To further increase the sustainability effect, the drive unit may be refilled with the fluid supply. Thus, the kit of parts optionally comprises one or more fluid supply reservoirs configured for removably mounting to the fluid supply in the drive unit.

[0035] Pressure Source Expulsion of a substance, such as a medical paste, from the applicator means that the substance held in the tube is forced through a delivery tube to the distal and tip end where the substance is expelled and administered. The pressure source for pressurizing the substance in the applicator can be any sufficient pressure source, such as a solid needle or in the form of a fluid that is advanced into the tube via a manually or motor driven piston, spring force, and / or trigger.

[0036] For accurate and reliable ejection of the substance at a given site and time, the delivery tube or applicator tip is advantageously configured to hold the substance under pressure at least immediately prior to the substance being ejected. Depending on the form of the substance to be pressurized, the distal end of the delivery tube or applicator tip may include one or more flow control elements, such as a valve adapted to allow the substance to be contained and pressurized within the delivery tube. Alternatively or additionally, the delivery tube may be dimensioned such that the substance can be pressurized due to existing capillary forces.

[0037] A fifth aspect of the present disclosure relates to a laparoscopic applicator further comprising at least one pressure source configured to apply pressure to at least one fluid source and / or to an interior of the delivery tube, such as to a material in the delivery tube.

[0038] Thus, the pressure source advantageously comprises at least one fluid source and / or a drive mechanism configured to move the substance in the delivery tube towards the distal end. The drive mechanism may be mechanically and / or electrically operated. For example, the at least one pressure source may comprise a drive mechanism selected from the group of a manual piston, a motorized piston, a spring force, and a gas pressure.

[0039] Mechanical Drive Mechanism For easy assembly of the kit according to the third and fourth aspects, to reduce the number of operating steps and for manual operation of the laparoscopic applicator, the pressure source may advantageously comprise a predetermined pressure force and / or a controllable pressure force. For example, the pressure source may comprise a fluid source with a predetermined propellant, such as a predetermined gas pressure in a gas cartridge, or a syringe with a predetermined amount of liquid. Alternatively, the pressure source may be a spring with a predetermined spring energy stored. The drive mechanism of the pressure source is thus mechanically controlled. For example, by simple assembly of the applicator and the pressure source, the applicator is adapted to administer a (medical) substance, such as a medical paste.

[0040] Electrical Drive Mechanism Additionally or alternatively, the drive mechanism of the pressure source may be controllable via a motor, such as a piston driven by a motor that pressurizes the substance in the delivery tube and provides for the ejection of the substance. The pressure source may be a fluid stream driven by a motor, such as a fluid stream obtained from a bellows, piston, wheel with paddles, or compressor that pressurizes and dispenses the substance from the delivery tube. Thus, the drive mechanism of the pressure source is a motor or is electrically controlled. For example, an actuator on the laparoscopic applicator or applicator tip may be configured to send an electrical signal to the drive mechanism or motor, which is configured to exert pressure on the pressure source or on the substance in the delivery tube upon receiving the electrical signal.

[0041] powder The laparoscopic applicator is configured to administer or draw in a substance, including a hemostatic agent, which may be in the form of a liquid, paste, or powder. Due to the flow characteristics of the powder, the pressure source or drive mechanism for transporting the hemostatic agent powder through and out of the delivery tube advantageously comprises a combination of a variable speed feeder, such as a screw conveyor, or a vibrating device, in combination with a gas pressure source.

[0042] A sixth aspect of the present disclosure is a laparoscopic applicator for administering a hemostatic agent powder at a selected site using a surgical robotic arm, comprising: - a delivery tube for holding a hemostatic agent powder; a variable speed delivery device, such as a screw conveyor, configured to transport the hemostatic agent powder through the delivery tube and out of the delivery tube such that the hemostatic agent powder is dispensed from the applicator; The present invention relates to a laparoscopic applicator comprising:

[0043] A seventh aspect of the present disclosure is a laparoscopic applicator for administering a hemostatic agent powder at a selected site using a surgical robotic arm, comprising: - a delivery tube for holding a hemostatic agent powder; - a valve positioned at a distal end of the delivery tube and configured to open at a predetermined opening pressure; a vibration device, such as an ultrasonic vibration device, configured to shake the hemostatic agent powder out of the delivery tube when the valve is open; The present invention relates to a laparoscopic applicator comprising:

[0044] Preferably, the applicator for administering the hemostatic agent powder further comprises one or more pressure sources, such as one or more gas pressure sources configured to transport the hemostatic agent powder through the delivery tube. The gas pressure source can be a motorized gas pressure source or a pressurized container, such as a gas cartridge. The pressurized container can be characterized as having stored pressure energy, which can be converted to kinetic energy by releasing the pressure, such as by manually opening the container. For example, the pressurized container can contain a fluid, which is simultaneously expelled from the container when the pressure is released.

[0045] An eighth aspect of the present disclosure relates to the use of a laparoscopic applicator according to the first aspect for administering a substance, such as a substance comprising a hemostatic agent, from the applicator.

[0046] The invention is explained in more detail below with reference to the accompanying drawings. [Brief description of the drawings]

[0047] [Figure 1] 1A-1D are diagrams of an embodiment of an applicator according to the present disclosure. [Diagram 2] FIG. 1 is a perspective view of an embodiment of an applicator according to the present disclosure manipulated by a robotic arm; [Diagram 3] 1A and 1B are diagrams of embodiments of an applicator according to the present disclosure comprising a delivery tube that is telescopic and has a rigid surface area at the tip, (C) a delivery tube that has a rigid surface area positioned a distance from the tip, and (D) an embodiment of a delivery tube that is semi-rigid. [Figure 4]1A-1C are diagrams of embodiments of applicators according to the present disclosure that include embodiments of deformable sections that are stretchable, compressible, and / or flexible. [Diagram 5] 1A-1D are diagrams of an embodiment of an applicator according to the present disclosure including a spring-loaded check valve; [Figure 6] 1A-1C are diagrams of an embodiment of an applicator according to the present disclosure comprising a duckbill valve; [Figure 7] 1 illustrates an embodiment of an applicator according to the present disclosure including a pressure source; [Figure 8] 1 illustrates an embodiment of an applicator according to the present disclosure including a pressure source; [Figure 9] 1 illustrates an embodiment of an applicator according to the present disclosure including a pressure source; [Figure 10] 1 illustrates an embodiment of an applicator according to the present disclosure including a pressure source; [Figure 11] 1 illustrates an embodiment of an applicator according to the present disclosure including a pressure source; [Figure 12] FIG. 2 is a diagram of an embodiment of an applicator according to the present disclosure, wherein the applicator comprises a delivery tube for holding a substance, a fluid source for holding a fluid, and a pressure source for exerting pressure on the fluid source. [Figure 13] 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator comprises a drive unit for holding a fluid supply and a delivery tube. [Figure 14] 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator comprises a drive unit for holding a fluid supply and a delivery tube. [Figure 15] FIG. 1 illustrates three different actuation mechanisms of the actuator: (A) pushing, (B) pulling, and (C) rotating. [Figure 16] FIG. 1 illustrates three different embodiments of an actuator: (A) a single button that covers a portion of the applicator tip; (B) two buttons positioned opposite each other at the tip; and (C) a single button that encompasses the entire periphery of the applicator tip. [Figure 17] 1A-1C are diagrams of embodiments of applicators according to the present disclosure, in which the applicator comprises a deformable section and actuators that may be disposed on either side of the deformable section. [Figure 18] FIG. 1 is a diagram of a drive unit that holds a fluid source (here, a syringe). The drive unit may feature various controls, such as a flow control device, to control the flow rate of the substance emitted from the applicator. [Figure 19] 1A is a diagram of an embodiment of an applicator tip according to the present disclosure, the tip comprising an actuator and a pressure light indicator for indicating applied pressure to the actuator. [Figure 20] FIG. 1 is a diagram of an embodiment of an applicator tip according to the present disclosure, the tip comprising an actuator, a pressure light indicator for indicating the pressure applied to the actuator, and a status indicator for indicating the remaining volume of substance in the delivery tube. [Figure 21] 1 is a diagram of an embodiment of an applicator tip according to the present disclosure, the tip comprising a status indicator, an actuator, a rigid section, and a deformable section.Measurements are provided by way of example only. [Figure 22] 1 is a cross-sectional view of an embodiment of a delivery tube according to the present disclosure, in which the delivery tube comprises multiple lumens (here, four lumens). [Figure 23] 1A-1D are diagrams of three different embodiments of a delivery tube with various deformable and rigid sections. [Figure 24] 1A-1C are diagrams of three embodiments of applicators according to the present disclosure, in which (A) the deformable section allows approximately 360° steering of the applicator, (B) the delivery tube comprises a malleable wire such that the position of the applicator tip can be changed but remains in the same position relative to the tube, and (C) the wire allows the deformable section to bend at a predetermined angle along one or more planes. [Diagram 25] 1 is a diagram of an embodiment of an applicator according to the present disclosure, the applicator tip including an actuator and a status indicator. [Figure 26]FIG. 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator includes a screw conveyor for transporting powder through a delivery tube. [Figure 27] FIG. 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator includes a vibration device for shaking the powder through a delivery tube. [Figure 28] FIG. 28 is a view of the embodiment of FIG. 27 from another angle, with the end of the valve visible. [Figure 29] 28 is a view of the embodiment of FIG. 27 from another angle, with the robotic arm squeezing the valve, thereby causing it to open so that powder is released from the applicator. [Diagram 30] FIG. 1 illustrates an embodiment of an applicator according to the present disclosure, in which the applicator includes two fluid sources (here, two syringes) and a drive mechanism for pressurizing the two fluid sources. [Diagram 31] 1A and 1B are diagrams of an embodiment of an applicator according to the present disclosure, in which the applicator includes a gas pressure source for transporting powder through a delivery tube, the gas pressure source being a bellows actuated by a primed piston, such as a piston that oscillates back and forth in a horizontal direction, (A) shows a perspective view of the applicator, and (B) shows a cross-sectional view. [Diagram 32] 1A and 1B are diagrams of an embodiment of an applicator according to the present disclosure, in which the applicator comprises a gas pressure source for transporting powder through a delivery tube, the gas pressure source being obtained via a motorized propeller and optionally a gas inlet, (A) showing a perspective view of the applicator and (B) showing a cross-sectional view. [Diagram 33] 1A-1C are diagrams of an embodiment of an applicator according to the present disclosure, in which the applicator comprises a pressure source for transporting powder through a delivery tube, the pressure source being a distally positioned piston with an opening, the distally positioned piston being powered to oscillate back and forth in a horizontal direction, (A) shows a partial perspective view with the distal end enlarged with an inserted frame, and (B) shows a cross-sectional view with the distal end enlarged in the perspective view with the inserted frame. [Diagram 34] 1 is a diagram of an embodiment of an applicator according to the present disclosure, in which the applicator includes a gas pressure source for transporting powder through a delivery tube, the gas pressure source being obtained by rotating a paddle wheel or impeller, which may be further controlled by a gas cartridge in combination with a gas flow control valve. [Diagram 35] FIG. 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator comprises a pressure source for transporting powder through a delivery tube and further comprises a flow restricting element for reducing gas flow at the powder delivery site, the flow restricting element being (A) a grid or slit element in the delivery tube and (B) a screw conveyor for transporting powder through the delivery tube in combination with a separate gas flow path. [Diagram 36] 1A-1C are diagrams of an embodiment of an applicator according to the present disclosure, wherein the applicator comprises a first substance reservoir and a second substance reservoir. [Figure 37] 1A-1B are diagrams of an embodiment of an applicator according to the present disclosure, the applicator comprising a first substance reservoir and a second substance reservoir, the second substance reservoir being removably attached to the first substance reservoir via an auxiliary connector element, (A) shows the attached reservoir and (B) shows the removed reservoir. [Figure 38] (A) A diagram of an embodiment of an applicator according to the present disclosure, the applicator configured to be loaded with a substance from a distal end, the distal end comprising (B) an auxiliary connector element removably attached to a substance reservoir, and (C) a flow control element. [Figure 39] 1A-1D are diagrams of an embodiment of an applicator according to the present disclosure, the applicator being configured to be loaded with a substance from a distal end as shown in (B) and the pressure source for pressurizing and dispensing the substance being a spring as shown in (C-D). [Diagram 40]1A-D are diagrams of an embodiment of an applicator according to the present disclosure, the applicator being configured to be loaded with a substance from a distal end as shown in (B) and the pressure source for pressurizing and dispensing the substance being a gas cartridge as shown in (C-D). [Diagram 41] FIG. 1 illustrates an embodiment of an applicator according to the present disclosure, wherein the applicator comprises two first substance reservoirs and a detached drive mechanism for pressurizing the two first substance reservoirs. [Diagram 42] 42A-42B are diagrams of the applicator of FIG. 41 having two first substance reservoirs and two second substance reservoirs (here, two syringes), where (A) shows the loading of the first reservoirs with syringes and (B) shows the loaded applicator. [Diagram 43] 43A-43C are views of the applicator of FIGS. 41-42, in which a removable drive mechanism for pressurizing the two first substance reservoirs is attached in (A) and in which the drive mechanism is emptying the two first reservoirs in (B). [Diagram 44] 1A-1D are diagrams of an embodiment of an applicator according to the present disclosure including a gripping area. [Diagram 45] 1 is a diagram of an embodiment of an applicator according to the present disclosure during spatial steering. [Diagram 46] 1A-D show an embodiment of a gripping area according to the present disclosure, shown in (A) longitudinal cross section and (B-D) transverse cross sections. [Figure 47] 1A-C show three embodiments of gripping areas according to the present disclosure, seen in perspective side view (lower image) and cross-sectional view (upper image). [Figure 48] 1A-F are perspective views of embodiments of gripping areas according to the present disclosure, the gripping area including (A) no actuation area, combined actuation areas, or (B-F) separate actuation areas. [Figure 49] 1A-C show an embodiment of a gripping area according to the present disclosure comprising a transmission unit, seen in (A) perspective side view, (B-C) longitudinal cross-sectional views, and (insert of B) transverse cross-sectional view. [Figure 50]1A-C are diagrams of embodiments of cross-sectional profiles of deposited material following ejection of an applicator and nozzle according to the present disclosure, where material is ejected from (A) a cylindrical nozzle, or (B-C) a non-cylindrical nozzle. [Figure 51] 1A-1C are diagrams of embodiments of deposited material profiles following ejection of an applicator and nozzle in accordance with the present disclosure, where material is ejected from (A) a cylindrical nozzle, or (B) a non-cylindrical nozzle. [Figure 52] FIG. 1 shows two embodiments (A and B) of a gripping area and nozzle according to the present disclosure, seen in a longitudinal cross-section (top left image), an oblique side view (bottom left image), and a view from the distal end (right image). [Diagram 53] 1A-E are diagrams of an embodiment of a gripping area according to the present disclosure comprising a transmission unit as seen in transverse cross section, (F) oblique view, (G) side view, and (H) distal end perspective. [Figure 54] (A-D) An embodiment of a gripping area according to the present disclosure comprising a nozzle or nozzle unit as seen in longitudinal cross section (top image) and side view (bottom image) and (E-F) views from the distal end. [Figure 55] 1A-C show three embodiments (A-C) of gripping areas according to the present disclosure as seen in cross-section (top image) and side view (bottom image). [Figure 56] 1A-1C are diagrams of an embodiment of an applicator according to the present disclosure, optionally including (A) a delivery tube with low tension build-up, and (B) the delivery tube when the applicator is inserted into a trocar. [Figure 57] 1A and 1B are diagrams of an embodiment of an applicator according to the present disclosure comprising an insertion guide for supporting a delivery tube, the insertion guide being (A) a reinforced post-section, and (B) a retractable exoskeleton as seen in the top and bottom figures with and without the tube, respectively. [Figure 58]1A and 1B are views of an embodiment of an applicator according to the present disclosure comprising an insertion guide for supporting a delivery tube, where the insertion guide is a retractable outer tube as seen in (A) the top and bottom figures with and without the tube, respectively, and (B) when the applicator with the retractable outer tube is inserted into a trocar. [Figure 59] 1A-1C are diagrams of an embodiment of an applicator according to the present disclosure, comprising an insertion guide for supporting a delivery tube, the insertion guide being a retractable guide wire as seen in (A) oblique view and (B) side view (top view) and cross-sectional view (bottom view). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] The present invention is described below with the aid of the accompanying drawings. It will be understood by those skilled in the art that the same features or components of a device are referred to by the same symbols in different drawings. A list of symbols can be found at the end of the detailed description section.

[0049] Applicator for administering a substance For surgical procedures, particularly endoscopic and / or laparoscopic procedures, a substance, such as a medical substance, such as a surgical hemostatic substance, such as in the form of a powder, fluid, or paste, is administered to a target site in a body cavity via an elongated applicator 1 comprising a delivery tube 2 configured to be pre-filled with a medical fluid / paste / powder 4 or filled with a medical fluid / paste / powder during surgery, as shown in FIG. 1. The delivery tube may be referred to as a cannula, and the inner lumen of the tube or cannula may be referred to as a flow path for the substance. A distal end 2.2 of the delivery tube may be introduced into the body cavity, such as through a trocar port, such as by manual manipulation by an assistant. To facilitate handling and insertion of the delivery tube, which may be flexible, the applicator advantageously comprises a rigid sheath 3 configured to insert the delivery tube into the trocar. The rigid sheath may be in the form of, for example, a rigid, tubular sheath, and may be attached to a section of the delivery tube, as shown in FIG. 1, or positioned around a section of the delivery tube, such as forming a covering layer around the outer delivery tube section.

[0050] The delivery tube can have an inner diameter of approximately 1-8 mm, such as approximately 5 mm, or an inner lumen with a diameter of approximately 1-8 mm, such as approximately 5 mm, which ensures good flow of the substance without requiring significant power from a pressure source or variable speed feeder to transport the substance through the delivery tube. The delivery tube can have an inner diameter of less than 5 mm, less than 3 mm, or less than 2 mm. When the delivery tube comprises multiple lumens, the inner diameter refers to the inner diameter of the lumen configured to contain the substance to be administered.

[0051] If the delivery tube or lumen for holding the substance has an internal diameter of less than 2 mm, this means that only a small amount of substance residue will be left behind in the delivery tube after administration of the substance.

[0052] In an embodiment of the present disclosure, the applicator further comprises a rigid sheath configured to insert the delivery tube into the trocar, such as a sheath configured to be positioned around a section of the delivery tube.

[0053] The delivery tube may be pre-filled with a substance (e.g., a medical fluid, paste, or powder) and / or may be configured to be filled with a substance after insertion into the trocar port. Thus, the delivery tube may contain a substance, such as a substance containing a bioactive agent, said substance being in the form of a liquid, a paste, or a powder. The substance may be a hemostatic agent substance containing a hemostatic agent. Advantageously, filling the delivery tube may be performed via the proximal end 2.1 of the delivery tube, which is accessible to the surgeon or assistant during the operation, as shown in FIG. 1. Filling the delivery tube is advantageously performed using a separate syringe with the substance in the syringe barrel, which may be pre-filled with the substance or may be configured to aspirate the substance from a source of the substance, such as a medical fluid source. Thus, the container or syringe containing the substance may be referred to as the substance reservoir 24. To facilitate safe and accurate filling with minimal material waste, the proximal end 2.1 advantageously includes one or more connectors 6 for removably attaching a fluid source, such as a syringe, that is pre-filled with the substance. Examples of connectors are a luer lock for attaching a syringe, or a compression or adhesive connection for attaching a substance reservoir or fluid container. Alternatively, the delivery tube and fluid source, such as a syringe, may be attached without the use of a connector.

