WO2025241190A1

WO2025241190A1 - A delivery device for medical material, a connection system, and an assembly method of the delivery device

Info

Publication number: WO2025241190A1
Application number: PCT/CN2024/095274
Authority: WO
Inventors: Yuhan GUAN; Shiwei Xie
Original assignee: Guangzhou Bioseal Biotech Co Ltd
Current assignee: Guangzhou Bioseal Biotech Co Ltd
Priority date: 2024-05-24
Filing date: 2024-05-24
Publication date: 2025-11-27
Anticipated expiration: 2026-11-24

Abstract

A delivery device for at least one medical material comprises: an inner tube; an outer sheath sleeved around the inner tube; and a manifold including a main body, wherein the manifold is configured to couple with the inner tube and the outer sheath at a distal side of the main body, and wherein the manifold further includes a crown head connector protruding distally from the main body, wherein a proximal end of the inner tube connects with the crown head connector at a radial inner side of the crown head connector, and a proximal end of the outer sheath detachably couples with the crown head connector at a radial outer side of the crown head connector. A connection system of the delivery device and a method for assembly of the delivery device are provided.

Description

A DELIVERY DEVICE FOR MEDICAL MATERIAL, A CONNECTION SYSTEM, AND AN ASSEMBLY METHOD OF THE DELIVERY DEVICE

FIELD

The present application is generally related to a delivery device for dispending medical materials during surgical procedures, a connection system for the delivery device, and a method for assembly of the delivery device, and is more specifically related to a delivery device for dispensing therapeutic fluids that are used for e.g., sealing support for dura mater suture in adults and assisting in the surgical hemostasis for unsatisfactory control of hemorrhage in conventional surgical operation.

BACKGROUND

In a wide variety of circumstances, mammals can suffer from bleeding due to wounds or during surgical procedures. In some instances, the bleeding is relatively minor and will stop due to normal blood clotting functions or by using simple first aid techniques. In other instances, however, substantial bleeding can occur. These latter instances require the use of specialized equipment and materials, as well as the services of trained personnel in order to administer effective aid to control excessive bleeding.

To address the more challenging circumstances noted above, various materials have been developed for controlling excessive bleeding. For example, topical absorbable hemostats (TAHs) are widely used in surgical applications. TAHs encompass products based on oxidized cellulose (OC) , oxidized regenerated cellulose (ORC) , gelatin, collagen, chitin, chitosan, starch, etc. To improve the hemostatic performance, scaffolds based on the above materials can be combined with biologically derived clotting factors, such as thrombin and fibrinogen.

Recently, minimally invasive surgery (MIS) techniques have emerged as an alternative to conventional surgical techniques for performing a wide range of surgical procedures. MIS procedures differ from conventional surgical procedures in that a plurality of devices and/or surgical tools may be introduced into the body through cannulas and/or trocars, which are inserted into small incisions made in the body. As a result of using MIS techniques, trauma to the body is greatly reduced, which decreases recovery time for patients. Two types of minimally invasive surgery involve laparoscopic surgical procedures and endoscopic surgical procedures. Controlling bleeding is essential and critical in these surgical procedures to minimize blood loss, shorten the duration of the surgery, and reduce post-surgical complications.

One challenge presented when performing MIS procedures relates to controlling bleeding at the surgical site. In contrast to conventional open surgical procedures; during a laparoscopic or endoscopic procedure, a surgeon's access to a surgical site or surgical cavity is greatly reduced. In response, tissue sealants and other biological adhesive materials have been developed for use in closing incisions and wounds at surgical sites. Tissue sealants may include fibrin sealants, which is composed of thrombin, and a fibrinogen material; although other formulations are also available. Typically, the individual components of the tissue sealants (e.g., thrombin and fibrinogen) are stored separately in isolated reservoirs because the components will rapidly react once they come in contact with one another. In many instances, the two separate components are mixed together for the first time immediately prior to being applied to a tissue, or a bleeding site. Once mixed, the components coagulate very quickly, yielding an adhesive gel within a short period of time (e.g., within 10-20 seconds) .

There have been some developments related to systems for reconstituting therapeutic powders/fluids to form therapeutic solutions and delivering the therapeutic solutions to patients. For example, European Patent Application EP2506893A2, entitled “ADHESIVE DELIVERY DEVICES, SYSTEMS AND METHODS” , discloses adhesive delivery devices, systems and methods, wherein an adhesive material injection system for delivering adhesive to a patient site comprises: adhesive material; and a delivery device comprising a housing and a nozzle, wherein the nozzle comprises a proximal end and a distal end, and wherein the adhesive material is configured to exit said nozzle distal end.

U.S. Patent Application Publication US2010/0206905A1 titled “DUAL FLUID DISPENSER” discloses a self-contained dual fluid dispenser for storing and dispensing two fluids, comprising: a dual fluid container having an outer cartridge wall and a first outlet; a delivery tube disposed at least partially within the outer cartridge wall and including a second outlet; a first piston disposed between the outer cartridge wall and the delivery tube, the first piston forming a first fluid chamber for a first fluid; a neck connected with the outer cartridge wall and adapted to be coupled to an applicator; a second piston disposed at least partially within the neck and coupled with a side wall defining a second fluid chamber for a second fluid wherein the side wall slides within the neck in a telescoping manner and also slides over the delivery tube in a telescoping manner; and a transmission structure operative to transmit force from the second piston to the first piston to thereby dispense the first and second fluids from the first and second outlets.

U.S. Patent. US7946417B2, entitled “curable material mixing and delivery device” discloses a device for introducing liquid component into a mixing chamber comprising: an elongated ampule holder having a longitudinal axis and having a chamber operative to hold an ampule; and at least one breaker pin slidably received within an opening of the ampule holder wherein rotational movement of the ampule holder about the longitudinal axis causes the at least one breaker pin to move radially and pierce an ampule when the ampule is present in the ampule holder.

