An endoscopic and / or laparoscopic applicator for delivering a medical substance or fluid to a surgical site and a method of providing a medical substance or fluid to a surgical site

Abstract

An endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the applicator comprising a delivery tube comprising: a proximal delivery tube end comprising a first connector configured to engage with a corresponding second mating connector of a distal syringe end of a syringe for transferring the substance from the syringe to the delivery tube, and a support element configured to support the distal syringe end when the syringe is connected to the first connector, and a distal delivery tube end with an opening for delivering the substance to the surgical site, wherein the support element extends in the proximal direction less than 50 mm past a proximal first connector end of the first connector.

Description

[0001] An Endoscopic and / or Laparoscopic Applicator for Delivering a Medical Substance or Fluid to a Surgical Site and a Method of Providing a Medical Substance or Fluid to a Surgical Site

[0002] Technical Field

[0003] The present disclosure relates to an endoscopic and / or laparoscopic applicator for delivering a substance, like a medical substance or a fluid to a surgical site or bleeding site and a method of providing the substance to the surgical site.

[0004] Background

[0005] Many of the instruments and much of the equipment used during a surgical procedure is disposed after having been used once. There is a discussion about this heavy environmental imprint and how to reduce it. From WO 2008 / 014144 is known a laparoscopic applicator with a pistol grip, which is complicated and provides a lot of waste.

[0006] There is also a need for an applicator insertable through a trocar, where the surgeon by one and the same hand can easily control and navigate the applicator to the surgical site in no time and apply the right amount of substance.

[0007] Summary

[0008] Surgical procedures are typically subject to time constraints, and the time consumption of each medical procedure thus of importance. For example, the time consumption may be critical when using a haemostatic paste for inhibiting bleedings as the surgeon will have to interrupt his / her procedure while waiting for the applicator with the haemostat to be prepared. Thus, the preparation time of the applicator may cause increased blood loss and longer operating time of the surgical procedure.

[0009] For more efficient paste application procedures, improved applicators are needed.

[0010] A first aspect of the disclosure relates to an endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site or a bleeding site, the applicator comprising a delivery tube comprising: a proximal delivery tube end comprising a first connector configured to engage with or connect to a corresponding second mating connector of a distal syringe end of a syringe, wherein the syringe is configured to initially hold the substance, for transferring the substance from the syringe to the delivery tube, and a support element configured to, optionally receive and, support, like mechanically support, the distal syringe end when the syringe is connected to the first connector and / or the delivery tube, and a distal delivery tube end with an opening for delivering the substance to the surgical site, wherein the support element extends in the proximal direction less than 50 mm past a proximal first connector end of the first connector. The term surgical may be replaced by the term bleeding site within the context of the present disclosure.

[0011] The corresponding second mating connector may be designed to connect to the first connector in a substance and / or a gas and / or liquid tight way. In addition, the corresponding second mating connector may be designed to connect to the first connector, wherein the first connector and the corresponding second mating connector are kept together by a frictional force and / or locked together.

[0012] The first connector when engaged with the corresponding second mating connector of the distal syringe end of the syringe will provide some support between the applicator and the syringe. However, for allowing a user to manipulate the applicator when introducing the applicator into a trocar and possibly for positioning the applicator correctly in relation to the surgical site by holding on to the syringe only without risking the first connector and / or the corresponding second mating connector to break, the applicator may advantageously have the support element that engages with the syringe at another location than the first connector. The distance between the corresponding second mating connector and the other location of the syringe will allow higher bending forces acting on the connection between the first connector and the corresponding second mating connector without breaking the first connector and / or the corresponding second mating connector. The connection between the applicator and the syringe will be strong enough, so that the applicator can be manipulated by the user holding the syringe only without the connection between the applicator and the syringe breaks during the surgery.

[0013] The applicator may be charged by a medical substance or fluid, e.g. a substance comprising a haemostatic agent, e.g. from a first syringe. A second syringe comprising saline is attached to the charged applicator and the applicator is ready to be used by a surgeon during surgery, e.g. for stopping a haemorrhage. Such a ready and charged applicator can be easily handled by a user. The user can move and control the applicator by one single hand and can, using the same hand press on the piston (or piston rod) for moving saline from the syringe to the applicator and expelling the medical substance or fluid in the applicator to surgical site.

[0014] In an embodiment, the first connector may be configured to engage with the corresponding second mating connector of the distal syringe end of the syringe comprising a barrel, wherein the support element is configured to support the distal end of the barrel of the syringe when the syringe is connected to the first connector. By engaging with the barrel of the syringe, the distance between the corresponding second mating connector and the other location of the syringe will be even bigger than presented above, so that the connection between the applicator and the syringe will be even stronger.

[0015] In an embodiment, the support element may have a support interface or receiving section configured to receive the distal end of the syringe or of the barrel of the syringe. The support interface may form a circular collar, like a ring, configured to support and / or surround the distal end of the syringe or the distal end of the barrel of the syringe connected to the applicator. The support interface may form an inner diameter of between 10 and 16 mm, preferably between 12 and 14 mm, such as around 13 mm, like 12.7 mm, or between 16 and 25 mm, preferably between 18 and 20 mm, such as around 20 mm, like 19.1 mm, for receiving a barrel of a normal syringe. Alternatively, the inner diameter may be around 18 mm. The support interface may extend in the proximal direction at least 3 mm beyond the proximal end of the first connector, so that the support element can provide solid support for the barrel of the syringe with a piston. The receiving section may be integrated in the support element, i.e. made in one piece with the support element, like the receiving section may be moulded together with the support element, for providing even more strength to the connection between the applicator and the syringe.

[0016] In an embodiment, the receiving section may be configured to receive and mechanically support one single syringe. Preferably, the receiving section may be positioned so that the syringe when received and supported by the receiving section is coaxial with the delivery tube and / or a malleable tip positioned at the distal end of the delivery tube.

