Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
CANNULATING DEVICE

2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a cannulating device.
BACKGROUND OF INVENTION
[2] An organ chamber is a device used to preserve organs, which are surgically removed from a human and/or an animal body, for the purpose of transplantation. The organ chambers mimic similar conditions as it is inside the human and/or the animal body, for example, temperature, pressure, pH level, etc. The organ chambers are crucial in cases where the organ is stored for longer than usual or transported from one place to other.
[3] Blood vessels of the organ placed inside the organ chamber are cannulated. Cannulation is a medical procedure that involves the insertion of a cannula (a hollow tube) into a vessel or a cavity of the body. This technique is widely used in medical field for various purposes, for example, intravenous cannulation, arterial cannulation, organ cannulation for perfusion, etc.
[4] A cannulating device inserts the cannula in a blood vessel and temporarily fixating the cannula with the blood vessel. For example, in organ cannulation for perfusion, the cannula and/or tube is inserted into the blood vessel. In conventional techniques, post insertion, the cannula is secured to the organ’s blood vessel using suture.
[5] However, suturing involves various medical complications, such as, air embolism, cannula dislodgement, re-suturing due to improper placement, weakening/rupturing of vessel’s tissue, etc. Additionally, the inappropriate suturing may cause improper perfusion.
[6] Thus, there arises a need for an organ preservation chamber that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[8] The present disclosure relates to a cannulating device for cannulating a vessel. In an embodiment, the cannulating device includes an inner tube, an outer tube and a locking member. The inner tube has a distal end configured to be inserted into a vessel for a pre-defined distance. The outer tube includes a proximal portion fixedly coupled to the inner tube. The outer tube includes a forked portion. A proximal end of the forked portion is coupled to the proximal portion of the outer tube. The forked portion includes two or more branches. The forked portion is configurable to be in an open configuration and a closed configuration. In the closed configuration, the two or more branches are configured to longitudinally align with the inner tube and the forked portion is configured to enclose at least a length of a cannulated portion of the vessel. The locking member is slidably disposed over the outer tube and configured to lock the forked portion during the closed configuration.
[9] According to an embodiment, an organ chamber is disclosed. The organ chamber includes a body, a tray, a lid, a connector and a cannulating device. The body encloses a space and has an opening at top of the body. The tray is disposed with the body and is configured to receive an organ. The lid is removably coupled to the body and is configured to seal the opening of the body. The connector is coupled with a port of a plurality of ports provided within the body. The connector has a first end disposed inside the body and a second end disposed outside the body. The cannulating device is configured to cannulate a vessel of the organ. The cannulating device includes an inner tube, an outer tube and a locking member. The inner tube has a distal end configured to be inserted into the vessel for a pre-defined distance and a proximal end coupled to the first end of the connector. The outer tube includes a proximal portion fixedly coupled to the inner tube and a forked portion coupled to the forked portion of the outer tube at a proximal end of the forked portion. The forked portion is configurable to be in an open configuration and a closed configuration. The forked portion includes two or more branches. In the closed configuration, the two or more branches are configured to longitudinally align with the inner tube and the forked portion is configured to enclose at least a length of a cannulated portion of the vessel. The locking member is slidably disposed over the outer tube and is configured to lock the forked portion at the closed configuration.
BRIEF DESCRIPTION OF DRAWINGS
[10] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[11] Fig. 1 depicts a side view of a cannulating device 100, according to an embodiment of the present disclosure.
[12] Fig. 1a depicts a cross-sectional view of the cannulating device 100, according to an embodiment of the present disclosure.
[13] Fig. 1b depicts a cross-sectional view of the cannulating device 100 without a locking member 130, according to an embodiment of the present disclosure.
[14] Fig. 1c depicts an assembled view of the cannulating device 100, according to an embodiment of the present disclosure.
[15] Fig. 2a depicts a pre-assembled view of the cannulating device 100 and a vessel 141 of a liver 140, according to an embodiment of the present disclosure.
[16] Fig. 2b depicts a partially assembled view of the cannulating device 100 and the vessel 141 of the liver 140, according to an embodiment of the present disclosure.
[17] Fig. 2c depicts an assembled view of the cannulating device 100 and the vessel 141 of the liver 140, according to an embodiment of the present disclosure.
