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:
PTA BALLOON WITH INCREASED STRENGTH AND METHOD OF MANUFACTURE THEREOF
2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

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

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a percutaneous transluminal angioplasty (PTA) balloon and a method of manufacture thereof.
BACKGROUND OF INVENTION
[002] Blood vessels carry oxygen and nutrients throughout the body and remove waste from the tissues. However, over time the waste from the tissue may deposit itself on the inner wall of the blood vessels causing vascular problems. The waste deposits are commonly referred to as plaque. A plaque is made of cholesterol, fat, calcium, and other substances. Over time, a plaque can narrow or block the arteries, reducing blood flow to the organs and tissues.
[003] Common way to treat such conditions might involve dilating (opening/expanding) the blood vessel using a minimally invasive procedure. During the procedure, a thin, flexible tube called a catheter is inserted into a blood vessel, usually through the groin or arm of an individual. The catheter is then guided to the blocked or narrowed blood vessel. A balloon (also known as percutaneous transluminal angioplasty (PTA) balloon) is inflated at the end of the catheter to widen the blood vessel and improve blood flow.
[004] However, conventional PTA balloons are operated under significantly high pressure resulting in a risk of balloon rupture. Under high inflation pressure, the PTA balloon tends to bulge or deform, losing their intended cylindrical shape. This reduces the contact area between the balloon and the lesion, thus compromising dilation.
[005] More often than not, the blocked/narrowed blood vessels do not have uniform diameter. Also, the conventional PTA balloons are not inflated to their maximum diameter, to avoid chances of rupture. In such cases, using the conventional PTA balloons which are not inflated to their maximum diameter, fail to fit in with the non-uniform blood vessels leading to incomplete dilation of the lesion, persistent narrowing and reduced blood flow, higher risk of restenosis etc. Thus, to circumvent the vessel-balloon diameter mismatch, multiple PTA balloons having different diameter corresponding to the diameter of the blood vessel are used. This results in further complications in the surgical procedure, taking a significant amount of surgical time and increases the cost of treatment.
[006] Therefore, in light of the foregoing discussion, there arises a need for a device to overcome the aforementioned drawbacks.
SUMMARY OF INVENTION
[007] The present invention relates to a percutaneous transluminal angioplasty (PTA) balloon device and method of manufacture thereof. The percutaneous transluminal angioplasty (PTA) balloon device includes, a balloon and a support structure. The balloon includes a proximal section, a distal section and a central section. The support structure coupled to at least one of the proximal section or distal section of the balloon. The support structure includes, a plurality of first members and a plurality of second members. The plurality of first members is placed over the proximal section. Each of the first member includes a plurality of rows of interconnected struts. The plurality of second members is placed over the distal section. Each of the second member includes a plurality of rows of interconnected struts. The plurality of rows of interconnected struts are configured to expand, providing flexibility to the balloon to undergo greater expansion.
[008] In an embodiment, the process of manufacturing the device includes, providing a balloon 200 having an outer surface and a support structure having an inner surface. Thereafter, the outer surface of the balloon is coupled to the inner surface of the support structure, using a UV-curable adhesive. Further, misalignments if any between the balloon and the support structure, are adjusted. Further, a second layer of an adhesive liquid at one or more contact points of the balloon and the support structure is applied, thereby resulting in an assembly of the balloon and the support structure.
[009] 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
[0010] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0011] Fig. 1 depicts a device 100, according to an embodiment of the present disclosure.
[0012] Fig. 2 depicts a balloon 200 of the device 100, according to an embodiment of the present disclosure.
[0013] Figs. 3a-3c depict different embodiments of a support structure 300a, 300b, 300c of the device 100, according to one or more embodiments of the present disclosure.
[0014] Figs. 4a-4b depict different views of a first member 340, according to a first embodiment of the present disclosure.
[0015] Figs. 4c-4d depict different views of the first member 340, according to a second embodiment of the present disclosure.
[0016] Figs. 4e-4f depict different views of the first member 340, according to a third embodiment of the present disclosure.
[0017] Fig. 5a depicts the device 100 in an expanded state, according to an embodiment of the present disclosure.
[0018] Fig. 5b depicts the device 100 in the expanded state when the balloon 200 is inflated to its maximum diameter, according to an embodiment of the present disclosure.
[0019] Fig. 6a depicts a first attachment 400, according to an embodiment of the present invention.
[0020] Fig. 6b depicts a second attachment 450, according to an embodiment of the present disclosure.
[0021] Fig. 6c depicts an assembly of the device 100, the first attachment 400 and the second attachment 450, according to an embodiment of the present disclosure.
[0022] Figs. 7a-7b depict deployment of the device 100 using a catheter 500, according to an embodiment of the present disclosure.
