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:
RAPID EXCHANGE CATHETERS

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.

3. 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 medical devices. More particularly, the present disclosure relates to rapid exchange catheters.
BACKGROUND OF INVENTION
[2] Coronary artery disease (CAD) is a prevalent cardiovascular condition characterized by the buildup of plaque in the arteries supplying blood to the heart. Treatment options for CAD often involve using coronary stents, small mesh-like tubes inserted into narrowed or blocked coronary arteries to restore normal blood flow and cardiac function. Traditional stents were made of bare metal and aimed to physically prop open the artery. However, these stents had limitations, such as a higher risk of restenosis (artery re-narrowing) and blood clot formation (thrombosis) at the stent site. To overcome these challenges, drug-eluting stents (DES) were introduced.
[3] A drug-eluting coronary stent is a specialized stent coated with a thin polymer layer containing drugs that inhibit cell proliferation and reduce the risk of restenosis. These drugs, typically anti-proliferative agents, are released slowly over time, preventing the artery from narrowing again.
[4] Effective implantation of a drug-eluting coronary stent requires a delivery system, which includes various components, including a guidewire. The guidewire facilitates in accurately navigating the coronary arteries and positioning the stent. Rapid exchange catheters are typically used to deliver a DES. However, when using conventional rapid exchange catheters, predilation process is required. The predilation process may cause vascular trauma. Further, due to the complexity of the procedure, delivering DES using conventional rapid exchange catheters involve lengthy procedural time, prolonged exposure of the user to radiation and lengthy administration of contrast agents.
[5] Thus, there is a need for a device that overcomes the challenges associated with conventional devices.
SUMMARY OF INVENTION
[6] 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.
[7] The present disclosure relates to a catheter assembly and a method for assembling the same. In an embodiment, the method includes inserting a guidewire into a guidewire port of the catheter assembly. The method further includes adjusting the guidewire to have pre-defined length of the guidewire outside a distal end of a shaft. The method further includes bonding a proximal end of guidewire with a distal end of the guidewire port.
[8] In an embodiment, the catheter assembly includes a shaft and a guidewire. The shaft includes a guidewire port towards a proximal end of the shaft. The guidewire has a proximal end bonded with a distal end of the guidewire port. The guidewire has a pre-defined length outside of a distal end of the shaft.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[9] 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.
[10] Fig. 1 depicts a catheter assembly 100, according to an embodiment of the present disclosure.
[11] Fig. 2A illustrates an enlarged view of a section 2A of a shaft 104 of the catheter assembly 100, in accordance with an embodiment of the present disclosure.
[12] Fig. 2B illustrates an enlarged view of a section 2B of the shaft 104, in accordance with an embodiment of the present disclosure.
[13] Fig. 3 illustrates an enlarged view of a section 3A of a balloon 106, in accordance with an embodiment of the present disclosure.
[14] Fig. 4 depicts a flowchart of a method 400 for assembling a catheter assembly, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[15] 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.
[16] 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.
[17] 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.
[18] 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.
[19] The present disclosure relates to a catheter assembly and a method for assembling the catheter assembly. In an embodiment, the catheter assembly is used for delivering Drug Eluting Stents (DES). The Drug-eluting stents (DES) are vascular prostheses used for reopening and maintaining patent coronary arteries narrowed by arteriosclerosis. The catheter assembly includes a guidewire port, such as, a rapid exchange (Rx) guidewire port. A guidewire is inserted into the catheter assembly from the guidewire port. In an embodiment, once the length of the guidewire outside a distal end of the catheter assembly is adjusted, the guidewire is bonded at a distal end of the guidewire port. This enhances the pushability and trackability. Further, the pre-dilation procedure is not required. This reduces the overall procedure time, and improves outcome for the patients.
[20] Fig. 1 illustrates a catheter assembly 100, in accordance with an embodiment of the present disclosure. The catheter assembly 100 includes a proximal end 100a and a distal end 100b. The catheter assembly 100 includes a guidewire 102, a shaft 104, and a balloon 106.
[21] The guidewire 102 is a thin and flexible wire. The guidewire 102 includes a proximal end 102a and a distal end 102b. The distal end 102b, including a tip 102c, of the guidewire 102 extends outside of the distal end 100b of the catheter assembly 100. The guidewire 102 can be made of, without limitation, nitinol, stainless steel, etc. In an embodiment, the guidewire 102 is made of Stainless steel.
[22] In an embodiment, the guidewire 102 may be J-shaped or having a J-tip. In another embodiment, the guidewire 102 may have a straight tip, which may be bent in J-shape (as shown by the tip 102c). Though the tip 102c of the guidewire 102 is disclosed as having a J-shape, the tip 102c may have any other suitable shape (e.g., sinusoidal) depending upon the requirements of the medical procedure. The guidewire 102 may be of any suitable type such as, a coiled guidewire, a solid core wire, a mandrel wire, a ribbon wire, etc. In an embodiment, the guidewire 102 is a coiled guidewire. In an embodiment, the diameter of the guidewire 102 is 0.014’’, though the guidewire 102 can be of any suitable diameter.
