Laparoscopic applicator with reservoir and one-way valve

Abstract

A laparoscopic applicator for distributing a substance, such as a hemostatic agent, to a selected site by a surgical robotic arm, comprising: a delivery tube; an applicator tip connected to the distal end of the delivery tube, configured to be controllable by the robotic arm by a grip section of the axially extending portion of the delivery tube, the grip section having a circumference traversing an axis including a vertex-shaped section, such that the grip section is clamped and spatially manipulated by the robotic arm; a reservoir connected to the proximal end of the delivery tube, having a constant volume; and a one-way valve connected to the proximal end of the reservoir, configured to prevent the flow of substance from the reservoir through the one-way valve.

Description

[Technical Field]

[0001] This disclosure relates to an applicator, and more specifically, to a laparoscopic applicator for distributing a medical substance or fluid to a site selected by a surgical robotic arm. [Background technology]

[0002] Robotic systems are increasingly being used in minimally invasive surgical procedures to avoid more invasive conventional open surgery techniques. A robotic system includes several robotic arms to which medical devices are attached. These robotic arms and medical devices are controlled and operated 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 remotely from the patient via a display showing a three-dimensional view of the surgical site.

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

[0004] Surgical hemostatic agents and other medical fluids and pastes are traditionally distributed to the target site using a manually operated syringe containing the paste in a syringe barrel. However, in minimally invasive surgical procedures, the target site cannot be directly accessed from the syringe cannula or syringe tip. Therefore, to distribute the paste to the target site within the body cavity, an elongated applicator tube primed with the paste is typically introduced into the body via a trocar port. The insertion of the elongated applicator tube is performed via the trocar port.

[0005] The invasiveness of minimally invasive surgical procedures using trocars depends on the diameter of the trocars and the number of trocars used. The smaller the diameter, the less invasive the surgical procedure and the faster the patient's recovery. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] This disclosure relates to an applicator particularly suitable for robot-assisted surgery. In particular, this disclosure provides an applicator suitable for insertion into a trocar port, having an applicator tip, whose orientation can be controlled via the distal end or applicator tip of the inserted applicator. Thus, the applicator may be operated and actuated via the applicator tip, and is therefore particularly suitable for being operated and actuated by a robotic arm interacting with the distal end / tip of the applicator during a medical procedure at the surgical site, for example, in the abdominal cavity, where the applicator is configured for intraperitoneal delivery of medical substances. The medical substance may be a medical fluid, a medical paste, and / or a medical powder. [Means for solving the problem]

[0007] A first aspect of this disclosure relates to a laparoscopic applicator for distributing or withdrawing a substance, such as a hemostatic agent, to a selected site using a surgical robotic arm, wherein the laparoscopic applicator - Delivery tube and, - An applicator tip connected to the distal end of a delivery tube, configured to be controllable by a robotic arm via a grip section on the axially extending portion of the delivery tube, and configured so that the grip section is clamped and spatially manipulated by the robotic arm, the applicator tip having a circumference that crosses an axis including a vertex-shaped section, - A reservoir connected to the proximal end of a delivery tube, having a fixed volume, -Optionally, a one-way valve connected to the proximal end of a reservoir, configured to prevent the flow of material from the reservoir through the one-way valve, It is equipped with.

[0008] The terms substance, drug, or paste may be understood to be interchangeable throughout this application.

[0009] The target volume of the applicator may be 8 mL, which corresponds to the volume of a standard syringe or may be slightly smaller. The applicator may be primed with a substance such as a hemostatic agent by supplying the substance from a syringe connected at the reservoir opening.

[0010] The inner diameter of the delivery tube must, on the one hand, be as small as possible to keep the outer diameter of the applicator below a certain limit, thus fitting a small trocar, such as a 5mm trocar, which is therefore not invasive. On the other hand, the inner diameter must be large enough so that the force required for priming and dispensing the hemostatic agent does not exceed a certain level, and so that pressing the syringe is not uncomfortable for the user. By positioning the syringe in a pistol grip or power grip suitable for the syringe, higher pressure can be provided, and the inner diameter of the delivery tube can be further reduced. The syringe can be operated by hand or by a pinch grip without a pistol grip, and still, if the viscosity of the substance is low, the inner diameter of the delivery tube can be reduced. The fact that the syringe can be operated by hand without a pistol grip has the advantage that the substance can be delivered to the surgical site and the substance can be delivered at a constant rate. In order to make it possible to have a flexible delivery tube that can be operated by an external robotic arm, the delivery tube must be made of a material that requires thicker walls than when the delivery tube is made of metal. Preferably, the delivery tube has a deformable section or a portion of the delivery tube is configured to be tension-free and flexible, so that when the robotic arm moves the delivery tube and releases it, the delivery tube retains its shape without bending back to its original form. This reduces the risk of the delivery tube moving out of the camera's field of view if the robotic arm loses its grip on the delivery tube during laparoscopic surgery. The material of the deformable section or the portion of the delivery tube configured to be tension-free and flexible may be a vibration energy dissipating material selected from the group consisting of silicone elastomers, butyl rubber, polyurethane, thermoplastic elastomers, polyvinyl chloride, polypropylene, and combinations thereof.