[0017] The support element should extend less than 50 mm past the proximal first connector end for providing a support element with a reduced environmental imprint. In addition, such a short support element will provide a smaller applicator that is easier and more flexible to handle, and will not take up so much space on the table for surgical equipment in the operating room.

[0018] In an embodiment, the first connector may be a Luer connector, like a Luer-lock or a Luer-slip. A Luer-lock or a Luer-slip is a standard connector that provides a fluid tight connection in an easy way. The Luer-lock is a screwable connection that provides a connection between the syringe and the applicator with an improved strength, which is an asset when controlling the applicator by holding on to the syringe.

[0019] A second aspect of the disclosure relates to an endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the applicator comprising a delivery tube of stainless steel comprising a distal delivery tube end with a malleable tip for delivering the substance to the surgical site via a trocar, wherein the delivery tube has an outer diameter of not more than 5.5 mm such that the delivery tube is insertable into and through a 5 mm trocar, or the delivery tube has an outer diameter such that the delivery tube is insertable into and through a 5 mm trocar.

[0020] That the delivery tube is made of stainless steel provides a delivery tube that is stiff even though the wall of the delivery tube is thin.

[0021] The maximum outer diameter of the delivery tube of up to 5.5 mm combined with a thin tube wall of the delivery tube will allow 8 mL or even 10 mL of a standard syringe to be fully contained without the delivery tube having to be very long. If the applicator can contain at least 7 mL, not so much of the medical substance or fluid will be wasted. If the delivery tube has an inner diameter of at least 4.0 mm, a length of the delivery tube of at least 640 mm will allow the delivery tube to contain all of the 8 mL from the syringe. If the delivery tube is 560 mm long the delivery tube may contain 7 mL.

[0022] Likewise, if the delivery tube has an inner diameter of at least 4.5 mm, at least 4.8 mm, or at least 5.0 mm the delivery tube will be able to contain 8 mL even though the delivery tube is no longer than 503 mm, 442 mm, or 407 mm. Likewise, if the delivery tube has an inner diameter of at least 4.0 mm, at least 4.5 mm, at least 4.8 mm, or at least 5.0 mm the delivery tube will be able to contain 10 mL even though the delivery tube is no longer than 795 mm, 630 mm, 523 mm, or 510 mm, respectively. The shorter the delivery tube is, the easier the applicator will be for the user to handle. However, the delivery tube should be longer than the trocar, so that the applicator can reach the surgical site. The length will depend on the surgery to be performed and where in the body surgical site will be located and from which direction the applicator can enter the surgical site. To give better visual access to the surgical site, the abdomen is enlarged by being filled with gas like e.g. nitrogen or carbon dioxide, which will extend the distance between the surgical site and the trocar. Generally, a length of the delivery tube of between 340 mm and 470 mm will be optimal in most cases.

[0023] If the delivery tube can handle 7 mL, or preferably 8 mL or 10 mL, a first 8 mL or 10 mL syringe with the substance like the haemostatic agent can be emptied, or at least nearly emptied, so that the delivery tube is filled by the substance and a second 8 mL or 10 mL syringe with saline can be used to expel the substance out of the applicator.

[0024] The malleable tip will allow jaws of a laparoscopic grasper or of a robotic arm to hold on to and bend the malleable tip so that the malleable tip can be controlled and directed to the right position and direction from outside the patient. The malleable tip will retain the new shape regarding bending, position and / or direction in relation to the delivery tube. During laparoscopic procedures, the applicator is controlled from outside the patient by the surgeon / assistant manually navigating the applicator tip to the bleeding site / surgical site by e.g. holding the syringe connected to the applicator. Even though the applicator is correctly positioned in relation to the surgical site, the malleable tip may still point in the wrong direction. The laparoscopic grasper or the robotic arm may then grasp and bend the malleable tip so that the malleable tip is pointing towards the surgical site. When the laparoscopic grasper or the robotic arm disconnects from the malleable tip, the malleable tip will retain the shape and be directed towards the surgical site. The applicator with the malleable tip provides an instrument that in a short time can be directed to a bleeding site for delivering haemostatic paste at the bleeding site that will stop the bleeding. In case the applicator is used for robotic surgery, the surgeon may be able to bend the malleable tip if needed and move the applicator to a desired position, and / or an assistant may navigate the applicator to the bleeding site and the malleable tip may be bent by the robotic arm. Then haemostat may be dispensed while e.g. looking at a monitor showing the applicator and the bleeding site.

[0025] A third aspect of the disclosure relates to a method of providing a substance, such as a medical substance and / or fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the method comprising the steps of:

[0026] - connecting a first syringe comprising the medical substance or fluid to a first connector of an applicator according to the first and / or the second aspect(s) having a delivery tube with an opening and / or with a malleable tip,

[0027] - transferring the substance from the first syringe to the delivery tube,

[0028] - connecting a second syringe with saline to the first connector,

[0029] - transferring the saline from the second syringe to the delivery tube for expelling the substance out of the opening and / or out of the malleable tip to the surgical site.

[0030] The applicator is filled by the substance, like the medical substance or by the medical fluid, from the first syringe and then saline from the second syringe will be pushed into the delivery tube for expelling the substance out of the opening and / or out of the malleable tip. At the end of the procedure, no or very little medical substance or medical fluid is left in the delivery tube and wasted. The method will reduce waste of the medical substance or the medical fluid.

[0031] Further Description

[0032] The present disclosure may relate to yet another aspect, wherein an endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent to a surgical site, the applicator comprising a delivery tube comprising: a proximal delivery tube end comprising a first connector configured to engage with a corresponding second mating connector of a distal syringe end of a syringe, holding the substance, for transferring the substance from the syringe to the delivery tube, and a distal delivery tube end with an opening for delivering the substance to the surgical site. In an embodiment, the delivery tube may be made of stainless steel. Such a delivery tube will be stiff and endurable even though the wall of the delivery tube is very thin, so that the delivery tube is able to hold a larger volume for the same outer diameter of the delivery tube. If the delivery tube is made of stainless steel the wall of the delivery tube can be made thin like e.g. less than 0.5 mm, preferably less than 0.4 mm, more preferably less than 0.3 mm such as 0.25 mm.

