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:
SOFT TIP FOR A CATHETER
2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

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

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a soft tip for a catheter.
BACKGROUND OF INVENTION
[002] In endovascular procedures such as angioplasty, aneurysm coiling, or thrombectomy, a catheter is inserted into a patient’s vasculature. The catheter is then navigated to the target site through the patient’s vasculature. To minimize trauma and enhance navigation through delicate or tortuous vessels, a soft tip is provided at the distal end of the catheter. The soft tip bends at curves, allowing for smooth navigation while reducing the risk of vessel injury or perforation.
[003] A distal end of the soft tip may be coupled to one of the tubes of the catheter. Due to the significant stress the soft tip endures during catheter navigation, especially at a curve in the vasculature, there is an elevated risk of the soft tip decoupling or detaching from the catheter during the procedure. Additionally, there are increased chances that the soft tip may deform and/or break when subjected to elevated pressure and/or stresses within the vessel of the patient.
[004] In such cases, an immediate surgical intervention may be required to remove the detached soft tip from the patient’s vasculature, causing trauma to the patient and reducing efficacy of the procedure.
[005] Therefore, there is a need of a soft tip that addresses the shortcomings of the conventionally available soft tips.
SUMMARY OF INVENTION
The present invention relates to a soft tip for a catheter. The soft tip includes a first member having a cavity and a second member. The first member is made of a flexible material. The second member is at least partially disposed within the cavity of the first member. The second member is made of a metal and includes an attachment mechanism, configured to couple the second member with the catheter.
[006] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[007] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[008] Fig. 1 depicts a soft tip 100, coupled to a catheter 10, in accordance with an embodiment of the present disclosure.
[009] Fig. 1a depicts an exploded view of the soft tip 100, in accordance with an embodiment of the present disclosure.
[0010] Fig. 1b depicts a cross-section view of the soft tip 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 2 depicts another exploded view of the soft tip 100 along with a tube 11 of the catheter 10, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] In accordance with the present disclosure, a soft tip for a catheter is disclosed. The soft tip of the present disclosure, includes a first member and a second member, disposed within the first member. The second member is configured to provide structural stability and strength to the first member. Thus, allowing it to withstand stresses developed during the navigation of the catheter without deforming and/or breaking. Further, the second member includes an attachment mechanism for secure coupling of the soft tip with the catheter thereby reducing the chances of the soft tip being detached or decoupled form the catheter.
[0017] Now referring to Fig. 1, a soft tip 100 for a catheter 10 is depicted. The soft tip 100 forms a distal end of the catheter 10 and facilitates smooth navigation through the patient's vasculature, allowing the catheter to reach the target site within the vasculature efficiently.
[0018] Referring to Fig. 1a, the soft tip 100 has a proximal end 100a and a distal end 100b. In an embodiment, the soft tip 100 includes a first member 110 and a second member 130.
[0019] The first member 110 is positioned towards the distal end 100b of the soft tip 100. The first member 110 has a distal portion 111 and a proximal portion 113. The distal portion 111 of the first member 110 has a conical shape, configured to facilitate easy navigation of the catheter 10 through the vasculature of a patient. Such shape of the distal portion 111 of the first member 110, helps in gradually dilating the vasculature of the patient, while the catheter 10 is navigated through the vasculature. This reduces trauma to the vasculature of the patient. The proximal portion 113 has a cylindrical shape, configured to provide easy coupling with the catheter 10.
[0020] The distal portion 111 of the first member 110 is configured to bend at the curves of the vasculature, to avoid damage or rupture to the vasculature. This minimizes the chances of vessel injury and/ or perforation.
[0021] The first member 110 may be made of a flexible material, such that the distal portion 111 of the first member 110 is capable of bending at the curves of the vasculature without breaking or deforming. The flexible material may include, without limitation, thermoplastic polyurethane (TPU), nylon, silicone, medical grade rubber, etc. In an embodiment, the first member 110 is made of TPU.
[0022] The first member 110 includes a cavity 115 that extends at least partially along a central axis of the first member 110. For example, the cavity 115 may extend up to 70% of the length of the first member. Alternately, the cavity 115 may extend from 60 to 80 % of the length of the first member 110. In an embodiment, the cavity 115 extends from the proximal portion 113 to a partial length of the distal portion 111. The cavity 115 is configured to receive the second member 130. In an embodiment, the shape of the cavity 115 corresponds to the shape of the second member 130.
