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:
CATHETER HAVING AN INFLATING ELEMENT

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 catheter having an inflating element.
BACKGROUND OF INVENTION
[2] Catheters having a balloon are widely used in various medical procedures. For example, balloon dilation catheters are used for treating respiratory conditions such as, tracheal stenosis, bronchial stenosis, laryngotracheal stenosis etc. They are also used to dilate blood vessels. Further, balloon catheters are also deployed in medical procedures such as angioplasty, valvuloplasty procedures, stent placements, transcatheter heart valve implantation, etc.
[3] During such a medical procedure, once the balloon catheter reaches a target site, the balloon is inflated using an inflation liquid (e.g., a saline solution). The inflated balloon dilates the airway and/or the blood vessels at the target site, which helps in expanding the narrowed or obstructed passages. A stent or a transcatheter valve is deployed at the target site by first inflating the balloon and then deflating it.
[4] Traditional balloons used in the conventional catheters block the airway or the blood vessel (e.g., an artery) during the medical procedure, when the balloons are inflated. This causes discomfort in the patient, leading to increased procedure time. Further, the traditional balloons are also prone to bending, slippage and displacement, thereby reducing the effectiveness and efficiency of the medical procedure and may also lead to adverse consequences for the patient. The traditional balloons are also less stable, cause uneven dilation and lead to trauma to the blood vessels or the airways.
[5] Thus, there arises a need for a device that overcomes the problems associated with the 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. In an embodiment, the catheter includes a shaft having a proximal end and a distal end. The shaft includes at least one inflation lumen. The catheter further includes an inflating element having a proximal end and a distal end. The inflating element is configurable to be in an inflated state. The inflating element includes a central portion, a first set of protrusions and a second set of protrusions. The first set of protrusions extend from the central portion towards the proximal end of the inflating element. A proximal end of each protrusion of the first set of protrusions is coupled to a distal end of a respective inflation lumen of the at least one inflation lumen. The second set of protrusions extend from the central portion towards the distal end of the inflating element. An inflation fluid passed from the at least one inflation lumen enters the central portion via the first set of protrusions, thereby causing the inflating element to be in the inflated state. In the inflated state, the central portion defines a hollow space extending longitudinally between a proximal end of the central portion and a distal end of the central portion. The hollow space provides a passage for at least one of a body fluid or air.
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. 1A depicts an assembled view of a catheter 100, according to an embodiment of the present disclosure.
[10] Fig. 1B depicts an exploded view of the catheter 100, according to an embodiment of the present disclosure.
[11] Fig, 2A depicts a perspective view of a shaft 102, according to an embodiment of the present disclosure.
[12] Fig. 2B depicts a cross sectional view of the shaft 102, according to an embodiment of the present disclosure.
[13] Fig. 3A depicts an isometric view of an inflating element 106, according to an embodiment of the present disclosure.
[14] Fig. 3B depicts a side view of the inflating element 106, according to an embodiment of the present disclosure.
[15] Fig. 3C depicts a cross-sectional view of the inflating element 106, according to an embodiment of the present disclosure.
[16] Fig. 4A depicts a side view of a distal portion of the catheter 100, according to an embodiment of the present disclosure.
[17] Fig. 4B depicts a sectional view illustrating a coupling of the inflating element 106 with the shaft 102, according to an embodiment of the present disclosure.
[18] Fig. 5A depicts a proximal portion of the catheter 100 showing a hub 112, according to an embodiment of the present disclosure.
[19] Fig. 5B depicts a cross sectional view showing coupling of the hub 112 with the shaft 102, according to an embodiment of the present disclosure.
[20] Fig. 6A depicts the catheter 100 in a closed configuration, according to an embodiment of the present disclosure.
[21] Fig. 6B depicts a cross-sectional view of a distal portion 112c of the hub 112 showing a coupling of a slot 118 with a key 122 in an open configuration, according to an embodiment of the present disclosure.
[22] Fig. 6C depicts a cross-sectional view of the distal portion 112c of the hub 112 showing a coupling of the slot 118 with the key 122 in the closed configuration, according to an embodiment of the present disclosure.
[23] Fig. 7 depicts a flowchart of a method 300 of operating the catheter 100, according to an embodiment of the present disclosure.
[24] Fig. 8A depicts an assembled view of a catheter 200, according to an embodiment of the present disclosure.
[25] Fig. 8B depicts an exploded view of the catheter 200, according to an embodiment of the present disclosure.
[26] Fig. 9A depicts an isometric view of an inflating element 206, according to an embodiment of the present disclosure.
[27] Fig. 9B depicts a side view of the inflating element 206, according to an embodiment of the present disclosure.
[28] Fig. 9C depicts a sectional view of the inflating element 206, according to an embodiment of the present disclosure.
[29] Fig. 10A depicts a front view of the inflating element 206, according to an embodiment of the present disclosure.
[30] Fig. 10B depicts a back view of the inflating element 206, according to an embodiment of the present disclosure.
[31] Fig. 11A depicts a side view of a distal portion of the catheter 200, according to an embodiment of the present disclosure.
[32] Fig. 11B depicts a cross-sectional view illustrating a coupling of the inflating element 206 and the shaft 202, according to an embodiment of the present disclosure.
