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

TITLE OF THE INVENTION
GUIDE EXTENSION BALLOON CATHETER

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 guide extension balloon catheter.
BACKGROUND OF INVENTION
[2] Thrombosis is a disease in which blood clots are formed in blood vessels like arteries, veins, etc. Due to the formation of blood clots, passage of blood is blocked in a blood vessel which can also lead to a heart attack/stroke.
[3] Generally, patients suffering from thrombosis undergo a thrombectomy procedure. Thrombectomy is a surgery to remove a blood clot from a blood vessel and to restore the blood flow through the blood vessel. In thrombectomy, a surgeon makes an incision in a patient’s body to access the blocked blood vessel through a guidewire, removes the blood clot using a balloon, and then repairs the blood vessel. For instance, first, a guidewire is inserted through an incision. The guidewire guides the catheter to gain access to the treatment site inside a blood vessel. Thereafter, once the blood clot is broken, a balloon aspiration catheter is inserted to remove the fragmented blood clots from the blood vessel, say an artery. The surgeon can use one or more aspiration catheters to remove the fragmented blood clots from the blood vessel.
[4] The above procedure is complex and time consuming. Further, it involves use of multiple devices due to which, significant blood loss and/or trauma may be experienced by a patient. In addition, the conventional devices/catheters may not be able to reach the treatment site, which can lead to inefficient blood clot(s) aspiration.
[5] Moreover, the conventional catheters often lead to the collapse of the wall of the blood vessel which may be fatal for the patient. The blood vessel wall collapse occurs when a vessel lumen collapses because of low internal lumen pressure or the external pressure exceeds the internal pressure by a critical value. Due to the collapse, the positioning and adjustment of the catheter while removing the blood clot is also hindered which leads to improper removal of the blood clot(s).
[6] Thus, there arises a need for a device 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.
The present disclosure relates to a guide extension balloon catheter. In an embodiment, the guide extension balloon catheter includes a hub, a wire, a balloon shaft, and a balloon. The hub includes an inflation port. The wire coupled to the hub extends along the longitudinal axis of the catheter. The balloon shaft is disposed at the distal end of the catheter. The distal portion of the wire is integrated partially with the proximal portion of the balloon shaft. The balloon is disposed over the outer surface of the balloon shaft. The distal end of the balloon is coupled to the balloon shaft. The polymeric sleeve is provided at least partially on the outer surface of the wire and the balloon shaft. The distal end of the polymeric sleeve is coupled to the balloon and the proximal end of the balloon is coupled to the polymeric sleeve, thereby coupling the hub, the wire, the balloon shaft and the balloon altogether.

BRIEF DESCRIPTION OF DRAWINGS
[8] 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.
[9] Fig. 1 depicts a perspective view of a catheter 100, according to an embodiment of the present disclosure.
[10] Fig. 2a depicts a cross-sectional view of a proximal end 100a of the catheter 100, according to an embodiment of the present disclosure.
[11] Fig. 2b depicts a 3-d view of the distal end 100b, according to an embodiment of the present disclosure.
[12] Fig. 2c depicts a cross-sectional view of the coupling between a balloon shaft 130 and a wire 120, according to an embodiment of the present disclosure.
[13] Fig. 3 depicts the insertion of the catheter 100 in a guide catheter 200, according to an embodiment of the present disclosure.
[14] Fig. 4 depicts a method 400 to suck out the blood clot from the treatment site, according to an embodiment of the present disclosure.
[15] Fig. 5a depicts a perspective view of the flow of a saline/ fluid released from an inflation port 111, according to an embodiment of the present disclosure.
[16] Fig. 5b depicts a perspective view of the flow of the saline flowing inside a balloon 140, according to an embodiment of the present disclosure.
[17] Fig. 5c depicts the placement of the catheter 100 along with the guide catheter 200 in the treatment site, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE DRAWINGS
[18] 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.
[19] 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.
[20] 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.
[21] 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.
[22] The present disclosure relates to a guide extension balloon catheter (hereinafter, the catheter) for treating a thrombosis, for example, an arterial thrombosis. The catheter is inserted inside the guide catheter and extends along the treatment site. The catheter therefore, may be used to extend the length of a guide catheter to easily access the treatment site for one or more blood clot(s) aspiration.
[23] In an embodiment, the catheter includes a balloon provided towards the distal end of the catheter. The balloon is mounted on a balloon shaft that extends at least partially from the distal end towards the proximal end. The balloon of the catheter is inflated during the aspiration process creating a negative pressure on the wall of a blood vessel, thereby preventing the blood vessel wall from collapsing. The balloon also ensures optimal vessel wall apposition, minimizing the risk of dislodging plaque or causing vascular injury during aspiration, thereby enhancing patient’s safety and reducing procedural complexity. The blood clot(s) at the treatment site are aspirated through the balloon shaft. The proposed catheter thus allows the surgeon to remove the blood clot(s) without the danger of the blood vessel collapse. Further, the proposed catheter being a single device, namely a catheter including a balloon, eliminates trauma caused to a patient due to insertion and removal of multiple devices to complete the procedure.