[0033] In an embodiment, the opening may be a malleable tip, so that a laparoscopic grasper or a robotic arm can control the malleable tip by moving and bending the malleable tip and the malleable tip will retain the new shape. If the opening is the malleable tip, the distal delivery tube end ends with the malleable tip. When the opening is the malleable tip, the distal delivery tube end can be bent and moved around in the smallest cavity or space. There is no stiff unbendable part at the distal end of the malleable tip that cannot be bent and will limit mobility in a small cavity or space.

[0034] In an embodiment, the delivery tube may have an outer diameter of not more than 5.5 mm e.g. such that the delivery tube is insertable into and through a 5 mm trocar.

[0035] Trocars can be described as 3 mm, 3.5 mm, 5 mm, 8 mm, 12 mm, 18 mm, etc. Trocars even though the actual nominal size often is slightly bigger. The delivery tube having an outer diameter of not more than 5.5 mm can be inserted in most trocars.

[0036] All 5 mm trocars have at least 5.5 mm inside diameter.

[0037] In an embodiment, a proximal applicator end of the applicator may comprise a support element configured to support the syringe when the syringe is connected to the first connector. The support element will then provide a stronger connection between the applicator and the syringe.

[0038] In an embodiment, the support element may comprise a receiving section configured to support the syringe by supporting a distal barrel end of a barrel of the syringe when the syringe is connected to the first connector.

[0039] In an embodiment, the receiving section may be integrated in the support element for providing extra strength between the applicator and the syringe, or a lighter applicator still providing a strong connection between the applicator and the syringe. In an embodiment, the receiving section may form a circular collar, like a ring, for receiving the distal barrel end of the barrel of the syringe.

[0040] In an embodiment, the support element and / or the receiving section may be coaxial with the delivery tube for reducing the back force when pressing the substance or the paste out of the applicator by pressing on the piton of the syringe.

[0041] In an embodiment, the support element is configured to support the syringe by supporting a distal barrel end of a barrel of the syringe when the syringe is connected to the first connector or to the delivery tube or to the applicator.

[0042] In an embodiment, the support element may extend in the proximal direction less than 50 mm past a proximal first connector end of the first connector. The environmental imprint will be low. In an embodiment, the support element may extend in the proximal direction less than 40 mm past the proximal first connector end. In an embodiment, the support element may extend in the proximal direction less than 30 mm past the proximal first connector end. The environmental imprint will be even less with the support element extending less than 30 mm past the first connector end. In addition, that the support element may extend in the proximal direction less than 50 mm past a proximal first connector end of the first connector provides an applicator that will take up less space and be easier to navigate.

[0043] In an embodiment, the support element may extend in the proximal direction more than 3 mm past the first connector end. If the support element extends at least 3 mm past the first connector end, the support element will touch the distal barrel end of a barrel of a syringe having a piston, so that the support element can provide a solid support for the barrel of the syringe with a piston, so that the user can move and control the applicator by one single hand and can at the same time press on the piston for moving a medical substance or fluid.

[0044] In an embodiment, the first connector may be a Luer-lock or a Luer-slip or a Luer-taper connector.

[0045] In an embodiment, the first connector and the delivery tube may be coaxial, so that the applicator is easily handled by the user using one hand. The coaxial arrangement means that a syringe connected to the first connector and the delivery tube will also be coaxial, so that the force acting on the medical substance or fluid by the piston (maybe through the saline) will push the medical substance or fluid through the opening or the malleable tip without any deflections, which means that the force necessary to apply on the piston for forcing the medical substance or fluid out of the applicator will be lower. There is less back force that has to be overcome when pressing the substance or paste out of the applicator.

[0046] In an embodiment, the first connector and the delivery tube may be positioned so that the delivery tube and the syringe, when connected to the first connector, are coaxial for reducing the force necessary for pressing the substance or paste out of the applicator.

[0047] In an embodiment, the support element may comprise a support interface configured to receive a syringe or a barrel of the syringe. The support interface is preferably open in the proximal direction. The support element by the support interface may touch the distal barrel end or the distal syringe end of the syringe having a piston, so that the support element can provide a solid support for the barrel of the syringe, so that the user can move and control the applicator by one single hand and can at the same time press on the piston for moving a medical substance or fluid out of the syringe.

[0048] In an embodiment, the support interface may form a cylinder, i.e. a support interface cylinder, preferably open in the proximal direction. That is a suitable shape, since most syringes have a cylindrical barrel.

[0049] In an embodiment, the support interface may be configured to surround the distal syringe end or the distal barrel end, when the syringe is connected to the delivery tube. That the support interface surrounds the distal barrel end will provide a solid support between the applicator and the syringe.

[0050] In an embodiment, the support interface may comprise two or more wings, preferably open in the proximal direction, for supporting the distal syringe end or the distal barrel end, when the syringe is connected to the delivery tube. The two or more wings may form parts of the shape of the syringe or the distal barrel end for receiving and supporting the syringe or the distal barrel end, when the syringe is connected to the delivery tube. The two or more wings may not touch and / or be connected to each other so that less material will be needed for manufacturing the applicator. The two or more wings may not necessarily form a cylindrical shape, but will still support the barrel of the syringe when the syringe is engaged with the applicator through the first connector. Each of the two or more wings may form a fourth, a sixth, or an eighth of a circle for supporting the barrel of the syringe. The two or more wings may be located opposite each other or symmetrically around the space for receiving the syringe with the concave shape facing each other or the space for receiving the barrel between the two or more wings.

[0051] In an embodiment, the support interface comprises three or more protruding elements, preferably open in the proximal direction, for supporting the syringe or the distal barrel end, when the syringe is connected to the delivery tube. The three or more protruding elements may form parts of the shape of the syringe or the distal barrel end for receiving and supporting the syringe or the distal barrel end, when the syringe is connected to the delivery tube. The three or more protruding elements may not touch each other so that less material will be need for manufacturing the applicator. The environment impact will be minimal.