[33] Fig. 12 depicts the catheter 200 in a closed configuration, according to an embodiment of the present disclosure.
[34] DETAILED DESCRIPTION OF THE DRAWINGS
[35] 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.
[36] 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.
[37] 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.
[38] 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.
[39] The present disclosure proposes an inflating element and a catheter having such an inflating element. The proposed inflating element is designed such that, when the inflating element is inflated (i.e., in an inflated state), the inflating element has a hollow shape defining a hollow space extending along a longitudinal axis of the inflating element. The hollow space provides a passage for at least one of: a body fluid (e.g., blood) or air during a medical procedure. In an embodiment, in the inflated state, the inflating element is generally shaped as a hollow cylinder. The catheter can be used in various medical procedures such as angioplasty, stent placement, drug delivery, and transcatheter heart valve implantation, etc. The catheter can also be used in medical procedures to treat respiratory conditions such as tracheal stenosis, bronchial stenosis, valvuloplasty procedure and/or other respiratory conditions that cause difficulty in breathing.
[40] During a medical procedure, the catheter is inserted into an airway through an oral or a nasal cavity of a patient or into the patient’s vasculature through a surgical cut. The catheter is guided to a target site. Once the catheter reaches the target site, the inflating element is inflated. The inflation causes the inflating element to gently press the walls of the blocked airway and/or blood vessels and expand them. The structure of the inflating element allows continuous blood and air flow during the medical procedure. This reduces the patient’s discomfort and improves the medical procedure’s efficiency and effectiveness. Further, due to the hollow shape of the inflating element, the inflating element is lighter in weight, enables faster inflation and requires lesser inflation fluid, and provides improved positioning and stabilization during the medial procedure as compared to traditional balloons. According to an embodiment, the inflating element has a hollow, cylindrical shape. This results in more dilation and higher strength to weight ratio, which makes it more resistant to bending and buckling. Since the proposed inflating element conforms better to the shape of the airway or the vessel, overall outcome for the patient is improved.
[41] Referring now to figures, Fig. 1A depicts a catheter 100, according to an embodiment. The catheter 100 has a proximal end 100a and a distal end 100b. The catheter 100 includes a shaft 102, an inflating element 106, a support member 108, and a hub 112.
[42] Referring to Figs. 2A – 2B, the shaft 102 has a proximal end 102a and a distal end 102b, defining a length therebetween. The shaft 102 has a tubular structure and a flexible, elongated body. The proximal end 102a of shaft 102 is coupled to the hub 112 and the distal end 102b of the shaft 102 is coupled to the inflating element 106. As illustrated in Fig. 2B, the shaft 102 includes a guidewire lumen 102c. The guidewire lumen 102c is situated in the center of the shaft 102 and extends through the length of the shaft 102. The guidewire lumen 102c may be made up of materials such as, without limitation polyether block amide (PEBAX), silicone, polyethylene, polyurethane, Polyvinyl chloride (PVC), Thermoplastic elastomers (TPE). In an embodiment, the guidewire lumen 102c is made of polyether block amide (PEBAX). The guidewire lumen 102c is constructed by extrusion technique according to an embodiment.
[43] The guidewire lumen 102c provides a passage for a guidewire 110. The guidewire 110 is used to guide the catheter 100 through the patient’s vasculature (or an airway) to the target location. The guidewire 110 may be a solid core wire, a mandrel wire, a ribbon wire, etc. The guidewire 110 can be made of steel, nickel alloy, titanium, nitinol etc. In an embodiment, the guidewire 110 is a solid core wire made of nitinol. The guidewire 110 extends from the proximal end 100a to the distal end 100b of the catheter 100.
[44] Further, the shaft 102 includes at least one inflation lumen 102d. In an embodiment, the at least one inflation lumen 102d includes six inflation lumens as shown in Fig. 2B. The at least one inflation lumen 102d is arranged around the guidewire lumen 102c in a circular manner. The at least one inflation lumen 102d have a flexible, elongated body and a tubular structure. The at least one inflation lumen 102d has a proximal end and a distal end. The at least one inflation lumen 102d is configured to pass an inflation fluid. The inflation fluid is used to inflate or deflate the inflating element 106. The inflation fluid may be a liquid or a gas. The inflation fluid may be a drug, a saline liquid, air, etc. In an embodiment, the inflation fluid is a saline liquid. The inflation fluid may further include a contrast dye to allow the medical professional to observe the passage of the inflation fluid. The shaft 102 may include additional lumens (not shown) for the delivery of medicines or other fluids. The shaft 102 can be made of a material including, but not limited to, polyether block amide (PEBAX), polyurethane or any other biocompatible polymer material. In an embodiment, the shaft 102 is made of polyether block amide (PEBAX). The length of the shaft 102 may be between 30 cm and 200 cm. The diameter of the shaft 102 may be between 1 mm and 5 mm. In an exemplary implementation, the length and the diameter of the shaft 102 are 80 cm and 3 mm, respectively.