[0054] The substance is then dispensed from the filled delivery tube by a driving force such as a pressure source 8. The driving force for expelling the substance is advantageously pressure generated at the proximal end 2.1 of the delivery tube, which is directly accessible to the assistant during surgery. For example, pressure can be generated by a second fluid that is forced into the proximal end from a separate fluid source 7, thereby pressurizing the substance present in the delivery tube, as can be seen in FIG.

[0055] In an embodiment of the present disclosure, the applicator further comprises at least one pressure source configured to apply pressure to the at least one fluid source and / or configured to apply pressure to an interior of the delivery tube, such as to a substance in the delivery tube.

[0056] Thus, the pressure source advantageously comprises at least one fluid source and / or a drive mechanism configured to move the substance in the delivery tube towards the distal end. The drive mechanism may be mechanically and / or electrically operated. For example, the at least one pressure source may comprise a drive mechanism selected from the group of a manual piston, a motorized piston, a spring force, and a gas pressure.

[0057] Further advantageously, the pressure of the second fluid is predetermined and / or controllable, such as by being in the form of a predetermined pressurized fluid source, the predetermined pressure being released in fluid connection with the proximal end of the delivery tube. To facilitate safe and accurate pressure transfer, the proximal end of the delivery tube advantageously comprises one or more connectors 6 for removably attaching a pressure source 8 or a fluid source 7, such as a fluid container, more preferably a fluid container configured to be pressurized.

[0058] Further advantageously, the fluid connector is configured to form a fluid connection between the fluid source and the proximal end of the delivery tube when connected, for example in the same manner as a vial adapter where the rubber seal of the fluid source is pierced by a hollow piercing element. Thus, a fluid connection can be obtained between the sealed fluid source and the delivery tube via the piercing element. Alternatively, the fluid source does not need to be pierced to form a fluid connection. Instead, the fluid source may simply be attached to the delivery tube, either directly (e.g., a tube and a syringe are connected) or via a connector.

[0059] In an embodiment of the present disclosure, the proximal end of the delivery tube includes one or more connectors 6 for removably attaching a fluid source, such as a luer lock, a compression connection, and / or an adhesive connection for attaching a syringe and / or a fluid container. In further or alternative embodiments, the one or more connectors include a hollow piercing element for piercing the fluid source, thereby establishing a fluid connection between the fluid source and the delivery tube.

[0060] The drive mechanism of the pressure source may thus be mechanically controlled by attachment of the pressure source to the applicator, such that by mechanical assembly the applicator is adapted to dispense a (medical) substance, such as a medical paste.

[0061] Additionally or alternatively, the drive mechanism of the pressure source may be controllable via a motor, such as a piston driven by a motor that pressurizes the substance in the delivery tube or fluid source, thereby providing for the ejection of the substance. For example, the pressure source 8 may be a flow of fluid source 7 driven by a motor. Thus, the drive mechanism of the pressure source is a motor or is electrically controlled.

[0062] Advantageously, the delivery tube of the applicator is configured to hold the substance under pressure, or to hold the pressurized substance at least immediately prior to the substance being expelled. This provides for more accurate and reliable expulsion of the substance at a determined site and at a determined time. For example, this has the advantage that the substance can be expelled from the delivery tube by simple interaction with the applicator tip, without any significant time delay.

[0063] Thus, depending on the form of the substance to be pressurized, the distal end of the delivery tube may include one or more flow control elements 26, such as a valve adapted to allow the substance to be contained and pressurized within the delivery tube. For example, the applicator tip may include at least one valve configured to hold and release the substance under pressure, or a flow control element, such as a three-way valve. Additionally or alternatively, the valve may be a throttle valve. A valve is defined as a device that regulates, directs, or controls the flow of fluids (i.e., gases, liquids, and fluidized solids such as pastes and slurries) by opening, closing, and / or partially obstructing a flow path. Thus, an example of a valve includes a flow restricting element, such as a protrusion in a fluid passageway, which obstructs the fluid passageway when the fluid pressure is below a threshold value, and when the fluid pressure is above the threshold value, the fluid flows and bypasses the protrusion. A valve including a flow restricting element is also referred to as a "throttle valve."

[0064] In an embodiment of the present disclosure, the delivery tube is configured to hold a substance under pressure or to hold a pressurized substance. In other or further embodiments, the laparoscopic applicator tip includes at least one valve configured to hold and release a substance under pressure. For example, the valve may include a flow control device, such as a three-way valve, that can control the amount and direction of flow.

[0065] Alternatively or additionally, the delivery tube and / or the applicator tip may be dimensioned such that the substance can be pressurized in the delivery tube due to the capillary forces present. Advantageously, therefore, the delivery tube has a length of more than 200 mm, preferably between 300-600 mm or 350-500 mm, such as 440 mm or 500 mm, the length being defined as extending from the proximal pressure source to the distal end of the tip. Furthermore, the outer diameter of the delivery tube is preferably between 3-10 mm, such as 5 mm, or between 2.5-4.5 mm, such as 3 mm, 3.5 mm, or 4 mm. Furthermore, the inner diameter or lumen of the delivery tube, or at least the inner diameter of the applicator tip, is preferably 2 mm or less, preferably between 1.5-2.0 mm, such as 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, or 1.9 mm. Additionally, the applicator tip may comprise an inner diameter or lumen having the same or different shape or size as the inner diameter of the main delivery tube, for example the gripping area shown in FIG. 46A. For example, the delivery tube may comprise a lumen with a cross-sectional diameter between 1.2-1.5 mm (indicated as D_FC in FIG. 46A), or a cross-sectional area corresponding to a diameter between 1.2-1.5 mm for a non-circular lumen or flow passage. If the delivery tube comprises multiple lumens, the inner diameter refers to the inner diameter of the lumen configured to contain the substance to be administered. If the delivery tube or lumen for holding the substance has an inner diameter of less than 2 mm, this means that only a small amount of substance residue will be left in the delivery tube after administration of the substance.

[0066] Thus, the delivery tube, and particularly the applicator tip, is advantageously dimensionally configured to hold a substance under pressure or configured to hold a pressurized substance, and / or configured to include one or more flow control elements.

[0067] The delivery tube may comprise multiple lumens, such as at least two lumens, at least three lumens, or at least four lumens. FIG. 22 shows an embodiment in which the delivery tube comprises four lumens. At least one of the multiple lumens should be configured to contain the substance to be administered from the applicator, i.e., to act as a flow path for the substance. In one embodiment, the delivery tube comprises a first lumen and a second lumen, the first lumen configured to contain the substance and the second lumen configured to contain electrical wiring or optical fiber. The electrical wiring may be used to electrically connect an actuator located, such as at the distal or tip end of the tube, to a control unit or pressure source located, such as at the proximal end of the tube. The delivery tube may comprise multiple lumens, with at least two lumens configured to hold the substance. As an example, the tube may comprise a first lumen for holding a first type of substance and a second lumen for holding a second type of substance. In some applications, two types of substances are mixed once the substances are administered or before they are administered. In this case, one substance may be in the form of a liquid and the other substance may be a powder that is mixed in a liquid. The two substances may be two liquids or two pastes, or other combinations of liquids, pastes, and powders. An applicator with a delivery tube having two lumens is shown in FIG.

[0068] In other embodiments, at least one of the multiple lumens is configured to include a malleable wire or rod disposed in the internal lumen of the delivery tube (as shown in FIG. 24(B) and (C)). Thus, the applicator may further comprise a malleable wire or rod configured to allow the deformable section of the delivery tube to bend into a desired shape, which shape is approximately maintained upon release of the delivery tube. This has the advantage that the deformable section can be bent without the tube returning to its original point. This provides the surgeon with greater freedom to orient the distal end of the tube and / or the applicator tip in a desired orientation, such as to more easily reach difficult to access areas inside the body. In one embodiment, the deformable section of the delivery tube may be bent along two planes at two predetermined angles, such as at least 30° or at least 45°. This may be similarly achieved using a malleable wire or rod disposed in the internal lumen of the delivery tube.

[0069] The gripping area in the axial extension of the delivery tube is advantageously adapted so that the lumen is also axially extending. Figures 53A-53F show embodiments of a delivery tube, cannula, or gripping area in a transverse cross-section, i.e., as seen transverse to the tube axis. For flexible and safe spatial manipulation, the dimensions or contours of the gripping area are advantageously circular, such as circular with an outer diameter (DO) between 2.5-4.5 mm, as shown in Figure 53A. The inner dimensions or contours of the tube or lumen configured as a flow passage are also advantageously circular and concentric for efficient flow, as also shown in Figures 53A, 53C-53E. For example, the inner diameter (DI) may have a diameter between 1.5-2.0 mm.

[0070] As described above, the delivery tube may include one or more additional lumens configured to contain a signal carrying or transmitting device 28, such as electrical wiring or optical fiber. For example, a lumen may include a wire configured to carry or transmit an electrical signal from a distally positioned transmitting unit 27 to a proximally positioned receiving unit, which is optionally connected to a drive mechanism to apply pressure to a material inside the delivery tube. A tube including one or more wires is obtained, for example, by co-extrusion.

[0071] For example, the distally positioned transmission unit may be a light source, a sensor, and / or a camera. Examples of sensors include detection sensors and / or actuators, such as electromechanical switches, pressure-sensitive membranes, and optical pressure sensors. The transmission unit may be integrated into the applicator tip and / or gripping area, and preferably the transmission unit is integrated and dimensioned such that the dimensions of the applicator tip and / or gripping area allow for penetration through a trocar. For example, the maximum diameter of the applicator tip and / or gripping area including the integrated transmission unit is preferably less than 5 mm, such as 4.5 mm.

[0072] 53F-53H show an applicator tip 9 with a gripping section 29 with an integrated camera or light source 27 optionally positioned in a separate section at the applicator tip and the more distal end of the gripping section. FIG. 49 shows an applicator tip 9 including a gripping section 29 with an integrated actuator 2.6 or sensor 27 positioned adjacent the applicator tip and the more distal end of the gripping section, with a signal carrying or transmitting wire 28 disposed in the second lumen 15 of the tube, as seen in (A) oblique side view, (B-C) longitudinal section, and (insert in B) transverse section. To facilitate contact between the robotic arm and the actuator or sensor, the surface of the actuator / sensor may include one or more protrusions, such as a series of parallel ridges as shown in FIG. 49A. The actuator / sensor may alternatively or additionally comprise a transmission unit cover 27.1, such as a rigid cover that is in physical, mechanical or electromechanical contact with the transmission unit such that only the cover is in direct contact with the robot arm, as shown in Figures 49B-49C.

[0073] In an embodiment of the present disclosure, the applicator tip and / or gripping section comprises one or more integrated transmission units selected from a light source, a sensor, a camera, and combinations thereof. In a further embodiment, the applicator comprises one or more lumens configured to comprise one or more signal carrying or transmitting devices, such as electrical or optical signal carrying devices.

[0074] Spatial Maneuvering Replacing the movements of a human hand with a robotic arm controlled by computer software facilitates highly accurate and controlled movements. Thus, a laparoscopic applicator spatially steered by a robotic arm can be more precisely controlled, as well as more reliable with reduced risk of accidental movement. Thus, for example, a laparoscopic applicator for administering a substance using a robotic arm can more precisely and reliably administer the substance at a selected site. Specifically, a robotically steered applicator for administering a hemostatic agent substance at a selected site can result in bleeding being stopped more efficiently.

[0075] 2 is a perspective view of an embodiment of an applicator configured to be spatially maneuvered by a robotic arm 5. The robotic arm may include a medical device, such as a tool for surgery, such as a grasper, tweezers, or similar robotic finger elements for grasping, pushing, or forming an attachment to the applicator.

[0076] The robotic arm and fingers may not include haptic feedback. Thus, to ensure a safe robotic use of the applicator with reduced risk of destroying the applicator, the applicator may advantageously comprise a rigid surface area 2.4 or a rigid area 2.8, which area or area is configured for manipulation by the robotic arm / fingers. Thus, the delivery tube may comprise at least one rigid area, such as a rigid tubular area or a rigid surface area. The rigid area and / or the rigid surface area is preferably dimensioned such that the robotic arm / fingers can grip, press or form an attachment to the rigid surface area without risking destroying the applicator. For example, for a robotic arm including a gripper, the rigid surface area is advantageously a rigid tubular area, as shown in FIG. 2. The rigid area is preferably provided with an opening so that the robotic arm can press an actuator arranged in said opening, the actuator being configured to open a valve when the pressure exceeds a predetermined pressure level, whereby the medical substance can be dispensed from the applicator.

[0077] In an embodiment of the present disclosure, the distal end of the delivery tube comprises one or more rigid surface regions configured for manipulation by a robotic arm. In a further embodiment, the rigid surface region is dimensioned to be palpable by a robotic arm, such as palpable by grasping, pushing, or attachment. In a further embodiment, the distal end comprises a rigid tubular section.

[0078] To facilitate precise and convenient discharge of the substance at a selected site, one or more rigid surface regions 2.4 are advantageously positioned at the distal end 2.2 of the applicator and / or the applicator tip, as shown in Figures 1 and 2. Thus, discharge of the substance can be more precisely and easily directed when there is a rigid surface in the vicinity of where the substance is to be administered.

[0079] However, the rigid surface region 2.4 may also be positioned at a distance from the distal tip, as shown in Figure 3C. This may be advantageous when the substance is administered where there is limited space in a body cavity. Thus, the rigid surface region may be a rigid tubular section of the delivery tube 2 positioned at a distance from the distal tip, as shown in Figure 3C. Thus, the orientation of the distal end is steered by the use of a rigid tubular section positioned at a distance from the tip.

[0080] Additionally or alternatively, flexible steering of the distal end of the delivery tube can be obtained through the use of a delivery tube, where either a section of the delivery tube, or optionally the entire delivery tube, comprises a semi-flexible or semi-rigid material, as shown in Figure 3D. Because the semi-rigid material is sufficiently palpable by a robotic arm / fingers, interaction can occur at any point along the delivery tube and at any distance to the spatially steered distal tip 2.2.

[0081] The flexible and precise steering of the distal end can be further improved by a delivery tube comprising a deformable section 2.3. By the term deformable section is meant a section that can be deformed plastically or elastically when exposed to a deformation force such as tension, compression or bending. Advantageously, the deformable section is plastically deformed, meaning that the deformation remains after the deformation force is removed. Alternatively, the deformation is elastic, meaning that the deformation is reversible on removal of the deformation force.

[0082] For example, the deformable region 2.3 may be configured to be telescoping or expandable when exposed to tension in the longitudinal direction, such as by a robotic arm pulling on the delivery tube tip, causing the delivery tube to lengthen, as indicated in Figures 3A-3B and 4A-4B by the arrows. Correspondingly, the deformable region may also be configured to be compressible when exposed to a compressive force, such as by a robotic arm pushing on the delivery tube tip, as indicated in Figure 4B. Correspondingly, the deformable region may further be advantageously configured to be flexible or bendable, as indicated in Figure 4B.

[0083] The deformable zone may comprise an elastically or plastically stretchable, compressible, and / or flexible material. Additionally or alternatively, the deformable zone may comprise a wavy surface profile, such as in the form of a plurality of circumferentially extending crimped folds, as shown in Figures 4A-4D and 17. The wavy surface profile allows for extension, compression, and / or bending in the same manner as a drinking straw. Thus, the delivery tube may comprise a deformable zone that is compressible, such as in the form of a wavy tube, such that the length of the tube can be changed.

[0084] In an embodiment of the present disclosure, the delivery tube comprises a deformable section. Advantageously, the deformable section is located at the distal end of the delivery tube so that the applicator tip can be steered by a smaller torque / moment. Alternatively, the deformable section is located at a distance from the distal end of the delivery tube so that the tip can be steered by a defined torque / moment. In a further embodiment, the deformable section is configured to be elastic and / or flexible, such as comprising an elastic and / or flexible tubing. In a further or alternative embodiment, the deformable section comprises a wavy surface profile. In a further embodiment, the wavy surface profile comprises a plurality of circumferential folds in the manner of a drinking straw crimping.

[0085] Spatial Maneuvering-Grabbing Area As described above, spatial steering of the applicator tip by the robot arm means that the robot arm physically contacts the applicator tip. To ensure accurate and reliable spatial steering, the applicator tip is advantageously configured to be gripped by the robot arm such that at least two opposing contact points are obtained, thereby providing a stable and robust contact. For example, the applicator tip may be configured to be gripped by the robot arm in the manner of tweezers with a gripping direction parallel to the longitudinal axis of the applicator and tip and to the material flow direction. The tweezers jaws are thus gripping or clamping around a cross section or circumference transverse to the axis of the applicator tip. This is obtained in particular when the applicator tip comprises a gripping area 29 in the axial extension of the delivery tube 2, as shown, for example, in Figs. 44 and 48, and the robot arm grips or clamps around a cross section or circumference transverse to the longitudinal axis.

[0086] The gripping area can therefore be configured to be gripped by a robot arm so that a particularly stable and robust contact area and surface can be obtained, particularly for the non-tactile gripping forces of the robot. Advantageously, the gripping area has a periphery transverse to the longitudinal axis with a top-shaped area so that the shape of the top can essentially match at least a part of the shape of the grip of the robot arm. Thus, a maximum contact area between the gripping area and the robot arm can be obtained. Typically, the grip of the robot arm is a jaw gripper acting transversely to the length or axis of the applicator tip, i.e. the jaw opening tightens transversely across the gripping area, as shown in Figs. 2 and 45. The gripping area 29 of the applicator tip can therefore include a matching cross-sectional reduction to the jaw opening. For example, the gripping area can have a periphery with a top-shaped area in the form of an ellipse, as shown in the perspective view in Fig. 48 and in the cross-sectional view in Fig. 46B.

[0087] An aspect of the present disclosure is a laparoscopic applicator for administering a substance, such as a substance including a hemostatic agent, at a selected site using a surgical robotic arm, comprising: - a delivery tube; - an applicator tip connected to a distal end of a delivery tube, the applicator tip being configured to be controllably moved by a robotic arm near a gripping area in an axial extension of the delivery tube, the applicator tip being configured to be gripped and spatially manipulated by the robotic arm, the gripping area having an outer periphery with a molded apex area; The present invention relates to a laparoscopic applicator comprising:

[0088] Thus, the robotic arm or jaw 5 will stay in place when clamping the applicator tip 9 or gripping area 29 without slipping inward or slipping off the instrument jaws, and can overcome any resistance from the flexible tube during movement and manipulation, as shown in Figure 45 A. The surgeon can then grasp and hold the applicator tip by the robotic arm or by one or more instruments docked to the robotic arm.

[0089] The gripping area facilitates the applicator tip to establish a well-defined grip and fixation to the robotic arm or instrument, and is configured so that the surgeon can move it freely to follow the high mobility of the robot. Examples of robotic instruments that can be docked to the robotic arm include Bipolar Fenestrated Forceps, Pro Grasps, and needle holders. These instruments are particularly suitable for small-scale surgery, where the site of surgery has smaller dimensions. Robotic instruments for small-scale surgery are adapted with a jaw opening of less than 55°, such as 30°, and a jaw length of less than 28 mm, such as 10 mm.

[0090] Advantageously, the applicator tip or gripping area is configured to be grasped by a robotic arm comprising a robotic instrument selected from the group of forceps, graspers, needle holders, and combinations thereof. Thus, the applicator tip or gripping area is configured to be grasped by an arm or instrument with a jaw opening angle of less than 55°, such as 50°, 45°, 40°, 35°, 30°, or 25°, and / or a jaw length of less than 28 mm, such as 25 mm, 20 mm, 15 mm, 10 mm, or 5 mm.