[0052] In an embodiment, the support interface may comprise a collar, preferably open in the proximal direction, for supporting the syringe or the distal barrel end, when the syringe is connected to the delivery tube. The collar will provide a solid support between the applicator and the syringe, when the syringe is connected to the delivery tube.

[0053] In an embodiment, the support interface cylinder, or the two or more wings, or the three or more protruding elements or the collar may be formed for providing the support interface with a support interface depth for receiving the syringe or the distal barrel end of less than 30 mm, preferably less than 15 mm, even more preferably less than 5 mm, and most preferably less than 1 mm of and still provide a solid support between the applicator and the syringe.

[0054] In an embodiment, the support interface cylinder, or the two or more wings, or the three or more protruding elements or the collar may form an inner diameter of between 10 and 16 mm, preferably between 12 and 14 mm, such as around 13 mm, like 12.7 mm or between 16 and 25 mm, preferably between 18 and 20 mm, such as around 20 mm, like 19.1 mm for receiving a barrel of a normal syringe. Alternatively, the inner diameter may be between 17 and 19 mm, like around 18 mm.

[0055] In an embodiment, the support element may have a first opening or a slit for allowing a view of the first connector perpendicular to a longitudinal direction of the delivery tube. The first opening will provide an inspection window to the first connector and to the distal syringe end when assembling the applicator and the syringe. The assembly will be easier.

[0056] In an embodiment, the delivery tube may have an inner volume of at least 7 mL or preferably at least 8 mL or at least 10mL.

[0057] A syringe is normally 8 mL or 10 mL, so that an inner volume of at least 7 mL will not waste very much of the medical substance or the fluid to be applied by the applicator. Haemostatic substance is expensive. If the inner volume is at least 8 mL or 10 mL no haemostatic substance will be wasted.

[0058] In an embodiment, the delivery tube has an inner delivery tube diameter, where the inner delivery tube diameter refers to the inner diameter of a first lumen of the delivery tube configured to contain the substance to be dispensed, where the first lumen is in fluid connection to the opening and is configured to be in fluid connection to the syringe, when the syringe is connected to the applicator. The inner delivery tube diameter may be at least 3 mm or 3.0 mm, preferably at least 4.0 mm, more preferably at least 4.5 mm most preferably at least 4.8 mm, like 5.0 mm. Since using an applicator of the present disclosure requires the substance to be blended before entering the syringe and introduced into the applicator, the substance will have the viscosity already in the syringe that the substance needs to have when being delivered and / or pushed and / or moved and / or sprayed out of the opening. To be able to deliver and / or push and / or move and / or spray the substance over the wound, the viscosity of the substance should not be too low. Such a substance with a high viscosity will require a higher force when pushed through the applicator. For that reason, if the inner delivery tube diameter is at least 3.0 mm, or the delivery tube cross-section is at least 7.0 mm2, it will be possible to push the substance through the delivery tube with a force, like e.g. less than 60 N and preferably less than 40 N, that a normal user, like a nurse, is able to provide on the piston of the syringe. In an embodiment, the malleable tip has an inner malleable tip diameter, where the inner malleable tip diameter refers to the inner diameter of a second lumen of the malleable tip configured to contain the substance to be dispensed, where the second lumen is in fluid connection to the opening and is configured to be in fluid connection to the syringe, when the syringe is connected to the applicator. The inner malleable tip diameter may be at least 3.0 mm or with a cross-section of at least 7.0 mm2, preferably at least 4.0 mm. If the inner malleable tip diameter is at least 3.0 mm or the malleable tip cross-section is at least 7.0 mm2, it will be possible to push the substance through the malleable tip with a force that a normal user, like a nurse, is able to provide on the piston of the syringe.

[0059] Preferably, the inner diameter of the lumen connecting the syringe and the opening, wherein the lumen comprises the first lumen and the second lumen, is at least 3.0 mm or the lumen has a cross-section of at least 7.0 mm2, so that it is possible for a normal user, like a nurse, to push the substance through the applicator by pressing on the piston of the syringe.

[0060] In an embodiment, the delivery tube may have a length of at least 300 mm, preferably at least 400 mm, and most preferably at least 500 mm. The delivery tube may have a length between 410 and 450 mm, like a length of around 430 mm.

[0061] In an embodiment, the malleable tip may have an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, or preferably an inner diameter of at least 4.0 mm. With an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, the force acting on the piston of the syringe for pressing a flowable haemostat with a typical viscosity out of the applicator will not exceed 60 N.

[0062] In an embodiment, the malleable tip may have an outer tip diameter that is at least 0.1 mm smaller than the inner diameter of the delivery tube, so that the malleable tip is insertable into the delivery tube and still provide space for a glue between the malleable tip and the delivery tube. The applicator may have a malleable tip receiving section with an increased inner diameter compared to the inner delivery tube diameter for providing a smooth transition for the substance between the delivery tube and the malleable tip, like e.g. the inner delivery tube diameter and the inner diameter of the malleable tip to be the same. Such applicators would require a lower force to press the substance out of the applicator.

[0063] In an embodiment, the malleable tip may extend at least 20 mm into the delivery tube, which will provide enough surface area for the glue between the malleable tip and the delivery tube for providing an adhesion between the malleable tip and the delivery tube that is strong enough.

[0064] In an embodiment, the malleable tip and the delivery tube may be glued together.

[0065] In an embodiment, the malleable tip may comprise a metal wire, preferably a longitudinal metal wire. The metal wire is one way of providing the malleability of the malleable tip.

[0066] That the metal wire is arranged longitudinally in the malleable tip means that the metal wire is along the length of the malleable tip preferably along the length of the whole malleable tip, maybe except for the very tip of the malleable tip, so that the metal wire can be fully enclosed by the malleable tip to avoid openings or spots, where bacteria can grow. In addition, the metal wire should preferably be fully enclosed to fixate the wire inside the small tube lumen and avoid that the wire will get exposed to haemostatic agent or body liquids.