[18] Fig. 3a depicts a top view of the cannulating device 100 assembled in an organ chamber 200, according to an embodiment of the present disclosure.
[19] Fig. 3b depicts a side view of the organ chamber 200, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[20] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[21] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[22] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[23] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[24] The present disclosure relates to a cannulating device (or a device). In an embodiment, the device is used to cannulate blood vessel (interchangeably referred to as a vessel) of an organ, for example, liver, kidney, heart, lungs, etc. for organ perfusion during, say, organ transplant. The device can also be used to cannulate a vessel of a heart during a bypass procedure. The cannulating device include an inner tube, an outer tube and a locking member.
[25] Unlike the conventional techniques, where a surgical method (e.g., suturing) is performed to secure a cannula with the blood vessel of an organ, the cannulating device of the present disclosure does not use any surgical method to perform the cannulation. Thus, the proposed cannulating device prevents any mechanical damage and weakening of the blood vessel due to the surgery.
[26] Now referring to figures, Fig. 1 shows a side view of a cannulating device 100 (hereinafter, device 100), according to an embodiment. Fig. 1b shows a cross sectional view of the device 100, according to an embodiment. The device 100 has a distal end 100a and a proximal end 100b, thus defining a length therebetween. The device 100 includes an inner tube 110, an outer tube 120 and a locking member 130.
[27] In an embodiment, the inner tube 110 extends from the distal end 100a to the proximal end 100b. The inner tube 110 has a distal end 110a and a proximal end 110b. The inner tube 110 is flexible and has a tubular structure. The inner tube 110 is used to cannulate a blood vessel (interchangeably referred to as a vessel).
[28] The distal end 110a is configured to be inserted into the blood vessel. The proximal end 110b is configured to be coupled with any tube, connector and/or cannula which assists the blood vessel and/or organ by supplying an assisting medium, for example, blood, medicine, perfusion solution, etc.
[29] The length and the diameter of the inner tube 110 are designed based upon the diameter of the vessel to be cannulated and/or the application area of the device 100. For example, the inner tube 110 may have a length ranging from 20 mm to 150 mm. The inner tube 110 may have a diameter ranging from 4 mm to 15 mm. In an exemplary embodiment, the length and the diameter of the inner tube 110 are 100 mm and 13 mm, respectively.
[30] The inner tube 110 may be made of a biocompatible material such as, without limitation, polyurethane, polysulfone, silicone, etc. In an exemplary embodiment, the inner tube 110 is made of polysulfone.
[31] The outer tube 120 is disposed on an outer surface of the inner tube 110 and encloses at least portion of the inner tube 110. In an embodiment, the outer tube 120 encloses a distal section of the inner tube 110. The outer tube 120 is provided at a suitable location.
[32] The outer tube 120 has a distal end 120a and a proximal end 120b. The outer tube 120 has a tubular shape. In an embodiment, a proximal portion 120c of the outer tube 120 is fixedly coupled to the inner tube 110. The proximal portion 120c of the outer tube 120 is coupled to the inner tube 110 using any suitable coupling technique, such as, without limitation, adhesive bonding, UV bonding, etc. In an exemplary embodiment, the proximal portion 120c of the outer tube 120 is glued to the inner tube 110 (depicted in Fig. 1b). In an embodiment, the outer tube 120 and the inner tube 110 may form an integrated structure and may be fabricated using, for example, an extrusion process or a molding process.
[33] The outer tube 120 includes a forked portion coupled to the proximal portion 120c and having two or more branches. A proximal end of the two or more branches of the forked portion are coupled integrally to the proximal portion 120c, at a distal end of the proximal portion 120c of the outer tube 120. The forked portion is configurable to be in an open configuration and a closed configuration. In the open configuration, the two or more branches of the forked portion make an angle A with the longitudinal axis of the inner tube 110. In the closed configuration, each branch of the forked portion is configured to be flex at a proximal end of the branch and to longitudinally align with the inner tube 110. Further, each longitudinal edge of the branch aligns with a corresponding longitudinal edge of an adjacent branch so that the forked portion forms a tubular structure (as depicted in Fig. 1c). In the depicted embodiment, the forked portion has two branches 120d and 120e. The branches 120d and 120e have a semicircular cross section.