[24] Now, referring to figures, Fig. 1 depicts a catheter 100 according to an embodiment of the present disclosure. The catheter 100 includes a proximal end 100a and a distal end 100b. The catheter 100 includes a hub 110, a wire 120, a balloon shaft 130, and a balloon 140. The proximal end 100a includes a hub 110 coupled to a wire 120.
[25] The hub 110 (as shown in Fig. 2a) is disposed at the proximal end 100a of the catheter 100. The hub 110 may be made of a material, including, but not limited to, acrylonitrile butadiene styrene (ABS), nylon, high density polyethylene (HDPE), low density polyethylene (LDPE), and polycarbonate. In an exemplary embodiment, the hub 110 is made of polycarbonate. The dimensions of the hub 110 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The hub 110 is provided with at least one port, namely, an inflation port 111. The inflation port 111 releases a fluid for example, saline which passes in between the wire 120 and a polymeric sleeve 120a and the balloon shaft 130 and a second lumen 123 up to the balloon 140 (explained later).
[26] The wire 120 has a proximal end and a distal end. The proximal end of the wire 120 (as shown in Fig. 2a and Fig. 2b) coupled to the hub 110, extends along the longitudinal axis of the catheter 100, thereby enabling the catheter 100 to reach the target site. The wire 120 may be made of a material, including, but not limited to, stainless steel, nitinol. In an exemplary embodiment, the wire 120 is made of stainless steel. The dimensions of the wire 120 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[27] The balloon shaft 130 (as shown in Fig. 2b and Fig. 2c) is disposed at the distal end 100b of the catheter 100. In an embodiment, the balloon shaft 130 is a hollow tubular shaft, open at both the proximal end and the distal end. Other variations with respect to the shape of the balloon shaft having a cross-section including, triangular, oval, etc. are within the teachings of the present disclosure.
[28] At least a portion (i.e., a distal portion) of the wire 120 disposed towards the distal end of the wire 120 is integrated partially with at least a portion (i.e., a proximal portion) of the balloon shaft 130 disposed towards the proximal end of the balloon shaft 130 (as shown in Fig. 2b and Fig. 2c). Though in the depicted embodiment, the wire 120 and the balloon shaft 130 form an integrated structure, in an alternate embodiment, the wire 120 and the balloon shaft 130 may be separate components coupled together using any suitable coupling technique including without limitation, adhesive bonding, UV bonding, laser welding, and mechanical fastening.
[29] The balloon shaft 130 may be made of a material, including, but not limited to, polyether block amide (PEBAX), polyether ether ketone (PEEK), polyamide, nylon. In an exemplary embodiment, the balloon shaft 130 is made of Polyether block amide (PEBAX). The dimensions of the balloon shaft 130 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration.
[30] The balloon shaft 130 includes a distal end, a proximal end, and a central lumen 131 extending therebetween via which the one or more blood clots present at the treatment site, are removed. For example, the blood clots enter via the distal tip of the balloon shaft 130 and travel through the central lumen 131 configured to be subjected to a suction force released by a suction port 201 of a guide catheter 200 (as shown in Fig. 3). The balloon shaft 130 provides enhanced accessibility and support thereby ensuring that the blood clot is removed from the treatment site securely.
[31] Towards the distal end 100b of the catheter 100, a balloon 140 is disposed over the outer surface of the balloon shaft 130 (as shown in Fig. 2b). For example, the distal end of the balloon 140 is coupled to the balloon shaft 130 at a pre-defined distance from the distal end 100b of the catheter 100. The predefined distance may be 1mm. The balloon is expandable in nature. That is, in an undeployed state, the balloon is in collapsed state while in a deployed state, the balloon expands due to injection of a fluid, say saline. The balloon 140 may be made of a material, including, but not limited to, polyether block amide (PEBAX), polyurethane, nylon, polyester. In an exemplary embodiment, the balloon 140 is made of polyether block amide (PEBAX). The dimensions of the balloon 140 may vary according to or based upon the anatomy of the patient and/or of the patient population in consideration. The balloon 140 helps in creating an external pressure on the wall of the blood vessel and prevents the wall of the blood vessel from collapsing.
[32] The balloon 140 includes a distal end and a proximal end. The distal end of the balloon 140 is coupled to the balloon shaft 130 via one or more of adhesives, laser welding, solvent welding etc. The proximal end and the distal end of the balloon 140 is coupled to a polymeric sleeve 120a via one or more of adhesives, laser welding, solvent welding etc.
[33] The polymeric sleeve 120a (detailed view in Figs. 2b and 2c) is a thin layer provided at least partially on the outer surfaces of the wire 120 and the balloon shaft 130. In an embodiment, the distal end of the polymeric sleeve 120a is coupled to the proximal end of the balloon 140. Alternately, the distal end of the polymeric sleeve 120a is coupled to the balloon 140 at an intermediate point and the proximal end of the balloon is coupled to the polymeric sleeve 120a.