[0067] In an embodiment, the substance may be a paste. In an embodiment, the substance may be a haemostatic medical substance or fluid.

[0068] In an embodiment, the delivery tube may have a longitudinal direction, and the support element may comprise a base or plate, wherein the base or plate may have a two dimensional extension that is perpendicular to the longitudinal direction.

[0069] In an embodiment, the base or plate may have an outer non-circular circumference that prevents rotation of the applicator when the applicator is positioned on a table.

[0070] In an embodiment, the support element may comprise proximal buttresses connecting the base or plate to the support interface. The proximal buttresses will strengthening the connection between the support element and the delivery tube and thus the applicator.

[0071] In an embodiment, the support element may comprise a connecting section, wherein the connecting section connects the support element to the delivery tube.

[0072] In an embodiment, the support element may comprise distal buttresses connecting the connecting section and the base or plate. The distal buttresses will strengthening the connection between the support element and the delivery tube and thus the applicator.

[0073] Description of Drawings

[0074] The invention will in the following be described in greater detail with reference to the accompanying drawings.

[0075] Figure 1 shows an embodiment of the applicator according to the present disclosure.

[0076] Figure 2 shows an embodiment of the applicator according to the present disclosure view from the distal direction.

[0077] Figure 3 shows a cross-sectional view of an malleable tip according to the present disclosure.

[0078] Figure 4 shows a second embodiment of the supporting element according to the present disclosure

[0079] Figure 5 shows a third embodiment of the supporting element according to the present disclosure

[0080] Figure 6 shows a distal end of an syringe connected to the supporting element of an applicator according to the present disclosure

[0081] Figure 7 shows a perspective view of the third embodiment of the supporting element connected to a syringe

[0082] Figure 8a-c show perspective views of the first, the second, and the third embodiments of the supporting element.

[0083] Detailed Description

[0084] The invention is described below with the help of the accompanying figures. It would be appreciated by the people skilled in the art that the same feature or component of the device are referred with the same reference numeral in different figures. A list of the reference numbers can be found at the end of the detailed description section. Fig. 1 shows an endoscopic and / or laparoscopic applicator 1 having a proximal applicator end 2 and a distal applicator end 4. The endoscopic and / or laparoscopic applicator 1 comprises a delivery tube 6 with a proximal delivery tube end 8 and a distal delivery tube end 10. For illustrative purposes only, the middle section of the applicator is not shown.

[0085] The applicator 1 also comprises at the proximal applicator end 2 a support element 12 with a first connector 14 like a Luer connector as shown in Fig. 1 , where the first connector 14 is configured to connect a corresponding second mating connector (not shown) of a syringe (not shown) with a piston (not shown). Another type of the first connector than a Luer lock connector, a Luer-slip connector or a Luer taper connector may be contemplated within the scope of the present disclosure.

[0086] The support element 12 may also comprise a support interface or a receiving section 16 e.g. in the form of a collar 16 for supporting the syringe when the corresponding second mating connector is connected to the first connector 14. In this embodiment, the support interface has a shape of a collar or cylindrical collar for receiving the syringe or the barrel of the syringe (not shown). When the corresponding second mating connector is connected to the first connector 14, the support interface will provide the necessary mechanical strength for allowing a user to move and control the applicator 1 by holding on to the syringe. The user can move and control the applicator by one single hand and can at the same time press on the piston for moving a medical substance or fluid, e.g. a substance comprising a haemostatic agent, from the syringe to the applicator 1 and possibly out of the applicator.

[0087] A suitable inner diameter of the support interface 16 may be between 10 and 16 mm, preferably between 12 and 14 mm, such as around 13 mm, like 12.7 mm or between 16 and 25 mm, preferably between 18 and 20 mm, such as around 20 mm, like 19.1 mm for receiving the barrel of a standard syringe. Alternatively, the inner diameter may be around 18 mm.

[0088] The support element 12 may comprise a plate or a base 18. When the applicator 1 is positioned on a surface of e.g. a table, the base 18 is configured to touch the surface at least for some positions of the applicator. The base may have a non-circular circumference or a circumference that is non coaxial with the delivery tube 6, so that the applicator will not roll on the surface, or at least will not roll on the surface more than one revolution around the circumference of the base 18.

[0089] The support element may comprise a connecting section 20, wherein the connecting section connects the support element to the delivery tube. The connecting section 20 may e.g. be a tube, like a cylinder, having the same profile as the delivery tube with an inner diameter suitable for receiving the delivery tube and maybe also provide space for a layer of glue between the connecting section and the delivery tube. For providing a mechanical strong connection between the support element 12 and the delivery tube 6, the support element 12 may comprise distal buttresses 22 between the base 18 and the connecting section 20, as shown in Fig. 1.

[0090] For providing a mechanical strong connection between the support element 12 and the syringe (not shown), when the syringe is connected to the first connector 14, the support element 12 may comprise proximal buttresses 24 between the base 18 and the support interface 16, as shown in Fig. 1.

[0091] The first connector 14 may have a proximal first connector end 26 at the proximal end of the first connector 14. The support interface 16 may have a proximal support interface end 28 at the proximal end of support interface 16. The distance between the proximal first connector end 26 and the proximal support interface end 28 may be at least 3 mm or preferably at least 4 mm or more preferably at least 6 mm so that the proximal support interface end 28 is engageable with the barrel of a standard syringe for providing the support of the syringe. That the distance between the proximal first connector end 26 and the proximal support interface end 28 may be at least 3 mm or preferably at least 4 mm or more preferably at least 6 mm may be true for the support interface of the first embodiment, of the second embodiment and / or of the third embodiment.

[0092] The support element may have a first opening 30 for allowing the user to control that the direction of the corresponding second mating connector of the syringe is well aligned with the first connector 14 before and during engagement between the corresponding second mating connector of the syringe (not shown) and the first connector 14. The delivery tube may be made of stainless steel that will enable the wall of the delivery tube to be made thin e.g. less than 0.5 mm, preferably less than 0.4 mm, more preferably less than 0.3 mm, such as 0.25 mm, and still structurally strong.

