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:
AIRWAY INFLATING ELEMENT DILATION CATHETER

2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the 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
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an inflating element dilation catheter.
BACKGROUND OF INVENTION
[2] Respiratory conditions such as tracheal stenosis, bronchial stenosis, laryngotracheal stenosis have become very common these days. These conditions cause the narrowing of airway passage and ultimately, situations leading to stridor, retractions and shortness of breath on exertion and difficulty in breathing.
[3] A common procedure to treat such conditions involve dilating (opening) the airway passage using a small, angioplasty-type balloon, which is inflated in the airway to compress or stretch the stenosis. The traditionally designed airway dilation balloons are spherical or cylindrical in shape to dilate the airway.
[4] Several modifications have been made to improve the effectiveness of these devices. Some techniques use a cluster of traditional balloons to overcome ventilation problems during the airway dilation procedure. The traditional balloons inflate on both inside and outside leaving less area for ventilation. The lower ventilation may lead to a respiratory effort against an occluded airway causing NPPE. Negative pressure pulmonary edema (NPPE) is a dangerous and potentially fatal condition with a multifactorial pathogenesis. Frequently, NPPE is a manifestation of upper airway obstruction, the large negative intrathoracic pressure generated by forced inspiration against an obstructed airway is thought to be the principal mechanism involved. This negative pressure leads to an increase in pulmonary vascular volume and pulmonary capillary transmural pressure, creating a risk of disruption of the alveolar–capillary membrane. In the case of inflating element dilation, this complication is most likely to occur with attempted inspiration while the inflating element is dilated.
[5] Thus, there arises a requirement of a device which overcomes the challenges associated with the use of traditional balloon catheters.
SUMMARY OF INVENTION
[6] The present disclosure relates to a catheter comprising a shaft, having a proximal end and a distal end, and an inflating element structure having a proximal end and a distal end. The shaft comprises at least one inflation lumen configured to pass an inflation fluid. The inflating element structure comprises at least one inflating element comprising a proximal end coupled to a distal end of a respective inflation lumen of the at least one inflation lumen and a distal end. The at least one inflating element is configured to be in an inflated state in response to passage of an inflation fluid from the respective inflation lumen, wherein in the inflated state, the at least one inflating element has an asymmetric shape with respect to a longitudinal axis (X-X) of the at least one inflating element.
[7] 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
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1 illustrates a catheter 100, according to an embodiment of the present disclosure.
[10] Fig. 2A illustrates a perspective of a shaft 130, in accordance with an embodiment of the present disclosure.
[11] Fig. 2B illustrates a cross- section of the shaft 130, in accordance with an embodiment of the present disclosure.
[12] Fig. 2C illustrates a section view of a hub 150, in accordance with an embodiment of the present disclosure.
[13] Fig. 2D illustrates a section view of a coupling between the hub 150 and the shaft 130, in accordance with an embodiment of the present disclosure.
[14] Fig. 2E illustrates another section view of the coupling between the hub 150 and the shaft 130, in accordance with an embodiment of the present disclosure.
[15] Fig. 2F illustrates an isometric and a section view of a nose cone 160, in accordance with an embodiment of the present disclosure.
[16] Fig. 3 illustrates an enlarged view of a distal end 100b of the catheter 100, in accordance with an embodiment of the present disclosure.
[17] Fig. 3A illustrates a cross-sectional view of the distal end 100b of the catheter 100, in accordance with an embodiment of the present disclosure.
[18] Fig. 3B illustrates a cross-sectional view of a cluster of inflating elements 120n during deployment stage, in accordance with an embodiment of the present disclosure
[19] Fig. 4 depicts a side view of an inflating element 120n, in accordance with an embodiment of the present disclosure.
[20] Fig. 5A illustrates a cross sectional view of an inflating element structure 120 in an inflated state, in accordance with an embodiment of the present disclosure.
[21] Fig. 5B illustrates a side view of the inflating element structure 120, according to an embodiment.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[22] 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.
[23] 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.
[24] 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.
[25] 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.