[23] The shaft 104 includes a proximal end 104a and a distal end 104b. The shaft 104 has a tubular structure. The shaft 104 can be made of, without limitation, nitinol, stainless steel, CoCr, etc. In an embodiment, the shaft 104 is made of stainless steel. During a medical procedure, the shaft 104 is inserted into a blood vessel, arterial passages, urinary tract, a digestive system, an airway, etc. The shaft 104 is navigated to a target area and thus, provides a pathway for further steps in the medical procedure such as the delivering or extracting fluids, delivering medicines, deploying stents, etc. at the targeted area. In an embodiment, the size of the shaft 104 is between 2 French and 4 French. In an embodiment, the size of the shaft 104 is at least 2.1 French.
[24] Fig. 2A illustrates an enlarged view of a section 2A of the shaft 104 according to an embodiment. The shaft 104 may include a balloon tubing 104f disposed within a lumen of the shaft 104. In an embodiment, the balloon tubing 104f may be bonded with the lumen of the shaft 104 to form an integral structure. The balloon tubing 104f has a tubular structure extending from the proximal end 104a and the distal end 104b of the shaft 104 and includes a lumen 104e. The lumen 104e may be used to pass an inflation fluid to inflate the balloon 106. The balloon tubing 104f may be made of materials, such as, without limitation, PEBAX, Vestamid, etc. In an embodiment, the balloon tubing 104f may be made of PEBAX 7200.
[25] Further, the shaft 104 includes a guidewire port 104c towards a proximal end 104a of the shaft 104. The guidewire port 104c extends from an outer sheath of the shaft 104 as shown. The guidewire port 104c includes a guidewire lumen (not shown). The guidewire 102 is inserted into the guidewire lumen. As shown in Fig. 2A, the guidewire lumen and the lumen 104e are offset to each other in the section 2A. In an embodiment, the guidewire lumen may be slanted towards the distal end 104b of the shaft 104 such that the guidewire lumen merges with the lumen 104e at a location towards the distal end 104b of the shaft 104.
[26] Further, the proximal end 102a of guidewire 102 is bonded with a distal end 104c1 of the guidewire port 104c such that a pre-defined length of the guidewire 102 is outside of the distal end 104b of the shaft 104. The pre-defined length may be determined based on the requirement of the medical procedure. The pre-defined length may be decided based upon the requirement of the medical procedure. In an embodiment, the pre-defined length is between 20 mm and 50 mm. In an exemplary embodiment, the pre-defined length is 30 mm. The proximal end 102a of guidewire 102 can be bonded with the distal end 104b of the guidewire port 104c using, without limitation, laser welding, UV bonding, adhesive bonding, etc. In an embodiment, the guidewire 102 is bonded using UV bonding.
[27] Fig. 2B illustrates an enlarged view of a section 2B of the shaft 104, according to an embodiment. The section 2B represents a section of the shaft 104 towards the distal end 104b after the guidewire lumen merges with the lumen 104e. The guidewire 102 passes through the lumen 104e when the guidewire lumen merges with the lumen 104e as can be seen in Fig. 2B.
[28] Fig. 3 illustrates an enlarged with of a section 3A of the shaft 104 including the balloon 106, according to an embodiment. The balloon 106 has a proximal end 106a and a distal end 106b. The distal end 104b of the balloon 106 is coupled to the balloon tubing 104f towards the distal end 104b of the shaft 104. The proximal end 106a of the balloon 106 is coupled to the balloon tubing 104f towards the proximal end 104a of the shaft 104. Once the shaft 104 reaches the targeted area, the balloon 106 can be inflated or deflated using an inflating fluid to achieve different objectives, depending on the medical procedure. The inflation fluid may be passed through the lumen 104e. In embodiment, the balloon 106 may be used to deliver a stent 108, such as a Drug Eluting Stent (DES). A proximal end 108a of the stent 108 is coupled with the proximal end 106a of the balloon 106 and a distal end 108b of the stent 108 is coupled with the distal end 106b of the balloon 106. In an embodiment, the stent 108 is a DES having a plurality of struts (not shown). The thickness of each strut may be between 40 µm and 70 µm. In an embodiment, the thickness of each strut is 50 µm. The length of the stent 108 may range from 8 mm to 48 mm. In an embodiment, the length of the stent 108 is 33 mm. The diameter of the stent 108 may range from 2 mm to 4.50 mm. In an embodiment, the diameter of the stent 108 is 2.75 mm. The stent 108 can be made of, without limitation, a medial grade biocompatible metal, a fabric, silicone, etc. In an embodiment, the stent 108 is made of electropolished L605 Cobalt Chromium Alloy. In an embodiment, the stent 108 is made by laser-cutting a tubing in a suitable design pattern. In an embodiment, the balloon 106 may be used without any stent 108. In an embodiment, the balloon 106 can be a double wire balloon, a cutting balloon, a drug-eluting balloon etc. In an embodiment, the balloon 106 is made of, without limitation, silicon, latex, PEBA, PEBA blend, etc. Though the catheter assembly 100 is shown to include a single balloon 106, a cluster of balloons 106 may be used in the catheter assembly 100 without deviating from the scope of the present disclosure.