[0091] To further improve the stability and robustness of the gripping area 29, the peripheral apex molded area can have a rounded shape, for example, the gripping area can have a peripheral shape or cross-sectional shape that is an oval or ellipse, as shown in the perspective view of Figure 48 and the cross-sectional view in Figure 46B. However, other apex shapes and peripheral shapes may also be applied, such as an ellipse (Figure 46C) or a triangle (Figure 46D) with one axis of symmetry.

[0092] In an embodiment of the present disclosure, the shaped apex area is selected from the group of rounded apex, blunt apex, sharp apex, pointed apex, and combinations thereof. In a further embodiment, the perimeter has a shape selected from the group of oval, ellipse with one axis of symmetry, ellipse with two axes of symmetry, equilateral triangle, isosceles triangle, scalene triangle, parallelogram, and rhombus.

[0093] The applicator tip and gripping area are advantageously dimensioned so that they can be stably and robustly gripped by a robotic arm or tool. For the applicator tip shown in Figs. 46A-B, example dimensions are shown in the table below. The length (L) of the gripping area can be adapted to include an actuation area 29.3, which can partially cover the gripping area and include an actuator or sensor configured to actuate the substance release mechanism. The actuation area can be located in front / distal (Fig. 48C), behind / proximal (Fig. 48D), opposite (Fig. 48E) or circumscribing (Fig. 48F) the gripping area, as also described in connection with Fig. 16. For applicators without an actuation area or with an actuation area combined or matched with the gripping area, the gripping area can be relatively short, such as 30-35 mm, since it only provides an area for gripping and fixation.

[0094] [Table 1]

[0095] In an embodiment of the present disclosure, the circumference is defined by a major axis defining the longest dimension and a minor axis defining the shortest dimension. In a further embodiment, the major axis is between 2.5-5.2 mm, more preferably between 3-4.5 mm, and most preferably between 3.5-4 mm. In a further embodiment, the minor axis is between 2.5-3.5 mm, more preferably between 2.7-3.3 mm, and most preferably between 2.9-3.1 mm, such as 3 mm. In an embodiment of the present disclosure, the gripping area has a length between 20-25 mm, such as 21 mm, 22 mm, 23 mm, or 24 mm. In an alternative embodiment, the gripping area has a length between 30-35 mm, such as 31 mm, 32 mm, 33 mm, or 34 mm.

[0096] As illustrated in FIG. 46A, the gripping section 29 can include a connection section 29.1 configured to connect or couple the applicator tip and the gripping section to the delivery tube 2, thereby forming a fluid communication with the delivery tube. The connection section can be an axial extension of the gripping section and can have a rounded outer periphery, for example in the form of a cylindrical section with a lumen, to provide a smooth transition from the delivery tube to the tip / gripping section, as shown in FIG. 46A. The connection can be obtained by a joint or adhesive joint that includes an overlap in the axial direction between the connection section 29.1 and the delivery tube 2, optionally with an adhesive between them, as shown in FIG. 55. For example, the overlap can be obtained by a vertical cut delivery tube inserted into the connection section, as shown in FIG. 55A. Alternatively, the overlap can be obtained by a stepped cut tube inserted into the connection section, as shown in FIG. 55B.

[0097] Additionally or alternatively, the connection section 29.1 may include a shrink tube 30, as shown in FIG. 55C. The shrink tube covers the connection section 29.1 and optionally a portion of the gripping section 29. Thus, the shrink tube further establishes a smooth transition between the delivery tube 2 and the gripping section 29, and may also provide protection for the connection between the tip and the tube. Advantageously, the shrink tube covers at least a portion of the gripping section, such that the gripping section can provide a more stable and robust grip. For example, the shrink tube may comprise a material configured to have low hardness properties, such as a soft polymeric material, such as a polyolefin, which allows for a more stable and robust grip of the robotic arm to the tip due to greater friction.

[0098] In an embodiment of the present disclosure, the gripping section comprises a connection section in fluid communication with the delivery tube, hi a further embodiment, the connection section comprises a connection selected from the group of a straight break connection, a stepped break connection, an adhesive connection, a shrink tube connection, and combinations thereof.

[0099] Spatial Manipulation-Grabbing Materials The gripping area and / or the connection area advantageously comprise a robust material, such as having sufficient mechanical strength such that the material is robust against occlusion, such that the lumen of the applicator tip and the gripping area are not occluded, crushed or permanently deformed even when subjected to a stable and robust grip of a robotic arm, such as including a sufficient gripping force. Furthermore, the material is advantageously a robust material with high wear resistance, such that shedding of small pieces is avoided even after prolonged handling by the robotic arm. Thus, the applicator tip and the gripping area preferably comprise a material with a high wear rate constant (i.e. specific wear rate). Furthermore, the material must be robust, i.e. should not be brittle, to reduce the risk of sudden brittle fracture during operation.

[0100] In an embodiment of the present disclosure, the gripping area comprises an occlusion-resistant material selected from the group of steel, stainless steel, ABS, polycarbonate, polyamide, polymers such as PEEK, and combinations thereof.

[0101] The gripping area 29 may comprise or consist of a robust material, such as steel, as shown in FIG. 47A. The gripping area may also include a shrink tube 30, as shown in FIG. 47B-C. The shrink tube may cover only the gripping area 29, as shown in FIG. 47B, or may cover the gripping area 29, some or all of the connection area 29.1, and / or a portion of the delivery tube 2, as shown in FIG. 47C. The shrink tube may comprise a material configured to have a lower hardness, such as a polymeric material, such as polyolefin, which allows for a more stable and robust grip of the robotic arm to the tip due to greater friction. In particular, the covering material may have a lower level of hardness against the surgical instrument, and the material may have a high coefficient of friction. Thus, the robust gripping area may comprise a strong and durable steel covered with a softer polyolefin covering. To further improve the stability and robustness of the grip, the gripping area may be designed with geometric features, such as ridges that provide engagement with the surgical instrument to achieve a better grip, as shown in FIG. 49A.

[0102] In an embodiment of the present disclosure, the gripping area comprises a coating comprising a soft polymer selected from the group of polyolefins, ABS, and combinations thereof, hi a further embodiment, the coating is provided by shrink tubing.

[0103] In the event that the surgeon inadvertently releases the grip of the robotic arm or instrument on the applicator tip or gripping area, it is beneficial to have a safety release mechanism included within the applicator tip and / or gripping area. For example, a magnet can be embedded in the tip with a holding force that is sufficient to secure the tip to a surgical instrument (including the weight of the tubing), while at the same time having a holding force that is low enough to ensure that the surgeon can easily remove the instrument from the tip, if desired. An example of such a magnet is a 400 g / cm 2 The magnet may be a neodymium magnet with a coercive force of .

[0104] In an embodiment of the present disclosure, the applicator tip and / or gripping section comprises a magnetic element configured to magnetically attach the tip to a surgical instrument, the magnetic element preferably having a magnetic resistance of at least 400 g / cm 2 , more preferably 425 to 800 g / cm 2 Between 450~700g / cm 2 Between 500 and 600 g / cm 2 It is a neodymium magnet with a coercive force between

[0105] Spatial Steering-Delivery Tube The gripping area facilitates that the robotic arm or jaws can clamp the applicator tip to stay in place without slipping inward or off the instrument jaws, and overcome any resistance from the flexible cannula or delivery tube during movement and steering, as shown in FIG. 45A. To further ensure easy, accurate and reliable spatial steering, the delivery tube is advantageously configured to be flexible, deformable and soft, and mechanically stress-free or stress-relieved upon deformation associated with steering of the tip. This will reduce whipping or bouncing of the delivery tube that can occur when the delivery tube is bent or steered (FIG. 45A) and subsequently released (FIG. 45B), as shown in FIG.

[0106] When operating a robotic surgery, the image seen by the surgeon through the endoscopic camera is magnified by up to 15 times. This means that the field of view is very narrow and even a relatively small movement in the instrument or applicator will move the instrument or applicator out of the field of view of the camera and the surgeon. A common situation that occurs when maneuvering an applicator tip attached to a flexible tube is that when the surgeon moves the tip with the instrument, tension accumulates in the flexible tube because the tube is partially immobilized by the trocar in which the tube is inserted. Therefore, when the surgeon releases the tip, the accumulated tension is released, resulting in a whiplash effect in which the tip is moved out of the field of view. In order to reduce the problem of "whiplash" as much as possible, it is important to select materials and tubing dimensions that create as little "whiplash" as possible. Therefore, advantageously, the delivery tube or at least a part or section is configured to be flexible without tension, which means that the material is adapted to bend without mechanical stress. This can be obtained by a material having sufficient flexibility (i.e. a sufficiently small Young's modulus) in combination with sufficient energy dissipation properties, such as to sufficiently dissipate vibration energy (corresponding to a sufficiently high damping coefficient or mechanical loss coefficient). For example, a tension-free flexible tube suitable for the relative movements occurring in robotic arm surgery can have a Young's modulus between 0.0001 and 0.035 GPa, as measured by the tensile test for plastics according to standard ISO 527-1 / -2 and described in more detail in standard ASTM D638. Furthermore, a tension-free flexible tube suitable for the relative movements occurring in robotic arm surgery can have a damping coefficient between 0.2 and 2.0, as measured by standards ASTM D4065-20 and ISO 6721-1:2019.

[0107] In an embodiment of the present disclosure, at least a portion of the delivery tube is configured to be flexible without tension. In a further embodiment, the delivery tube comprises a flexible material having a Young's modulus between 0.0001 and 0.035 GPa, more preferably between 0.001 and 0.03 GPa or between 0.01 and 0.25 GPa, and most preferably between 0.015 and 0.020 GPa. In a further embodiment, the delivery tube comprises a material having a damping coefficient between 0.2 and 2.0, more preferably between 0.4 and 1.8 or between 0.6 and 1.6, and most preferably between 0.8 and 1.4. In a further embodiment, the delivery tube comprises or consists of a vibration energy dissipative material selected from the group of silicone elastomers, butyl rubber, polyurethane, and combinations thereof.

[0108] Applicator Insertion The applicator 1 is typically introduced or inserted circumferentially into a target site in a body cavity, such as the abdomen, via a trocar 31, as shown, for example, in Fig. 56B. Insertion thus involves guiding the distal end of the applicator into the surgeon's field of view at the console before the applicator is handed over to the robotic instrument and the applicator is grasped and steered by the robotic arm.

[0109] Insertion guidance is accomplished by pushing the applicator forward, i.e., in a distal direction, while orienting the applicator distal end 2.2 or tip 9 toward the target site. Tip orientation can be obtained by tilting the applicator or trocar, which pivots about the trocar insertion point. Insertion and guidance can be assisted by a video feed presented on the OR monitor, for example connected to a robotic camera. In this way, the assistant has the same view of the abdomen as the surgeon at the console.

[0110] Insertion guidance is facilitated by the mechanical properties of the delivery tube, which may be particularly advantageous if the delivery tube 2 and / or an assembly including the delivery tube is stiff enough to carry the weight of the distal section 2.2, optionally including the gripping section 29, so that the delivery tube exits or exits the trocar 31 with minimal deflection, as shown in FIG. 56B. If the delivery tube is soft (e.g., by comprising a material with a lower elastic modulus) and / or is deformable with limited tension buildup (e.g., by comprising an energy dissipating material), the tube will not have the inherent mechanical support to be self-supporting or self-supporting, and the distal end and tip will sag just below the insertion point such that it cannot be pulled by gravity and guided to the desired target area. However, once inserted and delivered to the robotic instrument, the delivery tube is advantageously soft and flexible with no inherent mechanical stiffness, and is deformable with limited tension buildup, as described above, so that it can move freely around without tension buildup.

[0111] To facilitate that the delivery tube can be easily introduced or inserted and oriented from the environment to the target site while being spatially maneuvered with minimal tension buildup at the target site in the body cavity, the applicator advantageously further comprises an insertion guide 32 for at least temporarily supporting the mechanically deformable and soft delivery tube during insertion. The insertion guide can thus form an assembly with the delivery tube. The insertion guide thus facilitates an applicator that is both rigid and oriented during insertion and during the transition of handover from the applicator to the robotic instrument, and soft and flexibly deformable without tension buildup under the surgeon's control of the robotic arm and console. The insertion guide thus enables switching from a rigid applicator to a flexible and soft applicator.

[0112] In an embodiment of the present disclosure, the applicator further comprises an insertion guide for supporting the delivery tube.

[0113] Preferably, when the delivery tube is configured to be flexible, deformable and soft, and mechanically stress-free or stress-relieved upon deformation associated with tip manipulation, the insertion guide 32 is advantageously a temporary or provisional mechanical support for the delivery tube. FIG. 56A shows an embodiment of an applicator 1 according to the present disclosure, which may include a soft delivery tube 2 with low tension buildup. The distal end 2.2 may include a gripping area 29, and the proximal end 2.1 may include a connector 6, for example, for connection of the delivery tube to a fluid source. For example, the connector may be directly attached to a reservoir or syringe containing a hemostatic agent, such as a luer connector, or may be configured to be integrated as part of a drive unit, as shown in FIG. 18. As shown in FIG. 56B, when the applicator is inserted into a trocar 31 and the delivery tube is soft and does not have inherent mechanical support to be self-supporting or self-supporting, the distal end and tip will simply be pulled by gravity as it exits the trocar and cannot be guided to the desired target area.

[0114] The insertion guide may be in the form of a partially supporting frame or a retractable frame, as illustrated in Figures 57-59. The frame thus supports or carries the delivery tube, thereby providing a partial or temporary stiffness or rigidity such that the assembly may be easily guided to a desired target area and handed over to a robotic arm. For example, the frame may be removably attached to the delivery tube, such as slidably mounted in the axial direction of the tube, such that the frame may be easily retracted after the robotic arm has gained contact with the delivery tube. To act as an insertion guide, the guide comprises a rigid material with a higher modulus of elasticity than the delivery tube.

[0115] In an embodiment of the present disclosure, the applicator includes an insertion guide for supporting the delivery tube, the insertion guide configured to be slidable along the axial direction of the delivery tube.

[0116] Fig. 57A shows an embodiment of an applicator 1 according to the present disclosure with an insertion guide 32 for supporting the delivery tube 2, which is the reinforced post-section or proximal end 2.1. Thus, the delivery tube is reinforced with additional material, for example in the form of a sheath or outer tube mounted on the flexible delivery tube, or by the addition of other materials with higher elastic modulus. The reinforcement is located at the proximal end of the delivery tube, i.e., a certain distance from the applicator tip, to facilitate the movement of the tube in the distal direction, and can extend over the flexible delivery tube up to or at a distance from the connector element 6, as shown in Fig. 57A.

[0117] 57B shows an embodiment of an applicator 1 according to the present disclosure with an insertion guide 32 for supporting a delivery tube 2, which is a retractable exoskeleton. The retractable exoskeleton is seen with the delivery tube in the top figure and without the tube in the bottom figure.

[0118] The rigid exoskeleton can be fitted to the outside of the delivery tube and can include a retainer, such as a U-shaped hoop, to secure attachment of the distal end of the delivery tube to the frame, for example by the hoop being located just behind the applicator tip. The retainer or U-shaped hoop can thus maintain assembly of the tube and insertion guide, preventing the exoskeleton from being unintentionally dropped or separated from the flexible tube. The exoskeleton can push the applicator tip and flexible tube forward in the distal direction during insertion by the user pushing on the handle 32.1, as shown in FIG. 57B.

[0119] When the distal end or applicator tip is moved towards the robotic instrument and thus contacts the robotic arm, the exoskeleton can be pulled back to release the tube, so that the tube is free to flex and stress-free during manipulation by the robotic instrument. The U-shaped hoop can slide axially along the delivery tube, thereby moving the trocar relative to the tube. Furthermore, the hoop can also act as an end stop, so that the exoskeleton can only be pulled back until it hits the connector element 6. This can facilitate reintroduction of the insertion guide. For example, if the applicator is removed and later reinserted during a surgical procedure, the exoskeleton can be easily pushed forward once more to the front position or distal end of the delivery tube.

[0120] Fig. 58 shows an embodiment of an applicator 1 according to the present disclosure with an insertion guide 32 for supporting a delivery tube 2, which is a retractable outer tube, i.e., a tube that circumferentially surrounds the delivery tube and is axially slidable. Fig. 58A shows the retractable outer tube with (top view) and without (bottom view) the delivery tube, and Fig. 58B shows the applicator with the retractable outer tube as it is inserted into a trocar 31.

[0121] For example, the outer tube can be a thin-walled tube that is mounted to a flexible delivery tube such that the assembly with the applicator tip and the distal end of the tube can be pushed forward in the distal direction during insertion by the outer tube, as indicated in FIG.

[0122] When the distal end or applicator tip is moved towards the robotic instrument and thus into contact with the robotic arm, the outer tube can be pulled back to release the tube so that it is free to flex and stress-free during manipulation by the robotic instrument. The tube can be slidably advanced and pulled back along the axial direction of the tube by handle 32.1 positioned on the outer tube.

[0123] The proximal section of the outer tube may be cut off at the top, i.e., cut open to form a half-pipe, as seen most clearly in the lower portion of FIG. 58A. This may facilitate the flexible delivery tube being able to flex or bend aside at the trocar entrance as it is retracted. The length of the cut section may preferably be shorter than or correspond to the length of the trocar, as indicated in FIG. 58B, to provide sufficient stiffness in the distal section by ensuring overlap between the outer tube and the trocar.

[0124] If the applicator must be removed and reinserted later during a surgical procedure, the outer tube can be re-advanced distally by once again pushing it forward to the forward position.

[0125] Figure 59 shows an embodiment of an applicator 1 according to the present disclosure with an insertion guide 32 for supporting a delivery tube 2, which is a retractable guidewire. Figure 59A shows the guidewire in a perspective view, (B) in a side view (top view) and in a cross-sectional view (bottom view).

[0126] The guidewire can move back and forth inside a dedicated lumen 16 in the delivery tube 2. The lumen can be similar to that described in FIG. 22. When the guidewire is positioned at the distal end of the delivery tube, it can provide sufficient stiffness and rigidity during insertion. When the guidewire is retracted so that it is positioned at the proximal end, the distal end is free to flex and stress-free during manipulation by the robotic instrument. Advancement and retraction of the guidewire can be controlled by the handle 32.1, as shown in FIG. 59.

[0127] If the applicator must be removed and reinserted later during a surgical procedure, the guidewire can be advanced distally by once again pushing it forward to a distal position.

[0128] Controllable substance release For precise, reliable and convenient discharge of the substance at a selected site, such as administration of the substance intraperitoneally, substance release can be advantageously controlled by a robotic arm. This can be obtained by one or more actuators 2.6, such as in the form of a valve, configured to release the substance from a delivery tube.

[0129] To make the movement of the robot arm more efficient, one or more actuators are preferably positioned near the applicator tip, which is used for spatial steering of the delivery tube. Thus, the actuators are preferably positioned at the distal end, in one or more rigid surface areas of the delivery tube, and / or at the applicator tip. For example, the actuator 2.6 may be advantageously positioned in the opening 2.5 of the rigid surface area, as shown in FIG. 2. Thus, after the robot arm orients the distal end through the rigid surface area to the selected target site, only a relatively small translation of the robot arm is required for the robot arm to activate the actuator to release the substance. The actuator may be configured to be activated, for example, by a pressure force applied by the robot arm, or by an electric current applied, for example, by an energy tool. In one embodiment, the actuator is provided in the form of a pressure-sensitive button, such as positioned at the applicator tip, which is configured to open the valve when pressed. The actuator / button may be sensitive to the magnitude of pressure (e.g., stepwise, continuous), such that the valve opens to a certain degree based on the pressure applied to the actuator / button. In other embodiments, the actuator is configured to be actuated by pulling the actuator along the longitudinal axis of the tube / applicator tip and / or by rotating the actuator about the longitudinal axis. These embodiments are shown in FIG.