[0093] The applicator may have at the distal applicator end 4 a malleable tip 32 as shown in Fig. 1. The malleable tip may have an outer diameter that is a little less than the inner diameter of the delivery tube 6, e.g. less than 0.2 mm less, like 0.1 mm less, so that the malleable tip 32 can be inserted into the delivery tube 6 as shown in Fig. 1 and still provide space for a glue between the malleable tip 32 and the delivery tube 6. The malleable tip 32 may extend between 10 mm and 30 mm, or at least 20 mm, into the delivery tube 6. The malleable tip 32 may extend at least 30 mm past the distal delivery tube end 10 or at least 50 mm past the distal delivery tube end 10. That the malleable tip 32 may extend at least 30 mm allows the malleable tip to be controllable by a laparoscopic grasper or an external robotic arm.

[0094] In some embodiments, the applicator may not comprise a malleable tip and the distal end of the delivery tube just ends with an opening without a tip. Without the malleable tip the friction force working against the applied force on the piston for expelling the medical substance or fluid will be even lower.

[0095] The delivery tube 6 may be stiff and non-bendable, while the malleable tip 32 is bendable e.g. by a laparoscopic grasper or an external robotic arm (not shown).

[0096] A corresponding second mating connector of a first syringe comprising a medical substance or fluid, like a haemostatic substance or fluid, may be connected to the first connector 14 for transferring a substance or fluid from the first syringe to the delivery tube 6. The first syringe is disconnected from the delivery tube and a corresponding second mating connector of a second syringe with saline is connected to the first connector for transferring the saline from the second syringe to the delivery tube 6, so that the substance or fluid in the delivery tube is expelled out of the opening or out of the malleable tip 32 to the surgical site (not shown).

[0097] Fig. 2 shows the applicator 1 seen from the distal applicator end. The base 18 may have a non-circular circumference as shown in Fig. 2, so that the applicator cannot move or at least not move or roll far when laid on a slightly tilted table (not shown). Instead of the base, the applicator 1 may be provided with an outer non-circular circumference that prevents rotation of the applicator 1 on a table. In Fig. 2, the circumference or the base is elliptic, but a square shape, triangular shape, or another polygonal shape or any other non-circular shape may be contemplated within the context of the present disclosure. The circumference or the base may alternatively be off centre compared to the delivery tube for preventing the applicator rotation of the applicator 1 on the table.

[0098] Fig. 3 shows a cross-section of the malleable tip 32. The malleable tip 32 may have a circular outer shape as shown in Fig. 3. The malleable tip 32 may have in addition to the main channel 34 for transporting the substance out of the applicator an additional channel 36 for housing a metal wire (not shown) so that the malleable tip 32 is malleable. The additional channel 36 may have closed ends for preventing bacterial growth inside the additional channel 36. The metal wire way have a diameter of at least 0.4 mm or between 0.4 mm and 1.0 mm, like e.g. 0.7 mm. There may be two or more additional channels, where each additional channel may house a metal wire.

[0099] Fig. 4 shows a second embodiment of a support element 12’ having a second support interface 16’ in the form of four (only three are visible) protruding elements 38 for supporting a syringe or a distal barrel end of the syringe, when the syringe is connected to the first connector 14. For illustrative purposes only, only a part of the delivery tube 6 is shown. Each protruding element 38 has a proximal buttress 24’ for providing extra strength to the protruding elements 38. The applicator having the support element 12’ of the second embodiment may have any or all of the combinations of features of the applicator presented in Fig. 1-3.

[0100] Fig. 5 shows a third embodiment of a support element 12” having a second support interface 16” in the form of two wings 40 for supporting a syringe or a distal barrel end of the syringe, when the syringe is connected to the first connector 14. For illustrative purposes only, only a part of the delivery tube 6 is shown. Each wing 40 has a proximal buttress 24” for providing extra strength to the wing 40. The wing may have an inside curvature (not shown) corresponding to the outer shape of the syringe or the barrel of the syringe. A standard syringe has a cylindrical barrel so each wing will normally have an inside curvature forming part of a cylinder with the diameter of the barrel to be received and supported, but other shapes of the wings are contemplated within the scope of the present disclosure, like e.g. part of a polygonal shape. The applicator having the support element 12” of the third embodiment may have any or all of the combinations of features of the applicator presented in Fig. 1-3.

[0101] Fig. 6 shows the third embodiment of the support element 12” with the wings 40. A syringe 42 with a barrel 44 and a corresponding second mating connector 46 of a distal syringe end 48 of the syringe is shown. The corresponding second mating connector 46 is attached to the first connector 14 and the barrel 44 is supported by the wings 40. In an alternative embodiment, the wings 40 may support or only support a tip interface 50, that may be bevelled, between the barrel 44 and the corresponding second mating connector 46. In that case a proximal wing end 52 of the wings will be shaped to support the tip interface 50. If the support interface only supports the tip interface 50, the connection between the support element and the syringe will still be strong enough for the user to move and manipulate the applicator by only holding on to the syringe. For illustrative purposes only, only the distal end of the syringe, the support element 12” of the applicator, and the proximal delivery tube end 8 are shown.

[0102] Like the proximal wing end 52 of the wings may support the syringe 42 by supporting the tip interface 50, a proximal protruding elements end of the protruding elements of the second embodiment may be shaped to support the tip interface 50.

[0103] Like the proximal wing end 52 of the wings may support the syringe 42 by supporting the tip interface 50, a proximal collar end of the collar of the first embodiment may be shaped to support the tip interface 50.

[0104] Fig. 7 shows the support element 12” having the wings 40 attached to the syringe 42 in a perspective view. The syringe comprises a piston 54 for expelling the material or fluid out of the syringe. For illustrative purposes only, only a part of the delivery tube 6 is shown.