[34] In an embodiment, the two or more branches (e.g., the branches 120d and 120e) are used to secure the blood vessel with the inner tube 110. For example, once a predefined length of the distal portion of the inner tube 110 is inserted into the vessel, the forked portion is configured to be in the closed configuration. The two or more branches (e.g., the branches 120d and 120e) flex and align longitudinally. Further, at least a part of length of the two or more branches (e.g., the branches 120d and 120e) from respective distal ends encompasses a portion of the vessel.
[35] The length and the diameter of the outer tube 120 are designed based upon the diameter of the vessel to be cannulated and/or the application area of the device 100. For example, the outer tube 120 may have a length ranging from 20 mm to 150 mm. The outer tube 120 may have a diameter ranging from 5 mm to 18 mm. In an exemplary embodiment, the length and the diameter of the outer tube 120 are 100 mm and 14 mm, respectively.
[36] The length and the diameter of the branches 120d and 120e of the outer tube 120 are also designed based upon the diameter of the vessel to be cannulated and/or the application area of the device 100. For example, each branch 120d and 120e of the outer tube 120 may have a length ranging 20 mm to 150 mm. Each branch 120d and 120e of the outer tube 120 may have a diameter ranging from 5 mm to 18 mm. In an exemplary embodiment, the length and the diameter of each branch 120d and 120e of the outer tube 120 are 100 mm and 14 mm, respectively.
[37] The outer tube 120 may be made of a biocompatible material including, without limitation, polyurethane, polysulfone, silicone, etc. In an exemplary embodiment, the outer tube 120 is made of polysulfone.
[38] In an embodiment, the locking member 130 is configured to set and lock the forked portion (i.e., the two or more branches) in the closed configuration (depicted in Fig. 1c). The locking member 130 is slidably disposed on the outer tube 120. The locking member 130 has a circular shape. The locking member 130 ensures a tight and reliable connection. In an embodiment, the locking member 130 is a luer lock. It should be appreciated that any other suitable locking member may be used.
[39] The locking member 130 is configured to be movable between a first position and a second position. In the first position, the locking member 130 is disposed on the proximal portion 120c. In the second position, the locking member 130 is disposed towards the distal end 120a of the two or more branches. The two or more branches (e.g., the branches 120d and 120e) are in the open configuration in response to the locking member 130 being in the first position. In response to the locking member 130 moving from the first position towards the second position, the two or more branches are configured to flex towards the longitudinal axis of the inner tube 110. In response to the locking member 130 being in the second position, the two or more branches (e.g., the branches 120d and 120e) are configured to align longitudinally with the inner tube 110, thereby setting the two or more branches are in the closed configuration.
[40] The locking member 130 may be made of a biocompatible material including, without limitation, polyurethane, polysulfone, silicone, etc. In an exemplary embodiment, the locking member 130 is made of polysulfone.
[41] The cannulating device 100 can be used to cannulate a vessel for various application scenarios, for example, organ cannulation, IV cannulation, etc. In an exemplary embodiment the cannulating device 100 is used to cannulate a vessel of an organ (e.g., a liver, a heart, a lung, a kidney, etc.) so that the organ can be perfused and preserved during, for example, organ transportation, organ transplant and so on.
[42] The use of the device 100 to cannulate a vessel of an organ is now explained using an example of a liver with reference to Figs. 2a - 2c. Fig. 2a shows a pre-assembled view of the cannulating device 100 with a blood vessel 141 (or a vessel 141) of a liver 140. In an embodiment, the distal end 110a of the inner tube 110 is configured to be inserted into the opening of the blood vessel 141 for a pre-defined distance (depicted in Fig. 2b). In an embodiment, the distal end 110a of the inner tube 110 is inserted into the blood vessel 141 until the end of the blood vessel, through which the inner tube 110 is inserted, reaches the proximal end of the branches 120d and 120e. Once the inner tube 110 is inserted, the branches 120d and 120e are pushed towards the inner tube 110 by moving the locking member 130 from the first position to the second position the blood vessel 141. When the locking member 130 is in the second position, inner surfaces of the branches 120d and 120e contact an outer surface of the blood vessel 141 and the branches 120d and 120e are locked in the closed configuration (as depicted in Fig. 2c). The forked portion thus forms a tubular structure. Consequently, a portion of the blood vessel 141 is disposed between the inner tube 110 and the forked portion of the outer tube 120. This provides a more secure connection. Also, since the inner tube 110 and the forked portion conform with the contour of the blood vessel 141, there is less trauma for the blood vessel 141. Further, the vessel 141 is cannulated by a simple process of inserting the inner tube 110 and moving the locking member 130. Consequently, the device 100 is easier to operate and saves time during the medical procedure.
