EP-4734855-A1 - A LAPAROSCOPIC APPLICATOR HAVING A RESERVOIR AND A ONE-WAY VALVE

Abstract

A laparoscopic applicator for dispensing a substance, e.g. a substance comprising a haemostatic agent, at a selected site by means of a surgical robotic arm, the laparoscopic applicator comprising: a delivery tube; an applicator tip connected to a distal end of the delivery tube, the applicator tip configured for being controllably operated by the robotic arm by a grip section in axial extension of the delivery tube, the grip section having a perimeter transverse to the axis comprising an apex shaped section, such that the grip section is configured for being clamped and spatially manipulated by the robotic arm, a reservoir connected to a proximal end of the delivery tube, the reservoir having a fixed volume, and a one-way valve connected to a proximal end of the reservoir, wherein the one-way valve is configured to prevent flow of the substance through the one-way valve from the reservoir.

Inventors

• AXELSSON, Lars Tamstrup
• CHRISTENSEN, Søren

Assignees

• Ferrosan Medical Devices A/S

Dates

Publication Date

20260506

Application Date

20240628

Claims (14)

1. 1. A laparoscopic applicator for dispensing a substance, e.g. a substance comprising a haemostatic agent, at a selected site by means of a surgical robotic arm, the laparoscopic applicator comprising: - a delivery tube; - an applicator tip connected to a distal end of the delivery tube, the applicator tip configured for being controllably operated by the robotic arm by a grip section in axial extension of the delivery tube, the grip section having a perimeter transverse to the axis comprising an apex shaped section, such that the grip section is configured for being clamped and spatially manipulated by the robotic arm, - a reservoir connected to a proximal end of the delivery tube, the reservoir having a fixed volume, and - a one-way valve connected to a proximal end of the reservoir, wherein the one-way valve is configured to prevent flow of the substance through the one-way valve from the reservoir.
2. 2. The applicator according to any of the preceding claims, wherein the one-way valve is a duckbill valve or a cross slit valve.
3. 3. The applicator according to any of the preceding claims, wherein the reservoir has a volume of between 0.5 ml and 3 ml, preferably between 0.7 ml and 2 ml, such as 1 ml.
4. 4. The applicator according to any of the preceding claims, wherein the reservoir has a reservoir cross-section that is larger than a delivery tube cross-section of the delivery tube.
5. 5. The applicator according to claim 4, wherein the delivery tube cross-section is less than 30 mm 2 , less than 20 mm 2 , less than 14 mm 2 , less than 11 mm 2 , and/or wherein the delivery tube cross-section is more than 5 mm 2 , preferably more than 9 mm 2 , and/or wherein the reservoir cross-section is more than 30 mm 2 , preferably larger than 50 mm 2 , and/or wherein the reservoir cross-section is less than 200 mm 2 , preferably less than 100 mm 2 , preferably less than 80 mm 2 , preferably less than 70 mm 2 .
6. 6. The applicator according to any of the preceding claims, wherein the delivery tube comprises a deformable section or a part of the delivery tube is configured to be tension free flexible.
7. 7. The applicator according to claim 6, wherein the applicator further comprises a malleable wire or rod, configured such that the deformable section of the delivery tube may be bent into a desired shape, said shape being approximately maintained upon release of the delivery tube.
8. 8. The applicator according to claim 6 or 7, wherein the grip section comprises the deformable section.
9. 9. The applicator according to any of the preceding claims, wherein the delivery tube comprises or consists of a vibrational energy dissipating material selected from the group of: silicone elastomers, butyl rubber, polyurethane, thermoplastic elastomers, polyvinyl chloride, polypropylene and combinations thereof.
10. 10. The applicator according to any of the preceding claims, further comprising an insertion guide for supporting the delivery tube, wherein the insertion guide optionally is configured to be slidable along the axial direction of the delivery tube.
11. 11. The applicator according to any of the preceding claims, wherein the applicator has a conical shape or a curved conical shape connecting the reservoir and the delivery tube.
12. 12. The applicator according to any of the preceding claims, wherein a first connection of the reservoir to the proximal end of the delivery tube is opposite a second connection of the reservoir to the one-way valve.
13. 13. The applicator according to claim 12, wherein the first connection and the second connection are positioned on a symmetry axis through the reservoir.
14. 14. A method for dispensing a substance using the applicator according to any of the preceding claims, wherein the method comprises the steps of - providing a first syringe comprising the substance and a second syringe comprising water or a watery solution like e.g. saline, - connecting the first syringe to the one-way valve, - transferring the substance to the applicator through the one-way valve into the reservoir and the delivery tube, - disconnecting first syringe from the one-way valve, - connecting the second syringe to the one-way valve, - transferring the water or the watery solution to the applicator through the one-way valve into the reservoir and the delivery tube for dispensing the substance out of the applicator.