[0011] Such a delivery tube can also be achieved by a delivery tube having a malleable wire or rod configured such that a deformable section of the delivery tube can be bent into a desired shape, which is largely maintained when the delivery tube is released.

[0012] A delivery tube of a certain length is required so that the applicator is operable and can access different areas of the patient. However, to provide the same volume, for example, 8 mL, the delivery tube must be longer if the inner diameter decreases. To solve the problem of delivery tubes that are too long, which are difficult to handle during preparation and when not inserted into the patient, the applicator may have a reservoir with a larger cross-section than the cross-section of the delivery tube. The reservoir is preferably located at or near the proximal end of the applicator.

[0013] The reservoir should preferably have a fixed volume such that the substance from the syringe fills the reservoir, and when the reservoir is full, it also fills the delivery tube.

[0014] Furthermore, the reservoir establishes a surface area that can be used as a gripping surface when attaching and detaching the syringe from the applicator. Finally, this surface area can be used to convey product information (e.g., brand name and product code).

[0015] During applicator priming, the hemostatic agent flows from the syringe into the applicator.

[0016] When the hemostatic agent enters the flexible tube, the pressure increases, and the hemostatic agent is compressed at the rear of the tube.

[0017] When the applicator is fully primed and the user releases the pressure from the syringe piston, the compressed hemostatic agent pushes the syringe piston backward and some of the hemostatic agent re-enters the syringe. Further, when an additional amount of hemostatic agent flows out of the applicator and the syringe is detached from the applicator, the syringe contaminates the opening connected to the reservoir.

[0018] To avoid backflow of the paste into the syringe after priming and outflow of the paste when detaching the syringe, a one-way valve such as a duckbill valve, a cross slit valve, or a ball check valve can be attached to the proximal end of the reservoir.

[0019] When pressure is applied to the syringe piston and the hemostatic agent begins to flow, the valve opens.

[0020] When the pressure from the syringe piston is released, the valve closes to prevent backflow of the hemostatic agent from the reservoir.

[0021] A second aspect of the present disclosure relates to a method of dispensing a substance using an applicator according to any one of the preceding claims, the method comprising: - providing a first syringe containing a substance and a second syringe containing water or an aqueous solution such as, for example, saline; - connecting the first syringe to a one-way valve; - transferring the substance through the one-way valve into the reservoir and the delivery tube up to the applicator; - disconnecting the first syringe from the one-way valve; - connecting the second syringe to the one-way valve; - transferring water or the aqueous solution through the one-way valve into the reservoir and the delivery tube up to the applicator to dispense the substance from the applicator; and comprising.

[0022] In this way, highly viscous substances, such as pastes, can be easily distributed to surgical sites without wasting any material.

[0023] The present invention will be described in more detail below with reference to the accompanying drawings. [Brief explanation of the drawing]

[0024] [Figure 1] This is a perspective view of one embodiment of the applicator described herein. [Figure 2] This shows a syringe for dispensing paste, powder, liquid, or fluid into an applicator. [Figure 3] This is an exploded perspective view of one embodiment of a reservoir. [Figure 4] This is a cross-sectional view of one embodiment of a reservoir connected to a one-way valve in the form of a duckbill valve. [Figure 5] This is a cross-sectional view of one embodiment of a reservoir connected to a one-way valve in the form of a ball valve. [Figure 6] This is a cross-sectional view of one embodiment of a reservoir connected to a one-way valve in the form of a duckbill valve. [Figure 7] This shows a duckbill valve with an elongated structure, and tweezers are acting on the duckbill valve in the elongated direction of the structure. [Figure 8] This shows a cross-slit valve having two slits that form a cross. [Modes for carrying out the invention]

[0025] The present invention is described below with the help of the accompanying drawings. Those skilled in the art will understand that the same features or components of the apparatus are referred to by the same reference numerals in different drawings.