[0023] Fig. 8 depicts a flowchart of a method 700 to manufacture the device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] In accordance with the present disclosure, a percutaneous transluminal angioplasty (PTA) balloon device (hereinafter referred as, a device) is disclosed. The device is used in peripheral vascular surgeries to, for example, dilate blood vessels or the like.
[0029] The device of the present disclosure includes a balloon and a support structure provided at least towards a distal end and a proximal end of the balloon. The support structure includes a plurality of first members and a plurality of second members provided towards the distal end and the proximal end, respectively, of the device. Each of the first member and the second member includes a plurality of struts arranged to form a mesh. The support structures facilitate dilation of the balloon without collapsing. Further, due to the mesh configuration of the struts, the balloon can attain their maximum diameter without the risk of rupture, when the balloon is inflated in the blood vessel reducing the need for introduction and removal of balloons of different sizes during a medical procedure. Post inflation of the device, the support structure helps in maintaining the intended shape of the device as bulging of the balloon is eliminated. This helps in increasing the contact area between the outer surface of the device and the inner surface of the blood vessel, improving uniform pressure distribution, which may help reduce endothelial damage and subsequent restenosis. Also, the support structure provides anchoring at the proximal and distal ends, preventing device migration during inflation and reducing the risk of displacement. Moreover, the support structure of the device mitigates the risk of recoil of the vessel, by counteracting the elastic recoil of the blood vessel.
[0030] Now referring to the figures, Fig. 1 depicts a PTA balloon device 100 (hereinafter a device 100). The device 100 is deployed in a blood vessel, to treat a blockage and/or stenosis. The device 100 includes a support structure 300 mounted on a balloon 200.
[0031] Fig. 2 depicts the balloon 200 of the device 100. The balloon 200 of the device 100, includes a proximal section 200a, a distal section 200b and a central section 200c. The central section 200c has a substantially tubular shape while the proximal section 200a and the distal section 200b are tapered. The balloon 200 is coupled to an inner surface of the support structure 300. The balloon 200 may be coupled to the support structure 300 using, without limitation, suturing, adhesive bonding, UV bonding, etc. In an embodiment, the balloon 200 is coupled to the support structure 300 using UV bonding. The balloon 200 may be made of any material such as, without limitation, polyurethane, pebax, nylon (non-compliant), silicone, PET (polyethylene terephthalate), etc. In an embodiment, the balloon 200 is made of nylon (non-compliant). The balloon 200 is used to radially collapse or expand the support structure 300 of the device 100.
[0032] According to an exemplary depiction in Fig. 3a, the support structure 300a of the device 100, includes a proximal connector 304, a distal connector 308, one or more first members 340 and one or more second members 360. The support structure 300 is coupled to at least one of the proximal section 200a or distal section 200b of the balloon 200. The one or more first members 340 are positioned over the proximal section 200a of the balloon 200, while the one or more second members 360 are positioned over the distal section 200b of the balloon 200.
[0033] Each first member 340 may include an elongated configuration having, without limitation, flat, rounded, polygonal, or elliptical etc. cross-section. In an embodiment, the first members 340 have a flat elongated configuration.
[0034] Each second member 360 may include an elongated configuration having, without limitation, flat, rounded, polygonal, or elliptical etc. cross-section. In an embodiment, the second members 360 have a flat elongated configuration. Two consecutive first members 340 and second members 360 are spaced apart, defining a gap between the two consecutive first members 340 and second members 360 respectively. This prevents introduction of excess metal inside a lumen of the body.
[0035] The first member 340 and the second member 360 help in maintaining the intended shape of the device as bulging of the balloon 200 is eliminated. Due to zero/minimal bulging, the contact area between the outer surface of the device 100 and the inner surface of the blood vessel is increased.
[0036] The support structure 300 of the device 100 mitigates the risk of recoil of the vessel, by counteracting the elastic recoil of the blood vessel.
[0037] The first member 340 and the second member 360 of the support structure 300 may be made of any suitable biocompatible and/or shape memory material such as, without limitation, nitinol, stainless steel, cobalt-chromium alloy, titanium, or a combination thereof. In an embodiment, the support structure 300 is made by laser cutting a nitinol tube of a predefined thickness ranging from 80 micron to 200 micron.
[0038] The first members 340 converge together at the proximal end 100a of the device 100 and are coupled to the proximal connector 304. In other words, the proximal connector 304 coupled to a proximal end 342a of the first members 340. Similarly, the second members 360 converge together at the distal end 100b of the device 100 and are coupled to the distal connector 308. In other words, a distal connector 308 coupled to a distal end 342b of the second members 360. The coupling between the first members 340 and the proximal connector 304 is via at least one of welding, adhesive bonding etc. The coupling between the second members 360 and the distal connector 308 is via at least one of welding, adhesive bonding etc. In an exemplary embodiment, the coupling between the first members 340 and the proximal connector 304 is via welding. In an exemplary embodiment, the coupling between the second members 360 and the distal connector 308 is via welding.