[45] The inflating element 106 is configurable to be in an inflated state or a deflated state. The inflating element 106 is configured to be in the inflated state in response to the passage of the inflation fluid into the inflating element 106. Figs. 3A-3C depicts various views of the inflating element 106 in the inflated state, according to an embodiment. The inflating element 106 has a proximal end 106a and a distal end 106b. The inflating element 106 comprises a central portion 106c, a first set of protrusions 106d and a second set of protrusions 106e. The central portion 106c extends longitudinally and has a proximal end and a distal end. The central portion 106c encloses a hollow space 106f. The hollow space 106f extends along the longitudinal axis of the inflating element 106. In an embodiment, the central portion 106c has a tubular structure with a hollow cylindrical shape, though it may have any other suitable shape, for example, hexagonal, octagonal, heptagonal, etc. The central portion 106c includes (or defines) an outer wall 107a and an inner wall 107b defining an inflating volume therebetween. The inner wall 107b encloses the hollow space 106f. In an embodiment, the inner wall 107b and the hollow space 106f are coaxial. The outer wall 107a and the inner wall 107b are coupled with each other at the proximal and distal end of the central portion 106c via a proximal surface 107c and a distal surface 107d, respectively, using any suitable technique. In the depicted embodiment, the central portion 106c is an integrated structure. The central portion 106c may be suitably dimensioned based upon requirements. For example, when inflated, the central portion 106c may have a length between 20 mm and 60 mm, an outer diameter between 3 mm and 30 mm, and an inner diameter between 1 mm and 28 mm. In an example implementation, the length, the outer diameter and the inner diameter of the central portion 106c are 40 mm, 10 mm and 8 mm, respectively.
[46] The first set of protrusions 106d extends from the proximal end of the central portion 106c to the proximal end 106a of the inflating element 106 and the second set of protrusions 106e extends from the distal end of the central portion 106c to the distal end 106b of the inflating element 106. In an embodiment, the first set of protrusions 106d and the second set of protrusions 106e form an integrated structure with the central portion 106c. In another embodiment, the first set of protrusions 106d, the second set of protrusions 106e and the central portion 106c are separate components removably or fixedly coupled using any suitable coupling technique. The first set of protrusions 106d and the second set of protrusions 106e are disposed circumferentially on the proximal surface 107c and the distal surface 107d, respectively, in a uniform or non-uniform manner. In an embodiment, the first set of protrusions 106d and the second set of protrusions 106e extend concentrically and uniformly from the proximal surface 107c and the distal surface 107d, respectively. The first set of protrusions 106d and the second set of protrusions 106e may include one or more protrusions. In an exemplary embodiment, the first set of protrusions 106d includes six protrusions and the second set of protrusions 106e includes six protrusions. In an embodiment, the first set of protrusions 106d and the second set of protrusions 106e have a tubular structure with a circular cross-section, though they may have any other suitable shape. The first set of protrusions 106d and the second set of protrusions 106e may have a length ranging from 3 mm to 15 mm and may have the same or different lengths. In an embodiment, the length of the first set of protrusions 106d and the second set of protrusions 106e is 8 mm and 8 mm, respectively. The first set of protrusions 106d and the second set of protrusions 106e may have the same or different diameters ranging from 0.3 mm to 3 mm. In an embodiment, the first set of protrusions 106d and the second set of protrusions 106e have a diameter of 0.5 mm.
[47] In an embodiment, the inflation fluid passed from the at least one inflation lumen 102d enters the central portion 106c via the first set of protrusions 106d and inflates the central portion 106c, thereby causing the inflating element 106 to be in the inflated state. The hollow space 106f provides a passage for air and/or blood and better dilation. The continuous flow of the blood and ventilation, reduces the patient’s discomfort and improves patient outcome. Due to the uniform distribution of the first set of protrusions 106d and the shape of the central portion 106c, the inflation fluid enters the central portion 106c in a uniform flow and provides uniform pressure distribution during the inflation of the inflating element 106. This causes even expansion of the inflating element 106 and consequently, uniform dilation of the body cavity. Thus, the inflating element 106 having the hollow shape improves the overall efficiency and effectiveness of the medical procedure.
[48] The inflating element 106 may be made of a biocompatible material such as, without limitation, silicone, nylon, polyamide, polyurethane, etc. In an embodiment, the inflating element 106 is made of nylon.
[49] The inflating element 106 is coupled to the shaft 102 towards the proximal end 106a and the support member 108 towards the distal end 106b as shown in Fig. 4A. A proximal end of each of the first set of protrusions 106d is coupled to the distal end of a respective inflation lumen 102d of the at least one inflation lumen 102d (as depicted in Fig. 4B) using a suitable coupling technique such as, without limitation, adhesive bonding, heat bonding, solvent bonding, UV bonding, etc. In an example implementation, the proximal ends of the first set of protrusions 106d are coupled to the distal ends of the at least one inflation lumen 102d using adhesive bonding.
[50] Referring to Figs. 5A-5B, the hub 112 is provided at the proximal end 100a of the catheter 100. The hub 112 has a hollow body. In an embodiment, the hub 112 is Y-shaped. During the medical procedures the hub 112 allows access to the shaft 102. The hub 112 has a proximal end 112a and a distal end 112b. The hub 112 may be made of a material such as, without limitation, polypropylene, polycarbonate, polyethylene terephthalate (PET), high density polyethylene (HDPE), low density polyethylene (LDPE), etc. In an embodiment, the hub 112 is made of polypropylene. The hub 112 is coupled to the shaft 102. For example, the distal end 112b of the hub 112 is coupled to the proximal end 102a of the shaft 102 using a suitable coupling technique such as adhesive bonding, RF welding, UV bonding, etc. In an example implementation, the distal end 112b of the hub 112 is coupled to the proximal end 102a of the shaft 102 using UV bonding.