[0026] Applicator for distributing substances In surgical procedures, particularly minimally invasive surgeries such as endoscopic and / or laparoscopic procedures, substances such as medical materials, including surgical hemostatic agents in the form of powders, fluids, or pastes, are distributed to a target site in a body cavity via an elongated applicator 1 equipped with a flexible delivery tube 2 that is pre-filled with the medical fluid / paste / powder or configured to be filled with the medical fluid / paste / powder during surgery, as shown in Figure 1. The delivery tube may also be called a cannula, and the lumen of the tube or cannula may also be called a material channel. The distal end or tip 2.2 of the delivery tube or applicator may be introduced into the body cavity manually, for example, by an assistant, for example, via a trocar port. To facilitate the handling and insertion of a delivery tube that may be flexible, the applicator may be advantageously equipped with an insertion guide, such as a rigid sheath 3 configured to insert the delivery tube into a trocar (not shown). The rigid sheath may take the form of, for example, a rigid tubular sheath, which may be attached to a section of the delivery tube, as shown in Figure 1, or positioned around a section of the delivery tube, such as by forming a coating layer around the section of the outer delivery tube. The insertion guide 3 may be equipped with a handle 3a so that the user can hold and guide the insertion guide 3, and optionally the delivery tube 2 within the insertion guide, for example, through a trocar. Because the insertion guide is rigid, the user can easily push the insertion guide and the delivery tube within the insertion guide to a position close to the robotic arm. The insertion guide can then be withdrawn, so that the flexible delivery tube can be easily held and manipulated by the external robotic arm and moved to the surgical site.

[0027] The proximal end 2.1 of the applicator 1 is equipped with a reservoir 4 for holding a larger amount of material per unit length than the delivery tube 2.

[0028] Figure 2 shows a syringe 11 having a syringe tip 13, and the proximal end 4.1 of the reservoir 4 is configured to receive and connect the syringe tip 13 in a fluid-tight and / or paste-tight manner, so that a paste-like substance can be delivered to the applicator 1 without any leakage.

[0029] When applicator 1 is used to deliver paste to the surgical site, typically a first syringe 11 containing the paste is connected to the reservoir 4 of applicator 1, filling the delivery tube 2 and reservoir 4 with paste. Preferably, the volume of the syringe is equal to the combined volume of the delivery tube 2 and reservoir 4 so that no paste is wasted. The volume of the syringe may be slightly less than the combined volume of the delivery tube 2 and reservoir 4 so that the hemostatic agent is not pushed out from the tip 2.2 of the delivery tube before the applicator is inserted into the trocar and the trocar is contaminated.

[0030] Applicator 1 may be used with a hemostatic substance, hemostatic agent, or hemostatic paste. The steps of use may be, for example, as follows:

[0031] The applicator is primed with a hemostatic agent or paste by connecting a first syringe 11 containing the hemostatic agent to the applicator, the first syringe may have a male connector such as a male Luer lock, and the applicator may have a female connector such as a female Luer lock, the male connector or male Luer lock and the male connector or female Luer lock are each releasably connected to each other. The user can push the piston rod manually or with a syringe pistol having a motor, power grip component, or gear mechanism until the hemostatic agent fills the lumen of the reservoir and delivery tube. The empty first syringe that contained the hemostatic agent is detached from the applicator, and the second syringe is filled with saline solution. The second syringe is connected to the applicator, and the applicator is inserted into the patient via a trocar. If a hemostatic agent is required, the applicator tip can be moved and positioned by a robotic arm (not shown) to precisely position the applicator relative to the surgical site so that the hemostatic agent can be delivered. While the surgeon holds the applicator tip with the robotic arm, the insertion guide 3 can be retracted to expose the flexible delivery tube. The applicator can then be freely moved by the robotic arm. By injecting saline solution from a second syringe into the applicator, the hemostatic agent is pushed from the applicator to the surgical site.

[0032] Figure 3 shows an exploded view of one embodiment of a reservoir 4, a one-way valve 15 in the form of a duckbill valve, and a connector 17. The distal end 4.2 of the reservoir is configured to receive the delivery tube 2 in a fluid-tight connection.

[0033] According to this disclosure, the reservoir 4 may have a larger cross-section than the delivery tube 2, and as a result, the reservoir shown in Figure 3 can hold a larger amount of material per unit length than the delivery tube 2.