[26] The present disclosure proposes an inflating element structure including at least one inflating element. The inflating element is configured to be in an inflated state in response to passage of an inflation fluid into the at least one inflating element. The at least one inflating element has an asymmetric shape with respect to a longitudinal axis of the at least one inflating element when in the inflated state. Due to the asymmetric shape, the at least one inflating element encloses a higher inflation volume on a lateral side of the at least one inflating element with respect to the longitudinal axis as compared to on a medial side of the at least one inflating element with respect to the longitudinal axis.
[27] In an embodiment, the proposed inflating element structure may be deployed in an airway balloon dilation catheter. The airway balloon dilation catheter can be used to treat various conditions affecting the airways, including tracheal stenosis, bronchial stenosis, and other respiratory conditions that cause breathing difficulties. The airway balloon dilation catheter may be inserted into the airway through the nose or the mouth of a patient, and guided to the site of obstruction. Once the airway balloon dilation catheter is in place, the inflating element is inflated. The proposed structure allows the inflating element to gently press against the walls of the blocked airway and expand the blocked airway. This results in improved airflow and breathing of the patient.
[28] Though the present disclosure describes the proposed inflating element structure deployed in the airway balloon dilation catheter, it can be widely used in various medical devices to perform a range of therapeutic procedures including, but not limited to, endoscopic procedures, gastrointestinal stent deployments, drug delivery, etc.
[29] Fig. 1 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 130, an inflating element structure 120, a nose cone 160, and a hub 150 including an inflation port 140 and a guide wire port 145.
[30] The shaft 130 has a proximal end 130a and a distal end 130b. The shaft 130 has an elongated body and a tubular structure. In an embodiment, the shaft 130 includes a multilayer lumen tubing (as shown in FIG. 2A). As illustrated in FIG. 2B, the shaft 130 includes a guide wire lumen 132 which provides a passage for the guide wire 110. Further, the shaft 130 includes at least one inflation lumen 134n. In an embodiment shown in FIG. 2B, the at least one inflation lumen 134n includes a plurality of inflation lumens 134a – 134f, collectively referred to as the inflation lumens 134. The at least one inflation lumen 134n surround the guide wire lumen 132 in a circular manner. The at least one inflation lumen 134n have a flexible, elongated body and a tubular structure. The at least one inflation lumen 134n have a proximal end and a distal end. The at least one inflation lumen 134n is configured to pass an inflation fluid. The inflation fluid is used to inflate or deflate the inflating element structure 120. The inflation fluid may be a liquid or a gas. In an embodiment, the inflation fluid may be a saline solution. The inflation fluid may further include a contrast dye to allow the medical professional to observe the passage of the inflation fluid. In an embodiment, each inflation lumen 134n of the at least one inflation lumen 134n corresponds to a respective inflating element 120n of the inflating element structure 120. The number of at least one inflation lumen 134n correspond to the number of inflating elements 120n in the inflating element structure 120. In the example shown in FIG. 2B, the shaft 130 includes six inflation lumens 134a – 134f. The shaft 130 may include additional lumens (not shown) for the delivery of medicines or other fluids. The shaft 130 can be made of, but not limited to, Polyether Ether Ketone (PEEK), Thermoplastic Polyurethane (TPU), Polyamide (PA), Polyether Block Amide (PEBA or PEBAX®), Polyetherimide (PEI), High Density Polyethylene (HDPE), Medium Density Polyethylene (MDPE), Low Density Polyethylene (LDPE), Polyvinyl Chloride (PVC) or any suitable high-quality, medical-grade material that is durable and flexible. In an embodiment, the shaft 130 is made of PEBAX®.
[31] The distal end 130b of the shaft 130 may also include one or more markers. The one or more markers help in positioning of the shaft 130 during medical procedures. The one or more markers may be fluoroscopic or non-fluoroscopic. In an embodiment, the one or more markers are made up of Platinum/Iridium (90/10), Platinum/Tungsten (92/08) or any other suitable material. In an embodiment, the one or more markers are made of Platinum/Iridium (90/10). In another embodiment, a polymeric marker may also be used. The length of the one or more markers may range from 1 mm to 3 mm.