[51] The hub 112 includes an inflation port 114 and a guidewire port 116. The inflation port 114 includes a cavity 114a coupled to the at least one inflation lumen 102d using a suitable coupling technique. In an example, implementation, a distal end of the cavity 114a is coupled to the proximal end at least one inflation lumen 102d using UV bonding such that the inflation fluid does not enter the guidewire lumen 102c. The inflation port 114 is configured to pass the inflation fluid into the at least one inflation lumen 102d via the cavity 114a. An inflation device (not shown), for example, a syringe is coupled to the inflation port 114 during the operation of the catheter 100. The inflation device is used to inject the inflation fluid into the inflating element 106 causing the inflating element 106to inflate or withdraw the inflation fluid from the inflating element 106 causing the inflating element 106 to deflate.
[52] The guidewire port 116 includes a cavity 116a coupled to the guidewire lumen 102c using a suitable coupling technique. In an example implementation, a distal end of the cavity 116a is coupled to a proximal end of the guidewire lumen 102c using UV bonding. The guidewire 110 is inserted into the guidewire lumen 102c from a proximal end of the guidewire port 116 via the cavity 116a.
[53] Referring again to Figs. 1A – 1B, in an embodiment, the catheter 100 is provided with a sleeve 104 configured to toggle the catheter 100 between an open configuration and a closed configuration. The sleeve 104 may at least partially cover the inflating element 106 in the closed configuration. In an example implementation, the sleeve 104 substantially covers the inflating element 106 (depicted in Fig. 6A) and helps in reducing the profile of the inflating element 106 during inserting, navigating and removing the catheter 100 through the patient’s vasculature and/or the airway, making the catheter 100 easier to navigate through the vasculature. The sleeve 104 may be made of a material such as, without limitation, polyether block amide (PEBAX), polyurethane (PU) etc. In an embodiment, the sleeves 104 is made of polyurethane (PU).
[54] The sleeve 104 has a hollow, elongated tubular structure. The sleeve 104 has a proximal end 104a and a distal end 104b. The sleeve 104 is slidably coupled to the shaft 102 such that the sleeve 104 can slide over the shaft 102 in a forward (i.e., distal) and backward (i.e., proximal) direction. In an embodiment, the sleeve 104 includes a first portion 104a1 provided towards the proximal end 104a and a second portion 104b1 provided towards the distal end 104b. The first portion 104a1 covers at least a part of a distal portion 112c of the hub 112 and has the diameter corresponding to the diameter of the distal portion 112c. The second portion 104b1 substantially covers the length of the shaft 102 and has the diameter corresponding to the diameter of the shaft 102.
[55] The sleeve 104 is coupled to the distal portion 112c. In an embodiment, a slot 118 is provided on the distal portion 112c of the hub 112 (depicted in Fig. 5A). The slot 118 extends longitudinally between a distal end of the distal portion 112c and a proximal end of the distal portion 112c. The slot 118 helps in locking and unlocking of the sleeve 104. The slot 118 may have shape such as, without limitation, L-shaped, inverted L-shaped, J-shaped, inverted J-shaped, Z- shaped, etc. In an embodiment, the slot 118 has an inverted L shape at both the proximal end and the distal end of the slot 118 (as shown in Figs. 6B and 6C). The sleeve 104 has a key 122 provided on an inner surface of the first portion 104a1 of the sleeve 104 towards the proximal end 104a. The key 122 is slidably disposed a proximal end and a distal end of the slot 118 and movable within the slot 118 when the sleeve 104 is moved forward or backward and when the sleeve 104 is moved clockwise or anticlockwise when the key 122 is at the proximal or the distal end of the slot 118.
[56] In an embodiment, the sleeve 104 is configurable to be in at least one of a first position and a second position. To configure the sleeve 104 in the first position, the sleeve 104 is moved in a backward (or proximal) direction such that the key 122 moves within the slot 118 to a proximal end of the slot 118. In the first position, the key 122 is disposed at the proximal end of the slot 118. The sleeve 104 is then rotated (e.g., counterclockwise in the depicted embodiment) to lock the sleeve 104 in the first position (depicted in Fig. 1A). Consequently, in the first position, the distal end 104b of the sleeve 104 is proximal to the distal end 102b of the shaft 102 and the inflating element 106 is uncovered, thereby configuring the catheter 100 in the open configuration (depicted in Fig. 1A). Once at the first position, the sleeve 104 can be unlocked by rotating the sleeve 104 in the opposite direction (e.g., clockwise in the depicted embodiment) to unlock the sleeve 104 from the first position. To configure the sleeve 104 in the second position, the sleeve 104 is moved in a forward (or distal) direction such that the key 122 moves within the slot 118 to a distal end of the slot 118, thereby configuring the sleeve 104 in the second position (depicted in Fig. 6A). In the second position, the key 122 is disposed at the distal end of the slot 118. The sleeve 104 is then rotated (e.g., clockwise in the depicted embodiment) to lock the sleeve 104 in the second position. Consequently, in the second position, the distal portion 104a2 of the sleeve 104 extends beyond the distal end 102b of the shaft 102 and the sleeve 104 at least partially (in the depicted embodiment, substantially) covers the inflating element 106, thereby configuring the catheter 100 in the closed configuration (depicted in Fig. 6A). Once at the second position, the sleeve 104 is rotated in the opposite direction (e.g., counterclockwise in the depicted embodiment) to unlock the sleeve 104 from the second position.
