AU2017420421B2

AU2017420421B2 - A haemostatic agent delivery device

Info

Publication number: AU2017420421B2
Application number: AU2017420421A
Authority: AU
Inventors: Vickneswaran A/L MATHENASWARAN; Hong Guan Ng
Original assignee: Epsilon Medical Devices Sdn Bhd
Current assignee: Epsilon Medical Devices Sdn Bhd
Priority date: 2017-06-22
Filing date: 2017-06-22
Publication date: 2021-02-25
Anticipated expiration: 2037-06-22
Also published as: AU2017420421A1; WO2018236204A1

Abstract

The present invention relates to a haemostatic agent delivery device (1) comprising an external tube (2) having a bridge portion (5) that has a first groove (6a) and second groove (6b) mounted on each end of the bridge (5), a gripping means (4) having a pair of finger holes for receiving user's fingers at the proximal end, and a longitudinal groove (12) at the rear surface of the tube terminating with a tubular portion (7) at the distal end; and an internal tube (3) having a singular gripping portion (9), an extended portion (14) beneath the gripping portion (9) that terminates with a resilient end that has an overlapping protrusion (10) as a locking means and a connecting means (11) at its proximal end for connecting to a suction applying device; wherein, when in use, the overlapping protrusion (10) interlocks with the first groove (6a) for loading of haemostatic agent into the device whereas the overlapping protrusion (10) interlocks with the second groove (6b) for delivering and compressing the haemostatic agent at the bleeding site.

Description

A HAEMOSTATIC AGENT DELIVERY DEVICE FIELD OF INVENTION

The present invention relates to a haemostatic agent delivery device and particularly for reducing bleeding in body cavities and vessels. More particularly, the haemostatic agent delivery device enables efficient delivery of haemostatic agent and provides simultaneous compression and blood suction at haemorrhagic site during surgical procedures.

BACKGROUND OF INVENTION

Perioperative bleeding depends on the coagulation status of the patient and on the complexity and extent of the surgical procedure. Surgical procedures often put patients at high risk of massive bleeding. Besides, massive blood loss could also arise during perioperative period from coagulation abnormalities such as dilutional coagulopathy and coagulation factor deficiency. Unexpected and excessive perioperative bleeding could cause complication to the surgical procedure, resulting in increased morbidity and mortality. Thus, the need exists for effective management of bleeding during operative and other invasive procedures.

The most common mechanical method to control bleeding is the application of direct pressure to the bleeding site. Direct pressure can either be applied manually or with pressure dressings at the bleeding site. The application of pressure is often considered as first choice to achieve haemostasis as it is easiest, simplest and cost effective. However, the mechanical method of applying direct pressure is not always practical, depending on the location and severity of the blood loss. Further, compression at the bleeding site may not be effective especially when the patient has a coagulation defect or has been on an anticoagulant medication.

In order to overcome these shortcomings, haemostatic agents have been widely used as modern approach to promote haemostasis. Haemostatic agents is known to establish haemostasis by means of different mechanisms which include concentrating coagulant factors, adhering to tissues to block bleeding from wounds and delivering procoagulant factors to promote clotting at haemorrhagic site. Nevertheless, in order for the haemostatic agents to facilitate rapid control of haemorrhaging, the need exists for an effective system to deliver the agents directly to the source of bleeding and promote clotting.

Prior art MY 154109 A relates to a haemostatic agent delivery device comprising an external tube and an internal tube, wherein in use, the internal tube is introduced into the external tube and pushed along the external tube distally to cause suction of blood through a backing material while simultaneously causes compression of haemostatic agent over the haemorrhagic site. The flaw associated with delivering a haemostatic agent using the system includes inability to monitor the amount of the agents within the device due to its opaque appearance, therefore it is difficult for the surgeon to both control and measure accurately on the amount of the agents to be dispensed. The opaque body of the device also renders the surgeon invisible to the position of the backing material within the device. Further, for insertion of the backing material into the device, the backing material has to be admitted from the proximal end and pushed towards the distal end and whereas for withdrawal of the backing material from the device, the backing material has to be pulled from the distal end to the proximal end. Such an approach is often time consuming and tedious. Moreover, the device is difficult to control and often clumsy as the position of the internal tube within the external tube could not be locked, thereby easily causing accidental dispersal of haemostatic agent and backing material. Thus, it is desirable to develop an improved haemostatic agent delivery device to overcome such problems.