[32] The inflating element structure 120 has a proximal end 120a and a distal end 120b. In an embodiment, the inflating element structure 120 may include at least one inflating element 120n. In an embodiment, the inflating element structure 120 may include one inflating element 120n. In an embodiment, the inflating element structure 120 may include more than one inflating elements 120n. For example, the inflating element structure 120 may include a cluster of inflating elements 120n. In an embodiment (shown in Fig. 1), the inflating element structure 120 includes a cluster of six inflating elements 120n. The proximal end 120a of the inflating element structure 120 is coupled to the distal end 130b of the shaft 130 using, without limitation, adhesive bonding, laser welding, etc. Embodiments of the coupling between the inflating element structure 120 and the shaft 130 are further explained in conjunction with Figs. 3 – 3A.
[33] The at least one inflating element 120n is configured to be in an inflated state in response to the passage of the inflation fluid into the at least one inflating element 120n. In an embodiment, the at least one inflating element 120n, in the inflated state has an asymmetrical shape with respect to a longitudinal axis of the inflating element 120n. That is, the at least one inflating element 120n, in the inflated state, encloses a higher inflation volume on a lateral side 120h of the at least one inflating element 120n with respect to the longitudinal axis than on a medial side 120g of the at least one inflating element 120n with respect to the longitudinal axis. Various embodiments of the at least one inflating element 120n are described in detail in conjunction with Figs. 4-5A,5B. The at least one inflating element 120n can be made of a flexible, biocompatible material. For example, the inflating element 120n can be made of, but is not limited to, latex, silicone, PEBAX, Polyethylene Terephthalate (PET), Nylon, Polyurethane (PU), etc.
[34] The hub 150 is provided at the proximal end 100a of the catheter 100. The hub 150 has a hollow body. The hub 150 allows access to the shaft 130 during the medical procedure. The hub 150 has a proximal end 150a and a distal end 150b (as shown in FIG. 1). The hub 150 includes an inflation port 140 and a guidewire port 145. As shown in FIG. 2C, the guide wire port 145 includes a cavity 145a. The cavity 145a is coupled to a proximal end of the guide wire lumen 132. The guide wire 110 is inserted into the guide wire lumen 132 from a proximal end of the guide wire port 145 via the cavity 145a. In an embodiment, the cavity 145a has a conical shape. The inflation port 140 includes a cavity 140a, coupled to the inflation lumens 134. The inflation port 140 is configured to pass the inflation fluid into the at least one inflation lumen 134n via the cavity 140a. In an embodiment, the cavity 140a has an eight-like shape.
[35] The distal end 150b of the hub 150 is coupled to the proximal end 130a of the shaft 130. In an embodiment, the hub 150 is coupled with the shaft 130 using, without limitation, UV bonding. FIG. 2D illustrates a section view of coupling of the hub 150 with the shaft 130, according to an embodiment. FIG. 2E illustrates a cross sectional view of the coupling of the hub 150 with the shaft 130. As shown in FIG. 2E, a distal end of the cavity 145a is coupled to a proximal end of the guide wire lumen 132 using, without limitation, UV bonding. A distal end of the cavity 140a is coupled to the proximal end of the at least one inflation lumen 134n, using without limitation, UV bonding. Further, a distal end of an inner layer of the hub 150 is coupled to an outer layer of the shaft 130 using, without limitation, UV bonding. In an embodiment, the catheter 100 is further provided with a strain relief 170. The strain relief 170 is a mechanical fixture providing support to and protecting the coupling between the hub 150 and the shaft 130. In an embodiment, the strain relief 170 is provided at the proximal end 130a of shaft 130. As shown in FIG. 2E, a proximal end of the strain relief 170 is coupled to the distal end 150b of the hub 150 using, without limitation, UV bonding. The strain relief 170 generally has a hollow, tubular structure. In an embodiment, the strain relief 170 may have a taper at a distal end of the strain relief 170. The strain relief 170 extends over the outer layer of the shaft 130 for a pre-defined length from the proximal end 130a of the shaft 130. During medical procedures, the shaft 130 is liable to the stress concentration at a joint between the shaft 130 and the hub 150. This may result in a damage due to bending of the shaft 130. The strain relief 170 helps in enhancing the strength of the joint between the shaft 130 and the hub 150.