[0130] In an embodiment of the present disclosure, the distal end includes one or more actuators configured to expel the substance from the delivery tube by the robotic arm. In a further embodiment, the one or more actuators are positioned within the one or more rigid surface regions, such as within an opening in the rigid surface region.

[0131] In an embodiment of the present disclosure, at least one actuator covers a predefined peripheral area of ​​the tube and / or applicator tip, such as less than 180°, preferably less than 140°, of the circumference of the tube and / or applicator tip 9. This embodiment is shown in FIG. 16(A). An advantage is that the applicator, and therefore also the applicator tip, can be rotated such that the risk of the robotic arm accidentally activating the actuator 2.6 is reduced. In another embodiment, at least one actuator covers at least 180° of the circumference of the tube and / or applicator tip. An advantage is that the robotic arm can activate the actuator 2.6 regardless of the rotational orientation of the applicator and actuator. Substance can be delivered from the applicator without the applicator being correctly oriented relative to the robotic arm. In yet another embodiment, two actuators are provided on opposite parts of the applicator tip and / or tube, each of said actuators covering less than 120°, preferably less than 90°, of the circumference of the tube and / or applicator tip. The advantage is that again the applicator, and therefore also the applicator tip, can be rotated such that the risk of the robotic arm accidentally activating the actuator 2.6 is reduced. This embodiment is shown in FIG. 16(B). In yet another embodiment, at least one actuator covers 360° of the circumference of the tube and / or applicator tip, so as to surround a portion of the tube and / or applicator tip. This is shown in FIG. 16(C). Providing an actuator such as a pressure sensitive button at the applicator tip that surrounds the entire circumference of the tip has the advantage of allowing 360° actuation, i.e. the robotic arm can actuate the actuator / button regardless of how the actuator is gripped.

[0132] The actuator(s) 2.6 may be in the form of a valve 2.7 or in combination with one or more valves, such as an electrically or manually controlled valve. Thus, the applicator may comprise at least one valve configured to release the substance from the delivery tube when opened. The valve may be controllable by an actuator located on the applicator and / or by an external actuator, such as a foot pedal. The actuator / button may be located at the distal end of the delivery tube, such as at the rigid section, at the applicator tip, or at an external device, such as a drive unit. Preferably, the actuator / button is located directly above the valve. Advantageously, the at least one valve is actuated by pressure, such as manual pressure from a robotic arm. Thus, by pressing the actuator 2.6, the valve 2.7 is actuated, either electrically or manually, to open and release the substance, such as shown in FIG. 5. Thus, the applicator may comprise at least one actuator configured to open / close the at least one valve. To ensure that the substance is efficiently transported to and through the distal tip, the valve is preferably a one-way valve. The at least one valve may be a pressure-activated valve, such as a valve with a predetermined opening pressure threshold. Preferably, the substance is dispensed from the applicator when the predetermined opening pressure threshold is exceeded. The at least one valve may be located in the delivery tube and / or the applicator tip. Alternatively, the applicator does not include a valve, but is dimensioned such that the substance is retained within the applicator below a certain pressure threshold. This may be achieved, such as by providing a long delivery tube (e.g., more than 30 cm) with a small diameter (e.g., 2-4 mm or less), whereby the delivery tube itself provides resistance to fluid flow inside the tube.

[0133] To improve the simplicity of the applicator and to reduce the number of electronic controls and components, the actuator is advantageously a manually controlled valve. An example of a manually pressure controlled valve is a spring loaded check valve 2.7 as shown in Figure 5, where the spring force can be configured to be overcome by pressure applied by a robotic arm or the like.

[0134] In other examples, the actuator 2.6, when actuated, does not necessarily mechanically actuate the valve 2.7, but can send an electrical signal to a pressure source (not shown) to be operated, providing pressure to the substance to overcome the spring of the spring check valve 2.7 so that the spring check valve 2.7 opens and the substance flows out of the delivery tube 2.

[0135] Other examples of one-way valves that may be manually pressure controlled are elastomeric one-way valves, such as duckbill valves and cross slit valves.

[0136] An example of a manually pressure controlled valve is the duckbill valve 2.7 as shown in FIG. 6. The duckbill valve is made of an elastically deformable material and comprises a deformable linear closure. A perspective view of the duckbill valve in an undeformed closed state is shown in FIG. 6B-6C. FIG. 6A shows an embodiment of the duckbill valve in a delivery tube 2, where the duckbill valve in an undeformed state is seen to prevent flow from left to right in the figure. When the duckbill valve is elastically deformed, such as by a compressive pressure parallel to the linear closure, as shown in FIG. 6D, the linear closure is deformed, thereby opening the valve and allowing flow from left to right in the figure. An enlarged perspective view of an embodiment of the duckbill valve in a deformed open state is shown in FIG. 6E-6F.

[0137] Thus, elastomeric valves with any number and orientation of deformable closures can be used. However, to ensure correct operation, elastomeric valves are preferred if valve opening is obtained by a well-defined pressure orientation. For duckbill valves, valve opening is only obtained when compression pressure is applied parallel to the linear closures.

[0138] Cross-slit valves are similar to duckbill valves, but with two deformable linear closures oriented perpendicular to each other. Opening of the valve can therefore be obtained when a compressive pressure is applied parallel to either of the linear closures. This has the advantage for the robotic gripper arm that the valve can be actuated in at least two positions.

[0139] In further embodiments, the one or more actuators are one or more valves. In further embodiments, the one or more valves are pressure-activated valves. In further embodiments, the at least one valve is selected from the group of a one-way valve, a resilient one-way valve, a duckbill valve, a cross-slit valve, and a spring-loaded check valve.

[0140] Controllable Material Release - Gripping Area The gripping section 29 may comprise an actuation section 29.3, which is located in a longitudinal or axial extension of the gripping section 29.1, as shown in Figures 48 and 49. The actuation section may comprise an actuator 2.6 or a transmission unit 27 such that the applicator tip is configured to controllably release the substance from the delivery tube by the robotic arm in the vicinity of the actuation section, which is configured to receive a predetermined force by the robotic arm.

[0141] To reduce the dimensions of the gripping area to a short length (L) between 30-35 mm, the actuation area can be combined with and matched to the gripping area, as shown in FIG. 48A. Thus, the gripping area is configured to not only facilitate robust gripping for spatial manipulation, but also to provide a separate actuation signal. For example, the gripping area may be both contacted and clamped by a robot arm or instrument jaw with different gripping forces that can be detected by the combined gripping area and actuation area. The different gripping forces can be detected by the gripping area with electronic or electromechanical switches, pressure sensitive membranes, or optical pressure sensors.

[0142] At a certain pressure, a signal is transmitted to the drive system and the hemostatic agent is delivered through the tip nozzle. The tip therefore also has space to be gripped without activating the drive system, so that the surgeon can guide the tip to a desired location for delivery with one instrument and initiate actuation with another. The actuation area and the force required to provide a signal to the drive system can be balanced. This allows the tip to be gripped in the actuation area with a certain force and therefore can move around without actuation. When the surgeon applies sufficient clamping force, the actuation area crosses a threshold and a signal is transmitted to the drive system. This allows the tip to be guided and actuated by only one instrument.

[0143] In embodiments of the present disclosure, the actuation section is located in an axial extension of the gripping section. In other embodiments, the actuation section is coincident with the gripping section. In further embodiments, the actuation section is configured to actuate the substance release mechanism when a predetermined force is exceeded.

[0144] Alternatively, the gripping area may be dimensioned to include one or more separate gripping and actuating areas in an axial extension, with the different areas configured to receive different predetermined forces by the robotic arm, as shown in Figures 48B-F.

[0145] Controllable Material Release - Nozzles The applicator tip comprises a nozzle for administering the substance, and the nozzle 29.2 may be contained within the gripping section 2, as shown in FIG. 46A. The nozzle is thus shaped to form the transition from the delivery tube and the inner flow passage of the applicator tip to the most distal end of the applicator tip. The outer shape of the nozzle is preferably rounded, such as spherical or elliptical, as shown in FIG. 46A, to establish a smooth surface that minimizes the risk of injury to the patient if the tip is pressed against tissue, organs, or intestines.

[0146] In an embodiment of the present disclosure, the nozzle shape is selected from the group of conical, blunt conical, biconic, nosecone, elliptical, and parabolic.

[0147] The nozzle shape 29.2 comprises a nozzle opening and a nozzle lumen (h) as indicated in FIG. 46A. The nozzle lumen thus forms part of the material flow path proceeding from the delivery tube 2. The shape of the material flow path from the delivery tube lumen to the nozzle opening determines the shape or profile of the administered material as it is deposited on a tissue matrix or the like, including the properties of the administered material as well as the shape of the nozzle. Specifically, the nozzle shape can affect the rate of administration, the angle of administration, and the degree of coverage.

[0148] The shape of the administered substance is particularly important for the administered hemostatic agent, as it determines the degree of adhesion, ability to cover an area, and effectiveness of the hemostatic agent. For example, hemostatic agents often need to be applied to inclined surfaces within the body, such as inclined tissue surfaces. Thus, the nozzle is advantageously configured to dispense the substance, preferably a substance including a hemostatic agent, in a predetermined shape that can provide improved coverage and adhesion. In an embodiment of the present disclosure, the applicator tip and / or gripping section comprises a nozzle at the distal end of the tip, the nozzle configured to dispense the substance in a predetermined shape.

[0149] The applicator may include a nozzle 29.2 with a cylindrically shaped opening. Thus, the profile of the extruded hemostatic agent, such as paste, will take the shape of the cylindrical opening, resulting in a cylindrical paste 4 seen in cross section in FIG. 50A and in perspective in FIG. 51A. The cylindrical profile has a relatively small contact area with the surface of the object, as shown in FIG. 50A, and is therefore prone to falling off. The surgeon may attempt to smear the hemostatic agent onto the bleeding surface to achieve improved adhesion, but this may be difficult to achieve due to the location and type of bleeding.

[0150] To provide improved adhesion, the nozzle 29.2 may be configured to eject material 4 with a non-cylindrical profile, at least by having a non-cylindrical nozzle opening. Advantageously, the nozzle opening is shaped to eject material in a pattern with a lower center of gravity and a wider area in cross section than it is tall, as shown in the cross section views in Figs. 50B-50C and in the perspective view in Fig. 51B. For example, the nozzle opening may comprise a series of cylindrical openings as shown in Fig. 50C, or a relatively rectangular opening as seen in the cross section view in Fig. 50B and in the perspective view in Fig. 51B. The nozzle opening may be further configured to provide an irregular profile, such as that in Fig. 50C, such that the ejected and deposited material has an irregular profile. For example, the shape of the nozzle opening when viewed from the distal end perspective may be sloped convexly and / or concavely (as seen in Fig. 52A) or wavy (as seen in Fig. 52B). The irregular shape may further enhance adhesion.

[0151] In an embodiment of the present disclosure, the nozzle is configured to eject the material in a predetermined shape selected from the group of cylindrical, planar, and corrugated planar, hi a further embodiment, the cross-sectional shape of the nozzle opening is selected from the group of circular, diamond, rectangular, curved rectangular, and concave rectangular.

[0152] To further improve the dispense angle, the nozzle opening can have a branched shape, for example, nozzle opening 29.2 can be a slit in a conical nozzle as shown in FIG. 48, thereby providing a larger dispense angle as indicated in FIG. 51B.

[0153] Thus, the nozzle shape is configured to provide a coating pattern that covers a much larger surface area than a nozzle with a cylindrical opening. For example, a non-cylindrical nozzle opening can cover a surface area 3.7 times larger than a cylindrical one, as indicated in FIG. 50B. Thus, the nozzle shape provides improved adhesion to the paste contour because the deposited paste contour is relatively wider and lower, and therefore has a higher ratio of surface area in contact with the bleeding site relative to the mass of hemostatic agent, and therefore the center of gravity of the dispensed paste is closer to the surface of the bleeding site compared to a cylindrical nozzle opening.

[0154] A nozzle opening adapted to deposit a substance 4 with a lower center of gravity has the further advantage of providing an increased foaming effect in the administered substance. The foaming effect is shown in FIG. 51 and is associated with a pressure drop as the substance leaves the nozzle opening. Thus, the high pressure in the delivery tube creates a foaming effect in the substance upon release, since there is an abrupt transition from a high pressure environment to a low pressure environment as the hemostatic agent leaves the high pressure environment in the delivery tube. For substances with a lower center of gravity, the travel distance to the surface for bubbles trapped in the membrane is shorter due to the flat thin layer of hemostatic agent deposited from the nozzle (FIG. 51B) compared to a cylindrical substance (FIG. 51A), thus resulting in a stronger foaming effect.

[0155] The foaming effect also depends on the dimensions of the delivery tube. The force applied to the delivery tube to dispense the paste is typically more than 100 N for delivery tubes with an internal diameter of less than 2 mm. The force is smaller for larger internal diameters, and for an internal diameter of approximately 3.8 mm the force to dispense the corresponding paste can be approximately 30 N, with negligible foaming effect.

[0156] Foaming is advantageous because it is associated with an increased angle of administration, further increasing coverage and improving adhesion. Foaming in the administered material is further advantageous because the number of cavities in the foaming hemostatic agent creates a larger internal surface area with a corresponding increase in the number of sites for platelets to attach and initiate hemostasis.

[0157] To improve the foaming effect, the nozzle shape 29.2 may be adapted to increase the pressure drop. This may be obtained, for example, by a nozzle opening having a height (h) of less than 1.0 mm and / or a nozzle length (l) of less than 3.5 mm, as indicated in Fig. 46A. Furthermore, the nozzle opening or lumen may be configured to diverge towards the distal end, such as shown in Figs. 52A and 54D.

[0158] In an embodiment of the present disclosure, the height of the nozzle opening is between 0.5-1.0 mm, such as 0.6 mm, 0.7 mm, 0.8 mm, or 0.9 mm. In a further embodiment, the length of the nozzle lumen is between 2.0-3.5 mm, such as 2.2 mm, 2.5 mm, 2.7 mm, or 3 mm. Additionally, the nozzle opening diverges towards the distal end.

[0159] The applicator can be adapted to have different nozzle shapes, which can be removed and attached. Thus, the applicator can include an interface that facilitates switching between different nozzle units for the same delivery tube by the same release and attachment mechanism, such as a snap fit or magnetic force. For example, the nozzle 29.2 can be a removable attached element, as indicated in FIG. 54, so that the same applicator can be applied to provide different profiles of hemostatic agent 4 for different purposes and types of bleeding, such as wide area coverage, small coverage, line coverage, etc. To facilitate switching between different nozzle units 29.2, the connection between the nozzle unit and the applicator tip 9 or gripping area 29 can be abutting and abrupt (FIGS. 54A and 54D) or gradual (FIGS. 54B and 54C).

[0160] In embodiments of the present disclosure, the connection between the nozzle unit and the gripping area is abrupt or gradual and / or configured to be removable.

[0161] Feedback Mechanism Advantageously, the applicator is configured to provide feedback such as on the applied pressure to an actuator / pressure sensitive button or feedback regarding the remaining volume of substance in the delivery tube. This feedback may be provided by integrating various sensors into the applicator. The applicator may comprise a first pressure sensor for sensing the pressure in the delivery tube. The pressure may be communicated wired or wirelessly to a user such as a surgeon.

[0162] In an embodiment, the applicator comprises a second pressure sensor for sensing the pressure applied to the actuator / pressure sensitive button. By way of example, the second pressure sensor may be a resistive membrane pressure sensor, a force sensitive resistor, and / or a weight sensor, preferably provided under the actuator. Thus, the applicator may comprise at least one pressure sensitive button covering a part of the applicator tip, with a second pressure sensor for sensing the pressure applied to the actuator being integrated in said button or located under the button. The applicator may further comprise a pressure indicator lamp for indicating the pressure applied to the at least one actuator / pressure sensitive button. The pressure indicator lamp may be located in or on the applicator tip, as shown in Figs. 19-20. In one embodiment, the pressure indicator lamp is provided as a circular band positioned along the periphery of the applicator tip, as shown in Fig. 19. Advantageously, the pressure indicator lamp is: - displaying a light of a first color, such as green, when the applied pressure falls below a first predetermined threshold; and - Display a second color light, such as red, when the applied pressure exceeds a second predefined threshold It is composed.

[0163] The pressure indicator lamp may be further configured to display a third color light, such as yellow, when the applied pressure is between the first predetermined threshold and the second predetermined threshold. Other alternative configurations of light or sound to indicate pressure by the pressure indicator lamp can be readily envisioned.

[0164] The applicator may further comprise a status indicator, such as in the form of a light diode, configured to indicate the remaining volume of substance in the applicator. By way of example, the status indicator may comprise four light diodes (e.g. LEDs), with, for example, two lit diodes indicating a remaining volume of 50% and three lit diodes indicating a remaining volume of 75% relative to the initial volume of contained substance. This is shown in FIG. 25. The status indicator may be located in any part of the applicator, such as the drive unit, the delivery tube, and / or the applicator tip. Thus, the applicator tip may comprise a status indicator, such as in the form of a light diode, configured to indicate the remaining volume of substance in the delivery tube. The remaining volume of substance in the applicator (i.e. in the delivery tube and / or the fluid source) may be estimated using various methods, depending on what type of substance is contained in the applicator. Some of these methods are described below. Other alternative configurations of light or sound to indicate the remaining volume of substance in the applicator can be readily envisaged. Alternatively, the status indicator may comprise only one lamp that is illuminated, such as when only 25% of the substance remains in the applicator.

[0165] In some embodiments, the laparoscopic applicator comprises a fluid source in the form of a syringe, such as a medical syringe, comprising a barrel for holding the fluid and a plunger for expelling the fluid from the syringe. The syringe can be filled with a fluid, such as saline or gas, to expel the substance from the delivery tube, or alternatively, can be filled with the substance to be administered. In embodiments, the applicator further comprises a second position sensor configured to determine the position of the plunger of the syringe. This can be achieved by providing a magnet on the plunger, the second position sensor being a magnetic sensor configured to detect the presence of the magnet. The position of the plunger can be used to estimate the remaining volume of fluid / substance in the barrel of the syringe and / or the position can be used to estimate the remaining volume of substance in the delivery tube. Thus, the applicator can comprise at least one fluid source comprising a plunger in the barrel, the position of the plunger being used to estimate the remaining volume of substance in the delivery tube, the remaining volume being indicated by a status indicator, preferably positioned at the distal / tip end. The second position sensor may alternatively be an optical sensor.

[0166] In other embodiments, the laparoscopic applicator comprises a hemostatic agent powder, for example contained in a delivery tube. In this case, the applicator may comprise a variable speed feeder, such as a screw conveyor, configured to transport the hemostatic agent powder through the delivery tube and out of the delivery tube, such that the hemostatic agent powder is dispensed from the applicator. To determine the remaining volume of powder, the applicator may comprise a first position sensor configured to determine the position of the variable speed feeder, such that the position of the variable speed feeder can be correlated with the remaining volume of powder. The variable speed feeder may be provided with a magnet, and the first position sensor is a magnetic sensor configured to detect the presence of the magnet. Alternatively, the first position sensor may be an optical sensor.

[0167] In yet other embodiments, the applicator comprises a vibration device, such as an ultrasonic vibration device, configured to shake the hemostat powder out of the delivery tube. In this case, the applicator may further comprise a clock configured to measure the elapsed time when the vibration device is activated / vibrates. The elapsed time can be used to estimate the remaining volume of hemostat powder in the delivery tube.

[0168] Thus, the remaining volume may be determined by the first position sensor, the second position sensor, a clock, and / or combinations thereof.

[0169] According to another embodiment, the delivery tube comprises one or more light-sensitive sensors configured to sense light in a predetermined wavelength range passing through the delivery tube; the delivery tube comprises a light source positioned opposite one or more light-sensitive sensors; and / or The delivery tube is transparent to at least a portion of the wavelength range.