[0039] In an exemplary embodiment, the proximal connector 304, and the distal connector 308 are ring shape structures. The distal connector 308 is used to couple the device 100 with the catheter 500 while the proximal connector 304 serves as the starting point of the device 100.
[0040] Additionally or optionally, as depicted in Fig. 3b, the support structure 300b of the device 100, includes one or more ribs 320 along with the one or more first members 340 and one or more second members 360. Each rib 320 is sandwiched between a corresponding first member 340 and a corresponding second member 360. The one or more ribs 320 of the support structure 300b are configured to at least partially couple to the central section 200c of the balloon 200. The ribs 320 are arranged in a substantially tubular shape around the balloon 200. The first members 340 and the second members 360 extend from the respective ends of the ribs 320 and converge at the proximal end 100a and the distal end 100b respectively. As described above, the converged ends of the first members 340 are coupled to the proximal connector 304 while the converged ends of the second members 360 are coupled to the distal connector 308. Details of first members 340 and the second members 360 are not repeated for the sake of brevity and can be referred therefrom.
[0041] The support structure 300b of the embodiment depicted in Fig. 3b thus attains a tubular structure with tapered ends. The support structure 300b is configured to be in one of a collapsed state or a radially expandable state.
[0042] The ribs 320 may have a suitable cross-section such as, without limitation, rectangular, circular, elliptical, triangular, hexagonal, etc. In an embodiment, the ribs 320 have a rectangular cross-section. Each rib 320 includes at least one vertical edge. The vertical edge of the rib 320 may be parallel to its length.
[0043] Two consecutive ribs 320 may be spaced apart, defining a gap between the two consecutive ribs 320. The gap between two consecutive ribs 320 may be uniform or non-uniform. In an embodiment, the gap between two consecutive ribs 320 is uniform. The one or more ribs 320 provide structural support to the balloon 200, and enhance the force applied to break the calcified region in a vasculature tissue of the body.
[0044] Additionally and optionally, as depicted in Fig. 3c, the support structure 300c of the device 100, includes one or more scoring elements 380. The one or more scoring elements 380 are provided on the respective vertical edge of the one or more ribs 320 of the support structure 300. The scoring elements 380 are configured to score (or cut) the deposits, that create blockages in the blood vessel.
[0045] Now, the structural details of the first member 340 and the second member 360, are explained. It is to be noted that given the structure of the first member 340 and the second member 360 is similar, the description provided for the first member 340 is equally applicable to the second member 360 with minor adaptations, if necessary, and hence not repeated for the sake of brevity.
[0046] A first embodiment of the first member 340 is shown in Fig. 4a. The first member 340 includes a proximal end 342a and a distal end 342b. The first member 340 includes a plurality of arms 344, a plurality of struts 346, a plurality of linkages 348 and a joining strut 350.
[0047] In an embodiment, the first member 340 includes two arms 344 (344a and 344b), included at the extremities of each row of the plurality of rows. The arms 344 extends from the proximal end 342a to the distal end 342b of the first member 340. The arms 344 may be bent towards each other, at the distal end 342b. The arms 344 may have a suitable cross-section such as, without limitation, rectangular, rounded. etc. In an embodiment, the arms 344 have a circular cross-section. The arms 344 may have a suitable configuration such as, straight, curved, angled, wavy, etc. In an embodiment, the arms 344 are straight. The arms 344 (344a, 344b) are coupled with the plurality of struts 346 at the respective ends of the plurality of rows of the first member 340. The arms 344 provide support to the struts and prevent trauma to the underlying body vasculature.
[0048] The plurality of struts 346 may have a lateral cross-section such as, without limitation, rectangular, rounded, oval, elliptical, polygonal, etc. In an embodiment, the plurality of struts 346 have a rounded lateral cross-section. The plurality of struts 346 may have a suitable configuration such as, straight, curved, angled, wavy, zigzag etc. In an embodiment, the plurality of struts 346 are straight.