[0034] The connector 17 is configured to connect the reservoir 4 and one-way valve 15 at one end to the syringe 11 at the other end. In one embodiment, the reservoir 4, the one-way valve 15, and the connector 17 are irremovably connected, for example, by adhesive. Preferably, the connector 17 and the syringe 11 are fluid-tightly and detachably connected to each other, so that the syringe can be easily replaced with another syringe.

[0035] The one-way valve 15 allows flow only from the proximal end 2.1 of the applicator 1 to the distal end 2.2 of the applicator.

[0036] Figure 4 shows an assembled cross-section of the reservoir 4, duckbill valve 15, and connector 17 from Figure 3. In the example shown in Figure 4, the applicator is already filled with substance 19, and the saline solution 21 is pushed into the applicator, pushing half of the substance out of the reservoir. The duckbill valve can be easily sterilized due to its uniform surface and the absence of pockets inside the valve.

[0037] A small pressure from the proximal end (from the right side in Figure 4) opens the duckbill valve, and as a result, a flow may exist in the direction toward the distal end (left side in Figure 4) through the duckbill valve 15.

[0038] Due to the viscosity of the substance, priming the applicator with the substance from the syringe creates a slightly excessive pressure that causes the substance to leak from the reservoir when the syringe is removed. By using a one-way valve located at the proximal end 2.1 of the applicator, no substance leaks from the primed applicator when the syringe is removed, thus avoiding contamination.

[0039] In one embodiment, the inner cross-section of the delivery tube is 30 mm 2 Less than 20mm 2 Less than 14mm 2 Less than, or 11mm 2 It may also be less than 14 mm. 2If it is less than, a delivery tube without an insertion guide can be inserted into a 5 mm trocar. The inner cross-section of the delivery tube is 11 mm 2 If it is less than, a delivery tube with an insertion guide can be inserted into a 5 mm trocar.

[0040] In one embodiment, the cross-section of the delivery tube is 5 mm 2 more than, 9 mm 2 more than, etc. may be. If the cross-section of the delivery tube is more than 9 mm 2 In such a case, the applicator can be primed with a hemostatic agent by a syringe that operates manually without any additional assistance such as a motor or a pistol grip.

[0041] In one embodiment, the cross-section of the reservoir is 30 mm 2 more than, 50 mm 2 more than, etc. may be. If the cross-section of the reservoir is more than 30 mm 2 In such a case, the length of the reservoir has a length suitable for providing a good grip for attaching and detaching the syringe to and from the applicator.

[0042] In one embodiment, the cross-section of the reservoir is 200 mm 2 less than, preferably 100 mm 2 less than, preferably 80 mm 2 less than, preferably 70 mm 2 less than may be.

[0043] To reduce waste of the substance, it is advantageous that the substance and the physiological saline are not mixed and the substance near the peripheral wall of the reservoir is pushed by the physiological saline at the same rate as the substance in the center of the reservoir. This preferred flow is called plug flow, and the velocity of the substance is constant across the cross-section of the delivery tube perpendicular to the axis of the delivery tube.

[0044] In one embodiment, the inner cross-section of the reservoir is preferably less than 70 mm 2 to maintain plug flow.

[0045] Figure 5 shows another embodiment in which the reservoir 4 is connected to the delivery tube 2, and the one-way valve is a ball valve 23, with a spring 25 pressing a ball 27 against a seat 29 to close the ball valve. In this embodiment, the ball valve 23 includes a connector 17' configured to receive a syringe (not shown). In another embodiment, the ball valve 23 and connector 17' may be two different units. When pressure presses the ball 27 against the spring and away from the seat 29, the ball valve opens, and as a result, the applicator can be primed with a substance such as a hemostatic agent or paste. Then, under pressure from the syringe, saline solution opens the ball valve, pushing the substance out of the applicator. The ball may have any other form, together with the corresponding seat, to prevent the substance from leaking from the reservoir out of the applicator. Other types of one-way valves exist, such as poppet check valves, swing check valves, or cross-slit valves, or butterfly check valves, which can also be used as one-way valves.

[0046] According to this disclosure, the distal end 4.2 of the reservoir 4 may have a transition section 22 from the reservoir to the delivery tube 2, the transition section having a conical shape as shown in Figures 4 and 5. In other embodiments, the transition section may have a curved conical shape as shown in Figure 6, or there may be another smooth transition section or smooth shape between different cross-sections of the reservoir and the delivery tube. The smooth transition section maintains a plug flow so that the saline solution does not mix with the hemostatic agent in the contact zone between the saline solution and the hemostatic agent during the distribution of the hemostatic agent, and so that a minimum amount of hemostatic agent remains in the reservoir after use.