[34] Between the polymeric sleeve 120a and the wire 120, a first lumen 121 is defined (as shown in Fig. 5a). Similarly, between the polymeric sleeve 120a and the balloon shaft 130, a second lumen 123 is defined (as shown in Fig. 5b). The first lumen 121 leads into the second lumen 123 or the two lumens (first lumen 121 and the second lumen 123) are in fluid communication with each other. The first lumen 121 and the second lumen 123 facilitate passage of saline for inflating the balloon 140. The saline accumulates inside the balloon 140 due to which the balloon 140 inflates/expands and creates a negative pressure on the blood vessel thereby preventing the blood vessel from collapsing. The saline provides support to a wall of a body vasculature while one or more blood clots 150 are removed.
[35] The polymeric sleeve 120a may be made of a material, including, but not limited to, Polyether block amide (PEBAX), Polyurethane, Nylon, Polyester. In an exemplary embodiment, the polymeric sleeve 120a is made of Polyether block amide (PEBAX). The polymeric sleeve 120a acts as a cover over the wire 120 and the balloon shaft 130.
[36] Referring to Fig. 4, the method 400 commences at step 401, by making a small incision in the body for inserting the guide catheter 200. The guide catheter 200 is pushed inside the body till the guide catheter 200 is placed at the treatment site. Thereafter, the catheter 100 is inserted inside a lumen of the guide catheter 200 (as shown in Fig. 5c). The catheter 100 is pushed inside the lumen of the guide catheter 200 till the catheter 100 including the wire 120, the balloon shaft 130, and the balloon 140 is placed as needed.
[37] At step 403, once the distal end 100b of the catheter 100 reaches the treatment site, saline is released from the inflation port 111. The saline passes through the first lumen 121 and the second lumen 123. Fig. 5a depicts the saline movement 402 in the aforesaid first lumen 121. Fig.5b depicts the saline movement 402 in the aforesaid second lumen 123. When the saline reaches the balloon140, the balloon 140 inflates and supports the blood vessel from collapsing.
[38] At step 405, a suction force is applied at the proximal end 100a via the suction port 201 of the guide catheter 200. Due to the suction force, the blood clots 150 are pulled inside the central lumen 131 of the balloon shaft 130 and finally withdrawn via the suction port 201 (as shown in Fig. 5c).
[39] It is to be noted that while the blood clots 150 are removed, the balloon 140 remains at the treatment site in expanded position. Due to this, not only is a blood vessel or wall supported, it is also prevented from any vascular injury. The balloon 140 provides external pressure to the blood vessel thereby minimizing the risk of blood vessel collapse.
[40] At step 407, once the blood clots 150 are removed, the suction force is removed. The balloon 140 is deflated and the catheter 100 along with the guide catheter 200 are removed from the body of the patient (or body vasculature).
[41] 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 guide extension balloon catheter (100) comprising:
a. a hub (110);
b. a wire (120) having a proximal end coupled to the hub (110);
c. a balloon shaft (130) having a distal end, a proximal end and a central lumen (131) extending therebetween, a proximal portion of the balloon shaft (130) coupled to a distal portion of the wire (120);
d. a balloon (140) disposed on an outer surface of the balloon shaft (130); and
e. a polymeric sleeve (120a) provided at least partially over the wire (120) and the balloon shaft (130) defining a first lumen (121) and a second lumen (123) respectively;
wherein the central lumen 131 is configured to be subjected to a suction force ;
wherein the balloon (140) is configured to expand upon injection of a fluid via the first lumen 121 and the second lumen 123, thereby providing support to a wall of a body vasculature while one or more blood clots (150) are removed.
2. The guide extension balloon catheter (100) as claimed in claim 1, wherein the balloon shaft (130) is disposed at a distal end of the guide extension balloon catheter (100).
3. The guide extension balloon catheter (100) as claimed in claim 1, wherein the balloon shaft (130) is a hollow tubular shaft, open at the proximal end and the distal end.
4. The guide extension balloon catheter (100) as claimed in claim 1, wherein at least one of the balloon shaft (130), the balloon (140) and the polymeric sleeve (120a) is made of one or more of polyether block amide (PEBAX), polyether ether ketone (PEEK), polyamide, nylon, polyester, polyurethane.
5. The guide extension balloon catheter (100) as claimed in claim 1, wherein a distal end of the balloon (140) is coupled to the balloon shaft (130) at a pre-defined distance from a distal end of the guide extension balloon catheter (100).
6. The guide extension balloon catheter (100) as claimed in claim 1, wherein a proximal end of the balloon (140) is coupled to the polymeric sleeve (120a).
7. The guide extension balloon catheter (100) as claimed in claims 5 and 6, wherein at least one of the distal end and the proximal end of the balloon (140) is coupled via one or more of an adhesives, laser welding, and solvent welding.
8. The guide extension balloon catheter (100) as claimed in claim 1, wherein the polymeric sleeve (120a) is a thin layer that acts as a cover for the wire (120) and the balloon shaft (130).