Patent Description:
The object of the present invention is a mold for forming such an expandable balloon.

The present invention further relates to a manufacturing method for an expandable balloon and an expandable balloon having a concave portion.

Furthermore, the present invention relates to a method for collecting material from a lumen of a patient's body.

Various types of expandable balloons for medical-surgical applications are generally known. These balloons are typically intended to be inserted in a collapsed configuration inside a lumen of a patient's body and then expanded radially inside the lumen.

Document <CIT> shows a known mold solution with tapered walls for forming an expandable balloon. Further examples of molds for making expandable balloons are known from documents <CIT>, <CIT>, <CIT> and <CIT>.

The known solutions mentioned above are all aimed at making an expandable balloon having a substantially cylindrical convex portion tapering towards the ends.

For example, <CIT> of the same Applicant discloses an embodiment of a catheter provided with expandable balloons which expand to isolate from the blood circulation an annular chamber inside the blood vessel in which to inject the sclerosing drug in a controlled manner. The presence of such radially expandable balloons, which isolate an annular chamber between the catheter shaft and the vessel wall, avoids having to inject the drug into the entire section of the vessel stretch to be treated, allowing the drug to be injected only in one annular area of the blood vessel in contact with the wall. The device disclosed therein allows performing empty vein sclerotherapy, without blood, therefore without plasma proteins which can neutralize the pharmacological activity of the sclerosing drug; this allows a fine control of the concentration of the drug injected on the internal wall of the vein; it allows positioning at <NUM>° the drug on the entire internal vein surface and it also allows managing a time of drug contact with the vein wall. The drug-to-part contact time is critical to allow the drug to penetrate the internal wall thickness of the vein and generate an inflammatory vein repair response.

The need is therefore felt to provide a mold having features such as to allow the production of an expandable balloon suitable for use in the medical-surgical field of different shape with respect to known solutions.

At the same time, the need is felt to provide an alternative solution of expandable balloons suitable for intraluminal use in the medical-surgical field with improved functionality with respect to known solutions.

An object of the present invention is to obviate the drawbacks of the known art described up to now.

This and other objects are achieved with a mold according to claim <NUM>, as well as with a method according to claim <NUM>.

Some advantageous embodiments are the subject of the dependent claims.

It is clear that the appended claims are an integral part of the present description.

Further features and advantages of the invention will become apparent from the description provided below of preferred exemplary embodiments thereof, given by way of nonlimiting example, with reference to the accompanying drawings, in which:.

In accordance with a general embodiment, a mold <NUM> is included for forming an expandable balloon <NUM>. The expandable balloon <NUM> is suitable for medical-surgical applications. For example, the expandable balloon <NUM> is adapted to be mounted on an intraluminal element <NUM>, for example a catheter shaft <NUM> of a vascular catheter <NUM>. In accordance with a preferred embodiment, the expandable balloon <NUM> comprises a concave portion of the balloon <NUM> for collecting material <NUM>, for example debris <NUM>, from the lumen <NUM> of a blood vessel.

The mold <NUM> comprises a die <NUM>. The die <NUM> comprises a first wall <NUM> at least partially delimiting a concave portion <NUM> of a mold cavity <NUM>. The inclusion of said concave portion <NUM> of the mold cavity <NUM> allows to form said concave balloon portion <NUM> of the expandable balloon <NUM>.

The first wall <NUM> of the die <NUM> comprises a protrusion <NUM> adapted to project cantilevered in said mold cavity <NUM> forming a free protrusion end <NUM> and a protrusion root <NUM> opposite said free end. According to the invention, said protrusion <NUM> is made in the form of a small cylinder.

The first wall <NUM> of the die <NUM> further comprises a mold tapered surface <NUM> tapering as it approaches said protrusion root <NUM> of the protrusion <NUM>. In other words, the extension of the tapered surface <NUM> of the first wall <NUM> of the die <NUM> is gradually and progressively reduced as it approaches the protrusion <NUM>.

By virtue of the inclusion of such a die <NUM> having such a first wall <NUM> it is possible to at least partially delimit a mold cavity <NUM> having a concave portion <NUM>, so as to allow the formation of an expandable balloon <NUM> provided with a concave balloon portion <NUM>.

The forming of the expandable balloon <NUM> thus made determines that at least when in an expanded configuration the expandable balloon <NUM> comprises a concave balloon portion <NUM>.

The concave balloon portion <NUM> can be indistinguishable when the expandable balloon <NUM> is in a collapsed configuration to manifest when the expandable balloon <NUM> is in an expanded configuration.