[0049] The plurality of struts 346, are connected in a predefined pattern such as, zig-zag, mesh-like, lattice etc. The plurality of struts 346 are arranged in a plurality of interconnected rows. In other words, the first member 340 includes the plurality of rows of interconnected struts 346. Similarly, the second member 360 includes a plurality of rows of interconnected struts 346. The plurality of rows of interconnected struts 346 of the first member 340 and the second member 360 are configured to expand, providing flexibility to the balloon to undergo greater expansion. Each row of the first member 340, includes one or more peaks and one or more troughs. In an embodiment, each peak of a row of the plurality of rows, aligns with the corresponding peak of the consecutive rows. In an embodiment, each trough of a row of the plurality of rows, aligns with the corresponding trough of the consecutive rows. This arrangement of peaks and troughs in each row results in a W-shaped configuration of a row and thereby, the first member. The W-shaped configuration enhances overall strength by distributing mechanical stress more evenly across the first structure. Additionally, the curved profile of the peaks and troughs, provides flexibility, allowing the first member to expand and compress efficiently.
[0050] The struts 346 are connected to each other using a suitable technique such as, without limitation, welding, adhesive bonding, etc. In an embodiment, the struts 346 are connected using welding. Alternately, the first member 340 having the struts 346, is made by laser cutting a sheet.
[0051] The plurality of rows is interconnected via one or more linkages 348. The linkages 348 may have a suitable cross-section such as, without limitation, rectangular, rounded. In an embodiment, the linkages 348 have a rectangular cross-section. The linkages 348 may have a suitable configuration such as, straight, curved, angled, wavy. In an embodiment, the linkages 348 is curved. The linkages 348 may be configured to connect, at least one of, the trough or the peak of each row, to at least one of, the trough or the peak of the consecutive row. In an embodiment, the linkage 348 connects one trough and one peak of two consecutive rows, of the plurality of rows (as shown in Figs. 4a-4b). In other words, the linkage 348 connects a trough of a first row with a peak of a second row of the plurality of rows.
[0052] The joining strut 350 of the first member 340, may be provided at the distal end 342b of the first member 340. The joining strut 350 may have a suitable cross-section such as, without limitation, rectangular, rounded. In an embodiment, the joining strut 350 have a rectangular cross-section. The joining strut 350 may have a suitable configuration such as, straight, curved, angled, wavy, etc. In an embodiment, the joining strut 350 is curved. The joining strut 350 is configured to join the arms 344. In an embodiment, the joining strut 350 is configured to join the arm 344a and the arm 344b at the distal end 342b of the first member 340.
[0053] A second exemplary depiction of the first member 340 is provided in Figs. 4c-4d. In this embodiment, at least one of the arms 344 of the first member 340, is discontinuous. In an embodiment, the arm 344b is discontinuous, defining a gap of width ‘w’. In an embodiment, the width ‘w’ ranges from 0.2 cm to 1.0 cm. In an embodiment, the row corresponding to the gap of width ‘w’, is discontinuous.
[0054] According to a third exemplary depiction in Figs. 4e-4f, the first member 340 includes a plurality of arms 344, a plurality of struts 346, a plurality of first linkages 348a, a plurality of second linkages 348b and a joining strut 350. It is to be noted the configuration of the arms 344, the struts 346, and the joining strut 350 is similar, as explained in exemplary depictions of Figs. 4a-4b and can be referred therefrom.
[0055] The linkages 348 may have a suitable cross-section such as, without limitation, rectangular, rounded. In an embodiment, the linkages 348 have a rectangular cross-section. The first linkage 348a and the second linkage 348b may have a suitable configuration such as, straight, curved, angled, wavy, zigzag. In an embodiment, the first linkage 348a is curved and the second linkage 348b is straight. In an alternate embodiment, both the first linkage 348a and the second linkage 348b are curved as depicted. The first linkage 348a and the second linkage 348b may be configured to connect, at least one of, a trough or a peak of a first row, to a peak or a trough respectively, of the consecutive row or the second row. In other words, the linkages 348 connects one of the trough of the first row with two peaks of the second row of the plurality of rows. In an embodiment, the first linkage 348a connects the trough of the first row with a first peak of the consecutive or second row while the second linkage 348b connects the same trough of the first row with a second peak of the consecutive or second row, as depicted.
[0056] The arms 344, the struts 346 and the linkages 348 of the first member340, may be laser cut from a tube. Alternately, these may be separate components and thereafter welded, soldered, brazed, etc.
[0057] Further, the one or more optional ribs 320, the one or more first members 340, the one or more second members 360 and the one or more optional scoring elements 380 of the support structure 300, may be laser cut from a tube. Alternately, these may be separate components and thereafter welded, soldered, brazed, etc.
[0058] Fig. 5a depicts the device 100 in an expanded state, when the diameter of the inflated balloon 200 is less than its maximum diameter, also known as a partially inflated state. Further, Fig. 5b depicts the device 100 in the expanded state when the balloon 200 is inflated to its maximum diameter, also known as a completely inflated state. As depicted in Figs. 5a-5b, in the partially inflated state the distance between two adjacent struts of each row of the first member 340 and the second member 360 is less than the distance between the two adjacent struts of each row of the first member 340 and the second member 360 in the completely inflated state.