However, there are still some disadvantages in the delivery devices and systems in the prior art. For example, common delivery devices are not easy to assemble and disassemble, i.e., different components in the delivery device are commonly pre-fixed with each other through various ways (such as adhesives or welding, etc. ) prior to use, especially before a surgeon unpacking packages of those devices and starting to conduct the surgical procedures, and after finishing surgical procedures, the entire device needs to be discarded. Therefore, there is a continuing need for an improved delivery device that is more convenient to easily and reliably assemble different components together by a surgeon just before or during the surgical procedures, and disassemble them after the procedures.

SUMMARY

An object of the present application is to provide a delivery device, a connection system for the delivery device, and a method for assembly of the delivery device, to solve or at least alleviate problems existing in the prior art.

According to a first aspect of the present application, there is provided a delivery device for at least one medical material, characterized in that, the delivery device comprises: an inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the inner tube; an outer sheath sleeved around the inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the outer sheath; and a manifold including a main body, wherein the manifold is configured to couple with the inner tube and the outer sheath at a distal side of the main body, and wherein the manifold further includes a crown head connector protruding distally from the main body, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector.

Optionally, in one embodiment, the delivery device further comprises a crown head plug at the distal end of the outer sheath, wherein a distal portion of the inner tube is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extend through a through hole of the crown head plug and protrude distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.

Optionally, in one embodiment, the crown head connector comprises: a proximal portion that protrudes distally from a distal surface of the main body of the manifold; and a distal portion, wherein, in an unassembled state, the distal portion of the crown head connector has an outer diameter over at least a portion of its length greater than an inner diameter of the proximal end of the outer sheath, and wherein the proximal portion of the crown head connector has an outer diameter greater than the distal portion of the crown head connector, such that when assembled together, the proximal end of the outer sheath is configured to connect with the distal portion of the crown head connector through interference fitting and abut against a distal surface of the proximal portion of the crown head connector.

Optionally, in one embodiment, the crown head plug comprises: a proximal portion; and a distal portion, wherein, in an unassembled state, the proximal portion of the crown head plug has an outer diameter over at least a portion of its length greater than an inner diameter of the distal end of the outer sheath, and wherein the distal portion of the crown head plug has an outer diameter greater than the proximal portion of the crown head plug, such that when assembled together, the distal end of the outer sheath is configured to connect with the proximal portion of the crown head plug through interference fitting and abut against a proximal surface of the distal portion of the crown head plug.

Optionally, in one embodiment, the crown head connector and/or the crown head plug further comprises an intermediate portion between the proximal portion and the distal portion of the crown head connector and/or the crown head plug, wherein the intermediate portion has an outer diameter no greater than an inner diameter of a corresponding portion of the outer sheath.

Optionally, in one embodiment, the distal portion of the crown head connector and/or the proximal portion of the crown head plug has an outer diameter gradually increasing from a free end of the crown head connector and/or the crown head plug, and wherein an outer diameter of the free end is no greater than an inner diameter of a corresponding portion of the outer sheath.

Optionally, in one embodiment, the crown head connector and/or the crown head plug is in a truncated cone shape with an outer diameter of a wider end greater than an inner diameter of the outer sheath and an outer diameter of a thinner end no greater than the inner diameter of the outer sheath.

Optionally, in one embodiment, the inner tube is a malleable tube with multiple lumens extending from the proximal end and the distal end of the inner tube, wherein the multiple lumens include: a first lumen for delivery of a first medical material; a second lumen for delivery of a second medical material; and a third lumen for accommodating at least one malleable wire to allow the inner tube to be flexible; wherein the first lumen and the second lumen are isolated from each other.

Optionally, in one embodiment, the distal end of the inner tube is configured to protrude distally than the distal end of the outer sheath and connect with a spray tip via a connector, wherein the spray tip includes: a spray tip housing, which contains a static mixer having mixing fins for mixing the first medical material and the second medical material which are directed into the spray tip respectively from the first lumen and the second lumen; and a spray cap, which connects with a distal end of the spray tip housing, and contains a dispensing opening for dispensing a third medical material formed by mixing the first medical material and the second medical material, and wherein the connector includes: a cavity at a proximal side, the cavity being configured to receive the distal end of the inner tube and secure with that distal end; and an outer threaded portion at a distal side, the outer threaded portion being configured to engage with a corresponding inner threaded portion at a proximal side of the spray tip housing.

Optionally, in one embodiment, the distal end of the inner tube is configured to protrude distally than the distal end of the outer sheath and connect with a drip tip, wherein the drip tip includes: a drip cap, which is configured to connect around the distal end of the inner tube and comprise a dispensing opening on a distal-most wall, for dispensing the first medical material and the second medical material respectively from the first lumen and the second lumen; and a heat shrinkable tube surrounding a connecting portion between the drip cap and the distal end of the inner tube to secure them with each other. Preferably, the cap is made of silicone material. Preferably, the drip tip has the non-clogging characteristic achieved by eliminating or at least minimizing the distance (i.e., the size of a gap) between the silicone drip cap and the tri-lumen tube. For example, the distance between the distal-most surface of the inner tube and the inner surface of the distal-most wall of the drip cap should be minimized, wherein considering the unavoidable tolerance during the realistic assembly process, this distance should be controlled to be no larger than 0.01 inch, such that the adhesives or fluids (such as biologics) will not mix and form the clot in the gap when in advance, and will only mixed with each other after being dripped outwardly from the entire delivery device. Furthermore, the leakage in the circumferential direction are also prevented or at least controlled to be minimized. Preferably, when assembled together, the engaging surfaces between the drip cap and the inner tube are tightly and snugly fitted with each other, e.g., a circumferential outer surface of the inner tube is tightly fitted with a circumferential inner surface of the drip cap, such that fluids will not leak laterally through a circumferential clearance between the cap and the inner tube and mix with each other to cause clot. In addition, as the inner tube and the silicone drip cap are generally made of soft materials (e.g., the drip cap is made of silicone) , such tight fitting between the drip cap and the inner tube is preferably achieved by the heat shrinkable tube as discussed above.

