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WO-2026092832-A1 - METHOD OF WELDING A BALLOON TO A TUBE, AND DEVICE OBTAINED THEREBY

WO2026092832A1WO 2026092832 A1WO2026092832 A1WO 2026092832A1WO-2026092832-A1

Abstract

A method of welding a balloon (10) to a tube (20), where the tube (20) has at least one coating layer (24) of a first material and at least one lumen (22) in flow communication with the outside of the tube (20) through at least one lateral opening (23), and where the balloon (10) has two opposite end portions (11) open at respective ends (12) and is made of a second material suitable for fusion with the first material of the coating layer (24) of the tube (20). The method comprises the steps of: - fitting the balloon (10) onto the tube (20) in correspondence with the at least one lateral opening (23); - applying to each end portion (11) of the balloon (10) a respective heat-shrink element (30) of a third material suitable for fusion with at least the second material; - supplying each heat-shrink element (30) with a quantity of heat (Q) such as to cause to shrink and compress the respective end portion (11) of the balloon (10) against the tube (20), such quantity of heat (Q) being transmitted at least partially to the end portion (11) and to the coating layer (24), obtaining the mutual welding of the balloon (10), the tube (20) and the heat-shrink element (30).

Inventors

  • STORER, Matteo
  • Spatarella, Nicola
  • STORER, Francesco
  • BORGHETTI, Elvis
  • Venturini, Monica
  • Pasotti, Simona

Assignees

  • ENKI S.R.L.

Dates

Publication Date
20260507
Application Date
20241029

Claims (13)

  1. 1) Method of welding a balloon (10) to a tube (20), wherein the tube (20) has at least one coating layer (24) of a first material and at least one lumen (22) in flow communication with the outside of the tube (20) through at least one lateral opening (23), and wherein the balloon (10) has two opposite end portions (11) open at respective ends (12) and is made of a second material suitable for fusion with the first material of the coating layer (24) of the tube (20); the method being characterised in that it comprises the steps: - fitting the balloon (10) onto the tube (20) in correspondence with the at least one lateral opening (23); - applying onto each end portion (11) of the balloon (10) a respective heat-shrink element (30) of a third material suitable for fusion with at least the second material; - supplying each heat-shrink element (30) with a quantity of heat (Q) such as to cause it to shrink and compress the respective end portion (11) of the balloon (10) against the tube (20), such quantity of heat (Q) being transmitted at least partially to the end portion (11) and to the coating layer (24), obtaining the mutual welding of the balloon (10), the tube (20) and the heat-shrink element (30).
  2. 2) Method according to claim 1 characterised in applying each heat-shrink element (30) in such a way that it covers one end (12) of the balloon (10), at least one adjacent part of the end portion (11), and at least one adjacent part of the tube (20) not covered by the balloon (10).
  3. 3) Method according to claim 1 or 2 characterised in that the third material is also suitable for fusion with the first material.
  4. 4) Method according to any one of the preceding claims characterised in that at least one of the first material, the second material and the third material comprises at least one polyolefin.
  5. 5) Method according to claim 4 characterised in that said at least one polyolefin is polyethylene (PE) and/or polypropylene (PP) and/or another thermoplastic polyolefin.
  6. 6) Method according to any of the preceding claims characterised in that at least the second material comprises at least one between styrene-butylene- styrene rubber (SBS) and styrene-ethylene-butylene-styrene rubber (SEBS).
  7. 7) Method according to any of the preceding claims characterised in that it comprises the step of applying the coating layer (24) on a support layer (21) of the tube (20), before the step of fitting the balloon (10) onto the tube (20).
  8. 8) Method according to any of the preceding claims characterised in supplying each heat-shrink element (30) with a quantity of heat (Q) sufficient to raise the temperature of the heat-shrink element (30) and of the parts of the balloon (10) and of the tube (20) covered by it to their respective melting temperatures, or at least to respective softening temperatures, such as to allow at least partial mixing of the first material, the second material and the third material.
  9. 9) Method according to any of the preceding claims characterised in that the supplying step causes each heat-shrink element (30) to be welded in a single body with the parts of the balloon (10) and of the tube (20) covered by it.
  10. 10) Device comprising: - a tube (20) having at least one coating layer (24) of a first material and at least one lumen (22) in flow communication with the outside of the tube (20) through at least one lateral opening (23); - a balloon (10) having two opposite end portions (11) open at respective ends (12), fitted onto the tube (20) in correspondence with the at least one lateral opening (23) and made of a second material suitable for fusion with the first material of the coating layer (24) of the tube (20); - a heat-shrink element (30) for each end portion (11) of the balloon (10), applied onto at least a part of the respective end portion (11) and made of a third material suitable for fusion with at least the second material; the device (1) being characterised in that the balloon (10), the tube (20) and each heatshrink element (30) are mutually welded.
  11. 11) Device according to claim 10 characterised in that at least one of the first material, the second material and the third material comprises at least one polyolefin.
  12. 12) Device according to claim 10 or 11 characterised in that each heat-shrink element (30) affects one end (12) of the balloon (10), at least one adjacent part of the end portion (11), and at least one adjacent part of the tube (20) not covered by the balloon (10).
  13. 13) Device according to any of claims 10-12 characterised in that each heat-shrink element (30) is welded in a single body with the parts of the balloon (10) and of the tube (20) affected by it.