[0059] The device 100 is coupled to a first attachment 400 and second attachment 450 in order to mount it on a catheter. The first attachment 400 is provided at the proximal end 100a of the device 100. The first attachment 400 has a substantially tubular structure. Fig. 6a depicts the first attachment 400. In an embodiment, the first attachment 400 includes a first portion 402, a second portion 404 and a third portion 406 provided therebetween. The first portion 402 is provided proximal to the second portion 404 and the third portion 406. The second portion 404 is provided distal to the third portion 406. The third portion 406 couples the first portion 402 with the second portion 404. In an embodiment, the third portion 406 tapers from a distal end of the first portion 402 to a proximal end of the second portion 404 (in other words, the third portion 406 extends between a distal end of the first portion 402 and a proximal end of the second portion 404).
[0060] The first portion 402 and the second portion 404 include a respective predefined length and a respective predefined diameter. The first portion 402 and the second portion 404 may have the same or different lengths ranging between 1mm and 4mm. In an embodiment, the first portion 402 and the second portion 404 have different lengths. In an exemplary embodiment, the respective predefined lengths of the first portion 402 and the second portion 404 are 2mm and 2.5mm, respectively.
[0061] In an embodiment, the first attachment 400 has a varying diameter. In an embodiment, the first portion 402 is narrower than the second portion 404. In an embodiment, the respective diameter of the first portion 402 and the second portion 404 may range between 1mm to 4mm and 1mm to 4mm respectively.
[0062] The first attachment 400 is coupled to a catheter 500 at one end and the support structure 300 at the other end. In an embodiment, the proximal end 100a of the first portion 402 of the first attachment 400 is configured to couple to a catheter 500 (as explained later, in reference to Figs. 7a-7b). In an embodiment, the second portion 404 of the first attachment 400 is configured to couple to the support structure 300. The first attachment 400 may be made of a biocompatible shape setting material, such as, without limitation, Pebax, Nitinol, polyurethane, silicone etc., or a combination thereof. In an embodiment, the first attachment 400 is made of Pebax.
[0063] The second attachment 450 has a tubular structure. The second attachment 450 is provided at the distal end 100b of the device 100. The second attachment 450 includes a proximal end 450a and a distal end 450b. Fig. 6b depicts the second attachment 450. In an embodiment, the second attachment 450 is closed at the distal end 450b. The second attachment 450 is tapered towards the distal end 450b. The second attachment 450 is configured to couple to the support structure 300 (as explained later). The second attachment 450 is used to break one or more blockages or calcified regions in the arteries. The second attachment 450 may be made of a biocompatible shape setting material, such as, without limitation, Nitinol, stainless steel, cobalt-chromium alloy, titanium etc., or a combination thereof. In an embodiment, the second attachment 450 is made of nitinol tube. The first attachment 400 and the second attachment 450 provides controlled inflation and deflation of the device 100.
[0064] Now the coupling of the first attachment 400, the second attachment 450 and the device 100 is explained further. The first attachment 400 may be coupled to or integrated at the proximal end 100a of the device 100. The first attachment 400 may be coupled to the device 100 using a suitable technique, such as, without limitation, UV (Ultraviolet) bonding, adhesive bonding, thermal bonding, welding etc. In an embodiment, the first attachment 400 is coupled to the device 100 using UV bonding. The second attachment 450 may be coupled to or integrated at the distal end 100b of the device 100. The second attachment 450 may be coupled to the device 100 using a suitable technique, such as, without limitation, UV (Ultraviolet) bonding, adhesive bonding, thermal bonding, welding etc. In an embodiment, the second attachment 450 is coupled to the device 100 using UV bonding.
[0065] Further, the assembly obtained post coupling the first attachment 400, the second attachment 450, and the device 100, is then deployed in the blood vessel at the target site using the catheter 500. Fig. 6c depicts the assembly. Herein, the target site without limitation, includes a blood vessel containing one or more blockages.
[0066] In an embodiment, the assembly is coupled to the catheter 500, at the proximal end 100a (as shown in Fig. 7a). The assembly post coupling with the catheter 500, is introduced in a body vasculature in a collapsed state.
[0067] Once the catheter 500 is positioned at the target site, the assembly is uncovered from a catheter sheath. Thereafter, the device 100 of the assembly, is expanded using the catheter 500. In an embodiment, an inflation media is injected into the catheter 500 to inflate the balloon 200. Consequently, the underlying balloon 200 applies a radial pressure on the support structure 300, causing it to expand (as shown in Fig. 7b).