[0170] In one embodiment, the one or more light-sensing sensors are positioned at a distal portion of the delivery tube. In other embodiments, the delivery tube comprises at least two light-sensing sensors, a first sensor positioned at a distal portion of the tube and a second sensor positioned at a different location than the first light-sensing sensor, such as further away from the distal portion. The one or more light-sensing sensors can be used to provide an indication of whether there is any remaining material in the tube and / or can be used to estimate the remaining volume of material in the tube.

[0171] Pressure Source The expulsion of the substance from the applicator means that the substance held in the tube is pushed through the delivery tube to the distal and tip end, where the substance is expelled and administered. If the substance is a paste, a pressure source 8 is preferred to provide the driving force for administering the paste. The pressure source is preferably configured to pressurize the delivery tube and / or to pressurize the fluid source. The substance held in the delivery tube will preferably be pressurized at least immediately before the paste is expelled. In an embodiment, the applicator forms a pressurized system, and the substance in the delivery tube is pressurized. On actuation of a valve (e.g. via an actuator or button), said pressure is released, whereby the substance is administered. In other embodiments, the system (applicator) is not pre-pressurized. Rather, pressure is applied when the actuator is actuated, for example by sending an electrical signal from said actuator to the pressure source. The advantage of the first type of embodiment (i.e. a pressurized applicator) is that there is a small delay between the actuation of the valve and the administration of the substance.

[0172] Where the medical substance is a powder, such as a hemostat powder, a pressure source is not necessarily required as the powder can be expelled from the applicator by other means. In this case, the applicator may, as an alternative to or in addition to a pressure source, include a variable speed feeder configured to transport the hemostat powder through and out of the delivery tube such that the hemostat powder is administered from the applicator. Alternatively, the applicator may include a vibration device to shake the powder out of the applicator.

[0173] By way of example, the pressure source can be a solid needle advanced through the delivery tube, such as by linear translation through the use of a piston, spring force, and / or trigger, which can be manually actuated or electronically controlled. An example of an intermediate pressure source comprises a fluid source 7 containing a liquid (e.g., liquid saline or medical paste to be administered) or a gas (e.g., air, nitrous oxide, or carbon dioxide), which is advanced through the delivery tube when the pressure source exerts a force on the fluid source, as shown in FIG. 7. The pressure source may comprise a spring, a gas, and / or a piston, which is configured to exert pressure on at least one fluid source. In this case, the piston, spring, and / or trigger can be manually actuated or electronically controlled. Advantageously, the fluid source comprises a non-compressible liquid for more efficient pressure transfer.

[0174] In an embodiment of the present disclosure, the applicator further comprises one or more pressure sources, hi a further embodiment, the pressure sources are selected from the group of a solid needle configured to be translated through a delivery tube, a drive mechanism such as a motor with a piston, a pump, and / or a pressurized fluid source.

[0175] In one embodiment, the pressure source is a drive mechanism, such as a motor, comprising at least one piston configured to exert pressure on at least one fluid source. The motor can be a mechanical motor or an electric motor. The applicator may comprise an actuator configured to, upon actuation, send an electrical signal to the drive mechanism, such that, upon receiving said electrical signal, the drive mechanism exerts pressure on at least one fluid source such that the substance is dispensed from the applicator.

[0176] In a further embodiment, the drive mechanism comprises two pistons, a first piston configured to exert a first pressure on a first fluid source and a second piston configured to exert a second pressure on a second fluid source. This embodiment is shown in FIG. 30. In this case, the drive mechanism may further comprise a switching mechanism, such as a gear mechanism, configured to switch between operating the first piston and / or operating the second piston. Alternatively, the drive mechanism may drive two pistons to administer two substances simultaneously. This is advantageous, for example, when two substances are both required to achieve a desired reaction. This may be the case, for example, for thrombin and fibrinogen. Preferably, the drive mechanism further comprises a directional control, configured to control the direction (forward or backward) of the selected piston. The backward direction allows for aspiration of the substance, for example, allowing for aspiration of blood from the surgical site to allow the surgeon to better decide what to do.

[0177] To ensure reproducible and convenient dosing of the substance, the pressure source is preferably configured to deliver a predetermined and / or controllable pressure. For example, the pressure source can be a pressurized fluid source, such as a fluid container that contains a pre-established positive pressure, such that when an opening is formed in the fluid container, the fluid source is forced through the opening as determined by the established pressure.

[0178] The pre-established positive pressure can be obtained by pressurizing the fluid source 7 with a propellant 8.1, such as a gas propellant, as known from food aerosol dispensers, such as aerosol creamers. Figures 8 and 10A show an embodiment of the fluid source 7, in which a gas propellant 8.1 is included. Upon forming a fluid connection between the applicator 2 and the pressure source 8, the propellant pressure is released and the fluid source is advanced into the delivery tube.

[0179] Alternatively, the pressure source may comprise a spring-loaded element contained in physical communication with the fluid source, upon release of the spring-loaded element, the element acts as a pusher 8.1 that propels the fluid source forward into the delivery tube, as shown in FIG.

[0180] Alternatively, the pressure source may comprise a movable piston, such as a manually driven piston as shown in Figure 9B, or a mechanically or electrically driven piston as shown in Figure 10B. In both embodiments, the piston acts as a propulsion 8.1 and a predetermined pressure force may be generated based on the movement of the piston.

[0181] Alternatively, pressure source 8 may be a fluid source 7 contained in an inflatable balloon or bladder, as shown in Figure 11. Upon forming a fluid connection between applicator 2 and pressure source 8, the inflated balloon will elastically contract or collapse, thereby exerting pressure on the substance contained in the delivery tube, thereby pressurizing the substance.

[0182] In an embodiment of the present disclosure, the pressure source is configured to deliver a predetermined pressure force. In a further embodiment of the present disclosure, the pressure source comprises a propellant selected from the group of a spring-loaded element, a gas propellant, an inflatable balloon or bladder, and / or a movable piston, such as an electrically or manually driven piston.

[0183] fluid source Preferably, the applicator comprises at least one fluid source for holding a fluid, said fluid source being in fluid connection with the delivery tube (see, for example, FIG. 7 or FIGS. 12-13). The fluid source can act as an intermediate pressure source, i.e. as a component that transfers pressure from the pressure source to the substance inside the delivery tube. As such, the fluid source need not contain the substance to be administered, but can instead contain an inert fluid, such as saline or a gas. In one embodiment, the fluid source comprises a liquid, such as saline. In another embodiment, the fluid source comprises a gas selected from the group of CO2 (carbon dioxide), N2 (dinitrogen), N2O (nitrous oxide), and air. However, the fluid source may alternatively contain the substance to be administered, such as a medical substance, such as a medical paste, such that said substance is contained in the fluid source and / or the delivery tube. In an embodiment, the delivery tube and the at least one fluid source comprise the same substance provided in the form of a liquid, a paste, or a powder. Thus, the fluid source constitutes the substance reservoir 24.

[0184] The applicator may include at least two fluid sources, as shown in Figure 30. This has the advantage that each fluid source can contain a particular type of substance, thereby allowing a number of different substances to be dispensed and / or withdrawn by the applicator.

[0185] Drive unit The applicator is - at least one fluid source for holding a fluid, in fluid communication with the delivery tube; and / or - at least one pressure source configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube; The device may further include a drive unit for holding the device.

[0186] In its simplest form, the drive unit may comprise a housing for holding a fluid source and / or for holding a pressure source. However, the drive unit may also comprise additional, more advanced features that are described in more detail in this section. The advantage of providing the drive unit as a separate component from the remaining parts of the laparoscopic applicator is that it provides a modular design, where the drive unit can be reused multiple times, and the delivery tube and fluid source can be disposed of after each use. FIG. 14 shows how the delivery tube and fluid source (here, a syringe) can be inserted into the drive unit, optionally via a connector. FIG. 18 shows another perspective view of the drive unit, with the fluid source inserted. The drive unit is preferably configured to exert pressure on the fluid source, such as via a drive mechanism such as a motor and a piston, so as to provide a driving force to drive the substance out of the applicator. By way of example, the fluid source can be a medical syringe or other container with a plunger, and the drive unit comprises a piston configured to exert a force on the plunger. In this case, the drive unit may also be configured to retract the plunger to draw the substance into the applicator.

[0187] The applicator may be provided with a safety mechanism configured for switching between two modes (on / off), "off mode" meaning that the substance cannot be discharged from the applicator and "on mode" meaning that the substance can be discharged. The safety mechanism may be located on the delivery tube, the applicator tip, or the drive unit. The applicator may further comprise a flow control device configured to control the flow rate of the substance discharged from the applicator. The flow control device may be located on the drive unit, the exterior of which may be provided with a button, or may be provided with a button or potentiometer configured to adjust the flow rate, such as by turning a button.

[0188] Drive unit - control As previously described, the applicator may include a pressure source for applying pressure to the delivery tube, which may include a fluid source and a piston drive mechanism for expelling the fluid. Thus, the drive mechanism for administering the substance may be a plunger piston from a chamber of a syringe or reservoir container that includes a fluid source that is expelled to push the hemostatic agent in the delivery tube.

[0189] The drive mechanism of the pressure source can be a mechanically controlled drive mechanism or a motor-controlled or electrically controlled drive mechanism. The drive mechanism controls the actuation of the dispensing, i.e., starts, stops, pauses, or pauses. When the dispensing is actuated, the hemostatic agent advances through the delivery tube to the dispensing nozzle for application to the bleeding surface.

[0190] When the drive mechanism is stopped, interrupted or paused, there is a risk of continued administration of the substance due to time delays, such as the delay between valve actuation and administration of the substance. In addition, there is a risk of delay because the delivery tube with the pressure source and the fluid source form a hydraulic system based on viscous friction and fluid dynamics. Thus, hemostatic agent spillage can occur after the drive system is stopped, interrupted or paused. This is due to the pressure in the hydraulic system and the continued expansion of the hemostatic agent after the plunger piston stops moving.

[0191] To minimize or eliminate delay, the drive mechanism may include a retractable piston, such as an automatically retractable piston. By retracting the piston, the drive mechanism creates a space for the hemostatic agent to expand into the syringe or reservoir container instead of expanding through the nozzle and creating undesired outflow through the tip. Specifically, the expansion volume is created by the drive system pulling back the actuation piston, thus allowing the plunger (rubber stop) inside the chamber of the syringe or reservoir container to retract. The retractable piston can be obtained, for example, by a mechanical trigger mechanism or by an electrically driven drive unit.

[0192] In an embodiment of the present disclosure, the applicator is configured to apply pressure to the interior of the delivery tube and includes a pressure source that includes a piston drive mechanism, such that the piston is retractable.

[0193] Parts Kit The applicator according to the present disclosure may be provided as a part in a kit of parts for laparoscopic procedures, in particular as a kit of parts suitable for robotic-assisted surgery. Preferably, the kit of parts is a medical substance kit, such as a hemostatic agent matrix kit for laparoscopic procedures. The kit comprises an applicator, one or more pressure sources, and optionally a syringe configured to be filled with a medical substance, such as a hemostatic agent substance, such as a hemostatic agent paste. Preferably, the syringe is pre-filled with the substance to form the substance reservoir 24. Optionally, the applicator may be provided as a separate part of the kit, such as a delivery tube and an applicator tip, which when assembled form the applicator according to the first aspect.

[0194] The kit may optionally further comprise one or more substance reservoirs 24 for loading or filling the delivery tube prior to use. For example, the substance reservoir may be a syringe configured to be filled with a substance and configured to form a fluid connection to the delivery tube of the applicator, such as via connector 6 to a proximal opening of the delivery tube or via auxiliary connector element 25 to a distal opening of the delivery tube.

[0195] To reduce the number of parts and simplify assembly, a kit of parts may include an applicator that is easily assembled and configured to deliver a substance under pressure when assembled, and a pressure source 8. For example, the pressure source may be a gas cartridge 8.2 configured to form a fluid connection to a delivery tube of the applicator, such as a proximal opening of the delivery tube, as shown in Figures 38 and 40.

[0196] To further simplify assembly, one or more pressure sources 8 may be integrated into the applicator. For example, a pressure source may be integrated into the delivery tube in the form of a spring 8.3 located at the proximal end, where spring energy is pre-stored and / or stored upon loading the delivery tube with substance, as shown in FIG.

[0197] A third aspect of the present disclosure relates to a kit of parts comprising an applicator according to the first aspect or an applicator tip according to the second aspect, one or more pressure sources, and optionally one or more substance reservoirs. For example, the substance reservoirs may be one or more syringes configured to be filled with a substance and configured to form a fluid connection to a delivery tube, such as a distal opening of the delivery tube.

[0198] A kit of parts has the advantage that all parts can be assembled and operated manually and that all parts are disposable after use and adapted for single use.

[0199] Alternatively, the kit of parts may include parts adapted for multiple uses to obtain a more renewable and sustainable applicator design, for example the applicator may be assembled into a reusable unit or carrier which may include a pressure source 8 in the form of a reusable piston or motor.

[0200] To further increase the sustainable effect, the drive unit may be refilled with substance 4 or fluid source 7. Thus, the kit of parts optionally comprises one or more substance reservoirs 24 or fluid source reservoirs configured for removably mounting to a fluid source within the drive unit.

[0201] According to one embodiment, a kit of parts comprises a laparoscopic applicator according to the first aspect and a drive unit for holding at least one fluid source for holding fluid in fluid connection with a delivery tube and / or at least one pressure source, such as a motor, configured to apply pressure to the at least one fluid source and / or configured to apply pressure inside the delivery tube.

[0202] The kit of parts may further comprise at least one fluid source for holding a fluid, said fluid source being in fluid communication with the delivery tube, hi one embodiment, the fluid source is a syringe having a plunger, and the drive unit further comprises a position sensor configured to determine a position of the plunger.

[0203] The kit of parts may further comprise at least one pressure source configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube.

[0204] The drive unit in the kit of parts may be configured to hold at least two fluid sources, such as at least two syringes. An advantage here is that two different substances can be administered from the applicator. Alternatively, one of the at least two syringes may be used to draw a substance, such as blood, from a patient.

[0205] material The applicator tube of the present disclosure is preferably configured for administering a substance. The substance may be in the form of a liquid, paste, or powder. As an example, the substance may be a medical paste. By the term "medical paste" is meant a paste that includes a bioactive agent. Examples of bioactive agents include thrombin or fibrinogen, also referred to as hemostatic agents. As another example, the substance may include a non-biological adhesive / glue, such as cyanoacrylate or polyethylene glycol hydrogel (PEG). As yet another example, the substance may include a material selected from the group of oxidized regenerated cellulose (OCR), microporous polysaccharide spheres, and microfibrillated cellulose. If the substance is a powder, the powder is preferably a hemostatic powder with particles having a particle size greater than 180 microns. A particle size greater than 180 microns means that the particles have good flowability so that they can be easily spread over an area. This is an added advantage when the powder is a hemostatic powder, since it is important to cover the entire wound as quickly as possible to stop the bleeding.

[0206] A "bioactive agent" is defined as any chemical, drug, compound, composition of matter, or mixture that provides some pharmacological, often beneficial, effect that can be demonstrated in vivo or in vitro. Thus, a chemical is considered bioactive if it has an interaction with or effect on cellular tissues in the human or animal body. As used herein, the term further includes any physiologically or pharmacologically active substance that produces a local or systemic effect in an individual. A bioactive agent may be a protein, such as an enzyme. Further examples of bioactive agents include, but are not limited to, chemicals that include or consist of oligosaccharides, polysaccharides, optionally glycosylated peptides, optionally glycosylated polypeptides, oligonucleotides, polynucleotides, lipids, fatty acids, fatty acid esters, and secondary metabolites. Bioactive agents may be used in connection with the treatment of an individual, such as a human or any other animal, either prophylactically or therapeutically. The term "bioactive agent" as used herein does not encompass cells, such as eukaryotic or prokaryotic cells.

[0207] A "paste" according to the present disclosure has a malleable, putty-like consistency, such as toothpaste. A paste is a viscous fluid mixture of a solid in comminuted / powdered form with a liquid. A paste is a substance that behaves like a solid until a sufficiently large load or stress is applied, at which point it flows like a fluid, i.e., the paste is flowable. Flowable properties allow it to effectively conform to irregular surfaces in application. A paste typically consists of a suspension of granular material in a background fluid. The individual particles pack together like sand on a beach, forming a disordered, glassy, ​​or amorphous structure, giving the paste its solid-like properties. It is this "packing together" that gives paste some of its most unique properties, which causes it to exhibit the properties of a brittle material. A paste is not a gel / jelly. A "slurry" is a fluid mixture of a powder / comminuted solid with a liquid, such as water. Slurries, in some instances, behave like a viscous fluid, flowing under gravity and being pumpable if the viscosity is not too high. Slurries can be functionally considered as a low viscosity water-like paste, although slurries generally contain more water than pastes. Substantially water-insoluble powder particles, such as cross-linked gelatin particles, will form a paste on mixing with an aqueous medium.

[0208] A "gel" is a solid, jelly-like material that can have properties ranging from soft and weak to strong and durable. A gel is defined as a substantially dilute crosslinked system that does not exhibit flow when in a steady state. By weight, a gel is mostly liquid, but behaves like a solid due to a three-dimensional network of crosslinks within the liquid. It is the crosslinks within the fluid that give the gel its structure (stiffness) and contribute to its cohesiveness (stickiness). In this way, a gel is a dispersion of liquid molecules within a solid, where the solid is the continuous phase and the liquid is the discontinuous phase. A gel is not a paste or a slurry. For example, non-crosslinked gelatin is soluble and forms a gel on contact with an aqueous medium, such as water.

[0209] For a medical paste to be expelled from a syringe and applicator tube, it should become flowable when exposed to a force applicable to a syringe. Thus, by the term "flowable paste" is meant a paste having a viscosity that facilitates steady flow when exposed to a force applicable to a syringe. An example of a flowable paste is a paste having a viscosity between 500 and 3500 Pa·s when measured at 30° C. and a relative humidity between 65 and 75%. In an embodiment of the present disclosure, the paste is flowable.

[0210] Forming a medical paste, such as a flowable medical paste, requires mixing a bioactive agent with a paste, or paste-forming material. Typically, the bioactive agent is stored in a solid, dry state, such as in powder form, to facilitate stable storage of the active agent, and mixing the bioactive agent with a diluent in an adjustable ratio to facilitate flexible concentrations. Thus, for a bioactive agent to be administered by injection of a syringe, the solid bioactive agent must first be reconstituted. Thus, forming a medical paste typically requires mixing the solid bioactive agent with a liquid or diluent to reconstitute the bioactive agent, followed by mixing the reconstituted bioactive agent with a paste-forming material, which may also be referred to as a "paste precursor." The bioactive agent may be a hemostatic agent, such as thrombin or fibrinogen.

[0211] By the term "paste-forming material" is meant a material for forming a paste from a liquid phase, such as a reconstituted bioactive agent. Thus, the paste-forming material may also be referred to as a precursor material for forming a paste.

[0212] A reconstituted bioactive agent can be obtained by mixing the bioactive agent with a low viscosity liquid, such as sterile water or saline, thereby ensuring a uniform reconstitution. Thus, the reconstituted bioactive agent is a liquid with a low viscosity. A paste can be obtained from the reconstituted bioactive agent by adding a paste-forming material that essentially increases the viscosity.

[0213] material loading As previously described, the delivery tube of the applicator may be pre-filled with a substance (e.g., a medical fluid, paste, or powder) prior to use, such as prior to insertion of the applicator into the trocar port. Alternatively, the delivery tube may be configured to be filled with a substance after insertion into the trocar port, such as immediately prior to application, or continuously during application of the substance.