[29] The balloon tubing 104f includes at least one marker band 112 adjacent to the distal end 106b and the proximal end 106a of the balloon 106. In an embodiment, the at least one marker band 112 is used to aid with guidance and placement of the catheter assembly 100 during the medical procedures. The at least one marker band 112 may be made of a radiopaque material, for example, gold, platinum, silver, platinum-iridium, tantalum, tungsten, etc.
[30] Fig. 4 depicts a flowchart of a method 400 for assembling a catheter assembly 100, in accordance with an embodiment.
[31] At step 402, a guidewire 102 compatible with the catheter assembly 100 is selected. The compatibility parameters for the selection of the guidewire 102 can be, without limitation, size of the shaft 104, target medical procedure, etc. For example, when the size of the shaft 104 is 4 French, a guidewire 102 compatible with the shaft 104 of size 4 French is selected. In an embodiment, the guidewire 102 having a diameter of 0.014’’ is used.
[32] At step 404, the guidewire 102 is inserted into the guidewire port 104c of the catheter assembly 100 The guidewire 102 is passed through the guidewire lumen of the guidewire port 104c and then through the lumen104e of the shaft 104 until the guidewire 102 comes out at the distal end 104b of the shaft 104.
[33] At step 406, the guidewire 102 is adjusted to have a pre-defined length outside the distal end 104b of the shaft 104. The pre-defined length may be determined as per the requirements of the medical procedure. In an embodiment, the pre-defined length is between 20 mm and 50 mm. In an exemplary embodiment, the pre-defined length is 30 mm.
[34] At step 408, the guidewire 102 is cut from a welded portion of the guidewire 102. In an embodiment, the welded portion of the guidewire 102 is cut to remove undesired length of the guidewire 102.
[35] At step 410, the guidewire 102 is bonded at the guidewire port 104c. In an embodiment, the proximal end 102a of the guidewire 102 is bonded with the distal end 104c1 of the guidewire port 104c. The guidewire 102 can be bonded using, without limitation, laser welding, UV bonding, adhesive bonding, etc. In an embodiment, the guidewire 102 is bonded using UV bonding. Thus, the guidewire 102 is locked in its position. Therefore, no extra step of inserting a guidewire 102 is needed during the medical procedure. Further, the predilation procedure is not needed since the guidewire 102 can be advanced along with the balloon 106 having the stent 108. As fewer steps are required for stenting, the overall procedure time is reduced and the patient’s exposure time to radiation is also decreased. This improves the patient outcome and reduces cost of performing the medical procedure. The bonding of the guidewire 102 also improves the pushability and trackability of the catheter assembly 100.
[36] 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 method (400) for assembling a catheter assembly (100) comprising:
a. inserting a guidewire (102) into a guidewire port (104c) of the catheter assembly (100);
b. adjusting the guidewire (102) to have a pre-defined length of the guidewire (102) outside a distal end (104b) of a shaft (104); and
c. bonding a proximal end (102a) of the guidewire (102) with a distal end (104c1) of the guidewire port (104c).
2. The method (400) as claimed in claim 1, wherein the bonding comprises bonding the proximal end (102a) of the guidewire (102) with the distal end (104c1) of the guidewire port (104c) using one of UV bonding, laser welding or adhesive bonding.
3. The method (400) as claimed in claim 1, wherein the method comprises cutting the guidewire (102) from a welded portion of the guidewire (102).
4. The method (400) as claimed in claim 1, wherein the pre-defined length of the guidewire (102) outside the distal end (104b) of the shaft (104) is between 20 mm and 50 mm.
5. A catheter assembly (100) comprising:
a. a shaft (104) comprising a guidewire port (104c) towards a proximal end (104a) of the shaft (104); and
b. a guidewire (102) having a proximal end (102a) bonded with a distal end (104c1) of the guidewire port (104c) and having a pre-defined length outside of a distal end (104b) of the shaft (104).
6. The catheter assembly (100) as claimed in claim 5, wherein the proximal end (102a) of the guidewire (102) is bonded with the distal end (104c1) of the guidewire port (104c) using one of UV bonding, laser welding or adhesive bonding.
7. The catheter assembly (100) as claimed in claim 5, wherein the pre-defined length of the guidewire (102) outside the distal end (104b) of the shaft (104) is between 20 mm and 50 mm.
8. The catheter assembly (100) as claimed in claim 5, wherein the guidewire (102) has a tip (102c) having a J-shape.
9. The catheter assembly (100) as claimed in claim 5, wherein the guidewire (102) is one of a coiled guidewire, a solid core wire, a mandrel wire, a ribbon wire.
10. The catheter assembly (100) as claimed in claim 5, wherein the catheter assembly (100) comprises:
a. a balloon tubing (104f);
b. a balloon (106) coupled to the balloon tubing (104f) and having a proximal end (106a) and a distal end (106b);
c. a stent (108) coupled to the balloon (106); and
d. at least one marker band (112) provided on the balloon tubing (104f) adjacent to the proximal end (106a) and the distal end (106b) of the balloon (106).