Optionally, in one embodiment, the first medical material and the second medical material is able to form the third medical material when mixed with each other.

Optionally, in one embodiment, the outer sheath is made of a semi-rigid material with hardness of 80 Shore A to 100 Shore A.

Optionally, in one embodiment, the outer diameter of a portion of the delivery device positioned more distal than the manifold is less than 5mm, and/or the outer diameter of the inner tube is less than 3mm.

Optionally, in one embodiment, the manifold is detachably couple with an applicator for applying at least one medical material at a proximal side of the main body, wherein the manifold further comprises: a first lock fitting; and a second lock fitting, wherein which first lock fitting and second lock fitting protrude proximally from the main body of the manifold, and the applicator comprises a first syringe for delivery of the first medical material and a second syringe for delivery of the second medical material, which are configured to respectively detachably couple with the first lock fitting and the second lock fitting through Luer connection, and wherein, when assembled together, the first syringe of the applicator, the first lock fitting of the manifold and the first lumen of the inner tube are in communication with each other, and the second syringe of the applicator, the second lock fitting of the manifold and the second lumen of the inner tube are in communication with each other.

Optionally, in one embodiment, the first lock fitting, the second lock fitting and the crown head connector is assembled onto the main body of the manifold by ultrasonic welding.

Optionally, in one embodiment, the delivery device is configured to be used with the outer sheath coupled with the crown head connector and sleeved around the inner tube under a laparoscope condition; and the delivery device is configured to be used without the outer sheath under an endoscopic condition.

According to a second aspect of the present application, there is provided a connection system for the delivery device according to the preceding articles, wherein the connection system comprises the crown head connector of the manifold, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector.

Optionally, in one embodiment, the connection system further comprises a crown head plug at the distal end of the outer sheath, wherein a portion of the inner tube adjacent to the distal end thereof is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extend in a through hole of the crown head plug and protrude distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.

According to a third aspect of the present application, there is provided a method for assembly of the delivery device according to the preceding articles, wherein the method comprises steps of: a) connecting the proximal end of the inner tube with the crown head connector of the manifold at a radial inner side of the crown head connector; b) sleeving the outer sheath around the inner tube; and c) coupling the proximal end of the outer sheath with the crown head connector at a radial outer side of the crown head connector.

Optionally, in one embodiment, the method further comprises steps of: d) providing a crown head plug at the distal end of the outer sheath; e) connecting a portion of the inner tube adjacent to the distal end thereof with the crown head plug at a radial inner side of the crown head plug, such that a distal portion of the inner tube is configured to extend through a through hole of the crown head plug and protrude distally beyond the through hole; and f) coupling the distal end of the outer sheath with the crown head plug at a radial outer side of the crown head plug.

The delivery device and the connection system of the present application promotes the convenience of the assembly process and leads in simple assembly just before using the device or during the surgical procedures. At the same time, the reliable fixation/connection between the manifold and the tubes can also be ensured.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference may be made to preferred embodiments shown in the figures to enable better understanding of the above and other objects, features, advantages and functions of the present application. The same reference numerals in the figures denote the same parts. Those skilled in the art should appreciate that the figures are intended to schematically illustrate the preferred embodiments of the present application, and not intended to impose any limitations to the scope of the present application. Wherein,

FIG. 1 exemplarily shows a perspective view of the device for delivery of medical materials of the present application, wherein an outer sheath is shown in a transparent or translucent manner;

FIG. 2 shows an exploded schematic view of the delivery device as shown in FIG. 1.

FIG. 3 and FIG. 4 exemplarily shows perspective views of a manifold in the delivery device as shown in FIG. 1;

FIG. 5 shows a partial view of a portion on the delivery device where the manifold couples with an inner tube and an outer tube;

FIG. 6A and FIG. 6B show schematic partial front views of crown head connectors of different preferred embodiments, which couple with the inner tube and the outer tube, wherein the outer sheath is shown in a transparent or translucent manner;

FIG. 7 exemplarily shows a perspective view of the delivery device with a crown head plug at a distal end of the outer sheath of the device, wherein the outer sheath is shown in a transparent or translucent manner.

FIG. 8A and FIG. 8B exemplarily show schematic partial front views of crown head plugs of different preferred embodiments, which couple with the inner tube and the outer tube, wherein the outer sheath is shown in a transparent or translucent manner;

FIG. 9 shows a perspective view of an exemplary inner tube in the delivery device of the present application;

FIG. 10 and FIG. 11 show perspective partial views of a portion on the delivery device where a spray tip is attached to a distal end of the inner tube;

FIG. 12 and FIG. 13 show perspective partial views of a portion on the delivery device where a drip tip is attached to the distal end of the inner tube;

FIG. 14 shows a perspective view of the delivery device shown in FIG. 1, wherein the outer sheath and tips are removed.

Listing of reference numbers:

1 device; 10 inner tube; 11 proximal end of the inner tube; 12 distal end of the outer tube; 13 first lumen; 14 second lumen; 15 third lumen; 20 outer sheath; 21 proximal end of the outer sheath; 22 distal end of the outer sheath; 30 manifold; 31 main body; 311 distal half part; 312 proximal half part; 313 crown head connector; 314a first lock fitting; 314b second lock fitting; 3131 proximal portion of the crown head connector; 3132 distal portion of the crown head connector; 3133 free end of the crown head connector; 3134 intermediate portion of the crown head connector; 40 spray tip; 41 spray tip housing; 42 spray cap; 50 crown head plug; 51 distal portion of the crown head plug; 52 proximal portion of the crown head plug; 53 free end of the crown head plug; 54 intermediate portion of the crown head plug; 60 connector; 61 cavity; 62 outer threaded portion; 70 drip tip; 71 drip cap; 72 heat shrinkable tube; 73 opening.

DETAILED DESCRIPTION OF EMBODIMENTS

Specific embodiments of the present application will now be described in detail with reference to the figures. The embodiments described herein are only preferred embodiments according to the present application. Those skilled in the art can envision other modes capable of implementing the present application on the basis of the preferred embodiments, and said other modes also fall within the scope of the present application.