[0214] Proximal Loading In a first preferred embodiment, filling of the delivery tube can be performed via the proximal end 2.1 of the delivery tube, which is accessible to the surgeon or assistant during surgery, as shown in FIG. 1. Filling of the delivery tube is advantageously performed using a separate syringe with the substance 4 in the syringe barrel, which can be pre-filled with the substance or can be configured to aspirate the substance from a source of the substance, such as a medical fluid source as shown in FIGS. 12-14. The container or syringe containing the substance 4 may therefore be referred to as the substance reservoir 24. To facilitate safe and accurate filling with minimal material waste, the proximal end 2.1 advantageously comprises one or more connectors 6 for removably attaching a fluid source, such as a syringe pre-filled with the substance. Examples of connectors are a luer lock for attaching a syringe, or a compression or adhesive connection for attaching a substance reservoir or fluid container. Alternatively, the delivery tube and the fluid source, such as a syringe, may be attached without the use of a connector.

[0215] In an embodiment of the present disclosure, the delivery tube and the at least one fluid source comprise or are configured to comprise the same substance, such as a substance comprising a hemostatic agent, the substance being provided in the form of a liquid, a paste, or a powder, such that the at least one fluid source constitutes a first substance reservoir.

[0216] Continuous loading In addition to being pre-filled and configured to be filled or loaded with substance 4 from the proximal end, after insertion into the trocar port, the applicator may advantageously be further configured to be continuously loaded during insertion into the trocar. This can be achieved by the applicator being configured to be loaded from a multiple number of substance reservoirs 24.

[0217] Fig. 36 shows an embodiment of an applicator according to the present disclosure, in which the applicator 1 comprises a first substance reservoir 24.1 and a second substance reservoir 24.2. Thus, the syringe substance reservoir 24 shown in Fig. 14 and the like is replaced by an integrated first substance reservoir 24.1 that is different from a separate syringe, thereby avoiding a separate syringe and plunger. The integrated first substance reservoir may comprise a barrel for holding the substance and a stop defining the first substance reservoir, which may also act as a piston for pushing the substance out of the barrel. The integrated first substance reservoir is not limited to having the dimensions of a conventional syringe, and may advantageously have a relatively wider diameter and shorter length than a conventional syringe.

[0218] In an embodiment of the present disclosure, the first material reservoir comprises a barrel for holding a fluid and a piston for expelling the material from the barrel. In a further embodiment, the barrel has a diameter between 10-30 mm, more preferably between 12-20 mm, and most preferably between 14-18 mm.

[0219] A second substance reservoir 24.2 is removably attachable to the first substance reservoir 24.1 via an auxiliary connector element 25 as shown in Figures 36-37. Figure 37A shows the second reservoir attached and Figure 37B shows the second reservoir removed.

[0220] To administer a substance from the applicator before or during the procedure, an assistant can attach a second substance reservoir 24.2, and optionally the applicator is inserted into the trocar port. The assembly can be configured to transfer a substance, such as a hemostatic agent, from the second substance reservoir to the first substance reservoir. For example, the second substance reservoir can be pressurized and the auxiliary connector element can include a luer lock one-way valve to facilitate transfer.

[0221] In an embodiment of the present disclosure, the applicator comprises one or more second substance reservoirs. In a further embodiment, the first and / or second substance reservoirs are disposable.

[0222] In an embodiment of the present disclosure, the second substance reservoir is removably attached to the first substance reservoir via at least one auxiliary connector element, hi further embodiments, the connector element comprises a luer lock, a compression connection, or an adhesive connection.

[0223] Thus, the substance can be dispensed by activating a dispense button of the actuator 2.6 at the distal end 2.2 of the delivery tube. The actuator can actuate a drive mechanism of a pressure source, for example a mechanically controlled drive mechanism or a motor-controlled or electrically controlled drive mechanism. For example, the pressure source can correspond to the drive unit 10 shown in FIG. 14, which is motor-controlled to advance a piston, which can exert pressure on the first substance reservoir 24.1. Due to the wider diameter and shorter length of the first substance reservoir, less force is needed to dispense the substance. Thus, the pressure force can be a manually driven piston, since a relatively small force is needed to prime it. Furthermore, the dimensions of the first substance reservoir allow any substance 4 to be easily dispensed, regardless of viscosity.

[0224] The auxiliary connector element may be configured to avoid backfilling from the pressure source into the second substance reservoir. This can be obtained by the auxiliary connector element being adapted to establish sequential fluid connections 1) between the first substance reservoir and the second substance reservoir, and 2) between the first substance reservoir and the delivery tube. Thus, the auxiliary connector element can have two configurations that can be obtained by the one-way valve.

[0225] In an embodiment of the present disclosure, the auxiliary connector element is configured to establish sequential fluid connections 1) between the first and second substance reservoirs, and 2) between the first substance reservoir and the delivery tube. In a further embodiment, the auxiliary connector element is adapted to have a first configuration that provides a fluid passage between the first and second substance reservoirs, and a second configuration that provides a fluid passage between the first substance reservoir and the delivery tube. In an embodiment of the present disclosure, the auxiliary connector element comprises at least one one-way valve.

[0226] Thus, the first substance reservoir can be refilled at any time by the nurse by removing and installing any number of further second reservoirs. Furthermore, the reservoirs are advantageously disposable for easy and flexible use. For example, all parts except the drive unit may be disposable.

[0227] From the above, it follows that an applicator comprising a first substance reservoir and a second substance reservoir can have a particularly compact design and, due to the shape factor of the first substance reservoir, can be particularly suitable for both high and low viscosity substances, such as liquids, pastes and powders.

[0228] Sequential loading can be applied to applicators with any number of substance reservoirs and to applicators for mixtures of substances. For example, this can be the case in the embodiment shown in FIG. 30, where the delivery tube comprises a first lumen for holding a first type of substance and a second lumen for holding a second type of substance, and the two types of substances are mixed as they are administered or before they are administered. For example, the applicator tip may comprise a nozzle with a mixing chamber. In this case, one substance may be in the form of a liquid and the other substance may be a powder that is mixed in a liquid. The two substances may be two liquids or two pastes, or other combinations of liquids, pastes, and powders. The drive mechanism of FIG. 30 comprises two pistons, the first piston configured to exert a first pressure on two different reservoirs simultaneously or with a time delay to ensure sufficient mixing.

[0229] Similar to Fig. 30, Fig. 41 shows an embodiment of an applicator according to the present disclosure, the applicator 1 comprising two first substance reservoirs 24.1 and a detached drive mechanism 10 for pressurizing the two first substance reservoirs. The drive mechanism is illustrated as a motorized drive unit with two pistons.

[0230] Figure 42 shows the applicator of Figure 41, with two first substance reservoirs 24.1 connected to two second substance reservoirs 24.2 (shown as two syringes) via check valves 25. (A) shows the loading of the first reservoirs with syringes, (B) shows the loaded applicator, with stops defining the first substance reservoirs, and with the two syringes removed.

[0231] Figure 43 shows the applicator of Figures 41-42 with a removable drive mechanism attached in (A) for pressurizing the two first substance reservoirs 24.1 and with the piston of the drive mechanism translating the stops in (B) thereby emptying the two first reservoirs.

[0232] Distal Loading In addition to or as an alternative to proximal loading, the applicator may be configured for loading from the distal end, which can further enhance the compact design, reduce the number of parts in the applicator, and provide a completely disposable applicator.

[0233] Fig. 38A shows an embodiment of an applicator according to the present disclosure, configured to be loaded with a substance 4 from a distal end 2.2 opposite a pressure source 8 located at a proximal end 2.1. This can be obtained by a distal end or tip of a delivery tube with a removably attached auxiliary connector element 25 to form a fluid communication with a substance reservoir as shown in Fig. 38B and a flow control element 26 as shown in Fig. 38C. The flow control element can be, for example, a three-way valve with three configurations: a first configuration providing a fluid passage from a distally attached substance reservoir to the delivery tube, a second configuration in which no fluid passage is provided so that the substance in the delivery tube can be pressurized, and a third configuration providing a fluid passage from the delivery tube to outside the distal end of the delivery tube. Advantageously, the flow control element is configured to establish sequential fluid connections in the opposite direction, first 1) between the substance reservoir and the delivery tube, and then 2) between the delivery tube and the detached substance reservoir.

[0234] In an embodiment of the disclosure, the delivery tube is configured to be loaded with substance from a distal end. In an embodiment of the disclosure, the delivery tube includes one or more removably attached connectors for a substance reservoir and / or a flow control element.

[0235] FIG. 39A shows an embodiment of an applicator according to the present disclosure, which is configured to be loaded with a substance from a distal end 2.2 via a substance reservoir 24 in the form of a syringe with a substance 4. The applicator 1 comprises a pressure source 8, which is advantageously a spring 8.3 integrated in the delivery tube, as shown in FIG. 39A. The syringe 24 is attached to the distal end 2.2 of the delivery tube via an auxiliary connector element 25, which may be a Luer lock connector as shown in FIG. 39B. The syringe contents are transferred to the delivery tube, whereby the spring 8.3 is compressed as shown in FIG. 39C. Thus, the pressure source in the form of spring energy is stored upon loading the delivery tube. Alternatively, the spring energy may be pre-stored by pre-compression, such that a predetermined amount of spring energy is provided by the applicator. The syringe and the auxiliary connector element can be removed, and the flow control element 26 facilitates the substance in the delivery tube to be pressurized by the spring force. The applicator is now ready for use and the substance 4 can be dispensed, such as via an actuator contained within the flow control element, as indicated by the arrow, as shown in FIG. 39D.

[0236] The present embodiment provides a particularly compact design and small form factor for the applicator.More advantageously, the embodiment provides a prime mover-less, completely disposable applicator for a single use.

[0237] In an embodiment of the present disclosure, the at least one pressure source is a spring configured to exert pressure on the at least one fluid source and / or on the substance in the delivery tube, hi further embodiments, the spring energy is pre-stored and / or stored upon loading the delivery tube.

[0238] Alternatively or in addition to the spring 8.3, the pressure source may comprise a gas pressure source, such as a pressurized container, such as a gas cartridge 8.2. FIG. 40A shows an embodiment of an applicator according to the present disclosure, where the applicator 1 is configured to be loaded with a substance from a distal end 2.2, via a substance reservoir 24 in the form of a syringe attachable to the distal end via an auxiliary connector element 25. The applicator further comprises a pressure source 8 in the form of a gas cartridge 8.2 for pressurizing and administering the substance. After loading, the syringe 24 and the auxiliary connector element 25 are removed as shown in FIG. 40B, and the substance 4 is administered by the exerted gas pressure, as shown in FIG. 40C. The gas pressure may therefore be obtained by means other than a gas cartridge, such as a motorized bellows, a propeller, a compressor.

[0239] In an embodiment of the present disclosure, the at least one pressure source is a gas configured to exert pressure on the at least one fluid source and / or on the substance in the delivery tube, In an embodiment of the present disclosure, the gas pressure source is selected from the group of a gas cartridge, a motorized bellows, a propeller, a compressor, and combinations thereof.

[0240] Application of Hemostatic Powder According to one embodiment, a laparoscopic applicator is configured to administer a hemostatic agent powder at a selected site using a surgical robotic arm, the laparoscopic applicator comprising: - a delivery tube for holding a hemostatic agent powder; a variable speed delivery device, such as a screw conveyor, configured to transport the hemostatic agent powder through the delivery tube and out of the delivery tube such that the hemostatic agent powder is dispensed from the applicator; Equipped with.

[0241] The hemostatic powder preferably comprises a hemostatic agent. Advantageously, the hemostatic powder comprises particles having a particle size greater than 180 microns. In an embodiment, the hemostatic powder comprises particles having an average particle size of at least 275 microns, such as an average of approximately 300 microns. Furthermore, the particles have a density of at least 0.3 g / cm 3 , more preferably at least 0.4 g / cm 3 , and even more preferably at least 0.44 g / cm 3 By way of example, the particles may have a tap density of 0.3-1 / cm. 3 In one embodiment, the variable speed infeed device is a screw conveyor. This is shown in FIG. 26. In another embodiment, the variable speed infeed device is a paddle wheel. The applicator may comprise a first position sensor, such as a magnetic or optical sensor, configured to determine the position of the screw conveyor and / or the paddle wheel. The first position sensor is preferably configured to record each revolution of the screw conveyor and / or the paddle wheel depending on the direction of rotation, each revolution being added or subtracted depending on the direction of rotation, so that the position of the screw conveyor and / or the paddle wheel can be determined. If a processing device is used to control, the processing device of the screw conveyor and / or the paddle wheel will know the direction of rotation. Alternatively, the first position sensor can sense the direction, such as by having two sensors next to each other. The position of the screw conveyor (determined, for example, by the number of revolutions) may be used to determine the remaining amount of powder in the delivery tube.

[0242] In another embodiment, a laparoscopic applicator for administering a hemostatic agent powder at a selected site using a surgical robotic arm includes: - a delivery tube for holding a hemostatic agent powder; - a valve positioned at a distal end of the delivery tube and configured to open at a predetermined opening pressure; a vibration device, such as an ultrasonic vibration device, configured to shake the hemostatic agent powder out of the delivery tube when the valve is open; Equipped with.

[0243] A laparoscopic applicator comprising a vibration device is shown in Figures 27-29. In this case, the applicator comprises a vibration device and may further comprise a clock configured to measure the elapsed time when the vibration device is activated / vibrated. The elapsed time can be used to estimate the remaining volume of hemostatic agent powder in the delivery tube. Alternatively, the applicator may comprise one of the sensors described above for determining the amount of material in the applicator.

[0244] The laparoscopic applicator is configured to administer or draw in a substance, including a hemostatic agent, which may be in the form of a liquid, paste, or powder. Due to the flow characteristics of the powder, the pressure source or drive mechanism for transporting the hemostatic agent powder through and out of the delivery tube advantageously comprises a combination of a variable speed feeder, such as a screw conveyor, or a vibrating device, in combination with a pressure source, such as a gas pressure source.

[0245] If the medical substance is a powder, such as a hemostatic powder, a pressure source is not necessarily required as the powder can be expelled from the applicator by other means. In this case, the applicator includes a variable speed feeder configured to transport the hemostatic powder through and out of the delivery tube so that the hemostatic powder is administered from the applicator, either as an alternative to or in addition to the pressure source. Alternatively, the applicator may include a vibration device to shake the powder out of the applicator. However, advantageously for efficient and accurate expulsion of the powder, such as to obtain sufficient flow characteristics and spray angle, the variable speed feeder further includes a pressure source, such as a gas pressure source.

[0246] FIG. 31 is a diagram of an embodiment of an applicator according to the present disclosure, in which the applicator 1 includes a gas pressure source 8 for transporting powder through a delivery tube. For example, the gas pressure source is a bellows actuated by a motorized piston 10.1, such as a piston that oscillates back and forth in a horizontal direction, as indicated by the larger double-headed arrow. (A) shows a perspective view of the applicator, and (B) shows a cross-sectional view. The drive mechanism of the pressure source can be actuated via an actuator 2.6, such as an electric actuator that sends an electric signal to a motor 10.1 as indicated in FIG. 31A, whereby powder 20 is dispensed from the distal end 2.2 of the delivery tube. Powder can be pre-filled into the applicator, or can be supplied from a second material reservoir 24.2 via an auxiliary connector element 25, or the bellows can include a material reservoir, such as a reservoir of powder 20, to be transported simultaneously with the gas pressure source, as shown in FIG. 31B.

[0247] FIG. 32 shows an embodiment of an applicator according to the present disclosure, in which the applicator comprises a gas pressure source 8 for transporting powder 20 through a delivery tube, the gas pressure source being obtained via a motorized propeller and optionally a gas inlet. (A) shows a perspective view of the applicator, and (B) shows a cross-sectional view. The drive mechanism of the pressure source can be actuated via an actuator 2.6, such as an electric actuator that sends an electric signal to a motor 10.1 as indicated in FIG. 32A, whereby powder 20 is dispensed from the distal end 2.2 of the delivery tube. Powder can be pre-filled into the applicator or can be supplied from a second substance reservoir 24.2 via an auxiliary connector element 25.

[0248] FIG. 33 is a diagram of an embodiment of an applicator according to the present disclosure, in which the applicator includes a pressure source for transporting powder through a delivery tube, the pressure source being a distally positioned piston or actuator 2.6 with an opening for establishing fluid communication with the distal end 2.2 of the delivery tube. The distally positioned piston may be equipped with a prime mover 10.1 that oscillates back and forth in the horizontal direction, as indicated by the large double-headed arrow, whereby powder 20 is dispensed from the distal end 2.2 of the delivery tube. (A) shows a partial perspective view, with the distal end enlarged in the inserted frame, and (B) shows a cross-sectional view, with the distal end enlarged in the inserted frame in the perspective view. Powder may be pre-filled into the applicator or may be supplied from a second material reservoir via an auxiliary connector element.

[0249] FIG. 34 shows an embodiment of an applicator according to the present disclosure, in which the applicator includes a gas pressure source for transporting powder through a delivery tube, the gas pressure source being obtained by rotating a paddle wheel or impeller. The impeller may be further controlled by a gas cartridge 8.2 in combination with a gas flow control valve, such as in combination with a connector 6. Thus, powder delivery can be controlled by the rotational speed of the impeller and the gas cartridge supply. The powder may be pre-filled in the applicator or may be supplied from a first or second material reservoir 24, such as contained within the impeller as most clearly indicated in FIG. 34B.

[0250] In an embodiment of the present disclosure, the variable speed feeding device further comprises a pressure source, such as a gas pressure source optionally selected from the group of a gas cartridge, a motorized bellows, a propeller, a compressor, and combinations thereof. In an embodiment of the present disclosure, the variable speed feeding device comprises a powder reservoir, the reservoir optionally comprising a container feeding control, such as an adjustable container opening.

[0251] For efficient and precise ejection of the powder, e.g. to obtain sufficient flow characteristics and spray angle, the gas pressure source advantageously provides the possibility of reduced gas flow, such as reduced air flow or reduced air volume, so that the powder ejection is more controlled and powder turbulence at the ejection is avoided. This can be obtained by an applicator equipped with a flow restricting element to reduce the gas flow at the powder delivery site.

[0252] Figure 35 shows an embodiment of an applicator according to the present disclosure, where the applicator 1 comprises a gas pressure source 8 for transporting powder through a delivery tube, and further comprises a flow restricting element for reducing gas flow at the powder delivery site. For example, the flow restricting element 22 can be a grid or slit element in the delivery tube through which the powder 20 and gas must pass, as shown in Figure 35A. Alternatively, the flow restricting element 22 can be a separate gas flow path as shown in Figure 35B, running parallel to the screw conveyor 19 that transports the powder 20.

[0253] In an embodiment of the present disclosure, the variable speed delivery device includes one or more flow restricting elements, such as a grid element or separate gas flow passages.

[0254] Further details of the invention 1. A laparoscopic applicator for administering or withdrawing a substance, such as a hemostatic agent, at a selected site using a surgical robotic arm, comprising: - a delivery tube for holding the substance; - an applicator tip connected to a distal end of a delivery tube, - To be spatially navigated by a robotic arm, - controllably releasing the substance from the delivery tube by the robotic arm; and / or - To controllably draw a substance from a selected site into a delivery tube. an applicator tip comprising: A laparoscopic applicator comprising:

[0255] 2. A laparoscopic applicator for administering a substance, such as a hemostatic agent-containing substance, at a selected site using a surgical robotic arm, comprising: - a delivery tube; - an applicator tip connected to a distal end of a delivery tube, the applicator tip being configured to be controllably moved by a robotic arm in the vicinity of a gripping area in an axial extension of the delivery tube, the gripping area having an outer periphery transverse to an axis and with a shaped apex area such that the applicator tip is configured to be clamped and spatially steered by the robotic arm; 2. The laparoscopic applicator of item 1, comprising:

[0256] 3. A laparoscopic applicator as described in item 1 or 2, wherein the delivery tube comprises at least one rigid section, such as a rigid tubular section or a rigid surface region.