[57] The distal end 100b of the catheter 100 is provided with the support member 108. Support member 108 has a proximal end 108a and a distal end 108b (shown in Fig. 4A). The support member 108 has a hollow, tubular structure. The support member 108 is tapered towards the distal end 108b such that the support member 108 has a conical shape, according to an embodiment. In an embodiment, the support member 108 has multiple lumens. The support member 108 includes a guidewire lumen (not shown) extending from the proximal end 108a to the distal end 108b to allow the passage of the guidewire 110. The support member 108 is further provided with at least one inflation lumen (not shown) arranged around the guidewire lumen of the support member 108 in a circular manner. The number of the at least one inflation lumen of the support member 108 correspond to the number of second set of protrusions 106e of the inflating element 106. The at least one inflation lumen of the support member 108 extends into the support member 108. The support member 108 is coupled to the inflating element 106. For example, a distal end of each of the second set of protrusions 106e is coupled to a proximal end of a respective inflation lumen of the at least one inflation lumen of the support member 108 using a suitable coupling technique such as, without limitation, adhesive bonding, heat bonding, solvent bonding, UV bonding, etc. In an example implementation, the distal ends of the second set of protrusions 106e are coupled to the at least one inflation lumen of the support member 108 using adhesive bonding. The second set of protrusions 106e provide a passage to the inflation fluid from the central portion 106c into the at least one inflation lumen of the support member 108. Whenever the inflation fluid is passed through the at least one inflation lumen 102d of the shaft 102, the inflation fluid would reach, via the second set of protrusions 106e, a distal end of the at least one inflation lumen of the support member 108 where the at least one inflation lumen of the support member 108 end. This leads to the accumulation of the inflation fluid within the central portion 106c of the inflating element 106, causing the inflating element 106 to inflate.
[58] The support member 108 may be made up of a material such as, without limitation, polyether block amide (PEBAX), polyurethane (PU), nylon, silicon, etc. In an embodiment, the support member 108 is made of polyether block amide (PEBAX). The support member 108 provides structural integrity to the inflating element 106 while maintaining the flexibility for navigation of the catheter 100 through the vascular system. The support member 108 also helps to minimize the trauma or damage to the interior blood vessel.
[59] In an embodiment, the catheter 100 includes a support tubing 120. The support tubing 120 extends from the proximal end 106a of the inflating element 106 to the distal end 106b of the inflating element 106 (as shown in Fig. 4A). The support tubing 120 provides support to the inflating element 106. A proximal end of the support tubing 120 is coupled to a distal end of the guidewire lumen 102c of the shaft 102 using, for example, adhesive bonding (as depicted in Fig. 4B) and a distal end of the support tubing 120 is coupled to a proximal end of the guidewire lumen of the support member 108 using, for example, adhesive bonding. The support tubing 120 has a tubular structure and includes a lumen provided centrally. The lumen of the support tubing 120 provides a passage to the guidewire 110. The support tubing 120 can be made of a material such as, without limitation, stainless steel, polymer, etc. In an embodiment, the support tubing 120 is a hypotube made of stainless steel.
[60] Fig. 7 depicts a method 300 of operating a catheter 100 during a medical procedure, according to an embodiment. At step 301, the catheter 100 is configured to be in the closed configuration. For example, a surgeon moves the sleeve 104 in the second position and thereby, configuring the catheter 100 in the closed configuration before introducing the shaft 102 inside the patient’s body. In the closed configuration, the sleeve 104 substantially covers the inflating element 106, which causes the crimping of the inflating element 106, reducing its surface area. The catheter 100 in the closed configuration leads to easy insertion of the shaft 102 inside the patient’s body. Further, the guidewire 110 is inserted from the guidewire port 116 until the guidewire 110 emerges at the distal end 100b. The guidewire 110 passes through the guidewire lumen 102c, the lumen of the support tubing 120and the guidewire lumen of the support member 108 before emerging from the catheter 100 at the distal end 100b.
[61] At step 303, the shaft 102 is introduced inside the patient’s body via an oral cavity, a nasal cavity or by any cuts made by a surgical process based upon requirements of the medical procedure.
[62] At step 305, the shaft 102 is navigated with the help of the guidewire 110 to the target site where the medical procedure is to be performed.
[63] At step 307, the catheter 100 is configured to be in the open configuration. For example, the surgeon moves the sleeve 104 to the first position by sliding the sleeve 104 in the backward direction on the slot 118 and locking the sleeve 104 by rotating the sleeve anticlockwise. This causes the catheter 100 to be in the open configuration as explained earlier.
[64] At step 309, the inflating element 106 is inflated to the inflated state using an inflation fluid. The inflation fluid is infused from the inflation port 114 and passed to the inflating element 106 via the at least one inflation lumen 102d. In response to the inflation of the inflating element 106, a body cavity (e.g., the airway or the blood vessel at the target site) is dilated. Due to the hollow shape of the inflating element 106, there is continuous ventilation or blood flow in body cavity. Additional steps based upon the requirements of the medical procedure may be performed at this stage.