[0047] Figure 6 shows another embodiment in which the transition section 22' from reservoir 4 to delivery tube 2 has a curved conical shape. The curved conical shape also provides a plug flow, similar to the conical shape shown in Figures 4 and 5. The conical or curved conical shape can be combined with any type of one-way valve.

[0048] Figure 7 shows the duckbill valve 15, with the pliers 31 pressing the duckbill valve 15 in the elongated direction of its elongated structure.

[0049] Figure 8 shows a cross-slit valve 41 having two slits 43 that form a cross. Similar to a duckbill valve, a cross-slit valve allows paste to pass through the cross-slit valve in only one direction, from right to left in Figure 8. A small pressure from the right side in Figure 8 will open the cross-slit valve, and as a result, a flow may be present through the cross-slit valve 41 in the direction toward the left side in Figure 8. Cross-slit valves are also easy to sterilize. Similar to the pliers that act on a duckbill valve in Figure 7 to open a duckbill valve, a cross-slit valve can be opened by pliers acting on either end of the two slits, or by any mechanism such as a button or mechanical button that presses either end of the two slits together. A cross-slit valve can replace a duckbill valve or any other one-way valve in any of the embodiments presented above and below.

[0050] In one embodiment, the pressure required to open the one-way valve may be very small, so by holding the applicator filled with saline solution vertically with the reservoir at the top and the distal end 2.2 of the applicator 1 at the bottom, the drag force caused by the water column draws air through the one-way valve into the reservoir and delivery tube, and as a result, the saline solution can be drained out of the distal end 2.2 of the applicator, for example, into a drain.

[0051] In another embodiment, the one-way valve may be designed so that the pressure required to open the valve can be 100 cm of water, 50 cm of water, or 10 cm of water. When the applicator is empty and filled with saline solution, and the applicator has been removed from the trocar and surgical site, the saline solution can be easily emptied by removing the syringe from the applicator and raising the reservoir 100 cm, 50 cm, or 10 cm above the distal end 2.2 of the applicator 1, respectively, so that the height difference between the reservoir and the distal end 2.2 of the applicator 1 provides the pressure required to open the one-way valve and allow air into the applicator to release the saline solution. Of course, the one-way valve may also be designed to open at any pressure of less than 100 cm of water, less than 50 cm of water, or less than 10 cm of water.

[0052] In one embodiment, the applicator may be equipped with a button that acts on a one-way valve, so that the one-way valve opens when the button is pressed. In this case, the saline solution in the applicator can be easily discharged after use by pressing the button, and the one-way valve can be designed so that a higher pressure is required to open it, reducing the risk of accidental discharge of saline solution from the applicator. The duckbill valve has an elongated structure with a shape similar to a duckbill. The button acts on the duckbill valve by pressing the duckbill in the elongated direction, as shown in Figure 7, to forcibly open the duckbill. Two opposite buttons acting in opposite directions in the elongated direction relative to the duckbill forcibly open the duckbill. The button can act on the ball by lifting the ball away from the seat. The button can be held in place in a recess in the wall surrounding the one-way valve without penetrating the wall. In this way, there is no risk of contamination through the opening in which the button is located. The wall surrounding the recess should preferably be made of a deformable material so that the button can be moved and act on the one-way valve.

[0053] Alternatively, the reservoir wall surrounding the one-way valve may be made of a deformable material such that the one-way valve, such as a duckbill valve or a ball valve, opens when the reservoir wall surrounding the one-way valve is pressed against it. A button is not required.

[0054] In one embodiment, the reservoir may have a volume of 0.5 ml to 3 ml, preferably 0.7 ml to 2 ml, for example, 1 ml. If the total volume of the applicator is 8 ml, the delivery tube may contain only 5 to 7.5 ml, 6 to 7.3 ml, or 7 ml, and as a result, the delivery tube will not be too short or too long.

[0055] In one embodiment, the first connection of the reservoir to the proximal end of the delivery tube may be on the opposite side of the second connection of the reservoir to the one-way valve. If the reservoir has an elongated shape, the first and second connections may be located on the opposite short side of the elongated reservoir. The elongated reservoir may have a toroidal shape, such as a quarter of a torus, where the two end cross-sections are oriented perpendicular to each other but are still opposite to each other due to the torus shape of the reservoir. However, two surfaces of a cube oriented perpendicular to each other are not considered to be opposite to each other.

[0056] The first and second connection points, located on opposite sides of each other, allow the plug flow to be maintained, resulting in less wasted material.