[0068] Simultaneously, as the balloon 200 expands, the device 100 comes in contact with the inner wall of the blood vessel, thereafter expanding the blood vessel and clearing the blockage. Once the blockage is cleared, the balloon 200 is deflated, consequently resulting in collapse of the device 100.
[0069] Now, the method for manufacturing the device 100 has been explained. Fig. 8 depicts the flowchart of a method 700, for the manufacturing the device 100. The method 700 commences at step 701 by fabricating the balloon 200 of the device 100 having an outer surface. First, a tube of a predefined length and thickness is extruded from a die. The predefined length of the tube corresponds to the length of the balloon 200. The predefined length ranges from 4 cm to 20 cm. The predefined thickness may range from 0.2 mm to 2.5 mm. In an embodiment, thickness of the tube is 1.6 mm. The tube is extruded at a predefined temperature and pressure. The temperature may range from 300°C to 400°C. In an embodiment, the temperature at which the tube is extruded is 360°C. Further, the predefined pressure may range from 50 MPa to 150 MPa. In an embodiment, the predefined pressure is 100 MPa. The material of the tube may without limitation include, a biocompatible material such as pebax, etc. In an embodiment, the material of the tube is pebax. The extruded tube may include one or more layers. In an exemplary embodiment, the tube includes two layers.
[0070] The tube is further blow molded, in a controlled pressure process at a predefined temperature. The predefined temperature may range from 250°C to 350°C. In an embodiment, the predefined temperature is 310°C. Blow molding the tube creates a hollow space in the tube, defining the predefined diameter. In an embodiment, the diameter ranges from 2mm to 6mm. Further, the inner surface of the tube is micro-patterned for enhanced stent bonding. The tube is micro-patterned using a suitable technique such as, without limitation laser ablation, embossing, or chemical etching techniques.
[0071] Thereafter, the tube undergoes post-molding annealing and cryogenic treatment to obtain the balloon 200 of a predefined thickness, ranging from 1.67 mm to 3 mm. The post-molding annealing can be carried out using a suitable apparatus. In an embodiment, post-molding annealing is carried out using Binder FP Series Forced Convection Oven, which provides stable and even heat distribution for annealing applications. In post-molding annealing, the tube is heated to a predefined temperature below its melting point, and is held at that predefined temperature for a set period, and then it is slowly cooled. In an embodiment, the predefined temperature ranges from 150 degrees to 250 degrees. In an embodiment, the set time ranges from 1 min to 5min. The post molding annealing provides stress relief, improved dimensional stability, enhanced mechanical properties.
[0072] In the cryogenic treatment, the tube is rapidly cooled down at a predefined temperature. In an embodiment, the predefined temperature ranges from -100°C degrees to -196°C degrees. The cryogenic treatment provides reduced residual stress, and enhanced flexibility.
[0073] At step 702, the support structure 300 of the device 100, is fabricated including an inner surface. The support structure 300 may be laser cut from a tube of a predefined thickness, ranging from 1 mm to 2.5 mm. In an embodiment, the predefined thickness of the tube is 1.6 mm. The tube may be composed of a shape memory material, such as, nitinol. In an embodiment, the tube is made of nitinol. In an embodiment, the process of cutting the support structure 300 from a tube is assisted by AI. The AI assisted cutting from the tube, facilitates real-time feedback, resulting in precise designs of the support structure 300. Further, AI assisted cutting adapts power, speed, and cutting paths dynamically based on the properties of the raw material. Also, automated quality control and error detection enhance the consistency and structural integrity of the support structure 300.
[0074] Further, the support structure 300 is cut from the tube, undergoes dual-stage heat setting, which involves heating the support structure 300 at a predefined temperature for a predefined time, twice. The predefined temperature at the first stage heat setting, ranges from 450 degrees to 550 degrees. The predefined time at the first stage heat setting, ranges from 3 min to 10 min. The predefined temperature at the second stage heat setting, ranges from 250 degrees to 400 degrees and the predefined time at the second stage heat setting, ranges from 5 min to 15 min. In an embodiment, the predefined temperature is 505 degrees and the predefined time is 5 to 10 min. The dual stage heat setting provides shape memory retention, and stress relief.
[0075] Thereafter, the support structure 300 undergoes cryogenic conditioning, which involves exposing the support structure 300 to a low temperature, ranging from -100 degrees to -196 degrees. In an embodiment, the temperature is -150 degrees. The cryogenic conditioning provides enhanced material toughness, reduced residual stress.