[0257] 4. A laparoscopic applicator as described in item 3, wherein at least one rigid section is dimensioned to be palpable by a robotic arm, such as palpable by grasping, pushing, or attaching.

[0258] 5. A laparoscopic applicator according to any of items 1 to 4, wherein the delivery tube comprises a deformable section.

[0259] 6. The laparoscopic applicator of item 5, wherein the deformable area is compressible, such as in the form of a corrugated tube, so that the length of the tube can be changed.

[0260] 7. A laparoscopic applicator according to item 5 or 6, wherein the deformable area comprises a wavy surface profile, preferably the wavy surface profile comprises a plurality of peripheral folds.

[0261] 8. A laparoscopic applicator according to any of items 5 to 7, wherein the deformable section is positioned at a distal end of the delivery tube.

[0262] 9. A laparoscopic applicator according to any of items 5 to 8, wherein the deformable section is positioned a distance from the distal end of the delivery tube.

[0263] 10. A laparoscopic applicator according to any of items 1 to 9, wherein the delivery tube and / or applicator tip are dimensionally configured to hold a substance under pressure and / or are configured to include one or more flow control elements.

[0264] 11. A laparoscopic applicator according to any of items 1 to 10, wherein the delivery tube and / or applicator tip has an inner diameter of less than 5 mm, preferably less than 3 mm, and even more preferably less than 2 mm.

[0265] 12. An applicator according to any of items 1 to 11, wherein the delivery tube has a length between 350 and 500 mm.

[0266] 13. An applicator according to any of items 1 to 12, wherein the delivery tube has an outer diameter between 2.5 and 4.5 mm and / or an inner lumen with a diameter of 1.5 to 2.0 mm.

[0267] 14. An applicator according to any of items 1 to 13, wherein the delivery tube comprises an inner lumen with a cross-sectional area corresponding to a diameter between 1.2 and 1.5 mm.

[0268] 15. An applicator described in any of items 1 to 14, wherein at least a portion of the delivery tube is configured to be flexible without tension, and / or the applicator further comprises an insertion guide for supporting the delivery tube, the insertion guide being optionally configured to be slidable along an axial direction of the delivery tube.

[0269] 16. An applicator according to any of items 1 to 15, wherein the delivery tube comprises a flexible material having a Young's modulus between 0.0001 and 0.035 GPa.

[0270] 17. The applicator of any of items 1 to 16, wherein the delivery tube comprises a material having an attenuation coefficient between 0.2 and 2.0.

[0271] 18. An applicator according to any of the preceding claims, wherein the delivery tube comprises or consists of a vibrational energy dissipative material selected from the group consisting of silicone elastomers, butyl rubber, polyurethane, and combinations thereof.

[0272] 19. The applicator of any of items 1 to 18, wherein the shaped-top area is selected from the group of rounded top, blunt top, sharp top, pointed top, and combinations thereof.

[0273] 20. An applicator according to any of items 1 to 19, wherein the periphery has a shape selected from the group of an oval, an ellipse with one axis of symmetry, an ellipse with two axes of symmetry, an equilateral triangle, an isosceles triangle, a scalene triangle, a parallelogram, and a rhombus.

[0274] 21. An applicator according to any of items 1 to 20, wherein the peripheral shape is defined by a major axis defining the longest dimension and a minor axis defining the shortest dimension.

[0275] 22. The applicator according to item 21, wherein the major axis is between 2.5 and 5.2 mm and / or the minor axis is between 2.5 and 3.5 mm.

[0276] 23. An applicator according to any of items 1 to 22, wherein the gripping area has a length between 20 and 25 mm or between 30 and 35 mm.

[0277] 24. An applicator according to any of items 1 to 23, wherein the gripping section includes a connection section in fluid communication with a delivery tube.

[0278] 25. The applicator of item 24, wherein the connection section comprises a connection selected from the group of a straight break connection, a stepped break connection, an adhesive connection, a shrink tubing connection, and combinations thereof.

[0279] 26. The applicator of any of items 1 to 25, wherein the gripping area comprises an occlusion-resistant material selected from the group consisting of steel, stainless steel, polymers such as ABS, polycarbonate, polyamide, PEEK, and combinations thereof.

[0280] 27. The applicator of any of items 1 to 26, wherein the gripping area comprises a coating comprising a soft polymer selected from the group of polyolefins, ABS, and combinations thereof.

[0281] 28. An applicator according to item 27, wherein the covering is provided by a shrink tube.

[0282] 29. An applicator according to any of items 1 to 28, wherein the applicator tip and / or gripping area comprises a magnetic element configured to magnetically attach the tip to a surgical instrument.

[0283] 30. The magnetic element has a resistance of at least 400 g / cm 2 30. The applicator according to item 29, wherein the magnet is a neodymium magnet, preferably with a holding force of

[0284] 31. A laparoscopic applicator according to any of items 1 to 30, wherein the delivery tube comprises a substance, e.g., the substance comprises a hemostatic agent, the substance being in the form of a liquid, a paste, or a powder.

[0285] 32. The laparoscopic applicator of item 31, wherein the substance comprises a bioactive agent and / or a hemostatic agent.

[0286] 33. The laparoscopic applicator according to item 31, wherein the substance comprises a material selected from the group consisting of polyethylene glycol (PEG), cyanoacrylate, oxidized regenerated cellulose, microporous polysaccharide spheres, and microfibrillar cellulose.

[0287] 34. The laparoscopic applicator of item 31, wherein the substance is a hemostatic paste containing a hemostatic agent.

[0288] 35. The laparoscopic applicator according to item 34, wherein the hemostatic agent is selected from the group of thrombin and fibrinogen.

[0289] 36. The laparoscopic applicator according to item 31, wherein the substance is a hemostatic powder.

[0290] 37. The laparoscopic applicator of item 36, wherein the hemostatic powder comprises particles having a particle size greater than 180 microns.

[0291] 38. A laparoscopic applicator according to item 36 or 37, wherein the hemostatic powder comprises particles having an average particle size of at least 275 microns.

[0292] 39. A laparoscopic applicator according to any of items 36 to 38, wherein the hemostatic powder comprises particles having a tap density of at least 0.4 g / mL.

[0293] 40. A laparoscopic applicator according to any of items 36 to 39, wherein the applicator further comprises a variable speed feed device, such as a screw conveyor, configured to transport the hemostatic agent powder through the delivery tube and out of the delivery tube so that the hemostatic agent powder is administered from the applicator.

[0294] 41. The laparoscopic applicator of item 40, wherein the variable speed delivery device is configured to be driven / rotated by an external motor.

[0295] 42. The laparoscopic applicator of item 40, wherein the applicator further comprises a motor for driving / rotating the variable speed delivery device.

[0296] 43. A laparoscopic applicator according to item 40 or 41, wherein the variable speed feeding device is a screw conveyor.

[0297] 44. A laparoscopic applicator according to item 40 or 41, wherein the variable speed delivery device is a wheel with a paddle.

[0298] 45. A laparoscopic applicator according to any of items 40 to 44, wherein the variable speed delivery device further comprises a gas pressure source optionally selected from the group of a gas cartridge, a motorized bellows, a propeller, a compressor, and combinations thereof.

[0299] 46. ​​A laparoscopic applicator according to any of items 40 to 45, wherein the variable speed delivery device comprises a powder reservoir, the reservoir optionally comprising an adjustable reservoir opening and / or a reservoir delivery control device, such as a wheel with a paddle.

[0300] 47. A laparoscopic applicator according to any of items 40 to 46, wherein the variable speed delivery device comprises one or more flow restricting elements, such as a grid element or a separate gas flow path.

[0301] 48. The laparoscopic applicator of any of items 40 to 47, wherein the applicator further comprises a first position sensor configured to determine a position of the variable speed delivery device.

[0302] 49. The laparoscopic applicator of item 48, wherein the first position sensor is an optical sensor.

[0303] 50. The laparoscopic applicator of item 48, wherein the variable speed delivery device is provided with a magnet, and the first position sensor is a magnetic sensor configured to detect the presence of the magnet.

[0304] 51. A laparoscopic applicator according to any of items 36 to 50, wherein the applicator further comprises a vibration device, such as an ultrasonic vibration device, configured to shake the hemostatic agent powder out of the delivery tube.

[0305] 52. The laparoscopic applicator according to item 51, wherein the applicator further comprises a clock configured to measure elapsed time when the vibration device is activated / vibrated.

[0306] 53. The laparoscopic applicator of item 52, wherein the elapsed time is used to estimate the remaining volume of hemostatic powder in the delivery tube.

[0307] 54. A laparoscopic applicator according to any of items 1 to 53, wherein the delivery tube comprises multiple lumens, such as at least two lumens, at least three lumens, or at least four lumens.

[0308] 55. The laparoscopic applicator of item 54, wherein the multiple lumens include a first lumen and a second lumen, the first lumen configured to contain a substance, such as a substance including a hemostatic agent, and the second lumen configured to contain electrical wiring or optical fiber.

[0309] 56. The laparoscopic applicator according to item 55, wherein the inner diameter of the first lumen is less than 4 mm, preferably less than 3 mm, and even more preferably less than 2 mm.

[0310] 57. A laparoscopic applicator according to any of items 54 to 56, wherein at least one of the multiple lumens is configured to contain a malleable wire or rod.

[0311] 58. A laparoscopic applicator according to any of items 5 to 57, wherein the applicator further comprises a malleable wire or rod configured to allow the deformable section of the delivery tube to bend into a desired shape, said shape being approximately maintained upon release of the delivery tube.

[0312] 59. A laparoscopic applicator according to any of items 5 to 58, wherein the deformable section of the delivery tube can be bent along two planes at two predetermined angles, such as at least 30° or at least 45°.

[0313] 60. An applicator according to any of items 1 to 59, wherein the applicator tip and / or gripping area comprises one or more light sources, detection sensors, and / or cameras.

[0314] 61. An applicator according to any of items 1 to 60, comprising one or more lumens configured to receive one or more signal carrying or transmitting devices, such as electrical or optical signals.

[0315] 62. A laparoscopic applicator according to any of items 1 to 61, wherein the applicator tip is removably attached to the distal end of the delivery tube.

[0316] 63. A laparoscopic applicator according to any of items 1 to 62, wherein the applicator tip is integrated in the delivery tube such that the delivery tube and the applicator tip are a single unit.

[0317] 64. A laparoscopic applicator according to any of items 1 to 63, wherein the delivery tube and / or the applicator tip are disposable.

[0318] 65. An applicator described in any of items 1 to 64, wherein the applicator tip is configured to controllably release the substance from the delivery tube by the robotic arm near an actuation zone configured to receive a predetermined force by the robotic arm.

[0319] 66. The applicator of item 65, wherein the working section is positioned in an axial extension of the gripping section.

[0320] 67. The applicator of item 65, wherein the actuation area coincides with the gripping area.

[0321] 68. An applicator according to any of items 65 to 67, wherein the actuation section is configured to actuate the substance release mechanism when a predetermined force is exceeded.

[0322] 69. A laparoscopic applicator according to any of items 1 to 68, wherein the applicator or applicator tip further comprises at least one valve configured to release the substance from the delivery tube when opened.

[0323] 70. The laparoscopic applicator of item 69, wherein at least one valve is a pressure-activated valve having a predetermined opening pressure threshold.

[0324] 71. The laparoscopic applicator of item 69, wherein the substance is administered from the delivery tube when a predetermined opening pressure threshold is exceeded.

[0325] 72. A laparoscopic applicator according to any of items 69 to 71, wherein at least one valve is controllable by an actuator positioned on the applicator.

[0326] 73. A laparoscopic applicator according to any of items 69 to 72, wherein at least one valve is controllable by an external actuator, such as a foot pedal.

[0327] 74. The laparoscopic applicator of any of items 69 to 73, wherein the at least one valve is selected from the group of a one-way valve, an elastic one-way valve, a duckbill valve, a cross-slit valve, and a spring-loaded check valve.

[0328] 75. The laparoscopic applicator of any of items 69 to 74, wherein at least one valve is positioned in the delivery tube.

[0329] 76. A laparoscopic applicator according to any of items 69 to 75, wherein at least one valve is positioned at the applicator tip.

[0330] 77. A laparoscopic applicator according to any of items 1 to 76, wherein the applicator or applicator tip further comprises at least one actuator configured to open and / or close the at least one valve.

[0331] 78. The laparoscopic applicator according to item 77, wherein the at least one actuator is configured to be actuated by a pressure force, e.g., applied by a robotic arm, or by an electric current, e.g., applied by an energy tool.

[0332] 79. A laparoscopic applicator according to item 77 or 78, wherein at least one actuator is actuated by pulling the actuator along the longitudinal axis of the tube / applicator tip and / or by rotating the actuator about the longitudinal axis.

[0333] 80. The laparoscopic applicator of any of items 77 to 79, wherein the at least one actuator is positioned at a distal end of the delivery tube.

[0334] 81. The laparoscopic applicator of any of items 77 to 80, wherein at least one actuator is positioned in a rigid section of the delivery tube.

[0335] 82. A laparoscopic applicator according to any of items 77 to 81, wherein at least one actuator is positioned at the applicator tip.

[0336] 83. The laparoscopic applicator of any of items 77 to 82, wherein at least one actuator is positioned on an external device.

[0337] 84. The laparoscopic applicator of any of items 77 to 83, wherein at least one actuator is a pressure sensitive button.

[0338] 85. A laparoscopic applicator according to any of items 77 to 84, wherein at least one actuator covers a predetermined peripheral area of ​​the tube and / or applicator tip.

[0339] 86. A laparoscopic applicator according to item 85, wherein at least one actuator covers less than 180°, preferably less than 140°, of the circumference of the tube and / or applicator tip.

[0340] 87. A laparoscopic applicator according to item 85 or 86, wherein two actuators are provided on opposite portions of the applicator tip and / or tube, each of said actuators covering less than 120°, preferably less than 90°, of the circumference of the tube and / or applicator tip.

[0341] 88. A laparoscopic applicator according to any of items 85 to 87, wherein at least one actuator covers at least 180° of the circumference of the tube and / or applicator tip.

[0342] 89. A laparoscopic applicator according to any of items 85 to 88, wherein at least one actuator covers 360° around the tube and / or applicator tip so as to encircle a portion of the tube and / or applicator tip.

[0343] 90. A laparoscopic applicator according to any of items 77 to 89, wherein at least one actuator is configured to, upon actuation, send an electrical signal to a pressure source, such as a drive mechanism, configured to exert sufficient pressure to dispense a substance from the laparoscopic applicator.

[0344] 91. A laparoscopic applicator according to any of items 1 to 90, wherein the applicator further comprises a first pressure sensor for sensing pressure in the delivery tube.

[0345] 92. A laparoscopic applicator according to any of items 77 to 91, wherein the applicator further comprises a second pressure sensor for sensing pressure applied to the actuator.

[0346] 93. The laparoscopic applicator of item 92, wherein the second pressure sensor is a resistive membrane pressure sensor and / or a force sensing resistor.

[0347] 94. A laparoscopic applicator according to any of items 77 to 93, wherein at least one actuator is a pressure sensitive button and a pressure sensor for sensing pressure applied to the actuator is integrated in or located beneath the button.

[0348] 95. A laparoscopic applicator according to any of items 77 to 94, wherein at least one actuator is a pressure sensitive button covering a portion of the applicator tip, said portion surrounding the entire periphery of the applicator tip, and wherein a second pressure sensor for sensing pressure applied to the actuator is integrated in or located beneath the button.

[0349] 96. A laparoscopic applicator according to any of items 77 to 95, wherein the applicator further comprises a pressure indicating lamp for indicating the pressure applied to the at least one actuator.

[0350] 97. The laparoscopic applicator of item 96, wherein the pressure indicating lamp is located within or on the applicator tip.

[0351] 98. A laparoscopic applicator according to item 96 or 97, wherein the pressure indicator lamp is provided as a circular band positioned along the periphery of the applicator tip.

[0352] 99. The pressure indicator lamp is - displaying a light of a first color, such as green, when the applied pressure falls below a first predetermined threshold; and - Display a second color light, such as red, when the applied pressure exceeds a second predefined threshold 99. A laparoscopic applicator according to any of items 96 to 98, configured as follows:

[0353] 100. The pressure indicator lamp is - displaying a third color light, such as yellow, when the applied pressure is between said first predetermined threshold and said second predetermined threshold. 100. The laparoscopic applicator of item 99, further comprising:

[0354] 101. A laparoscopic applicator according to any of items 1 to 100, wherein the applicator or the applicator tip further comprises a status indicator, such as in the form of a light diode, the status indicator configured to indicate a remaining volume of substance in the applicator.

[0355] 102. The laparoscopic applicator of item 101, wherein the remaining volume is determined by a first position sensor, a second position sensor, a clock, and / or a combination thereof.

[0356] 103. A laparoscopic applicator according to item 101 or 102, wherein the applicator further comprises at least one fluid source having a plunger in a barrel, the position of the plunger being used to estimate a remaining volume of the substance in the delivery tube, the remaining volume being indicated by a status indicator.

[0357] 104. A laparoscopic applicator according to any of items 101 to 103, wherein the status indicator is positioned within or on the applicator tip.

[0358] 105. The delivery tube includes a first light-sensitive sensor configured to sense light in a predetermined wavelength range passing through the delivery tube; the delivery tube comprises a light source positioned opposite the first light-sensitive sensor; and / or - A laparoscopic applicator according to any of the preceding claims, wherein the delivery tube is transparent to at least a portion of the wavelength range.

[0359] 106. The applicator of item 105, wherein the first light-sensitive sensor is positioned at a distal portion of the delivery tube.

[0360] 107. An applicator according to item 105 or 106, wherein the delivery tube is provided with a second light-sensing sensor positioned farther away from the distal end relative to the first light-sensing sensor.

[0361] 108. A laparoscopic applicator according to any of items 1 to 107, wherein the applicator tip further comprises a rigid section configured to be grasped by a robotic arm.

[0362] 109. A laparoscopic applicator according to any of items 1 to 108, wherein the applicator tip further comprises an adjustable nozzle for adjusting the rate or angle of administration of the substance.

[0363] 110. An applicator according to any of items 1 to 109, wherein the applicator tip and / or gripping area comprises a nozzle at a distal end of the tip, the nozzle being configured to eject the substance in a predetermined shape.

[0364] 111. The applicator of item 110, wherein the nozzle is configured to eject the substance in a predetermined shape selected from the group of cylindrical, planar, and corrugated planar.

[0365] 112. An applicator according to item 110 or 111, wherein the cross-sectional shape of the nozzle opening is selected from the group of a circle, a diamond, a rectangle, a curved rectangle, and a concave rectangle.

[0366] 113. An applicator according to any of items 110 to 112, wherein the height of the nozzle opening is between 0.5 and 1.0 mm.

[0367] 114. An applicator according to any of items 110 to 113, wherein the nozzle lumen branches toward the distal end.

[0368] 115. An applicator according to any of items 110 to 114, wherein the shape of the nozzle is selected from the group consisting of conical, blunt conical, biconic, nosecone, elliptical, and parabolic.

[0369] 116. An applicator according to any one of items 110 to 115, wherein the length of the nozzle lumen is between 2.0 and 3.5 mm.

[0370] 117. An applicator according to any of items 1 to 116, wherein the connection between the nozzle unit and the gripping area is abrupt or gradual and / or configured to be removable.

[0371] 118. A laparoscopic applicator according to any of items 1 to 117, wherein the applicator further comprises at least one fluid source for holding fluid, the fluid source being in fluid connection with the delivery tube.