SUMMARY OF INVENTION

The main aspect of the present invention is to provide a haemostatic agent delivery device that efficiently promotes haemostasis at haemorrhagic site in body cavities and blood vessels especially during surgical procedures.

Another aspect of the present invention is to provide a haemostatic agent delivery device that is developed for simultaneous blood suction and delivery of haemostatic agent to the haemorrhagic site. Still another aspect of the present invention is to provide a haemostatic agent delivery device that allow better monitoring of volume of haemostatic agents used in order to prevent wastage of materials. Yet another aspect of the present invention is to provide a haemostatic agent delivery device with a design that facilitate the easy insertion and withdrawal of backing material into and from the device.

Again another aspect of the present invention is to provide a haemostatic agent delivery device which uses bridge and locking knob mechanism to enable user to better control the movement of backing material and haemostatic agents to the haemorrhagic site.

At least one of the preceding aspects is met, in whole or in part, by the present invention, in which the embodiment of the present invention describes a haemostatic agent delivery device ( 1) comprising an external tube (2) having a bridge portion (5) that has a first groove (6a) and second groove (6b) mounted on each end of the bridge (5), a gripping means (4) having a pair of finger holes for receiving user's fingers at the proximal end, and a longitudinal groove (12) at the rear surface of the tube terminating with a tubular portion (7) at the distal end; and an internal tube (3) having a singular gripping portion (9), an extended portion (14) beneath the gripping portion (9) that terminates with a resilient end that has an overlapping protrusion (10) as a locking means and a connecting means ( 11) at its proximal end for connecting to a suction applying device; wherein, when in use, the overlapping protrusion ( 10) interlocks with the first groove (6a) during loading of haemostatic agent into the device whereas the overlapping protrusion ( 10) interlocks with the second groove (6b) during delivery of the haemostatic agent to the bleeding site.

According to one of the preferred embodiment, the gripping means (4) mounted on the external tube (2) has an index finger rest (4a) and a middle finger rest (4b).

According to another preferred embodiment, the singular gripping portion (9) mounted on the internal tube (3) is a thumb rest. Preferably, the external tube (2) is a transparent plastic tube.

The present preferred embodiment of the invention consists of novel features and a combination of parts hereinafter fully described and illustrated in the accompanying drawings and particularly pointed out in the appended claims; it being understood that various changes in the details may be effected by those skilled in the arts but without departing from the scope of the invention or sacrificing any of the advantages of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of facilitating an understanding of the invention, there is illustrated in the accompanying drawing the preferred embodiments from an inspection of which when considered in connection with the following description, the invention, its construction and operation and many of its advantages would be readily understood and appreciated.

Figure 1 (a) is a front view of the haemostatic agent delivery device (1) as described in one of the preferred embodiments of the present invention.

Figure 1 (b) is a sectional view of the haemostatic agent delivery device (1), showing the overlapping protrusion (10) of the internal tube (3) interlocks with the groove (6) on the bridge portion (5) of the external tube (2).

Figure 2 (a) is a front view of the external tube (2) of the haemostatic agent delivery device ( 1 ) as described in one of the preferred embodiments of the present invention.

Figure 2 (b) is a rear view of the external tube (2) of the haemostatic agent delivery device ( 1 ) as described in one of the preferred embodiments of the present invention.

Figure 3 (a) is a front view of the internal tube (3) of the haemostatic agent delivery device (1) as described in one of the preferred embodiments of the present invention. Figure 3 (b) is a rear view of the internal tube (3) of the haemostatic agent delivery device (1) as described in one of the preferred embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Hereinafter, the invention shall be described according to the preferred embodiments of the present invention and by referring to the accompanying description and drawings. However, it is to be understood that limiting the description to the preferred embodiments of the invention and to the drawings is merely to facilitate discussion of the present invention and it is envisioned that those skilled in the art may devise various modifications without departing from the scope of the appended claim.