[0076] At step 703, the surface of the balloon 200 and the support structure 300 are prepared for enhanced bonding. The outer surface of the balloon 200 and the inner surface of the support structure 300 are prepared using a suitable surface modification technique such as, plasma activation chemical etching. In an embodiment, plasma activation technique is used to prepare the surface of the balloon 200 and the support structure 300. The plasma activation technique is carried out for a predefined time ranging from 30 seconds to 5 minutes and at a predefined temperature ranging from 20°C to 80°C. In an embodiment, the predefined time is 2 mins and predefined temperature is 50°C. The plasma activation technique is carried out at a predefined vacuum pressure ranging from 0.1 to 1.0 Torr. In an embodiment, the vacuum pressure is 0.5 Torr. The gas used for plasma activation may without limitation include, argon, oxygen, or a combination thereof. In an embodiment, mixture of both the gases are used in a predefined composition. For example, the mixture includes 70% Argon, 30% Oxygen. The flow rate of gas may range from 10 sccm to 50 sccm. In an embodiment, the flow rate of gas is 30 sccm. The power input to ionize the gas (also known as plasma power) may range from 50 W to 300 W. In an embodiment, the plasma power is 150 W. The plasma activation technique under controlled environmental conditions is used to remove contaminants such as, oil, grease, organic residues, etc. Herein, the controlled environmental conditions include controlled gas flow rate, and specific power input.
[0077] Further, the outer surface of the balloon 200 and the inner surface of the support structure 300 are coated with at least one layer of a priming liquid, to smoothen the surfaces and optimize the adhesion. In an embodiment, the priming liquid includes, a hydrophobic base coat and an adhesive promoting liquid. In an embodiment, the adhesive promoting layer includes Silane Coupling Agent. The Silane Coupling Agent may be without limitation, 3-Aminopropyltriethoxysilane (APTES) or 3-Methacryloxypropyltrimethoxysilane (MPTMS) – enhances bonding between metal and polymer surfaces. In an embodiment, the adhesion-promoting layer includes 5% APTES in 95% Ethanol, applied via dip-coating or spray-coating and cured at 50°C for 10 minutes.
[0078] Thereafter, the balloon 200 and the support structure 300 may undergo a medical-grade ultrasonic cleaning at a predefined frequency ranging from 40 kHz to 80 kHz and a predefined temperature ranging from 30°C to 60°C for a predefined duration ranging from 5 to 20 minutes. In an embodiment, the predefined frequency is 60 kHz. In an embodiment, the predefined temperature is 45°C. In an embodiment, the predefined duration is 10 minutes. Further, thorough rinsing is done to remove any residual cleaning solution and contaminants. In an embodiment, rinsing is done thrice using deionized water including, 2% enzymatic detergent or isopropanol for organic residue removal. Then cavitation energy may range from 5 to 15 W/cm². In an embodiment, the cavitation energy is 10 W/cm². The medical-grade ultrasonic cleaning ensures removal of residues, optimizes adhesion and prevents structural weakness.
[0079] At step 704, the first adhesion process is caried out. The outer surface of the balloon 200 is coupled to the inner surface of the support structure 300, using an adhesive liquid. A layer of the adhesive liquid may be applied at the surface of the balloon 200 and the support structure 300. The adhesive liquid may be without limitation, UV-curable adhesive. In an embodiment, the adhesive liquid includes, 5% polyurethane (PU) in 95% ethanol, with 1% APTES as an adhesion promoter, applied via dip-coating or spray-coating, then cured at 50°C for 10 minutes. In an embodiment, the UV-curable adhesive is exposed to controlled UV light for 2 min to 10 min minutes. More specifically, the UV-curable adhesive is exposed to controlled UV light for 3 min. The controlled UV light provides partial curing, which allows adjustments between the balloon 200 and the support structure 300 before the final fixation.
[0080] At step 705, the support structure 300 is aligned with the balloon 200 of the device 100. The misalignment if any at step 704, is adjusted between the balloon 200 and the support structure 300. The support structure 300 is precisely aligned with the outer surface of the balloon 200. The support structure 300 may be clamped to the balloon 200 using a suitable clamping mechanism such as, micro-clamping mechanism.
[0081] At step 706, the second adhesion process is carried out. A second layer of adhesive liquid may be applied at one or more contact points of the balloon 200 and the support structure 300, resulting in an assembly of the balloon 200 and the support structure 300. The adhesive liquid may be without limitation, UV-curable adhesive. In an embodiment, the UV-curable adhesive is exposed to high intensity UV light for 3 minutes. The high intensity UV light provides complete curing, which allows uniform adhesion between the balloon 200 and the support structure 300, and also provides durability.
[0082] At step 707, the final fixation process is carried out. The final fixation of the balloon 200 with the support structure 300 is ensured using suitable bonding techniques such as, thermal bonding. In an embodiment, the final fixation (or bonding) of the balloon 200 and the support structure 300 is done using thermal bonding technique at a predefined temperature. In an embodiment, the temperature ranges from 40 degrees to 120 degrees and for 3 minutes to 10 minutes. In an embodiment, thermal bonding is done at the edges of the support structure 300, ensuring material fusion of the balloon 200.