[65] At step 311, upon completion of the necessary intervention, the inflating element 106 is deflated. This is done by removing the inflation fluid from the inflating element 106 via the inflation port 114.
[66] At step 313, the catheter 100 is configured in the closed configuration. For example, the surgeon unlocks the sleeve 104 by rotating the sleeve 104 in the clockwise direction and moves the sleeve 104 to the first position, thereby causing the catheter 100 to be in the closed configuration as explained earlier. The shaft 102 is then withdrawn from the patient’s body.
[67] Fig. 8A and 8B depicts an assembled and exploded view of the catheter 200, respectively, according to an embodiment. The catheter 200 has a proximal end 200a and a distal end 200b. The catheter 200 includes a shaft 202, a sleeve 204, an inflating element 206, a support member 208, a hub 212 and a support tubing 220. The hub 212 includes an inflation port 214 and a guidewire port 216. A guidewire 210 can be inserted from the guidewire port 216 of the hub 212. The details of the guidewire 210 can be referred from the corresponding description of the guidewire 110 and are not repeated for the sake of brevity.
[68] The shaft 202 has a proximal end 202a and a distal end 202b. The shaft 202 includes a guidewire lumen 202c and at least one inflation lumen 202d (as shown in Fig. 11B). In the depicted embodiment, the at least one inflation lumen 202d includes a single inflation lumen 202d. Further details of the shaft 202, the guidewire lumen 202c and the at least one inflation lumen 202d can be referred from the corresponding description of the shaft 102 and are not repeated for the sake of brevity.
[69] The support member 208 has a proximal end and a distal end. The support member 208 includes a guidewire lumen (not shown) and at least one inflation lumen (not shown). In the depicted embodiment, the at least one inflation lumen of the support member 208 includes a single inflation lumen. Further details of the support member 208 can be referred from the corresponding description of the support member 108 and are not repeated here for the sake of brevity.
[70] The inflating element 206 is configurable to be in an inflated state or a deflated state. The inflating element 206 is configured to be in the inflated state in response to the passage of the inflation fluid into the inflating element 206. Figs. 9A – 9C and 10A – 10B depict various views of the inflating element 206 in the inflated state, according to an embodiment. The inflating element 206 has a proximal end 206a and a distal end 206b. The inflating element 206 comprises a central portion 206c, a first set of protrusions 206d and a second set of protrusions 206e. The central portion 206c extends longitudinally and has a proximal end and a distal end. The central portion 206c encloses a hollow space 206f. The hollow space 206f extends along the longitudinal axis of the inflating element 206. The central portion 206c includes at least one coil of at least one tube coiled in a pre-defined coiling pattern. Each tube of the at least one tube is coiled to form one coil of the at least one coil. In an embodiment, the central portion 206c resembles a spring having a hollow cylindrical profile. In an embodiment, the central portion 206c includes a coil formed by coiling a tube 206g in a pre-defined coiling pattern, in the shape of a spring. For example, the tube 206g of a suitable material may be wrapped around a mandrel (not shown) to form the coil. In an exemplary implementation, the tube 206g of a polymeric material is wrapped on the mandrel with successive loops of the tube 206g bonded together by means of an adhesive to form the coil. Optionally, a polymeric film is bonded with an inner surface of the coil to provide additional strength to the coil. In an embodiment, the polymeric film is bonded with the inner surface of the coil using an adhesive. The adhesive may be, for example, loctite, glue, epoxy, etc. The polymeric film may be made of a material such as, without limitation, polyurethane (PU), polyether block amide (PEBAX), nylon, etc. The tube 206g may be made of a material such as, without limitation, polyether block amide (PEBAX), polyethylene terephthalate (PET), nylon, Polyurethane (PU), etc. or any other suitable polymeric material. The pre-defined coiling pattern may be helical, spiral, or any other suitable coiling pattern. In the depicted embodiment, the coil has a spiral-shaped pattern. In an embodiment, the central portion 206c includes two coils formed using two tubes 206g coiled in the pre-defined coiling pattern, e.g., in the shape of a spring having double helical pattern.
[71] The coil has a pre-defined pitch. According to an embodiment, the pitch of the coil is equal to the diameter of the tube 206g so that the tube 206g is tightly wrapped, thereby providing stability and strength to the central portion 206c. In another embodiment, the pitch of the coil may be more than the diameter of the tube 206g. In this case, a polymeric sleeve may be bonded (e.g., using adhesive bonding) with the spring from inside to provide support and stability.
[72] The central portion 206c defines an outer wall 207a and an inner wall 207b defining an inflating volume therebetween. The inner wall 207b encloses the hollow space 206f. In an embodiment, the inner wall 207b and the hollow space 206f are coaxial. The central portion 206c may be suitably dimensioned based upon requirements. For example, when inflated, the central portion 206c may have a length between 20 mm and 60 mm, an outer diameter between 3 mm and 30 mm, and an inner diameter between 2 mm and 28 mm. In an example implementation, the length, the outer diameter and the inner diameter of the central portion 206c are 40 mm, 10 mm and 8 mm, respectively. The diameter of the tube 206g may be between 0.3 mm and 3 mm. In an example implementation, the diameter of the tube 206g is 0.5 mm.