[43] In an embodiment, the device 100 can be integrated with an organ chamber used for maintaining one or more organs outside of a body and/or transporting them. The device 100 is used to cannulate vessels of the organs (e.g., for perfusion, administering medicine, etc.). The use of the device 100 in an organ chamber is now explained with an exemplary organ chamber 200. However, it should be construed as limiting and the device 100 can be used with any organ chamber including a casing, a tray and at least one perfusion port.
[44] Figs. 3a and 3b depict the organ chamber 200, according to an embodiment. In an exemplary embodiment, the organ chamber 200 is a preservation casing. The organ chamber 200 is a device used to preserve organs for transplantation, outside a donor’s body before transplanting into a receiver’s body. The organ chamber 200 includes a body 210, a tray 220 and a plurality of sensors (not shown).
[45] The body 210 is provided to preserve the organ. The body 210 provides an environment that preserves the viability of organs by supplying them with different necessary elements, for example, oxygenated blood, preservation solution, etc. This helps to prevent cellular damage and maintain organ function during the transit time from the donor to the recipient.
[46] The body 210 encloses a space utilized to keep one or more organs inside the body 210. In the depicted embodiment, the liver 140 is kept in the provided space.
[47] The body 210 may include an inner wall and an outer wall having a space there between, thus defining a jacket. The jacket is utilized to circulate a fluid, for example, water, to maintain a desired temperature inside the body 210 of the organ chamber 200.
[48] The body 210 may have an opening provided at a top of the body 210. The opening allows a user to place the one or more organs (e.g., the liver 140) inside the body 210 and remove them from the body 210.
[49] The opening is sealed by a lid 211. The lid 211 is removably coupled to the body 210. In an embodiment, the lid 211 may also include an inner wall and an outer wall defining a jacket, similar to the jacket in the body 210 for circulating the fluid for maintaining the desired temperature. The lid 211 has a handle 211a. The handle 211a is used to hold the lid 211. The body 210 and the lid 211 are suitably dimensioned and are made of suitable materials.
[50] The body 210 includes a plurality of ports 213. The plurality of ports 213 can be used for various purposes such as, allowing a passage to the perfusion tube, allowing a passage to the electrical wires, etc.
[51] In an embodiment, the organ chamber 200 includes the cannulating device 100. The cannulating device 100 is provided within the organ chamber 200, to cannulate the vessels of the organ inside the organ chamber 200. In an embodiment, the distal end 100a of the cannulating device 100 is coupled to the organ and the proximal end 100b of the cannulating device 100 is coupled to a connector 215.
[52] In an embodiment, the connector 215 is coupled with a port of the plurality of ports 213. The connector 215 is engaged in such a way that a first end of the connector 215 is disposed inside the body 210 and a second end is disposed outside the body 210. The connector 215 provides a secured passage to the device 100, to further couple with the perfusion solution reservoir. In an embodiment, the proximal end 110b of the inner tube 110 is coupled to the first end of the connector 215. The second end of the connector 215 is coupled to a reservoir (not shown) of medicinal solution, oxygenated blood, a perfusion fluid, etc.
[53] The organ chamber 200 includes a tray 220 placed inside the body 210 over one or more support elements 217. The tray 220 is configured to receive the one or more organs. The tray 220 provides a stable and secure platform for placing the one or more organs within the organ chamber 200.
[54] In an embodiment, the tray 220 may have multiple pores to allow a perfusion fluid (and/or blood) to contact the organ (e.g., the liver 140) placed on the tray 220 and/or the perfusion fluid (and/or the blood) flow downward in a reservoir below the tray 220. The tray 220 is suitably dimensioned and made of a suitable biocompatible material. The perfusion fluid may be provided in a section of the body 210 below the tray 220.