[36] The catheter 100 may further include an inflation device (not shown). The inflation device is coupled to a proximal end of the inflation port 140. The Inflation device may include a syringe-like mechanism having a handle and a plunger. The inflation device is used to inject the inflation fluid into the inflating element structure 120 causing the inflating element structure 120 to inflate or withdraw the inflation fluid from the inflating element structure 120 causing the inflating element structure 120 to deflate during the medical procedure. The inflation device may also include a pressure monitor to measure the pressure of the inflation fluid to control the rate of inflation.
[37] During medical procedures, a guide wire 110 may be inserted into the shaft 130 from the proximal end 150a of the hub 150. The guide wire 110 is used to guide the shaft 130 to a desired place during the medical procedures. The guide wire 110 may be solid or braided. The guide wire 110 can be made of steel, an alloy of nickel and titanium, nitinol, or any other suitable material.
[38] The catheter 100 may also include a nose cone 160 having a proximal end 160a and a distal end 160b. The proximal end 160a of the nose cone 160 is coupled to the distal end 120b of the inflating element structure 120. The nose cone 160 has a hollow, tubular structure. The nose cone 160 is tapered at the distal end 160b such that the nose cone 160 has a conical shape, according to an embodiment. In an embodiment, the nose cone 160 has multiple lumens. As shown in FIG. 2F, the nose cone 160 includes a guide wire lumen 162 extending from the proximal end 160a of the nose cone 160 to the distal end 160b of the nose cone 160 to allow the passage of the guide wire 110. The nose cone 160 further includes at least one inflation lumen 164n. In an embodiment, the nose cone 160 includes a plurality of inflation lumens 164 (collectively, referred to as the inflation lumens 164). The number of the at least one inflation lumen 164n corresponds to the number of the at least one inflating element 120n. The at least one inflation lumen 164n extends partially into the nose cone 160. The distal end 120b of the inflating element structure 120 is coupled to a proximal end of the at least one inflation lumen 164n (further explained in Fig. 3A). Whenever the inflation fluid is passed through the at least one inflation lumen 164n, the inflation fluid would reach a distal end of the at least one inflation lumen 164n where the at least one inflation lumen 164n end. This leads to the accumulation of the inflation fluid within the at least one inflating element 120n causing the at least one inflating element 120n to inflate. In an embodiment, the nose cone 160 is made of soft and flexible material to facilitate positioning over the shaft 130, and to minimize the trauma or damage to the interior blood vessels into which the shaft 130 may be positioned.
[39] The catheter 100 further includes a support tubing 180 (shown in Fig. 3A) provided inside the guide wire lumen 132. In an embodiment, the support tubing 180 may be attached to the guide wire lumen 132 using, for example, heat bonding. In an embodiment, the support tubing 180 and the guide wire lumen 132 may form an integrated structure. The support tubing 180 extends outside the shaft 130 in a distal direction to the distal end 160b of the nose cone 160. A proximal end of the support tubing 180 is coupled to the guide wire port 145 of the hub 150, using, for example, UV bonding. The guide wire 110 passes through the support tubing 180. A distal end of the support tubing 180 is coupled to the distal end 160b of the nose cone 160 (shown in Fig. 3A) using, for example, heat bonding. The inflating element structure 120 may be folded on the support tubing 180. In an embodiment, the inflating element structure 120 may be crimped on the support tubing 180 using any known technique. For example, the inflating element structure 120 may be covered with the help of a polymeric sleeve and then crimped using a crimping tool. The support tubing 180 provides additional support to the inflating element structure 120 while the shaft 130 is traversed to a desired location within the patient’s body during a medical procedure. In an embodiment, the support tubing 180 is made up of a polymeric material such as, without limitation, a nylon polymer. The support tubing 180 can also be made of, without limitation, PEBAX®, PEEK, metals (such as stainless steel, nitinol), etc. In an embodiment, a laser cut tube can be used as the support tubing 180.