Briefly, according to an aspect of the present application, there is provided a delivery device for at least one medical material, wherein the delivery device comprises: an inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the inner tube; an outer sheath sleeved around the inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the outer sheath; and a manifold including a main body, wherein the manifold is configured to couple with the inner tube and the outer sheath at a distal side of the main body, and wherein the manifold further includes a crown head connector protruding distally from the main body, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector.

In some preferable embodiments, the delivery device further comprises a crown head plug at the distal end of the outer sheath, wherein a portion of the inner tube adjacent to the distal end thereof is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extend through a through hole of the crown head plug and protrude distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.

The above mentioned delivery device can be used in surgical procedures, especially in MIS procedures such as laparoscopic or endoscopic surgical procedures, and can be used for delivering any medical materials occur to those skilled in the art. For example, the delivery device of the present application may be used for delivering tissue adhesives, such as fibrin-based sealants, during processes such as controlling bleeding, sealing wounds, sealing air leaks during lung surgery, sealing fluid leaks, and graft fixation. Other products appropriate to be used with this device and applications suitable for adopting this device should also be included in the claimed protection scope.

The contents of the present application will be described in detail with reference to the embodiments exemplarily shown in the drawings. It should be noted that the following description is only exemplary, not for limiting purposes. In addition, it should be noted that the orientational words or expressions, such as, “proximal” , “distal” or others, are all described with taking the user’s position as a reference. For example, a proximal portion/end refers to a portion/end that is more close to the user that is handling the device, and a distal portion/end is, opposite to the proximal one, farther away from the user.

Referring now to FIGS. 1-2, an exemplary embodiment of a device 1 for delivering at least one medical material is shown, more particularly, the device 1 is configured to, for example, expressing a multi-component sealant, hemostat or adhesive (or composition having one or more of these properties) . Preferably, the device 1 in this embodiment comprises an inner tube 10, an outer sheath 20 sleeved around the inner tube 10, and a connector, also referred as a manifold 30, coupled at a side of the inner tube 10 and the outer sheath 20. Specifically, the inner tube 10 includes a proximal end 11, a distal end 12, and an elongated portion extending between the proximal end 11 and the distal end 12; and the outer sheath, which is also referred as an outer tube, also includes a proximal end 21, a distal end 22, and an elongated portion extending between the proximal end 21 and the distal end 22. In addition, the outer sheath is preferably made of transparent or translucent materials (also shown in transparent or translucent manner in the figures) to enable a user to more clearly and conveniently see the state (such as orientations, working conditions, etc. ) of the inner tube 10 inside the outer sheath.

Preferably, the inner tube 10 is a malleable tube made of flexible materials that allows a user to easily bend/shape, and freely operate the tube 10 and control its orientation, and to further increase the maneuverability, a malleable wire may be provided in the inner tube, e.g., extending through the elongated portion between the proximal end 11 and the distal end 12. The outer sheath 20, when assembled together, is sleeved outside or surrounds around the inner tube 10, and the size of the outer sheath 20 may be configured to match with the inner tube 10, typically, the inner diameter of the outer sheath 20 can be coincident or slightly greater than the outer diameter of the inner tube 10, such that the inner and outer tubes 10, 20 are convenient to be assembled together and the assembled device 1 has a compact structure. More preferably, the outer sheath 20 may be made from semi-rigid materials such as materials with hardness of 80-100 Shore A (e.g., plastics such as polypropylene or polyethylene, or other commonly used, surgically safe metals, which satisfy the hardness requirements of semi-rigid materials) . Such semi-rigid outer sheath can provide protection for the softer and more flexible inner tube, increase structural rigidity and provide sufficient support to allow a user to readily maneuver device to the intended application area, e.g., to access into a trocar.

It can be understood that, the length of the above discussed inner tube 10 can be selected by users to satisfy different requirements for different surgery scenarios. For example, 350mm tube length will meet most laparoscopic surgeries and 1800mm tube length will meet most endoscopic surgeries. Those skilled in the art can adopt tubes with different lengths according to their actual needs. The length of the outer sheath 20 can be selected accordingly, e.g., coincide with the inner tube, or shorter than the inner tube so as to allow the distal end 12 of the inner tube to protrude outwardly from the distal end 22 of the outer sheath 20 to achieve the purpose of medical materials delivering and applying. Particularly, for laparoscopic surgery scenarios, the distal end 12 of the inner tube 10 can preferably be connected with or coupled to a medical applying tip, which can for example be a spray tip or a drip tip. For endoscopic surgery scenarios, no distal tip and the outer sheath is needed and the device can directly be operated with a bare inner tube. Users can decide whether to use or not to use any tips, or what type of tip to use, according to their actual needs and specific surgical scenarios.

Referring to FIG. 3-4, which exemplarily shows an embodiment of the above mentioned manifold 30. The manifold 30 comprises a main body 31 including a distal half part 311 and a proximal half part 312, wherein the distal half part 311 is configured to couple with or connect with the proximal ends 11, 21 of the inner tube 10 and the outer sheath 20, and the proximal half part 312 is configured to detachably couple with a proximal applicator that includes one or more syringes respectively for applying one or more types of medical materials. More specifically, in a preferred embodiment, the proximal half part 312 comprises a first lock fitting 314a and a second lock fitting 314b that protrude proximally from the proximal half part 312, and correspondingly, the coupled applicator comprises a first syringe for delivery of a first type of medical material and a second syringe for delivery of a second type of medical material, which are configured to respectively detachably couple with the first lock fitting 314a and the second lock fitting 314b through Luer connection. More preferably, the distal and proximal half parts 311, 312 can be assembled together by various ways, such as quick snapping, gluing, welding and/or other feasible and suitable ways, and more preferably, the above discussed components, including the crown head connector 313, the first and second lock fitting 314a, 314b can be assembled onto the main body 31 through ultrasonic welding.