[73] The first set of protrusions 206d extends from the proximal end of the central portion 206c to the proximal end 206a of the inflating element 206 and the second set of protrusions 206e extends from the distal end of the central portion 206c to the distal end 206b of the inflating element 206. In the depicted embodiment, the first set of protrusions 206d includes one protrusion coupled to a proximal end of the tube 206g and the second set of protrusions 206e includes one protrusion coupled to a distal end of the tube 206g using, for example, adhesive bonding, heat bonding, solvent bonding, etc. or any other suitable coupling technique. In an embodiment, the tube 206g, the first set of protrusions 206d and the second set of protrusions 206e form an integrated structure. In an embodiment, when the central portion 206c is formed using two tubes 206g, the first set of protrusions 206d includes two protrusions and the second set of protrusions 206e includes two protrusions, respectively, coupled to a respective tube 206g of the two tubes 206g in a similar manner. In an embodiment, the first set of protrusions 206d and the second set of protrusions 206e have a tubular structure with a circular cross-section, though they may have any other suitable shape. The first set of protrusions 206d and the second set of protrusions 206e may have a length ranging from 5 mm to 15 mm and may have the same or different lengths. In an embodiment, the length of the first set of protrusions 206d and the second set of protrusions 206e is 8 mm and 8 mm, respectively. The first set of protrusions 206d and the second set of protrusions 206e may have the same or different diameters ranging from 0.3 mm to 3 mm. In an embodiment, the first set of protrusions 206d and the second set of protrusions 206e has a diameter of is 0.5 mm.
[74] In an embodiment, the inflation fluid passed from the at least one inflation lumen 202d enters the central portion 206c via the first set of protrusions 206d and inflates the central portion 206c, thereby causing the inflating element 206 to be in the inflated state. The structure and design of the inflating element 206 including the hollow space 206f present similar advantages as described with respect to the inflating element 106.
[75] The inflation element 206 is coupled to the shaft 202 and the support member 208 (depicted in Fig. 11A). The first set of protrusions 206d are coupled to the shaft 102. For example, a proximal end of each protrusion 206d of the first set of protrusions 206d is coupled to a distal end of a respective inflation lumen 202d of the at least one inflation lumen 202d (shown in Fig. 11B) in a similar manner as described earlier. Further, the second set of protrusions 206e are coupled to the support member 208. For example, a distal end of each protrusion 206e of the second set of protrusions 206e is coupled to a proximal end of a respective inflation lumen of the at least one lumen of the support member 208 in a similar manner as described earlier.
[76] The support tubing 220 provides support to the inflating element 206. Further details of the support tubing 220 can be referred from the corresponding details of the support tubing 120 and are not repeated for the sake of brevity.
[77] Further details of the hub 212 and the coupling of the hub 212 with the shaft 202 can be referred from the corresponding description associated with the hub 112 and the shaft 102. A distal portion 212c of the hub 212 includes a slot (not shown) similar to the slot 118.
[78] Referring again to Figs. 8A – 8B, the sleeve 204 is configured to toggle the catheter 200 between an open configuration and a closed configuration. In the closed configuration, the sleeve 204 substantially covers the inflating element 206 (depicted in Fig. 12) and helps in reducing the profile of the inflating element 206 during inserting, navigating and removing the catheter 200 through the patient’s vasculature and/or the airway, making the catheter 200 easier to navigate through the vasculature.
[79] The sleeve 204 is slidably coupled to the shaft 202. The sleeve 204 has a proximal end 204a and a distal end 204b. In an embodiment, the sleeve 204 is configurable to be in at least one of a first position and a second position. In response to the sleeve 204 being moved to the first position, the catheter 200 is configured to be in the open configuration (depicted in Fig. 8A). Further, in response to the sleeve 204 being moved to the second position, the catheter 200 is configured to be in the closed configuration (depicted in Fig. 12). The details of the sleeve 204, how the sleeve 204 can be moved to the first and the second position and how that movement configures the catheter 200 in the open and closed configuration, respectively, can be understood from a corresponding description with respect to the sleeve 104 and are not repeated here for the sake of brevity.
[80] The catheter 200 can be operated in a similar manner as described above with respect to the method 300 to operate the catheter 100 and therefore, is not repeated for the sake of brevity.
[81] 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 catheter (100, 200) comprising:
a. a shaft (102, 202) having a proximal end (102a, 202a) and a distal end (102b, 202b) and comprising at least one inflation lumen (102d);
b. an inflating element (106, 206) having a proximal end (106a, 206a) and a distal end (106b, 206b) and configurable to be in an inflated state, the inflating element (106, 206) comprising:
i. a central portion (106c, 206c); and
ii. a first set of protrusions (106d, 206d) extending from the central portion (106c, 206c) towards the proximal end (106a, 206a) of the inflating element (106, 206), a proximal end of each protrusion (106d, 206d) of the first set of protrusions (106d, 206d) is coupled to a distal end of a respective inflation lumen (102d) of the at least one inflation lumen (102d); and
iii. a second set of protrusions (106e, 206e) extending from the central portion (106c, 206c) towards the distal end (106b, 206b) of the inflating element (106, 206);
c. wherein an inflation fluid passed from the at least one inflation lumen (102d) enters the central portion (106c, 206c) via the first set of protrusions (106d, 206d), thereby causing the inflating element (106) to be in the inflated state; and
d. wherein in the inflated state, the central portion (106c, 206c) of the inflating element (106, 206) defines a hollow space (106f, 206f) extending longitudinally between a proximal end of the central portion (106c, 206c) and a distal end of the central portion (106c, 206c); the hollow space (106f, 206f) providing a passage for at least one of a body fluid or air.