[55] The one or more organs (e.g., the liver 140) may be coupled to at least one sensor. The at least one sensor may be placed on a respective organ. The at least one sensor may include a temperature sensor, a pH sensor, a pressure sensor, an oxygen level detector, etc. The at least one sensor is configured to provide the status of the one or more organs. The at least one sensor is coupled to an analyzer (not shown) via electric cables. The electric cables are passed through a suitable port of the plurality of the ports 213. The analyzer is placed outside of the organ chamber 200.
[56] The proposed device presents several advantages. For example, the dual cannula, e.g., the inner and outer tubing, results in a more secure, leak proof connection. Since the inner tube extends inside the vessel and the outer tube encloses the cannulated portion of the vessel from outside, this provides support to the vessel (avoiding trauma to the vessel) and makes the cannulation joint more stable. Unlike the conventional devices, which have suture cannulation, the present cannulating device prevents any mechanical damage and weakening. These features improve efficiency and effectiveness of the device over the conventional devices.
[57] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. A cannulating device (100) for cannulating a vessel, the cannulating device (100) comprising:
a. an inner tube (110) having a distal end (110a) configurable to be inserted into a vessel for a pre-defined distance;
b. an outer tube (120) comprising:
i. a proximal portion (120c) fixedly coupled to the inner tube (110); and
ii. a forked portion coupled to the proximal portion (120c) of the outer tube (120) at a proximal end of the forked portion and configurable to be in an open configuration and a closed configuration, the forked portion comprising two or more branches, wherein in the closed configuration, the two or more branches are configured to longitudinally align with the inner tube (110) and the forked portion is configured to enclose at least a length of a cannulated portion of the vessel; and
c. a locking member (130) slidably disposed over the outer tube (120) and configured to lock the forked portion at the closed configuration.
2. The cannulating device (100) as claimed in claim 1, wherein the locking member (130) is movable between a first position and a second position, wherein in the first position, the locking member (130) is disposed on the proximal portion (120c) of the outer tube (120) and in the second position, the locking member (130) is disposed at a distal end (120a) of the outer tube (120); the locking member (130) is configured to set the forked portion in the closed configuration.
3. The cannulating device (100) as claimed in claim 2, wherein in response to the movement of the locking member (130) from the first position towards the second position, the two or more branches are configured to flex towards a longitudinal axis of the inner tube (110).
4. The cannulating device (100) as claimed in claim 1, wherein in the closed configuration, a longitudinal edge of a branch of the two or more branches is configured to align with a corresponding longitudinal edge of an adjacent branch of the two or more branches.
5. The cannulating device (100) as claimed in claim 1, wherein the forked portion comprises two branches (120d, 120e).
6. The cannulating device (100) as claimed in claim 1, wherein the locking member (130) is a luer lock.
7. The cannulating device (100) as claimed in claim 1, wherein the inner tube (110), the outer tube (120) and the locking member (130) are made of a biocompatible material.
8. The cannulating device (100) as claimed in claim 1, wherein in the open configuration, a longitudinal axis of each branch of the two or more branches is configured to make a pre-defined angle with the longitudinal axis of the inner tube (110).
9. An organ chamber (200) comprising:
a. a body (210) enclosing a space and having an opening at top of the body (210);
b. a tray (220) disposed within the body (210) and configured to receive an organ;
c. a lid (211) removably coupled to the body (210) and configured to seal the opening of the body (210);
d. a connector (215) coupled with a port (213) of a plurality of ports (213) provided within the body (210), the connector (215) having a first end disposed inside the body (210) and a second end disposed outside the body (210); and
e. a cannulating device (100) configured to cannulate a vessel of the organ, the cannulating device (100) comprising:
i. an inner tube (110) having a distal end (110a) configurable to be inserted into the vessel for a pre-defined distance and a proximal end (110b) coupled to the first end of the connector (215);
ii. an outer tube (120) comprising:
a proximal portion (120c) fixedly coupled to the inner tube (110); and
a forked portion coupled to the proximal portion (120c) of the outer tube (120) at a proximal end of the forked portion and configurable to be in an open configuration and a closed configuration, the forked portion comprising two or more branches, wherein in the closed configuration, the two or more branches are configured to longitudinally align with the inner tube (110) and the forked portion is configured to enclose at least a length of a cannulated portion of the vessel; and
iii. a locking member (130) slidably disposed over the outer tube (120) and configured to lock the forked portion at the closed configuration.