In a more preferred embodiment, the distal half part 311 is provided with a crown head connector 313 protruding distally from a distal surface of the main body, wherein, referring to FIG. 5, the proximal end 11 of the inner tube 10 is configured to connect with the crown head connector 313 at a radial inner side of the crown head connector 313, and the proximal end 21 of the outer sheath 20 is configured to detachably couple with the crown head connector 313 at a radial outer side of the crown head connector 313. The inner tube 10 can be fixed with an inner surface of the crown head connector 313 via various ways such as gluing, welding, molding, interference fitting, and/or other suitable connecting ways that occur to those skilled in the art. More preferably, the outer sheath 20 detachably couple with the crown head connector 313 in an interference fitting way.

The detailed connecting/coupling configuration between the crown head connector and the outer sheath will be described referring to FIGS. 6A-6B. Referring to FIG. 6A, which shows one preferred embodiment of the crown head connector 313, the crown head connector 313 comprises a proximal portion 3131 that protrudes distally from the distal surface of the main body 31 of the manifold 30; and a distal portion 3132. In an unassembled state (when there is no force applied) , the distal portion 3132 of the crown head connector 313 has an outer diameter d1 over at least a portion of its length (e.g., the proximal length as shown in FIG. 6A) greater than an inner diameter d0 of the proximal end 21 of the outer sheath 20, and wherein the proximal portion 3131 of the crown head connector 313 has an outer diameter d2 greater than, to avoid increasing the overall size of the device too much, preferably only slightly greater than, the distal portion 3132 of the crown head connector 313 and the outer diameter of the proximal end 21 of the outer sheath 20, such that when assembled together, the proximal end 21 of the outer sheath 20 is configured to connect with the distal portion 3132 of the crown head connector 313 through interference fitting and abut against a distal surface of the proximal portion 3131 of the crown head connector 313.

Such connecting configuration between the manifold 30 and the inner and outer tubes 10, 20 through the crown head of the present application promotes the convenience of the assembly process and leads in simple assembly just before using the device or during the surgical procedures. For example, the delivery device 1 of the present application can be stored and transported in the form of different separate parts (such as, packaging the tubes and the manifold independently) , and just before conducting a surgical procedure or even during the procedure, the surgeon or an assistant can easily unpack each of the packages and easily assemble them together, for example, directly connect an end of the outer sheath onto the outer surface of the crown head connector on the manifold by using a particular force to overcome the diameter difference between the inner diameter of the outer sheath and the outer diameter of the crown head connector.

More preferably, the distal portion 3132 of the crown head connector 313 has an outer diameter gradually increasing from a free end 3133 of the crown head connector 313, and wherein an outer diameter of the free end (near or at the distal-most position, the distal-most position having an outer diameter of d3) is no greater than the inner diameter d0 of a corresponding portion of the outer sheath 20. Such gradually increasing portion enables the crown head connector 313 to be more easily pushed into the outer sheath 20, such that these two components can be fitted together without the need of too much force, thus facilitating quick assembling.

In another preferred embodiment, as shown in FIG. 6B, the crown head connector further comprises an intermediate portion 3134 between the proximal portion 3131 and the distal portion 3132 of the crown head connector, wherein the intermediate portion 3134 has an outer diameter d4 no greater than (in this embodiment as shown in FIG. 6B, substantially align with) an inner diameter d0 of a corresponding portion of the outer sheath 20. The diameter of such intermediate portion further facilitates the convenience of the assembly process, i.e., when the crown head connector is pushed by a user such that the entire distal portion 3132 is included inside the outer sheath, the resistance rapidly drops as the outer diameter d4 decreases from the outer diameter d1 of the distal portion and the interference of the connection is eliminated or even disappears. Therefore, the crown head connector 313 adopts the wide distal portion 3132 to ensure the reliable fixation between the manifold 30 and the outer sheath 20, and adopts the gradually increasing portion and/or the intermediate portion to reduce the difficulty during the assembly.

In other embodiments, the crown head connector can be configured in different ways from the above contents. For example, the crown head connector may be an entire one without being divided into different portions as discussed above. In this configuration, the connector is in a truncated cone shape with its wider end protruding distally from the main body 31 of the manifold and its thinner end terminating being a free end. The outer diameter of the crown head connector in this embodiment gradually increases from the free end to the wider end, and to facilitate assembly, the free end has a no greater or even smaller outer diameter than the inner diameter of the outer sheath. Alternatively, the wider end may have a larger outer diameter than the inner diameter of the outer sheath, so that when assembled together, the outer sheath may get “stuck” on the wider end of the crown head connector, or, when more force is applied by the user, the outer sheath deforms until the proximal end of it abuts against the distal surface of the main body 31 of the manifold. Such configuration can also ensure the reliability of the connection and the assembly convenience at the same time.

Referring now to FIG. 7, in a preferred embodiment, a crown head plug 50 is further provided at the distal end 22 of the outer sheath 20, wherein a portion (adjacent to the distal end 12) of the inner tube 10 is configured to connect with the crown head plug 50 at a radial inner side of the crown head plug 50, and extend through a through hole of the crown head plug 50 and protrude distally beyond the through hole, and wherein the distal end 22 of the outer sheath 20 is configured to detachably couple with the crown head plug 50 at a radial outer side of the crown head plug 50.

More specifically, referring to FIGS. 8A-8B, the crown head plug 50 is similar to the crown head connector 313 as described above, and in an assembled state, the crown head connector and the crown head plug are arranged oppositely in orientation, i.e., arranged in a substantially mirror image. Preferably, referring to FIG. 8A, similar to the crown head connector 313, the crown head plug 50 comprises a distal portion 51 and a proximal portion 52, wherein, in an unassembled state, the proximal portion 52 of the crown head plug 50 has an outer diameter d1’ over at least a portion of its length greater than an inner diameter d0’ of the distal end 22 of the outer sheath 20, and wherein the distal portion 51 of the crown head plug 50 has an outer diameter d2’ greater than, preferably only slightly greater than (to avoid increasing the overall size of the device too much) , the proximal portion 52 of the crown head plug 50 and the outer diameter of the distal end 22 of the outer sheath 20. This configuration enables that, when assembled together, the distal end of the outer sheath is configured to connect with the proximal portion of the crown head plug through interference fitting and abut against a proximal surface of the distal portion of the crown head plug.