[40] Fig. 3 illustrates an enlarged view of the distal end 100b of the catheter 100, in an embodiment. The inflating element structure 120 includes a cluster of six inflating elements 120n as shown. It should be appreciated that the inflating element structure 120 may include less than or more than six inflating elements 120n. The number of inflating elements 120n in the inflating element structure 120 may be decided depending upon the application the catheter 100 is used for. As shown, the inflating elements 120n are in the inflated state.
[41] In an embodiment, the inflating elements 120n are attached concentrically to form the inflating element structure 120. The inflating elements 120n can be bonded to each other by, without limitation, heat bonding, adhesive bonding, or solvent bonding, etc.
[42] Fig. 3A illustrates a cross sectional view of the distal end 100b of the catheter 100, according to an embodiment. As shown in Fig. 3A, the proximal end 120a of the inflating element structure 120 is coupled with the distal end 130b of the shaft 130. In an embodiment, a proximal end 121a of each inflating element 120 of the inflating element structure 120 is coupled to a distal end of a respective inflation lumen 134n of the inflation lumens 134 using, without limitation, adhesive bonding, laser welding, etc. Further, the distal end 120b of the inflating element structure 120 is coupled with the proximal end 160a of the nose cone 160. In an embodiment, a distal end 121b of each inflating element 120n of the inflating element structure 120 is coupled to a proximal end of a respective inflation lumen 164n of the inflation lumens 164 using, without limitation, adhesive bonding, laser welding, etc.
[43] Fig. 3B illustrates a cross sectional view of an inflated state of the inflating element structure 120, according to an embodiment. Fig. 3B also illustrates the guide wire lumen 132 of the shaft 130, which allows the passage of the guide wire 110. Note that other structural components of the catheter 100 are omitted for brevity. As can be seen from Fig. 3B, the inflating element structure 120 inflates more in a direction radially away from a longitudinal axis of the shaft 130 due to the asymmetrical shape of the inflating element 120n in the inflated state. Thus, the inflating element structure 120 provides more dilation compared to the traditional inflating elements and achieve more widening of the blocked airway passage or other body cavity including blood vessels. The shape of the inflating element structure 120 upon inflation also provides a uniform pressure distribution. This improves the efficiency and effectiveness during the medical procedure. Additionally, this type of inflating element structure eliminates the need of multiple inflation and deflation to achieve proper dilation. The inflating element structure 120 can be used in longer procedures as it provides proper ventilation during the procedure and minimizes patient discomfort.
[44] Fig. 4 depicts a side view of one inflating element 120n of the inflating element structure 120 in the inflated state, according to an embodiment. As can be seen, in the inflated state, the inflating element 120n has an asymmetrical shape with respect to a longitudinal axis (X-X) of the inflating element 120n. In the inflated state, the inflating element 120n exhibits more inflation towards a lateral side 120h of the inflating element 120n as compared to a medial side 120g of the inflating element 120n due to the asymmetrical shape. In other words, the inflating element 120n encloses a higher inflation volume on the lateral side 120h as compared to the inflation volume on the medial side 120g with respect to the longitudinal axis (X-X).
[45] The inflating element 120n is hollow and has a generally tubular structure. The inflating element 120n includes a proximal end 121a and a distal end 121b. The inflating element 120n includes a central portion 120d, a first tapered portion 120e1, a second tapered portion 120e2, a first end portion 120f1 and a second end portion 120f2. In an embodiment, the inflating element 120n is coupled to the shaft 130, the medial side 120g is closer to the longitudinal axis of the shaft 130 and the lateral side 120h is radially away from the longitudinal axis of the shaft 130.
[46] According to an embodiment, the central portion 120d is cylindrical in shape and is generally symmetrical along Y-Y axis. As can be seen, the central portion 120d is asymmetric with respect to the longitudinal axis (X-X) of the inflating element 120n. The length of the central portion 120d may be between 20 mm and 100 mm. The diameter of the central portion 120d may be between 1 mm and 10 mm. In an embodiment, the length and the diameter of the central portion 120d are 40 mm and 4 mm, respectively.