[0372] 119. The laparoscopic applicator of item 118, wherein the at least one fluid source is a syringe, such as a medical syringe, such as a single-use medical syringe.

[0373] 120. The laparoscopic applicator of item 119, wherein the syringe includes a barrel for holding the fluid and a plunger for expelling the fluid from the syringe.

[0374] 121. The laparoscopic applicator of item 120, wherein the applicator further comprises a second position sensor configured to determine a position of the plunger.

[0375] 122. The laparoscopic applicator of item 121, wherein the second position sensor is an optical sensor.

[0376] 123. The laparoscopic applicator of item 121, wherein the plunger is provided with a magnet, and the second position sensor is a magnetic sensor configured to detect the presence of the magnet.

[0377] 124. A laparoscopic applicator according to any of items 121 to 123, wherein the position of the plunger is used to estimate the remaining volume of material in the barrel and / or delivery tube.

[0378] 125. The laparoscopic applicator of item 118, wherein the at least one fluid source is a container, such as a vessel configured to be pressurized.

[0379] 126. The laparoscopic applicator of item 118, wherein at least one fluid source is a flexible balloon.

[0380] 127. A laparoscopic applicator according to any of items 114 to 126, wherein the applicator includes at least one connector, such as a luer lock, a compression connection, and / or an adhesive connection, for removably attaching to at least one fluid source.

[0381] 128. The laparoscopic applicator of item 127, wherein the at least one connector comprises a hollow piercing element for piercing the at least one fluid source, thereby establishing a fluid connection between the fluid source and the delivery tube.

[0382] 129. The laparoscopic applicator of any of items 114 to 126, wherein at least one fluid source comprises a liquid, such as saline.

[0383] 130. The laparoscopic applicator of any of items 114 to 129, wherein at least one fluid source comprises a paste, such as a hemostatic paste containing a hemostatic agent.

[0384] 131. The laparoscopic applicator of any of items 114 to 130, wherein at least one fluid source comprises a gas.

[0385] 132. The laparoscopic applicator according to item 131, wherein the gas is selected from the group of CO2 (carbon dioxide), N2 (dinitrogen), N2O (nitrous oxide), and air.

[0386] 133. A laparoscopic applicator according to any of items 114 to 131, wherein the delivery tube and the at least one fluid source comprise the same substance, such as a substance including a hemostatic agent, and the substance is provided in the form of a liquid, a paste, or a powder, such that the at least one fluid source constitutes a first substance reservoir.

[0387] 134. The laparoscopic applicator of item 133, wherein the first substance reservoir comprises a barrel for holding fluid and a piston for expelling the substance from the barrel.

[0388] 135. A laparoscopic applicator according to item 134, wherein the barrel has a diameter between 10 and 30 mm, more preferably between 12 and 20 mm, and most preferably between 14 and 18 mm.

[0389] 136. A laparoscopic applicator according to any of items 133 to 135, comprising one or more second substance reservoirs.

[0390] 137. A laparoscopic applicator according to any of items 133 to 136, wherein the second substance reservoir is removably attached to the first substance reservoir via at least one auxiliary connector element.

[0391] 138. The laparoscopic applicator of item 137, wherein the auxiliary connector element comprises a luer lock, a compression connection, or an adhesive connection.

[0392] 139. A laparoscopic applicator according to item 137 or 138, wherein the auxiliary connector element is configured to establish sequential fluid connections 1) between the first substance reservoir and the second substance reservoir, and 2) between the first substance reservoir and the delivery tube.

[0393] 140. A laparoscopic applicator according to any of items 137 to 139, wherein the auxiliary connector element is adapted to have a first configuration providing a fluid passageway between the first substance reservoir and the second substance reservoir, and a second configuration providing a fluid passageway between the first substance reservoir and the delivery tube.

[0394] 141. A laparoscopic applicator according to any of items 137 to 140, wherein the auxiliary connector element comprises at least one one-way valve.

[0395] 142. A laparoscopic applicator according to any of items 133 to 141, wherein the first substance reservoir and / or the second substance reservoir are disposable.

[0396] 143. The laparoscopic applicator of any of items 114 to 142, wherein at least one fluid source is configured to be pressurized, such as by use of a pressure source.

[0397] 144. A laparoscopic applicator according to any of items 114 to 143, wherein the applicator comprises at least two fluid sources.

[0398] 145. A laparoscopic applicator according to any of items 1 to 144, wherein the delivery tube is configured to hold a substance under pressure or to hold a pressurized substance.

[0399] 146. A laparoscopic applicator according to any of items 1 to 145, wherein the applicator further comprises at least one pressure source configured to apply pressure to the at least one fluid source and / or to an interior of the delivery tube, such as to a substance in the delivery tube.

[0400] 147. The laparoscopic applicator of item 146, wherein the delivery tube is configured to be loaded with the substance from a distal end.

[0401] 148. A laparoscopic applicator according to item 147, wherein the delivery tube includes one or more removably attached connectors for a substance reservoir and / or a flow control element.

[0402] 149. A laparoscopic applicator according to any of items 146 to 148, wherein the at least one pressure source is a spring configured to exert pressure on the at least one fluid source and / or on a substance in the delivery tube.

[0403] 150. The laparoscopic applicator of item 149, wherein spring energy is pre-stored and / or spring energy is stored upon loading of the delivery tube.

[0404] 151. A laparoscopic applicator according to any of items 146 to 148, wherein the at least one pressure source is a gas configured to exert pressure on the at least one fluid source and / or on a substance in the delivery tube.

[0405] 152. The laparoscopic applicator of item 150, wherein the gas pressure source is selected from the group of a gas cartridge, a motorized bellows, a propeller, a compressor, and combinations thereof.

[0406] 153. The laparoscopic applicator of items 146 to 152, wherein the at least one pressure source comprises a propellant selected from the group of a spring-loaded element, a gas propellant, an inflatable balloon or bladder, and / or a movable piston, such as an electrically driven piston or a manually driven piston.

[0407] 154. The laparoscopic applicator of items 146 to 153, wherein the at least one pressure source is a drive mechanism selected from the group of a manual piston, a prime mover piston, a spring force, and gas pressure, such as a motor, comprising at least one piston configured to exert pressure on the at least one fluid source.

[0408] 155. The laparoscopic applicator of item 154, wherein the drive mechanism is an electric motor.

[0409] 156. A laparoscopic applicator according to item 154 or 155, wherein the at least one actuator is configured, upon actuation, to send an electrical signal to the drive mechanism, whereby, upon receiving the electrical signal, the drive mechanism is configured to exert pressure on at least one fluid source such that a substance is administered from the laparoscopic applicator.

[0410] 157. A laparoscopic applicator according to any of items 154 to 156, wherein the drive mechanism comprises two pistons, a first piston configured to exert a first pressure on the first fluid source and a second piston configured to exert a second pressure on the second fluid source.

[0411] 158. The laparoscopic applicator of item 157, wherein the drive mechanism includes a switching mechanism, such as a gear mechanism, configured to switch between operating the first piston and / or operating the second piston.

[0412] 159. The laparoscopic applicator of any of items 154 to 158, wherein the drive mechanism further comprises a directional control configured to control a direction (forward or rearward) of the at least one piston.

[0413] 160. An applicator according to any of items 1 to 159, comprising a pressure source configured to apply pressure to the interior of the delivery tube and comprising a piston drive mechanism, the piston configured to be retractable.

[0414] 161. The laparoscopic applicator of any of items 1 to 160, wherein the applicator further comprises a rigid sheath surrounding at least a portion of the delivery tube, the sheath configured to enable the delivery tube to be inserted into the trocar.

[0415] 162. The applicator is - at least one fluid source for holding a fluid, in fluid communication with the delivery tube; and / or - at least one pressure source configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube; 162. The laparoscopic applicator according to any of the preceding claims, further comprising a drive unit for holding the laparoscopic applicator.

[0416] 163. A laparoscopic applicator according to item 162, wherein the laparoscopic applicator comprises a syringe having a barrel for holding a substance fluid and a plunger for pushing the fluid out of the syringe and / or drawing the substance into the syringe, and wherein the drive unit is configured to receive and hold the syringe.

[0417] 164. The laparoscopic applicator of item 163, wherein the drive unit is further configured to retract the plunger such that the substance is drawn into the applicator.

[0418] 165. A laparoscopic applicator according to any of items 1 to 164, wherein the delivery tube and / or at least one fluid source are disposable.

[0419] 166. A laparoscopic applicator according to any of items 1 to 165, wherein the applicator further comprises a safety mechanism configured for switching between two modes (on / off), "off mode" meaning that the substance cannot be released from the applicator and "on mode" meaning that the substance can be released.

[0420] 167. The laparoscopic applicator of item 166, wherein the safety mechanism is located on the delivery tube, the applicator tip, or the drive unit.

[0421] 168. A laparoscopic applicator according to any of items 1 to 167, wherein the applicator further comprises a flow control device configured to control a flow rate of the substance emitted from the applicator.

[0422] 169. The laparoscopic applicator of item 168, wherein the flow control device is located on the drive unit.

[0423] 170. A laparoscopic applicator tip for connection to a laparoscopic delivery tube for holding a substance, such as a substance containing a hemostatic agent, comprising: - at least one valve configured to release the substance from the delivery tube when opened; at least one actuator configured to open / close at least one valve; A laparoscopic applicator tip comprising:

[0424] 171. The laparoscopic applicator tip of item 170, wherein the at least one valve is configured to retain and release a substance under pressure.

[0425] 172. A laparoscopic applicator tip according to any of items 170 to 171, wherein the applicator tip further comprises a pressure sensor, such as a resistive membrane pressure sensor, for sensing pressure applied to the actuator.

[0426] 173. A laparoscopic applicator tip according to any of items 170 to 172, wherein the applicator tip further comprises a pressure indicating lamp for indicating pressure applied to the at least one actuator.

[0427] 174. A laparoscopic applicator tip according to any of items 170 to 173, wherein the applicator tip further comprises a status indicator, such as in the form of a light diode, said status indicator configured to indicate a remaining volume of substance in the delivery tube.

[0428] 175. A laparoscopic applicator tip according to any of items 170 to 174, wherein the applicator tip or gripping section further comprises a rigid section configured to be gripped by a robotic arm.

[0429] 176. A laparoscopic applicator tip according to any of items 170 to 175, wherein the applicator tip further comprises an adjustable nozzle for adjusting the rate and / or angle of administration of the substance.

[0430] 177. A laparoscopic applicator for administering or withdrawing a substance, such as a hemostatic agent, at a selected site using a surgical robotic arm, comprising: - a delivery tube for holding the substance; - an applicator tip according to any of items 170 to 176, connected to a distal end of a delivery tube, - to be spatially navigated by a robotic arm; and / or - controllably releasing the substance from the delivery tube by the robotic arm or controllably drawing the substance from the selected site into the delivery tube. an applicator tip comprising: A laparoscopic applicator comprising:

[0431] 178. A kit of parts comprising a laparoscopic applicator according to any of items 1 to 169, one or more pressure sources, and optionally one or more fluid sources, such as one or more substance reservoirs.

[0432] 179. The kit of parts of item 178, wherein the substance reservoir is one or more syringes configured to be filled with the substance and configured to form a fluid connection to the delivery tube, preferably to a distal opening of the delivery tube.

[0433] 180. The kit of parts of item 178 or 179, wherein the pressure source is one or more gas cartridges configured to form a fluid connection to the delivery tube, preferably a proximal opening of the delivery tube.

[0434] 181. The kit of parts of any of items 178 to 180, wherein the pressure source is integrated into the applicator, and optionally the pressure source is a spring at the proximal end of the delivery tube.

[0435] 182. A kit of parts, - a laparoscopic applicator according to any of items 1 to 169, - a drive unit, - at least one fluid source for holding a fluid, in fluid communication with the delivery tube; and / or - at least one pressure source, such as a motor, configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube; A drive unit for holding the A kit of parts comprising:

[0436] 183. The kit of parts according to item 182, further comprising at least one fluid source for holding a fluid, said fluid source being in fluid communication with the delivery tube.

[0437] 184. The kit of parts of item 182 or 183, further comprising at least one pressure source configured to apply pressure to the at least one fluid source and / or configured to apply pressure to the interior of the delivery tube.

[0438] 185. The kit of parts according to any of items 182 to 184, further comprising at least one fluid supply source, the fluid supply source being a syringe having a plunger, and the drive unit further comprising a position sensor configured to determine a position of the plunger.

[0439] 186. The kit of parts of any of items 182 to 185, wherein the drive unit is configured to hold at least two fluid sources, such as at least two syringes.

[0440] 187. Use of a laparoscopic applicator according to any of items 1 to 169 to administer a substance, such as a substance containing a hemostatic agent, from the applicator. [Explanation of symbols]

[0441] 1 Laparoscopic applicator 2 Delivery tube 2.1 Proximal end 2.2 Distal end 2.3 Transformable Area 2.4 Rigid surfaces 2.5 Rigid surface aperture 2.6 Actuators 2.7 Valves 2.8 Rigid area 3 Rigid sheath 4 substances 5. Surgical Robot Arm 6 Connector 7 Fluid supply source 8 Pressure Supply Source 8.1 Propellant 8.2 Gas Cartridges 8.3 Springs 9 Applicator Tip 10 Drive unit 10.1 Motor 11 Flow Control Device 12. Pressure indicator lamp 13 Situation Indicator 14 First Lumen 15 Second Lumen 16 Third Lumen 17 Fourth Lumen 18 Malleable wire / rod 19 Screw Conveyor 20 Hemostatic Powder 21 Vibration Device 22 Flow Restriction Elements 24 Material storage section 24.1 First material reservoir 24.2 Secondary Material Reservoir 25 Auxiliary connector element 26 Flow Control Elements 27 Transmission Unit 27.1 Transmission unit cover 28 Signal Carrier Equipment 29 Gripping area 29.1 Connecting Areas 29.2 Nozzle 29.3 Working Area 30 Shrink tube 31 Trocar 32 Insertion guide 32.1 Insertion guide handle

Claims

1. A laparoscopic applicator for administering a substance, such as a substance containing a hemostatic agent, at a selected site using a surgical robot arm, comprising: a delivery tube, and an applicator tip connected to the distal end of the delivery tube, the applicator tip being configured to be controllably actuated by the robot arm near a gripping area in the axial extension of the delivery tube, the gripping area being configured to be clamped and spatially manipulated by the robot arm, and having an outer periphery with a region that is transverse to the axis and has a formed top, and an applicator tip A laparoscopic applicator comprising.

2. The applicator according to claim 1, wherein at least a part of the delivery tube is configured to have flexibility without tension.

3. The applicator according to claim 1 or 2, wherein the delivery tube comprises a flexible material having a Young's modulus between 0.0001 and 0.035 GPa.

4. The applicator according to claim 1 or 2, wherein the delivery tube comprises a material having a damping coefficient between 0.2 and 2.

0.

5. The applicator according to claim 1 or 2, wherein the delivery tube comprises a vibration energy dissipation material selected from the group consisting of silicone elastomers, butyl rubbers, polyurethanes, and combinations thereof, or consists of the vibration energy dissipation material.

6. The applicator according to claim 1 or 2, further comprising an insertion guide for supporting the delivery tube, the insertion guide being optionally configured to be slidable along the axial direction of the delivery tube.

7. The applicator according to claim 1 or 2, wherein the formed top region is selected from the group consisting of a rounded top, a non-pointed top, a sharp top, a pointed top, and combinations thereof.

8. The applicator according to claim 1 or 2, wherein the outer periphery has a shape selected from the group consisting of an ellipse, an ellipse with one axis of symmetry, an ellipse with two axes of symmetry, an equilateral triangle, an isosceles triangle, a scalene triangle, a parallelogram, and a rhombus.

9. The applicator according to claim 1 or 2, wherein the shape of the outer periphery is defined by a major axis defining the longest dimension and a minor axis defining the shortest dimension.

10. The applicator according to claim 9, wherein the major axis is between 2.5 and 5.2 mm and / or the minor axis is between 2.5 and 3.5 mm.

11. The applicator according to claim 1 or 2, wherein the gripping area has a length between 20 and 25 mm or between 30 and 35 mm.

12. The applicator according to claim 1 or 2, wherein the gripping area comprises a connection area in fluid communication with the delivery tube.

13. The applicator according to claim 12, wherein the connection area comprises a connection selected from the group consisting of a perpendicular cut connection, a stepped cut connection, an adhesive connection, a shrink tube connection, and combinations thereof.

14. The applicator according to claim 1 or 2, wherein the gripping area comprises a material resistant to occlusion selected from the group consisting of steel, stainless steel, ABS, polymers such as polycarbonate, polyamide, PEEK, and combinations thereof.

15. The applicator according to claim 1 or 2, wherein the gripping area comprises a coating comprising a soft polymer selected from the group consisting of polyolefin, ABS, and combinations thereof.

16. The applicator according to claim 15, wherein the coating is obtained by a shrink tube.

17. The applicator according to claim 1 or 2, wherein the applicator tip and / or the gripping area comprises a magnetic element configured to magnetically attach the applicator tip to a surgical instrument.

18. The magnetic element is a neodymium magnet preferably having a holding force of at least 400 g / cm 2 The applicator according to claim 17, which is accompanied by a holding force of

19. The applicator according to claim 1 or 2, wherein the applicator tip is configured to controllably discharge a substance from the delivery tube by the robotic arm in the vicinity of an operating area configured to receive a predetermined force by the robotic arm.

20. The applicator according to claim 19, wherein the operating area is positioned in the axial extension of the gripping area.

21. The applicator according to claim 19, wherein the operating area coincides with the gripping area.

22. The applicator according to claim 19, wherein the operating area is configured to activate a substance discharge mechanism when exceeding the predetermined force.

23. The applicator according to claim 1 or 2, wherein the applicator tip and / or the gripping area comprises a nozzle at the distal end of the applicator tip, and the nozzle is configured to discharge a substance in a predetermined shape.

24. The applicator according to claim 23, wherein the nozzle is configured to discharge a substance in a predetermined shape selected from the group consisting of cylindrical, planar, and corrugated planar.

25. The applicator according to claim 23, wherein the cross-sectional shape of the opening of the nozzle is selected from the group consisting of circular, rhombic, rectangular, curved rectangular, and concave rectangular.

26. The applicator according to claim 23, wherein the height of the opening of the nozzle is between 0.5 and 1.0 mm.

27. The applicator according to claim 23, wherein the inner cavity of the nozzle branches toward the distal end.

28. The applicator according to claim 23, wherein the shape of the nozzle is selected from the group consisting of conical, blunt conical, biconic, nose cone, elliptical, and parabolic.

29. The applicator according to claim 23, wherein the length of the inner cavity of the nozzle is between 2.0 and 3.5 mm.

30. The applicator according to claim 1 or 2, wherein the delivery tube has a length between 350 and 500 mm.

31. The applicator according to claim 1 or 2, wherein the delivery tube has an outer diameter between 2.5 and 4.5 mm and / or an inner cavity with an inner diameter between 1.5 and 2.0 mm.

32. The applicator according to claim 1 or 2, wherein the delivery tube has a lumen with a cross-sectional area corresponding to a diameter between 1.2 and 1.5 mm.

33. The applicator according to claim 1 or 2, wherein the connection between the nozzle unit and the gripping area is abrupt or gradual.

34. The applicator according to claim 1 or 2, wherein the applicator tip and / or the gripping area comprises one or more light sources, detection sensors, and / or cameras.

35. The applicator according to claim 1 or 2, comprising one or more inner cavities configured to receive one or more signal carriers such as electrical signals or optical signals.

36. The applicator according to claim 1 or 2, comprising a pressure supply source configured to apply pressure inside the delivery tube and having a piston drive mechanism, and the piston is configured to be retractable.

Images