[0057] In one embodiment, if the reservoir has an elongated shape, the first and second connectors may be positioned at the center of their respective short sides and on an axis of symmetry passing through the reservoir such that, for example, the distance to the surrounding cylindrical wall is equal in all directions. Such positions of the first and second connectors are ideal for maintaining plug flow. [Explanation of symbols]

[0058] 1 Applicator, 2 Tube, 2.1 Proximal end, 2.2 Distal end, 3 Rigid sheath, insertion guide, 3a Handle, 4 Reservoir, 4.1 Proximal end, 4.2 Distal end, 11 Syringe, 13 Syringe tip, 15 One-way valve, duckbill valve, 17 Connector, 17' Connector, 19 Substance, 21 Saline solution, 22 Transition zone, 22' Transition zone, 23 Ball valve, 25 Spring, 27 Ball, 29 Seat, 31 Pliers, 41 Cross-slit valve, 43 Slit

Claims

1. A laparoscopic applicator for distributing a substance, such as a hemostatic agent, to a selected site using a surgical robotic arm, - Delivery tube and, - An applicator tip connected to the distal end of the delivery tube, configured to be controllable by the robot arm by a grip section of the axially extending portion of the delivery tube, and configured so that the grip section is clamped by the robot arm and operated spatially, the applicator tip having a circumference that crosses an axis including a vertex-shaped section, - A reservoir connected to the proximal end of the delivery tube, having a certain volume, - A one-way valve connected to the proximal end of the reservoir, configured to prevent the flow of the substance from the reservoir through the one-way valve, A laparoscopic applicator equipped with the following features.

2. The applicator according to claim 1, wherein the one-way valve is a duckbill valve or a cross-slit valve.

3. The applicator according to claim 1 or 2, wherein the reservoir has a volume of 0.5 ml to 3 ml, preferably 0.7 ml to 2 ml, for example, 1 ml.

4. The applicator according to any one of claims 1 to 3, wherein the reservoir has a reservoir cross-section that is larger than the cross-section of the delivery tube.

5. The cross-section of the delivery tube is less than 30 mm ２ less than 20 mm ２ less than 14 mm ２ less than 11 mm ２ less than, and / or the cross-section of the delivery tube is more than 5 mm ２ preferably more than 9 mm ２ more than, and / or the cross-section of the reservoir is more than 30 mm ２ preferably more than 50 mm ２ larger than, and / or the cross-section of the reservoir is less than 200 mm ２ preferably less than 100 mm ２ preferably less than 80 mm ２ preferably less than 70 mm ２ less than, the applicator according to claim 4

6. The applicator according to any one of claims 1 to 5, wherein the delivery tube includes a deformable section, or a portion of the delivery tube is configured to be flexible without tension.

7. The applicator according to claim 6, further comprising a malleable wire or rod configured such that the deformable section of the delivery tube can be bent into a desired shape, the shape being substantially maintained when the delivery tube is released.

8. The applicator according to claim 6 or 7, wherein the grip section includes the deformable section.

9. The applicator according to any one of claims 1 to 8, wherein the delivery tube includes or consists of a vibration energy dissipation material selected from the group consisting of silicone elastomer, butyl rubber, polyurethane, thermoplastic elastomer, polyvinyl chloride, polypropylene, and combinations thereof.

10. The applicator according to any one of claims 1 to 9, further comprising an insertion guide for supporting the delivery tube, wherein the insertion guide is optionally configured to slide along the axial direction of the delivery tube.

11. The applicator according to any one of claims 1 to 10, wherein the applicator has a conical or curved conical shape that connects the reservoir and the delivery tube.

12. The applicator according to any one of claims 1 to 11, wherein the first connection of the reservoir to the proximal end of the delivery tube is on the opposite side of the second connection of the reservoir to the one-way valve.

13. The applicator according to claim 17, wherein the first connection portion and the second connection portion are arranged on an axis of symmetry passing through the reservoir.

14. A method for distributing a substance using an applicator according to any one of claims 1 to 13, The steps include providing a first syringe containing the substance and a second syringe containing water or an aqueous solution such as physiological saline, The steps include connecting the first syringe to the one-way valve, The steps include transferring the substance through the one-way valve into the reservoir and the delivery tube to the applicator, The first syringe is disconnected from the one-way valve, The steps include connecting the second syringe to the one-way valve, The steps include transferring the water or aqueous solution through the one-way valve into the reservoir and the delivery tube to the applicator in order to distribute the substance from the applicator, Methods that include...

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