[47] According to an embodiment, the first end portion 120f1 is cylindrical in shape and is generally symmetrical along the longitudinal axis (X-X) of the inflating element 120n. A proximal end of the first end portion 120f1 is coupled to the distal end of a corresponding inflation lumen 134n of the inflation lumens 134 of the shaft 130 as shown in Fig. 3A. The first end portion 120f1 provides an opening for the inflation fluid to enter the inflating element 120n for inflating the inflating element 120n to the inflated state. The length of the first end portion 120f1 may be between 4 mm and 16 mm. The diameter of the first end portion 120f1 may be between 1 mm and 3 mm. In an embodiment, the length and the diameter of the first end portion 120f1 are 8 mm and 2 mm, respectively. According to an embodiment, the second end portion 120f2 is cylindrical in shape and is generally symmetrical along the longitudinal axis (X-X) of the inflating element 120n. A distal end of the second end portion 120f2 is coupled to a proximal end of a corresponding inflation lumen 164n of the inflation lumens 164 of the nose cone 160 as shown in Fig. 3A. The length of the second end portion 120f2 may be between 4 mm and 16 mm. The diameter of the second end portion 120f2 may be between 1 mm and 3 mm. In an embodiment, the length and the diameter of the second end portion 120f2 are 8 mm and 2 mm, respectively. Though in the embodiment illustrated in Fig. 4, the first end portion 120f1 and the second end portion 120f2 have the same length and diameter, it should be appreciated that the first end portion 120f1 and the second end portion 120f2 may have different length and/or diameters depending upon the application in which the inflating element 120n is deployed.
[48] The first tapered portion 120e1 is disposed between a distal end of the first end portion 120f1 and a proximal end of the central portion 120d. According to an embodiment, the first tapered portion 120e1 tapers from a distal end of the first tapered portion 120e1 to a proximal end of the first tapered portion 120e1 along the lateral side 120h of the inflating element 120n such that the diameter of the first tapered portion 120e1 decreases from the distal end of the first tapered portion 120e1 to the proximal end of the first tapered portion 120e1. Further, as shown, the first tapered portion 120e1 has no taper (i.e., zero tapering gradient) along the medial side 120g of the inflating element 120n, according to an embodiment. The length of the first tapered portion 120e1 may be between 0.5 mm and 7 mm. In an embodiment, the length of the first tapered portion 120e1 is 3 mm.
[49] The second tapered portion 120e2 is disposed between a proximal end of the second end portion 120f2 and a distal end of the central portion 120d. According to an embodiment, the second tapered portion 120e2 tapers from a proximal end of the second tapered portion 120e2 to a distal end of the second tapered portion 120e2 along the lateral side 120h of the inflating element 120n such that the diameter of the second tapered portion 120e2 decreases from the proximal end of the second tapered portion 120e2 to the distal end of the second tapered portion 120e2. Further, as shown, the second tapered portion 120e2 has no taper (i.e., zero tapering gradient) along the medial side 120g of the inflating element 120n, according to an embodiment. The length of the second tapered portion 120e2 may be between 0.5 mm and 7 mm. In an embodiment, the length of the second tapered portion 120e2 is 3 mm. The length of the second tapered portion 120e2 may be the same or different than the length of the first tapered portion 120e1.