Description

A laparoscopic applicator having a reservoir and a one-way valve Technical field The present disclosure relates to an applicator, more specifically a laparoscopic applicator for dispensing a medical substance or fluid at a selected site by means of a surgical robotic arm. Background Robotic systems are increasingly used in surgery for minimally invasive surgical procedures, to avoid the more invasive traditional open surgery techniques. A robotic system includes a number of robotic arms to which medical devices are attached, and where the robotic arms and the medical devices are controlled and manipulated by the surgeon from a console, e.g. via control devices such as a joystick and foot pedal. Hence, the robotic arms replace the surgeon’s hands at the surgical site, and the surgeon is instead located remotely from the patient and views the surgical site via a display showing a three-dimensional view of the surgical site. Similarly to traditional open surgery techniques, where an assistant provides the physically present surgeon with the required medical devices, in robotic surgery an assistant is positioned near the robotic arms to provide the arms with the required medical devices. For example, the assistant may replace the medical devices of the robotic arms, and provide medical fluids, either directly as a medical device to the robotic arm, or via an applicator tube introduced into the body via a trocar port. Surgical haemostatics, as well as other medical fluids and pastes, are traditionally dispensed to a target site by use of a manually operated syringe comprising the paste within the syringe barrel. However, for minimally invasive surgical procedures, the target site is not directly accessible to syringe cannula or syringe tips. Hence, to dispense paste to a target site within a bodily cavity, an elongated applicator tube, which is primed with the paste, is typically introduced into the body via a trocar port. The insertion of the elongated applicator tube occurs at the trocar port. The invasiveness of minimally invasive surgical procedures using a trocar will depend on the diameter of the trocar and the number of trocars being used. The smaller the diameter, the less invasive is the surgical procedure, and the sooner the patient will recover. Summary of invention The present disclosure relates to an applicator, which is particularly suitable for robotic- assisted surgery. Particularly, the present disclosure provides an applicator suitable for insertion into a trocar port and having an applicator tip, where the orientation can be controlled via the inserted applicator’s distal end or the applicator tip. Thus, the applicator may be manipulated and activated via the applicator tip, and hence it is particularly suitable for being manipulated and activated by a robotic arm interacting with the applicator distal end/tip e.g. intra-abdominally during the medical procedure at the surgical site, e.g. wherein the applicator is configured for intra-abdominal delivery of a medical substance. The medical substance may be a medical fluid, a medical paste and/or a medical powder. A first aspect of the present disclosure relates to a laparoscopic applicator for dispensing or withdrawing a substance, such as a substance comprising a haemostatic agent, at a selected site by means of a surgical robotic arm, the laparoscopic applicator comprising: - a delivery tube; - an applicator tip connected to a distal end of the delivery tube, the applicator tip configured for being controllably operated by the robotic arm by a grip section in axial extension of the delivery tube, the grip section having a perimeter transverse to the axis comprising an apex shaped section, such that the grip section is configured for being clamped and spatially manipulated by the robotic arm, - a reservoir connected to a proximal end of the delivery tube, the reservoir having a fixed volume, and - optionally a one-way valve connected to a proximal end of the reservoir, wherein the one-way valve is configured to prevent flow of the substance through the oneway valve from the reservoir. The terms substance, agent or paste may be understood to be interchangeable terms throughout the present application. The target volume of the applicator may be 8 mL, which may correspond to or be a little less than the volume of a standard syringe. The applicator may be primed by a substance like a haemostatic agent by providing the substance from a syringe connected at an opening of the reservoir. The inner diameter of the delivery tube must on one hand be as small as possible to keep the outer diameter of the applicator below a certain limit, so it is compatible with e.g. a 5 mm trocar, which is considered a small trocar and therefore not really invasive. On the other hand the inner diameter must be sufficiently high, so the force required to prime and dispense the haemostatic agent does not exceed a certain level and it becomes uncomfortable for the user t