The present invention relates to a haemostatic agent delivery device ( 1) comprising an external tube (2) having a bridge portion (5) that has a first groove (6a) and second groove (6b) mounted on each end of the bridge (5), a gripping means (4) having a pair of finger holes for receiving user's fingers at the proximal end, and a longitudinal groove (12) at the rear surface of the tube terminating with a tubular portion (7) at the distal end; and an internal tube (3) having a singular gripping portion (9), an extended portion ( 14) beneath the gripping portion (9) that terminates with a resilient end that has an overlapping protrusion ( 10) as a locking means and a connecting means (1 1) at its proximal end for connecting to a suction applying device; wherein, when in use, the overlapping protrusion (10) interlocks with the first groove (6a) for loading of haemostatic agent into the device whereas the overlapping protrusion (10) interlocks with the second groove (6b) for delivering and compressing the haemostatic agent at the bleeding site. A haemostatic agent is used to promote haemostasis at the haemorrhagic site. The haemostatic agent used in the invention preferably includes but not limited to oxidized regenerated cellulose, beeswax, bovine thrombin, pooled human thrombin, recombinant, thrombin, gelatin particles with or without pooled human or recombinant thrombin, human plasma-derived fibrin sealant, skin sealant, synthetic tissue sealant, glutaraldehydes and polyethylene glycol polymer. According to the present invention, a backing material (8) is preferably used and placed in between the distal end of the internal tube (3) and the haemostatic agent. The function of the backing material is to allow user to apply continuous firm pressure on haemostatic agent at the bleeding site to promote haemostasis. Preferably, the backing material (8) is permeable to blood but impermeable to the haemostatic agent. The backing material (8) is preferably a surgical pattie in order to facilitate absorption of blood at bleeding site during suction.

Figures 1 (a) and 1 (b) show that the haemostatic agent delivery device ( 1 ) is made up of an external tube (2) and an internal tube (3). The external tube (2) is further illustrated in Figures 2(a) and 2(b) while the internal tube (3) is further illustrated in Figures 3(a) and 3(b).

According to the preferred embodiment of the present invention, the external tube (2) is preferably made of transparent plastic material. The transparency of the tube body enables user to monitor the amount of the haemostatic agent loaded into device (1) or released from the device (1). The transparent tube body is also crucial to provide visibility to its user on the location of the backing material (8) therein. As illustrated by Figure 2 (a) and 2 (b), the external tube (2) has a gripping means (4) mounted on its proximal end. The gripping means (4) is fabricated into an index finger rest (4a) and a middle finger rest (4b). Preferably, the gripping means (4) is formed into a U-shaped handle as shown in Figures 2(a) and 2(b).

Further, the external tube (2) comprises a bridge portion (5) at its proximal end. The bridge portion (5) refers to a semi-cylindrical protrusion along the front surface of the external tube (2) at its proximal end. The function of the bridge portion (5) is to provide friction force to slow the distal movement of the internal tube (3) along the external tube (2) when the overlapping protrusion (10) of the internal tube (3) slides along the bridge portion (5). The advantage of slowing the distal movement of the internal tube (3) is that it enables better control for dispersal of haemostatic agent over the haemorrhagic site.

According to yet another preferred embodiment, there is at least one groove (6) mounted on the bridge portion (5) of the external tube (2). Preferably, the bridge portion (5) has two grooves (6), with the first groove (6a) located adjacent to the proximal end while the second groove (6b) located further away from the proximal end. The grooves (6) of the external tube (2) are meant for receiving the overlapping protrusion ( 10) of the internal tube (3) for interlocking purposes. Interlocking of the overlapping protrusion (10) at the first groove (6a) prevents premature distal movement of internal tube that may cause accidental push out of the haemostatic agent and backing material (8) prior to delivery at the haemorrhagic site. On the other hand, when overlapping protrusion ( 10) engages with the second groove (6b), the unwanted proximal movement of the internal tube (3) could be prevented during blood suction procedure.