[50] In an embodiment illustrated in Fig. 4, the first tapered portion 120e1 and the second tapered portion 120e2 have a continuous tapering profile. In another embodiment, the first tapered portion 120e1 and the second tapered portion 120e2 may have a step-wise tapering profile or any other pre-defined tapering profile as per the requirements of the medical procedure in which the inflating element 120n is used. Further, though it is illustrated that the first tapered portion 120e1 and the second tapered portion 120e2 have no tapering (i.e., zero tapering gradient) along the medial side 120g, it is possible that the first tapered portion 120e1 and/or the second tapered portion 120e2 also have a tapered shape at the medial side 120g provided that the tapering gradient at the lateral side 120h is higher than the tapering gradient at the medial side 120g. In an embodiment, the first end portion 120f1 may have a tapered shape towards the proximal end of the first tapered portion 120e1 wherein the diameter of the first end portion 120f1 decreases towards the proximal end of the first end portion 120f1. In an embodiment, the second end portion 120f2 may have a tapered shape towards the distal end of the second tapered portion 120f2, wherein the diameter of the second end portion 120f2 decreases towards the distal end of the second end portion 120f2. In an embodiment, the central portion 120d may also have a tapered shape either towards the proximal end of the central portion 120d or towards the distal end of the central portion 120d. The dimensions of the central portion 120d, the first end portion 120f1, the second end portion 120f2, the first tapered portion 120e1 and the second tapered portion 120e2 are not limited to the dimensions provided herein, and may be suitably designed based upon the application where the inflating element 120n is deployed.
[51] Fig. 5A illustrates a cross sectional view of the inflating element structure 120 in the inflated state, in accordance with an embodiment of the present disclosure. Fig. 5B illustrates a side view of the inflating element structure 120, according to an embodiment. The inflating element structure 120 includes a plurality of inflating elements 502a – 502f. Each of the plurality of inflating elements 502a – 502f may be similar to the inflating element 120n. The plurality of inflating element 502a – 502f are coupled such that the inflating element structure 120 defines a lumen 504. The lumen 504 allows a passage of other components such as the guide wire 110. As illustrated, the plurality of inflating element 502a – 502f are attached in a circular manner to form the inflating element structure 120. As can be seen, the asymmetrical shape of the plurality of inflating elements 502a – 502f results in more inflation in a radially outward direction from the center of the first and the second end portions of the plurality of the inflating elements 502a – 502f, i.e., more inflation at a lateral side of the inflating element structure 120.
[52] During an example medical procedure, the shaft 130 is inserted into the airway passage (or blood vessels or any other body cavity) of a patient. The shaft 130 is then advanced to the site of the blockage. Once the shaft 130 reaches the site of the blockage, the inflation fluid is inserted using the inflation device through the inflation lumens 134 into the inflating element structure 120. The inflation fluid causes the inflating element structure 120 to expand to the inflated state. The inflation of the inflating element structure 120 widens the passage of the airway. The inflating element structure 120 is then deflated by pumping out the inflation fluid using the inflation device.
[53] The present disclosure proposes an inflating element 120n having an asymmetrical shape with respect to the longitudinal axis of the inflating element 120n in the inflated state and a catheter having an inflating element structure 120 including at least one proposed inflating element 120n. The proposed inflating element 120n presents several advantages. The asymmetrical shape of the inflating element 120n and thereby the asymmetrical shape of the inflating element structure 120 provides more dilation and thereby, more widening of the blocked passage. Further, a uniform pressure distribution is achieved during the inflating element 120n inflation, which improves efficiency and effectiveness of the medical procedure. The asymmetrical shape also allows improved positioning and stabilization during the medical procedure. As the proposed inflating element 120n, when inflated, better conforms to the shape of the airway passage, more effective dilation of the stenotic area is achieved, resulting in improved outcome for the patients. The asymmetrical shape also causes less damage to tissues in the airway passage and reduce trauma. As the proposed inflating element 120n inflates more in the lateral side 120h than the medial side 120g, more ventilation is provided at the medial side 120g, resulting in lesser discomfort for the patients. Further, the risk of complications such as perforation or tearing of the airway passage is also decreased.
[54] 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) comprising:
a. a shaft (130) having a proximal end (130a) and a distal end (130b), the shaft (130) comprising at least one inflation lumen (134n) configured to pass an inflation fluid; and
b. an inflating element structure (120) having a proximal end (120a) and a distal end (120b), the inflating element structure (120) comprising at least one inflating element (120n), wherein the at least one inflating element (120n) comprises a proximal end (121a) coupled to a distal end of a respective inflation lumen (134) of the at least one inflation lumen (134n) and a distal end (121b);
c. wherein the at least one inflating element (120n) is configured to be in an inflated state in response to passage of an inflation fluid from the respective inflation lumen (134); and
d. wherein in the inflated state, the at least one inflating element (120n) has an asymmetric shape with respect to a longitudinal axis (X-X) of the at least one inflating element (120n).