Such crown head plug 50 arranged at a distal portion of the tubes 10, 20 can effectively reduce the shaking of the tubes during the procedures, as it can fix the position of the distal portion of the inner tube 10 relative to the distal end of the outer sheath. For example, the plug 50 can be made of deformable materials with shock absorption function, such as rubber, EVA (ethylene-vinyl acetate copolymer) , ACF (anisotropic conductive film) or other materials. When assembling, the inner tube 10 extends through the central hole of the crown head plug 50 and is held by the plug 50 by friction fitting, interference fitting, gluing or other suitable connecting/fitting ways between the inner surface of the plug and the outer surface of the inner tube. In addition, similar to those advantages as discussed about the crown head connector, the plug also has the advantages of convenient assembly and reliable connection.

More preferably, the proximal portion 52 of the crown head plug 50 has an outer diameter gradually increasing from a free end 53, and wherein an outer diameter of the free end (near or at the proximal-most position, the proximal-most position having an outer diameter of d3’ ) is no greater than the inner diameter d0 of a corresponding portion of the outer sheath 20. Such gradually increasing portion enables the crown head plug to be more easily pushed into the outer sheath 20, such that these two components can be fitted together without the need of too much force, thus facilitating quick assembling.

In another preferred embodiment, as shown in FIG. 8B, the crown head plug further comprises an intermediate portion 54 between the proximal portion 52 and the distal portion 51 of the plug 50, wherein the intermediate portion 54 has an outer diameter d4’ no greater than (in this embodiment as shown in FIG. 8B, substantially align with) an inner diameter d0 of a corresponding portion of the outer sheath 20. The diameter of such intermediate portion further facilitates the convenience of the assembly process, i.e., when the crown head plug is pushed by a user such that the entire proximal portion 52 is included inside the outer sheath, the resistance rapidly drops as the outer diameter d4 decreases from the outer diameter d1 of the distal portion and the interference of the connection is eliminated or even disappears. Therefore, the crown head plug 50 adopts the wide distal portion 52 to ensure the reliable fixation between the plug and the outer sheath 20, and adopts the gradually increasing portion and/or the intermediate portion to reduce the difficulty during the assembly.

In other embodiments, the crown head plug can be configured in different ways from the above contents. For example, the plug may be an entire one without being divided into different portions as discussed above. In this configuration, the plug is in a truncated cone shape with its wider end distally positioned and its thinner end proximally positioned in an assembled state. The outer diameter of the crown head plug in this embodiment gradually increases from the thinner end to the wider end, and to facilitate assembly, the thinner end has a no greater or even smaller outer diameter than the inner diameter of the outer sheath. Alternatively, the wider end may have a larger outer diameter than the inner diameter of the outer sheath, so that when assembled together, the outer sheath may get “stuck” on the wider end of the crown head plug. Such configuration can ensure the reliability of the connection and the assembly convenience at the same time.

Referring to FIG. 9 which shows an exemplary structure of the inner tube 10, the inner tube is a malleable tube with multiple lumens respectively for receiving different objects (three lumens as shown in FIG. 9) extending from the proximal end 11 and the distal end 12 of the inner tube. For example, the multiple lumens include: a first lumen 13 for delivery of a first (or a first type of) medical material; a second lumen 14 for delivery of a second (or a second type of) medical material; and a third lumen 15 for accommodating at least one malleable wire to allow the inner tube to be flexible; wherein the first lumen 13 and the second lumen 14 are isolated from each other to avoid the first and second medical materials from mixing with each other before being applied on target surgical sites. In an exemplary embodiment, the first medical material and the second medical material is able to be mixed with each other to form a third medical material (e.g., mixed solution) that can be used for, e.g., controlling bleeding, sealing wounds, sealing air leaks during lung surgery, sealing fluid leaks, and graft fixation, when mixed with each other. For example, the first and second medical materials may be any types of medical precursors, medical liquids, medical powers, etc., that can be mixed together or can react with each other to form multi-component medical sealant, hemostat, adhesive formulation, preparation, medicant, dressing, medical solutions, and/or other medical materials that would be thought of by those skilled in the art. When assembled together, the first syringe of the applicator, the first lock fitting of the manifold and the first lumen of the inner tube are in communication with each other, and the second syringe of the applicator, the second lock fitting of the manifold and the second lumen of the inner tube are in communication with each other.

FIGS. 10-13 shows different types of tips attached to the distal end of the inner tube 10 for dispensing medical materials. Referring to FIGS. 10-11, in this embodiment, the distal end 12 of the inner tube 10 is configured to protrude distally than the distal end 22 of the outer sheath 20 and connect with a spray tip 40 via a connector 60. The spray tip 40 includes: a spray tip housing 41, which contains a static mixer 43 (within the housing, which can be seen in FIG. 11 in which the housing 41 is removed to clearly show the inner structures of the tip 40) having mixing fins for mixing the first medical material and the second medical material which are directed into the spray tip respectively from the first lumen 13 and the second lumen 14 of the inner tube 10; and a spray cap 42, which connects with a distal end of the spray tip housing 42, and contains a dispensing opening 44 for dispensing the third medical material (e.g., bioseal fibrin sealant) formed by mixing the first medical material and the second medical material. The connector 60 is preferably an over-molding one, which includes: an inner cavity 61 at a proximal side, the cavity being configured to receive the distal end 12 of the inner tube 10 and secure with that distal end through various ways such as welding, threading, interference fitting, gluing, or others; and an outer threaded portion 62 at a distal side, the outer threaded portion being configured to engage with a corresponding inner threaded portion at a proximal side of the spray tip housing 41.