[0105] Fig. 8a-c show the support element 12 of the first embodiment, the support element 12’ of the second embodiment, and the support element 12” of the third embodiment, respectively, in a perspective view. For illustrative purposes only, only a part of the delivery tube 6 is shown. Reference numbers

[0106] 1 - Applicator

[0107] 2 - Proximal applicator end

[0108] 4 - Distal applicator end

[0109] 6 - Delivery tube

[0110] 8 - Proximal delivery tube end

[0111] 10 - Distal delivery tube end

[0112] 12 - Support element

[0113] 14 - First connector or Luer connector

[0114] 16 - Support interface or Receiving section

[0115] 18 - Base

[0116] 20 - Connecting section

[0117] 22 - Distal buttresses

[0118] 24 - Proximal buttresses

[0119] 26 - Proximal first connector end

[0120] 28 - Proximal support interface end

[0121] 30 - First opening

[0122] 32 - Malleable tip

[0123] 34 - Main channel

[0124] 36 - Additional channel

[0125] 38 - Protruding elements

[0126] 40 - Wings

[0127] 42 - Syringe

[0128] 44 - Barrel

[0129] 46 - Corresponding second mating connector

[0130] 48 - Distal syringe end

[0131] 50 - Tip interface

[0132] 52 - Proximal wing end

[0133] Items

[0134] The present disclosure may be described in further detail with reference to the following items.

[0135] 1. An endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent to a surgical site, the applicator comprising a delivery tube comprising:

[0136] - a proximal delivery tube end comprising a first connector configured to engage with a corresponding second mating connector of a distal syringe end of a syringe, where the syringe may hold the substance, for transferring the substance from the syringe to the delivery tube, and

[0137] - a distal delivery tube end with an opening for delivering the substance to the surgical site.

[0138] 2. The applicator according to item 1 , wherein the delivery tube is made of stainless steel.

[0139] 3. The applicator according to any of the preceding items, wherein the opening is a malleable tip.

[0140] 4. The applicator according to any of the preceding items, wherein the delivery tube has an outer diameter of not more than 5.5 mm e.g. such that the delivery tube is insertable into and through a 5 mm trocar.

[0141] 5. The applicator according to any of the preceding items, wherein a proximal applicator end of the applicator comprises a support element configured to support the syringe when the syringe is connected to the first connector.

[0142] 6. The applicator according to item 5, wherein the support element comprises a receiving section configured to support the syringe by supporting a distal barrel end of a barrel of the syringe when the syringe is connected to the first connector.

[0143] 7. The applicator according to item 6, wherein the receiving section is integrated in the support element.

[0144] 8. The applicator according to item 6 or 7, wherein the receiving section forms a circular collar, like a ring, for receiving the distal barrel end of the barrel of the syringe.

[0145] 9. The applicator according to any of the preceding items 5-8, wherein the support element and / or the receiving section is / are coaxial with the delivery tube. 10. The applicator according to any of the preceding items 5-9, wherein the support element is configured to support the syringe by supporting a distal barrel end of a barrel of the syringe when the syringe is connected to the first connector.

[0146] 11. The applicator according to any of the preceding items 5-10, wherein the support element extends in the proximal direction less than 50 mm past a proximal first connector end of the first connector.

[0147] 12. The applicator according to any of the preceding items 5-11 , wherein the support element extends in the proximal direction less than 40 mm past the proximal first connector end, preferable less than 30 mm past the proximal first connector end.

[0148] 13. The applicator according to any of the preceding items 5-12, wherein the support element extends in the proximal direction more than 3 mm past a proximal first connector end.

[0149] 14. The applicator according to any of the preceding items, wherein the first connector is a Luer-lock or a Luer-slip.

[0150] 15. The applicator according to any of the preceding items, wherein the first connector and the delivery tube are coaxial.

[0151] 16. The applicator according to any of the preceding items, wherein the first connector and the delivery tube are positioned so that the delivery tube and the syringe, when connected to the first connector, are coaxial.

[0152] 17. The applicator according to any of the preceding items 5-16, wherein the support element comprises a support interface configured to receive the syringe or the barrel of the syringe or the distal syringe end or of the distal barrel end.

[0153] 18. The applicator according to item 17, wherein the support interface forms or comprises a hollow cylinder configured to receive the barrel of the syringe.

[0154] 19. The applicator according to any of the preceding items 17-18, wherein the support interface is configured to surround the distal syringe end or the distal barrel end, when the syringe is connected to the delivery tube or to the first connector. The applicator according to any of the preceding items 17-19, wherein the support interface comprises two or more wings for supporting the syringe or the distal barrel end, when the syringe is connected to the delivery tube and / or the first connector. The applicator according to any of the preceding items 17-20, wherein the support interface comprises three or more protruding elements for supporting the syringe, the distal syringe end, the barrel or the distal barrel end, when the syringe is connected to the delivery tube. The applicator according to any of the preceding items 17-21 , wherein the support interface comprises a collar for supporting the syringe, the distal syringe end, the barrel, and / or the distal barrel end, when the syringe is connected to the delivery tube. The applicator according to any of the preceding items 5-22, wherein the support element has a first opening or a slit for allowing a view of the first connector perpendicular to a longitudinal direction of the delivery tube. The applicator according to any of the preceding items, wherein the delivery tube has an inner volume of at least 7 mL or preferably at least 8 mL. The applicator according to any of the preceding items, wherein the delivery tube has an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, preferably an inner diameter of at least 4.0 mm, more preferably at least 4.5 mm most preferably at least 4.8 mm, like 5.0 mm. The applicator according to any of the preceding items, wherein the delivery tube has a length of at least 300 mm, preferably at least 400 mm, and most preferably at least 500 mm. 27. The applicator according to any of the preceding items 3-26, wherein the malleable tip has an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, or preferably an inner diameter of at least 4.0 mm.

[0155] 28. The applicator according to any of the preceding items 3-27, wherein the malleable tip has an outer tip diameter that is at least 0.1 mm smaller than the inner diameter of the delivery tube.

[0156] 29. The applicator according to any of the preceding items 3-28, wherein the malleable tip extends at least 20 mm into the delivery tube.