2. The catheter (100) as claimed in claim 1, wherein the inflating element structure (120) comprises more than one inflating element (120n).
3. The catheter (100) as claimed in claim 1, wherein the inflating element structure (120) is a cluster of inflating elements (120n).
4. The catheter (100) as claimed in claim 1, wherein in the inflated state, the at least one inflating element (120n) encloses a higher inflation volume on a lateral side (120h) of the at least one inflating element (120n) with respect to the longitudinal axis (X-X) than on a medial side (120g) of the at least one inflating element (120n) with respect to the longitudinal axis (X-X);
5. The catheter (100) as claimed in claim 1, wherein the at least one inflating element (120n) comprises:
a. a central portion (120d);
b. a first end portion (120f1) disposed at the proximal end (121a) of the inflating element (120n);
c. a second end portion (120f2) disposed at the distal end (121b) of the inflating element (120n);
d. a first tapered portion (120e1), disposed between a distal end of the first end portion (120f1) and a proximal end of the central portion (120d), wherein the first tapered portion (120e1) tapers from a distal end of the first tapered portion (120e1) to a proximal end of the first tapered portion (120e1) along a lateral side (120h) of the inflating element (120n) such that a diameter of the first tapered portion (120e1) decreases from the distal end of the first tapered portion (120e1) to the proximal end of the first tapered portion (120e1); and
e. a second tapered portion (120e2), disposed between a distal end of the central portion (120d) and a proximal end of the second end portion (120f2), wherein the second tapered portion (120e2) tapers from a proximal end of the second tapered portion (120e2) to a distal end of the second tapered portion (120e2) along the lateral side (120h) of the inflating element (120n) such that a diameter of the second tapered portion (120e2) decreases from the proximal end of the second tapered portion (120e2) to the distal end of the second tapered portion (120e2);
f. wherein at least one of the first tapering portion (120e1) and the second tapering portion (120e2) have a higher tapering gradient on a lateral side (120h) with respect to the longitudinal axis (X-X) compared to a tapering gradient on a medial side (120g) with respect to the longitudinal axis (X-X).
6. The catheter (100) as claimed in claim 5, wherein at least one of the first tapering portion (120e1) and the second tapering portion (120e2) have zero tapering gradient on the medial side (120g).
7. The catheter (100) as claimed in claim 5, wherein the first tapering portion (120e1) and the second tapering portion (120e2) have a pre-defined tapering profile.
8. The catheter (100) as claimed in claim 5, wherein the central portion (120d) has a tapered shape towards one of the proximal end of the central portion (120d) or the distal end of the central portion (120d).
9. The catheter (100) as claimed in claim 5, wherein the first end portion (120f1) has a tapered shape towards the proximal end of the first end portion (120f1).
10. The catheter (100) as claimed in claim 5, wherein the second end portion (120f2) has a tapered shape towards the distal end of the second end portion (120f2).
11. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises a nose cone (160) comprising a proximal end (160a), a distal end (160b), and at least one inflation lumen (164n), wherein the distal end (121b) of the at least one inflating element (120n) is coupled to a proximal end of a respective inflation lumen (164n) of the at least one inflation lumen (164n).
12. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises a support tubing (180) coupled to a guide wire port (145) at a proximal end of the support tubing (180) and to a nose cone (160) at a distal end of the support tubing (180), wherein the inflating element structure (120) is folded on the support tubing (180).
13. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises an Inflation port (140) having a proximal end and a distal end, the inflation port (140) comprises a cavity (140a) coupled to a proximal end of the at least one lumen (134n), wherein the inflation port (140) is configured to pass the inflation fluid to the at least one lumen (134n).
14. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises a guide wire port (145) comprising a cavity (145a) coupled to a proximal end of a guide wire lumen (132) of the shaft (130).