Referring to FIGS. 12-13, in this embodiment, the distal end 12 of the inner tube 10 is configured to protrude distally than the distal end 22 of the outer sheath 20 and connect with a drip tip 70. The drip tip includes: a drip cap 71, which is configured to connect around the distal end 12 of the inner tube 10 and comprises a dispensing opening 73 on a distal-most wall, for dispensing the first medical material and the second medical material respectively from the first lumen 13 and the second lumen 14; and a heat shrinkable tube 72 surrounding a connecting portion between the drip cap 71 and the distal end 12 of the inner tube 10 to secure them with each other. Preferably, the cap 71 is made of silicone material. Preferably, the drip tip has the non-clogging characteristic achieved by eliminating or at least minimizing the distance (i.e., the size of a gap) between the silicone drip cap 71 and the tri-lumen tube 10. For example, the distance between the distal-most surface of the inner tube 10 and the inner surface of the distal-most wall of the drip cap 71 should be minimized, wherein considering the unavoidable tolerance during the realistic assembly production and process, this distance should be controlled to be no larger than 0.01 inch, such that the adhesive or fluid (such as biologics) will not mix and clot in the gap when in advance, and will only mixed with each other after being dripped outwardly from the entire delivery device. Furthermore, the leakage in the circumferential direction are also prevented or at least controlled to be minimized. Preferably, when assembled together, the engaging surfaces between the drip cap and the inner tube are tightly and snugly fitted with each other, e.g., a circumferential outer surface of the inner tube is tightly fitted with a circumferential inner surface of the drip cap, such that fluids will not leak laterally through a circumferential clearance between the cap and the inner tube and in turn mix and clot. In addition, as the inner tube and the silicone drip cap are generally made of soft materials (e.g., the drip cap is made of silicone) , such tight fitting between the drip cap and the inner tube is preferably achieved by the heat shrinkable tube 72 as discussed above.

It should be understood that other types of tips can also be attached to the distal end of the inner tube 10 to apply medical material (s) in appropriate ways. In another embodiment, as shown in FIG. 14, in some scenarios (such as during endoscopic surgery) , no distal tip and the outer sheath is needed and the device can directly be operated with a bare inner tube. Therefore, users can decide whether to use or not to use any tips and/or outer sheath, or what type to use, according to their actual needs and specific surgical scenarios.

In addition, in some embodiments, the overall size (i.e., the outer diameter) of the delivery device distal than the manifold (i.e., including of the tips, the outer sheath, the inner sheath, the crown head connector, and the crown head plug) is controlled less than 5mm (especially with the outer sheath and the distal tip) so that the device can enter 5mm trocar, and the overall size of the device without the outer sheath and the distal tip is controlled less than 3mm which can enter 3.2mm trocar. In other words, the outer diameter of the inner tube is less than 3mm, and the outer diameters of the outer sheath, the spray/drip tips, the crown head connector, and the crown head plug are less than 5mm.

According to another aspect of the present application, there is provided a connection system for the delivery device as described above, wherein the connection system comprises the crown head connector of the manifold, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector. In a preferred embodiment, the connection system further comprises a crown head plug at the distal end of the outer sheath, wherein a portion of the inner tube adjacent to the distal end thereof is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extend in a through hole of the crown head plug and protrude distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.

According to a further aspect of the present application, there is provided a method for assembly of the delivery device as described, wherein the method comprises the following steps of: a) connecting the proximal end of the inner tube with the crown head connector of the manifold at a radial inner side of the crown head connector; b) sleeving the outer sheath around the inner tube; and c) coupling the proximal end of the outer sheath with the crown head connector at a radial outer side of the crown head connector. In a preferred embodiment, the method further comprises the following steps of: d) providing a crown head plug at the distal end of the outer sheath; e) connecting a portion of the inner tube adjacent to the distal end thereof with the crown head plug at a radial inner side of the crown head plug, such that a distal portion of the inner tube is configured to extend through a through hole of the crown head plug and protrude distally beyond the through hole; and f) coupling the distal end of the outer sheath with the crown head plug at a radial outer side of the crown head plug.

Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. The scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

A delivery device for delivering at least one medical material, characterized in that, the delivery device comprises:

an inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the inner tube;

an outer sheath sleeved around the inner tube, which includes a proximal end, a distal end, and an elongated portion extending between the proximal end and the distal end of the outer sheath; and

a manifold including a main body, wherein the manifold is configured to couple with the

inner tube and the outer sheath at a distal side of the main body, and

wherein the manifold further includes a crown head connector protruding distally from the main body, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector.
The delivery device according to Claim 1, characterized in that,

the delivery device further comprises a crown head plug at the distal end of the outer sheath, wherein a portion of the inner tube adjacent to the distal end thereof is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extends through a through hole of the crown head plug and protrudes distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.
The delivery device according to Claim 2, characterized in that,

the crown head connector comprises:

a proximal portion that protrudes distally from a distal surface of the main body of the manifold; and

a distal portion,

wherein, in an unassembled state, the distal portion of the crown head connector has an outer diameter over at least a portion of its length greater than an inner diameter of the proximal end of the outer sheath, and wherein the proximal portion of the crown head connector has an outer diameter greater than the distal portion of the crown head connector, such that when assembled together, the proximal end of the outer sheath is configured to connect with the distal portion of the crown head connector through interference fitting and abut against a distal surface of the proximal portion of the crown head connector.
The delivery device according to Claim 3, characterized in that,

the crown head plug comprises:

a proximal portion; and

a distal portion,

wherein, in an unassembled state, the proximal portion of the crown head plug has an outer diameter over at least a portion of its length greater than an inner diameter of the distal end of the outer sheath, and wherein the distal portion of the crown head plug has an outer diameter greater than the proximal portion of the crown head plug, such that when assembled together, the distal end of the outer sheath is configured to connect with the proximal portion of the crown head plug through interference fitting and abut against a proximal surface of the distal portion of the crown head plug.
The delivery device according to Claim 4, characterized in that,