[0083] 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:CLAIMS
1. A percutaneous transluminal angioplasty (PTA) balloon device (100) comprising:
a. a balloon (200) having a proximal section (200a), a distal section (200b) and a central section (200c); and
b. a support structure (300) coupled to at least one of the proximal section (200a) or distal section (200b) of the balloon (200), the support structure (300) comprising:
i. a plurality of first members (340) placed over the proximal section (200a), each first member (340) includes a plurality of rows of interconnected struts (346); and
ii. a plurality of second members (360) placed over the distal section (200b), each second member (360) includes a plurality of rows of interconnected struts (346);
wherein the plurality of rows of interconnected struts 346 of the first member (340) and the second member (360) are configured to expand, providing flexibility to the balloon (200) to undergo greater expansion.
2. The device (100) as claimed in claim 1 wherein, two consecutive first members (340) and second members (360) are spaced apart, defining a gap between the two consecutive first members (340) and second members (360) respectively.
3. The device as claimed in claim 1 wherein, the support structure (300) is made from a shape memory material.
4. The device (100) as claimed in claim 1 wherein each row of the plurality of rows includes one or more peaks and one or more troughs.
5. The device (100) as claimed in claim 4 wherein each peak of a row, aligns with a corresponding peak of a consecutive row.
6. The device (100) as claimed in claim 4 wherein each trough of a row, aligns with a corresponding trough of a consecutive row.
7. The device (100) as claimed in claim 1 wherein a linkage (348) connects two consecutive rows of interconnected struts (346).
8. The device (100) as claimed in claim 1 wherein a linkage (348) connects one of:
a. a trough of a first row with a peak of a second row of the plurality of rows; or
b. the trough of the first row with two peaks of the second row of the plurality of rows.
9. The device (100) as claimed in claim 1 wherein at least one of the first member (340) or the second member (360) includes a plurality of arms (344) provided at extremities of each row of the first member (340) or the second member (360) and optionally, joined by a joining strut (350).
10. The device (100) as claimed in claim 8 wherein, the plurality of arms (344) is bent towards each other, at the distal end (342b).
11. The device (100) as claimed in claim 1 wherein the support structure (300) includes at least one of:
a. a proximal connector (304) coupled to a proximal end (342a) of the first members (340); and
b. a distal connector (308) coupled to a distal end (342b) of the second members (360).
12. The device (100) as claimed in claim 1, wherein the support structure (300) includes one or more ribs (320), sandwiched between the corresponding first member (340) and the corresponding second member (360).
13. The device (100) as claimed in claim 1, wherein the support structure (300) includes one or more scoring elements (380).
14. A process of manufacturing the device (100) comprising:
a. providing a balloon (200) having an outer surface;
b. providing a support structure (300) having an inner surface;
c. coupling the outer surface of the balloon (200) to the inner surface of the support structure (300), using a UV-curable adhesive;
d. adjusting misalignment between the balloon (200) and the support structure (300) in step c, if any; and
e. applying a second layer of an adhesive liquid at one or more contact points of the balloon (200) and the support structure (300), thereby resulting in an assembly of the balloon (200) and the support structure (300).
15. The process of manufacturing the device (100) as claimed in claim 14 wherein the step of providing the balloon (200) includes fabricating the balloon (200), the fabricating includes optionally:
a. extruding a tube from a die;
b. blow molding the tube, to create a hollow space within the tube;
c. micro-patterning an inner surface of the tube; and
d. subjecting the tube to post-molding annealing and cryogenic treatment.
16. The process of manufacturing the device (100) as claimed in claim 14 wherein providing the support structure (300) includes:
a. laser cutting the support structure (300) from a tube;
b. heating the support structure (300) at a predefined temperature for a predefined time, at least twice; and
c. conditioning the support structure (300) cryogenically.
17. The process of manufacturing the device (100) as claimed in claim 14 wherein prior to the step of coupling, the method includes preparing the outer surface of the balloon (200) and the inner surface of the support structure (300), using plasma activation and coating the outer surface of the balloon (200) and the inner surface of the support structure (300) with at least one layer of a priming liquid, to smoothen the surfaces and optimize the adhesion.
18. The process of manufacturing the device (100) as claimed in claim 14 wherein the step of coupling includes exposing the UV-curable adhesive to a controlled UV light for a predefined duration.
19. The process of manufacturing the device (100) as claimed in claim 14 wherein after the step of applying, the method includes fixing the balloon (200) with the support structure (300) using suitable bonding techniques.