Preferably, the external tube (2) has a longitudinal groove ( 12) at its rear surface as shown in Figure 2 (b). The longitudinal groove ( 12) is preferably extended from its proximal end and terminating with a tubular portion at its distal end. The design of the longitudinal groove ( 12) at the rear surface eliminates the need for user to insert and withdraw the backing material (8) from the proximal end. It will be appreciated by those skilled in the art, that by providing the longitudinal groove (12) feature at the rear of external tube (2), the user could easily remove and replace the backing material (8) swiftly especially during the event when bleeding in patient is brisk.

On the other hand, the internal tube (3) is designed to have a smaller diameter than the external tube (2) in order to allow it to be inserted into the external tube (2). Moreover, the length of the internal tube (3) is longer as compared to that of the external tube (2). As shown in Figures 3 (a) and 3 (b), it is preferable that the internal tube (3) has a singular gripping portion (9) which is preferably a U-shaped thumb rest. The size of the U-shaped singular gripping portion (9) mounted on the internal tube (3) is preferably designed to be larger than that of the U-shaped gripping means (4) mounted on the external tube (2) to better accommodate thumb of the user. Such a design is adapted to allow its user to easily control the device single-handedly upon finger movements around the singular gripping portion (9) and the gripping means (4).

As described by the preferred embodiment of the present invention, a connecting means (1 1) is mounted at the proximal end of the internal tube (3). The connecting means ( 11) connects to a suction applying device for channeling suction force to remove blood at the haemorrhagic site. Besides, the internal tube has an extended portion ( 14) beneath the singular gripping portion that terminates with a resilient end. Preferably, there is an overlapping protrusion (10) at the resilient end that functions as a locking means to interlock with the grooves (6) of the external tube (2).

In practice, the haemostatic agent delivery system according to the present invention may be used in the following method which is only given as example. As set forth in the preceding description, the external tube (2) is a hollow tube with varying diameters depending on types of operation, whereas the internal tube (3) functions as a plunger that extends into the external tube (2). The backing material (8) is initially introduced into the external tube (2) via the longitudinal groove (12) thereof. Next, the internal tube (3) is thrusted distally into the external tube (2) so that the backing material (8) within the external tube (2) covers across the distal tip of the internal tube (3). Once the overlapping protrusion (10) of the internal tube (3) engages with the first groove (6a) mounted on the bridge portion (5) of the external tube (2) to lock the position of the tubes, the haemostatic agent is loaded into the device (1) from the distal end of the external tube (2). When the system is introduced into the operative field, the suction force is turned on when needed. Subsequently, the internal tube (3) is thrusted further in distal direction until the overlapping protrusion (10) interlocks with the second groove (6b). During this stage, the haemostatic agent is delivered to the bleeding site and react with blood to achieve haemostasis. At the meantime, the backing material (8) is compressed at the bleeding site, followed by the blood is removed by suction force through the distal end of the device (1). By using the present method, efficient and accurate haemostasis can be achieved via simultaneous blood suction, delivery of haemostasis agent and compression.

Although the invention has been described and illustrated in detail, it is to be understood that the same is by the way of illustration and example, and is not to be taken by way of limitation. The spirit and scope of the present invention are to be limited only by the terms of the appended claims.

Claims

1. A haemostatic agent delivery device (1) comprising:

an external tube (2) having a bridge portion (5) that has a first groove (6a) and second groove (6b) mounted on each end of the bridge (5), a gripping means (4) having a pair of finger holes for receiving user's fingers at the proximal end, and a longitudinal groove (12) at the rear surface of the tube terminating with a tubular portion (7) at the distal end; and an internal tube (3) having a singular gripping portion (9), an extended portion (14) beneath the gripping portion (9) that terminates with a resilient end that has an overlapping protrusion (10) as a locking means and a connecting means (11) at its proximal end for connecting to a suction applying device; wherein, when in use, the overlapping protrusion (10) interlocks with the first groove (6a) for loading of haemostatic agent into the device whereas the overlapping protrusion (10) interlocks with the second groove (6b) for delivering and compressing the haemostatic agent at the bleeding site.

2. A device according to claim 1 , wherein the gripping means (4) has an index finger rest (4a) and a middle finger rest (4b).

3. A device according to claim 1, wherein the singular gripping portion (9) is a thumb rest.

4. A device according to claim 1, wherein the external tube (2) is a transparent plastic tube.