Description

METHOD OF WELDING A BALLOON TO A TUBE, AND DEVICE OBTAINED THEREBY DESCRIPTION TECHNICAL FIELD The present invention falls within the sector of the production of biomedical tubes or catheters and for other sectors, and in particular concerns a method of welding a balloon to a tube. BACKGROUND ART A method of anchoring a balloon to a tube, catheter, duct, or similar is known. The tube, single-lumen or multi-lumen, is made of a relatively flexible but inextensible material, for example plastic or polymeric material such as polyamide, polyether block amide, polycarbonate, or similar. The balloon, on the other hand, usually requires good elastic properties, and is therefore made of elastic material, typically based on polyolefin or polyurethane, which is not compatible with fusion welding with the tube material. This known method therefore involves fitting the balloon onto the tube through two openings made at the ends of the balloon itself and fixing these ends to the tube by gluing, tying or other type of mechanical constraint. A disadvantage of this known method is that these constraints are fragile and not very robust, exposing the balloon to a high risk of tearing, breaking or detaching from the tube to which it is attached. Another disadvantage of the known method is that gluing and tying the balloon to the tube are procedures that generally must be performed manually by an expert operator, and which in any case are very costly in terms of time and checks required. There is a further method known for welding a balloon to a tube, wherein the tube has at least an external layer of material compatible with welding with the elastic material of the balloon. This known method involves the steps of fitting the balloon onto the tube, fitting onto each end of the balloon a sleeve-type heat-shrink element made of a material that is incompatible with fusion with the materials of the balloon and the outer layer of the tube, supplying the heat-shrink elements with sufficient heat to cause them to shrink and the balloon materials and the tube underneath to locally melt and mix, and then removing the heat-shrink elements from the resulting device formed by the tube with the balloon, which could otherwise possibly detach or cause scratches and other unwanted damages during use of the device. Alternatively, if the material of the heat-shrink elements can fuse with the balloon and/or tube, the method involves inserting a sheath element between them that allows heat transmission but prevents the heat-shrink elements and the balloon and tube from welding together. Each sheath element must then be removed together with the corresponding heat-shrink element. A disadvantage of this known method is that the removal of the heat-shrink elements is time-consuming and, if for example they are cut, there is a risk of damage to the tube and the balloon underneath. Another disadvantage of the known method is that the welding obtained by melting and mixing the materials of the balloon and of the tube generally affects a very limited and localized portion of the ends of the balloon. Consequently, the welding, although generally stronger than a constraint such as gluing or tying, does not have an excellent seal and may be fragile, yielding, and even risky, especially in application contexts such as the medical one. A further disadvantage is that the heat-shrink elements and, if present, the sheath elements are consumable, that is, once removed from the device obtained following welding they generally cannot be used again in welding on another device, and therefore constitute waste to be disposed of. DISCLOSURE OF THE INVENTION An object of the present invention is to propose a method of welding a balloon to a tube that is simple and quicker than known methods. Another object is to propose a method that provides a reinforced and robust welding of the balloon to the tube, to obtain an extremely effective mechanical and pneumatic seal of the balloon on the tube. A further object is to propose a method in which the use of additional consumable elements, such as sheath elements, is not required to perform the welding. BRIEF DESCRIPTION OF THE DRAWINGS The characteristics of the invention are highlighted below with particular reference to the attached drawings, schematic and not to scale, in which Figures 1-5 illustrate a sequence of steps of the method of welding a sleeve to a tube object of the present invention. BEST MODE TO CARRY OUT THE INVENTION With reference to Figures 1 to 5, an object of the present invention is a method of welding a balloon 10 to a tube 20 to obtain a device 1 (shown in Figure 5), typically but not exclusively employed in the medical field as a catheter with an inflatable balloon, or in the hydraulic or construction field as a probe, or in other similar applications. The tube 20 (shown in Figure 1) has at least one coating layer 24 of a first material that preferably extends along the entire length of the tube 20