the crown head connector and/or the crown head plug further comprises an intermediate portion between the proximal portion and the distal portion of the crown head connector and/or the crown head plug, wherein the intermediate portion has an outer diameter no greater than an inner diameter of a corresponding portion of the outer sheath.
The delivery device according to Claim 4, characterized in that,

the distal portion of the crown head connector and/or the proximal portion of the crown head plug has an outer diameter gradually increasing from a free end of the crown head connector and/or the crown head plug, and wherein an outer diameter of the free end is no greater than an inner diameter of a corresponding portion of the outer sheath.
The delivery device according to Claim 2, characterized in that, the crown head connector and/or the crown head plug is in a truncated cone shape with an outer diameter of a wider end greater than an inner diameter of the outer sheath and an outer diameter of a thinner end no greater than the inner diameter of the outer sheath.
The delivery device according to Claim 1, characterized in that,

the inner tube is a malleable tube with multiple lumens extending from the proximal end and the distal end of the inner tube, wherein the multiple lumens include:

a first lumen for delivery of a first medical material;

a second lumen for delivery of a second medical material; and

a third lumen for accommodating at least one malleable wire to allow the inner tube to be flexible;

wherein the first lumen and the second lumen are isolated from each other.
The delivery device according to Claim 8, characterized in that,

the distal end of the inner tube is configured to protrude distally than the distal end of the outer sheath and connect with a spray tip via a connector,

wherein the spray tip includes:

a spray tip housing, which contains a static mixer having mixing fins for mixing the first medical material and the second medical material which are directed into the spray tip respectively from the first lumen and the second lumen; and

a spray cap, which connects with a distal end of the spray tip housing, and contains a dispensing opening for dispensing a third medical material formed by mixing the first

medical material and the second medical material, and

wherein the connector includes:

a cavity at a proximal side, the cavity being configured to receive the distal end of the inner tube and secure with that distal end; and

an outer threaded portion at a distal side, the outer threaded portion being configured to engage with a corresponding inner threaded portion at a proximal side of the spray tip housing.
The delivery device according to Claim 8, characterized in that,

the distal end of the inner tube is configured to protrude distally than the distal end of the outer sheath and connect with a drip tip, wherein the drip tip includes:

a drip cap, which is configured to connect around the distal end of the inner tube and comprise a dispensing opening on a distal-most wall, for dispensing the first medical material and the second medical material respectively from the first lumen and the second lumen; and

a heat shrinkable tube surrounding a connecting portion between the drip cap and the distal end of the inner tube to secure them with each other.
The delivery according to Claim 10, characterized in that, a circumferential outer surface of the inner tube is tightly fitted with a circumferential inner surface of the drip cap through the heat shrinkable tube.
The delivery device according to Claim 10, characterized in that, a distance between the distal-most surface of the inner tube and the inner surface of the distal-most wall of the drip cap is no more than 0.01 inch.
The delivery device according to Claim 8, characterized in that, the first medical material and the second medical material are able to form the third material when mixed with each other.
The delivery device according to Claim 1, characterized in that, the outer sheath is made of a semi-rigid material with hardness of 80 Shore A to 100 Shore A.
The delivery device according to Claim 1, characterized in that, the outer diameter of a portion of the delivery device positioned more distal than the manifold is less than 5mm, and/or the outer diameter of the inner tube is less than 3mm.
The delivery device according to Claim 8, characterized in that,

the manifold is detachably couple with an applicator for applying at least one medical material at a proximal side of the main body, wherein the manifold further comprises:

a first lock fitting; and

a second lock fitting,

wherein which first lock fitting and second lock fitting protrude proximally from the main

body of the manifold, and

the applicator comprises a first syringe for delivery of the first medical material and a second syringe for delivery of the second medical material, which are configured to respectively detachably couple with the first lock fitting and the second lock fitting through Luer connection, and

wherein, when assembled together, the first syringe of the applicator, the first lock fitting of the manifold and the first lumen of the inner tube are in communication with each other, and the second syringe of the applicator, the second lock fitting of the manifold and the second lumen of the inner tube are in communication with each other.
The delivery device according to Claim 1, characterized in that, the first lock fitting, the second lock fitting and the crown head connector is assembled onto the main body of the manifold by ultrasonic welding.
The delivery device according to Claim 1, characterized in that, the delivery device is configured to be used with the outer sheath coupled with the crown head connector and sleeved around the inner tube under a laparoscope condition; and the delivery device is configured to be used without the outer sheath under an endoscopic condition.
A connection system for the delivery device according to Claim 1, characterized in that, the connection system comprises the crown head connector of the manifold, wherein the proximal end of the inner tube is configured to connect with the crown head connector at a radial inner side of the crown head connector, and the proximal end of the outer sheath is configured to detachably couple with the crown head connector at a radial outer side of the crown head connector.
The connection system according to Claim 19, characterized in that, the connection system further comprises a crown head plug at the distal end of the outer sheath,

wherein a portion of the inner tube adjacent to the distal end thereof is configured to connect with the crown head plug at a radial inner side of the crown head plug, and extend in a through hole of the crown head plug and protrude distally beyond the through hole, and wherein the distal end of the outer sheath is configured to detachably couple with the crown head plug at a radial outer side of the crown head plug.
A method for assembly of the delivery device according to Claim 1, characterized in that, the method comprises steps of:

a) connecting the proximal end of the inner tube with the crown head connector of the manifold at a radial inner side of the crown head connector;

b) sleeving the outer sheath around the inner tube; and

c) coupling the proximal end of the outer sheath with the crown head connector at a radial outer side of the crown head connector.
The method according to Claim 21, characterized in that, the method further comprises steps of:

d) providing a crown head plug at the distal end of the outer sheath;

e) connecting a portion of the inner tube adjacent to the distal end thereof with the crown head plug at a radial inner side of the crown head plug, such that a distal portion of the inner tube is configured to extend through a through hole of the crown head plug and protrude distally beyond the through hole; and

f) coupling the distal end of the outer sheath with the crown head plug at a radial outer side of the crown head plug.