[0023] The second member 130 is at least partially disposed within the cavity 115 of the first member 110. (shown in Fig. 1b). The second member 130 may have a suitable shape to be disposed within the cavity 115 of the first member 110. For example, the shape of the second member 130 includes, without limitation, cylindrical, or tubular. In an embodiment, the second member 130 has a cylindrical shape. In an embodiment, the second member 130 has a stepped diameter along its length. For example, the diameter of at least a portion of the second member 130 is larger compared to the remaining portion. For, example, the second member 130 has a first portion 131 and a second portion 133. In an embodiment, the diameter of the second portion 133 is larger compared to the diameter of the first portion 131. The diameter of the first portion 131 may range between 1.40mm and 1.60mm. In an embodiment, the diameter of the first portion 131 is 1.51mm. The diameter of the second portion 133 may range between 1.60 mm and 1.90 mm. In an embodiment, the diameter of the second portion 133 is 1.75 mm. Further, the second portion 133 may have a predefined length. In an embodiment, the length of the second portion 133 ranges between 3 mm and 6 mm. In an embodiment, the length of the second portion 133 is 4 mm. The first portion 131 may also have a predefined length ranging from 03mm to 08mm. In an embodiment, the length of the first portion 131 is 05mm. The combined length of the first portion 131 and the second portion 133 defines the length of the second member 130.
[0024] In an embodiment, the first portion 131 is provided with threads 137. The threads 137 of the first portion 131 are configured to mate with the corresponding threads provided in the cavity 115 of the first member 110. The threads 137 may at least partially extend along the length of the first portion 131 of the second member 130. In an embodiment, the threads 137 extend for the entire length of the first portion 131 of the second member 130. The threaded coupling between the first member 110 and the second member 130 eliminates any chances of detachment or decoupling between the first member 110 and the second member 130.
[0025] In an embodiment, the second member 130 is made of a metal such as without limitation stainless steel, aluminum, copper, titanium, gold, etc. In an embodiment, the second member 130 is made of stainless steel. The second member 130 by being of a metal, provides enhanced visibility to the soft tip 100. When seen under an imaging system, such as X-Ray or fluoroscopy, etc. The second member 130 by being partially disposed within the first member 110, provides structural strength to the first member 110. The second member 130 reinforces the first member 110, to allow the first member 110 to bend at the curves of the vasculature without breaking or deforming.
[0026] The second member 130 includes an attachment mechanism configured to couple the second member 130 with the catheter 10. The attachment mechanism provides a secure coupling between the catheter 10 and the soft tip 100. Specifically, the second portion 133 of the second member 130 includes the attachment mechanism to couple with a tube 11 of the catheter 10. The second portion 133 of the second member 130 and the tube 11 may be coupled using the attachment mechanism, such as, without limitation, thread coupling, slot fit arrangement, spot welding, UV gluing, etc. In an embodiment, the attachment mechanism includes a slot 135 provided in the second portion 133 of the second member 130 to couple the tube 11 of the catheter 10 to the second member 130 of the soft tip 100.
[0027] Referring to Fig. 2, the slot 135 is configured to receive a portion of the tube 11. In an embodiment, an inner surface of the slot 135 may be provided with threads (not shown). The threads of the slot 135 may mate with corresponding threads that may be provided on a distal end of the tube 11 thereby coupling the tube 11 and the soft tip 100.
[0028] The threaded coupling between the soft tip 100 and the tube 11 minimizes chances of the soft tip 100 being detached or decoupled with the tube 11 during the navigation of the catheter 10.
[0029] Additionally, or optionally, the soft tip 100 may include a central lumen 150 (shown in Fig. 1b) extending from the proximal end 100a to the distal end 100b of the soft tip 100. The central lumen 150 may be configured to allow a passage to a guide wire during the procedure. The catheter 10 may be navigated over the guidewire to the target site. The first member 110 and the second member 130 may include a respective lumen along the central axis of the soft tip 100. The lumen of the first member 110 and the lumen of the second member 130 align with each other. The combination of the lumens of the first member 110 and the second member 130 defines the central lumen 150, extending from the proximal end 100a to the distal end 100b of the soft tip 100.
[0030] 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 soft tip (100) for a catheter, comprising:
a. a first member (110) having a cavity (115), the first member (110) being made of a flexible material; and
b. a second member (130) at least partially disposed within the cavity (115) of the first member (110), the second member (130) being made of a metal; and
c. an attachment mechanism provided with the second member (130), configured to couple the second member (130) with a catheter (10).
2. The soft tip (100) as claimed in claim 1, wherein the metal includes one or more of stainless steel, aluminium, copper, titanium and gold.
3. The soft tip (100) as claimed in claim 1, wherein the flexible material includes one or more of thermoplastic polyurethane (TPU), nylon, silicone, and medical grade rubber.
4. The soft tip (100) as claimed in claim 1, wherein the cavity (115) extends for at least a partial length of the first member (110) ranging between 60 to 80 % of the length of the first member (110).
5. The soft tip (100) as claimed in claim 1, wherein the attachment mechanism includes one of a thread coupling, a slot fit arrangement, spot welding, and UV gluing.
6. The soft tip (100) as claimed in claim 1, wherein the second member (130) includes a slot (135) to couple the second member 130 to the catheter (10).
7. The soft tip (100) as claimed in claim 1, wherein the soft tip 100 includes a central lumen (150) configured to allow a passage for a guidewire.
8. The soft tip (100) as claimed in claim 1, wherein the second member (130) includes a first portion (131) having threads (137) configured to mate with corresponding threads of the first member (110).
9. The soft tip (100) as claimed in claim 1, wherein the second member (130) includes a stepped diameter along its length.