2. The catheter (100, 200) as claimed in claim 1, wherein in the inflated state, the central portion (106c, 206c) defines an inner wall (107b, 207b), wherein the inner wall (107b, 207b) encloses the hollow space (106f, 206f).
3. The catheter (100, 200) as claimed in claim 2, wherein the inner wall (107b, 207b) and the hollow space (106f, 206f) are coaxial.
4. The catheter (100) as claimed in claim 1, wherein the central portion (106c) has a tubular structure comprising an outer wall (107a) and an inner wall (107b) coupled with each other via a proximal surface (107c) and a distal surface (107d) at the proximal end and the distal end of the central portion (106c), respectively, wherein the first set of protrusions (106d) extend from the proximal surface (107c) and the second set of protrusions (106e) extend from the distal surface (107d).
5. The catheter (100) as claimed in claim 4, wherein the first set of protrusions (106d) and the second set of protrusions (106e) extend concentrically from the proximal surface (107c) and the distal surface (107d), respectively.
6. The catheter (200) as claimed in claim 1, wherein the central portion (206c) comprises at least one coil of at least one tube coiled in a pre-defined coiling pattern, wherein each tube of the at least one tube forms one coil of the at least one coil, wherein each protrusion (206d) of the first set of protrusions (206d) and each protrusion (206e) of the second set of protrusions (206e) extend from a proximal end and a distal end, respectively, of a respective tube of the at least one tube.
7. The catheter (200) as claimed in claim 6, wherein the central portion (206c) comprises a coil of one tube (206g) coiled in the pre-defined coiling pattern and having a pre-defined pitch.
8. The catheter (200) as claimed in claim 7, wherein the pre-defined pitch is equal to the diameter of the tube (206g).
9. The catheter (200) as claimed in claim 6, wherein the central portion (206c) comprises two coils of two tubes (206g) coiled in the pre-defined coiling pattern.
10. The catheter (200) as claimed in claim 6, wherein a polymeric film is bonded to an inner surface of the at least one coil.
11. The catheter (100, 200) as claimed in claim 1, wherein the catheter (100, 200) comprises a sleeve (104, 204), having a proximal end (104a, 204a) and a distal end (104b, 204b), slidably coupled to the shaft (102, 202), the sleeve (104, 204) is configurable to be in a first position and a second position, wherein in the second position, the sleeve (104, 204) at least partially covers the inflating element (106, 206) and in the first position, the distal end (104b, 204b) of the sleeve (104, 204) is proximal to the distal end (102b, 202b) of the shaft (102, 202) and the inflating element (106, 206) is uncovered.
12. The catheter (100, 200) as claimed in claim 11, wherein the sleeve (104, 204) comprises a key (122) provided on an inner surface of the sleeve (104, 204) towards the proximal end (104a, 204a) of the sleeve (104, 204), the key (122) is slidably disposed between a proximal end and a distal end of a slot (118) provided on a distal portion (112c, 212c) of a hub (112, 212), the slot (118) extends longitudinally, wherein in the first position, the key (122) is disposed at the proximal end of the slot (118) and in the second position, the key (122) is disposed at the distal end of the slot (118).
13. The catheter (100, 200) as claimed in claim 11, wherein in the second position, the sleeve (104, 204) substantially covers the inflating element (106, 206).
14. The catheter (100, 200) as claimed in claim 1, wherein a distal end of each protrusion (106e, 206e) of the second set of protrusions (106e, 206e) is coupled to a proximal end of a respective inflation lumen of at least one inflation lumen of a support member (108, 208), wherein the second set of protrusions (106e, 206e) provide a passage to the inflation fluid from the central portion (106c, 206c) into the at least one inflation lumen of the support member (108, 208).
15. The catheter (100, 200) as claimed in claim 1, wherein the catheter (100, 200) comprises a support tubing (120, 220) extending between the proximal end (106a, 206a) and the distal end (106b, 206b) of the inflating element (106, 206) and providing support to the inflating element (106, 206); the support tubing (120, 220) having a proximal end coupled to a distal end of a guidewire lumen (102c) of the shaft (102, 202) and a distal end coupled to a proximal end of a guidewire lumen of a support member (108, 208), the support tubing (120, 220) comprising a lumen provided centrally, wherein the guidewire lumen (102c) of the shaft (102, 202), the guidewire lumen of the support member (108, 208) and the lumen of the support tubing (120, 220) provide a passage to a guidewire (110, 210).
16. The catheter (100, 200) as claimed in claim 1, wherein the catheter (100, 200) comprises a hub (112, 212) comprising an inflation port (114, 214) having a cavity (114a) coupled to the at least one inflation lumen (102d) of the shaft (102, 202), the inflation port (214) is configured to pass the inflation fluid into the at least one inflation lumen (102d) of the shaft (102, 202) via the cavity (114a).