[0157] 30. The applicator according to any of the preceding items 3-29, wherein the malleable tip and the delivery tube are glued together.

[0158] 31. The applicator according to any of the preceding items 3-30, wherein the malleable tip comprises a metal wire, preferably arranged longitudinally in the malleable tip.

[0159] 32. The applicator according to any of the preceding items, wherein the medical substance is a medical paste.

[0160] 33. The applicator according to any of the preceding items 5-32, wherein the delivery tube has a longitudinal direction, and the support element comprises a base or plate, wherein the base or plate has a two dimensional extension that is perpendicular to the longitudinal direction.

[0161] 34. The applicator according to item 33, wherein the base or plate has an outer non-circular circumference that prevents rotation of the applicator when the applicator is positioned on a table.

[0162] 35. The applicator according to item 33 or 34, wherein the support element comprises proximal buttresses connecting the base or plate and the support interface.

[0163] 36. The applicator according to any of the preceding items 5-35, wherein the support element comprises a connecting section, wherein the connecting section connects the support element to the delivery tube. 37. The applicator according to item 36, wherein the support element comprises distal buttresses connecting the connecting section and the base or plate.

[0164] 38. A method of providing a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the method comprising the steps of:

[0165] - connecting a first syringe comprising the substance to a first connector of an applicator according to any of the preceding items having a delivery tube with an opening,

[0166] - transferring the substance from the first syringe to the delivery tube,

[0167] - connecting a second syringe with saline to the first connector,

[0168] - transferring the saline from the second syringe to the delivery tube for expelling the substance out of the opening.

[0169] 39. The method according to item 38, wherein the substance is a haemostatic medical substance or fluid.

[0170] 40. The method according to item 38 or 39, wherein the substance is a paste, like a medical paste.

Claims

Claims1. An endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the applicator comprising a delivery tube comprising:- a proximal delivery tube end comprising a first connector configured to engage with a corresponding second mating connector of a distal syringe end of a syringe for transferring the substance from the syringe to the delivery tube, and a support element configured to support the distal syringe end when the syringe is connected to the first connector, and- a distal delivery tube end with an opening for delivering the substance to the surgical site, wherein the support element extends in the proximal direction less than 50 mm past a proximal first connector end of the first connector.

2. The applicator according to claim 1, wherein the delivery tube is made of stainless steel.

3. The applicator according to any of the preceding claims, wherein the opening is a malleable tip.

4. The applicator according to any of the preceding claims, wherein the delivery tube has an outer diameter of not more than 5.5 mm.

5. An endoscopic and / or laparoscopic applicator for delivering a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the applicator comprising a delivery tube of stainless steel comprising a distal end with a malleable tip for delivering the substance to the surgical site via a trocar, wherein the delivery tube has an outer diameter of not more than 5.5 mm.

6. The applicator according to claim 5, wherein the delivery tube comprises a proximal end comprising- a first connector configured to engage with a corresponding second mating connector of an distal end of a syringe for transferring the substance from the syringe to the delivery tube, and- a support element configured to support the syringe when the syringe is connected to the delivery tube.

7. The applicator according to claim 6, wherein the support element extends in the proximal direction less than 50 mm past a proximal end of the first connector.

8. The applicator according to any of the preceding claims, wherein the support element comprises a support interface or receiving section configured to receive the distal end of the syringe or of the barrel of the syringe.

9. The applicator according to claim 8, wherein the support interface forms a collar, like a circular collar, like a ring, configured to support and / or surround the distal end of the syringe or the distal end of the barrel of the syringe connected to the applicator.

10. The applicator according to claim 8 or 9, wherein the support interface extends in the proximal direction at least 3 mm beyond the proximal end of the first connector.

11. The applicator according to any of the preceding claims 8-10, wherein the support interface is integrated in the support element.

12. The applicator according to any of the preceding claims, wherein the support element and / or the receiving section is / are coaxial with the delivery tube.

13. The applicator according to any of the preceding claims, wherein the first connector is configured to engage with the corresponding second mating connector of the distal end of the syringe comprising a barrel, wherein the support element is configured to support the distal end of the barrel of the syringe when the syringe is connected to the delivery tube.

14. The applicator according to any of the preceding claims, wherein the first connector is a Luer-lock or a Luer-slip.

15. The applicator according to any of the preceding claims, wherein the first connector and the delivery tube are coaxial.

16. The applicator according to any of the preceding claims, wherein the first connector and the delivery tube are positioned so that the delivery tube and the syringe, when connected to the first connector, are coaxial17. The applicator according to any of the preceding claims, wherein the delivery tube has an inner volume of at least 7 mL or preferably at least 8 mL.

18. The applicator according to any of the preceding claims, wherein the delivery tube has a length of at least 300 mm, preferably at least 400 mm, and most preferably at least 500 mm.

19. The applicator according to any of the preceding claims 3-18, wherein the malleable tip extends at least 20 mm into the delivery tube.

20. The applicator according to any of the preceding claims 3-19, wherein the malleable tip and the delivery tube are glued together.

21. The applicator according to any of the preceding claims, wherein the delivery tube has an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, preferably an inner diameter of at least 4.0 mm, more preferably at least 4.5 mm most preferably at least 4.8 mm, like 5.0 mm.

22. The applicator according to any of the preceding claims 3-21 , wherein the malleable tip has an inner diameter of at least 3.0 mm or an inner cross-section of at least 7.0 mm2, or preferably an inner diameter of at least 4.0 mm.

23. A method of providing a substance, such as a medical substance and / or a fluid, e.g. a substance comprising a haemostatic agent, to a surgical site, the method comprising the steps of:- connecting a first syringe comprising the substance to a first connector of an applicator according to any of the preceding claims having a delivery tube with an opening or with a malleable tip,- transferring the substance from the first syringe to the delivery tube,- connecting a second syringe with saline to the first connector,- transferring the saline from the second syringe to the delivery tube for expelling the substance out of the opening or out of the malleable tip to the surgical site.

Images