The expandable balloon <NUM> preferably has a thin wall and can be obtained starting from an internally hollow preform <NUM> or parison <NUM>. The cavity <NUM> of the parison <NUM> is preferably adapted to receive said protrusion <NUM> of the first wall <NUM> of the die <NUM>.

As shown for example in <FIG>, the parison <NUM> can be made by injection molding inside a convex pre-mold <NUM>. The parison <NUM> can be made by extrusion.

The mold <NUM> comprising the die <NUM> can be suitable for a blow-molding forming process. One or more blowing channels <NUM> can be provided for blowing inflation fluid in the cavity <NUM> of the parison <NUM> when the parison <NUM> is received inside the mold cavity <NUM>.

The mold <NUM> comprising the die <NUM> can be suitable for an injection molding process.

In accordance with an embodiment, said protrusion <NUM> has a substantially cylindrical shape. The term "substantially cylindrical" is intended to indicate a substantially cylindrical shape even though the side walls can be tapered to allow the molded piece to be drafted from the die <NUM>, and for example the substantially cylindrical side walls can form a convergence angle less than or equal to <NUM>°, where the convergence is in the direction of the free end <NUM> of the protrusion <NUM>.

In accordance with an embodiment, the protrusion root <NUM> is joined to the tapered surface <NUM>. For example, an annular edge can be included between the protrusion root <NUM>, which is preferably substantially cylindrical, and the tapered surface <NUM>, which is preferably substantially frustoconical, or an annular draft connection can be included. The angle formed between the tapered surface <NUM> and the protrusion <NUM> is an obtuse angle.

The protrusion <NUM> and the tapered surface <NUM> are made in a single piece. In accordance with an embodiment, the first wall <NUM> of the die <NUM> is preferably made in a single piece.

In accordance with a preferred embodiment, the tapered surface <NUM> of the die <NUM> is frustoconical.

The inclusion of said tapered surface <NUM> of the die <NUM> allows to obtain a concave portion <NUM> of the internal cavity <NUM> having an acute annular chamber, particularly when included in combination with a counter-die <NUM> forming an acute angle with the tapered wall <NUM> of the die <NUM>.

In accordance with a general embodiment, a mold <NUM> is provided comprising a die <NUM> according to any one of the preceding claims.

Said mold <NUM> further comprises at least one counter-die <NUM> at least partially delimiting a convex portion <NUM> of said mold cavity <NUM>.

The mold cavity <NUM> preferably has a cylindrical extension. In other words, the mold cavity <NUM> preferably has a cylindrical geometry around a definable axis which preferably passes through or coincides with the longitudinal extension direction of the protrusion <NUM> of the die <NUM>. Preferably, the protrusion <NUM> of the die <NUM> is aligned with the longitudinal extension axis of the mold cavity <NUM>.

In accordance with a preferred embodiment, the counter-die <NUM> of the mold <NUM> comprises a second tapered surface <NUM> tapering in a direction concordant with that of the first tapered surface <NUM> of the first wall <NUM> of the die <NUM>.

In accordance with an embodiment, the second tapered surface <NUM> of the counter-die <NUM> is parallel to the first tapered surface <NUM> of the first wall <NUM> of the die <NUM>.

In accordance with an embodiment, the first tapered surface <NUM> and the second tapered surface <NUM> face each other and face the mold cavity <NUM>, delimiting therebetween a substantially concave volume having a concavity facing the first tapered surface <NUM> of the die <NUM>.

In accordance with an embodiment, the counter-die <NUM> forms an acute angle with the tapered surface <NUM> of the first wall <NUM> of the die <NUM>. Preferably, the counter-die <NUM> comprises at least one side wall <NUM>, substantially cylindrical, connected to the second tapered surface <NUM> of the counter-die <NUM>, in which said at least one side wall <NUM> of the counter-die <NUM>, when the counter-die <NUM> abuts against the die <NUM>, forms an acute angle with the first tapered surface <NUM> of the first wall <NUM> of the die <NUM>.

Preferably, the die <NUM> comprises an abutment portion <NUM> and the counter-die <NUM> comprises a counter-abutment portion <NUM>, said abutment portion <NUM> and said counter-abutment portion <NUM> are adapted to mutually abut to delimit the mold cavity <NUM> of the mold <NUM>.

The mold <NUM> can be a closed mold. Preferably, burr channels are included for the formation of burrs resulting from the flow of material during the forming by molding.

The mold <NUM> can be an open mold. Preferably, the expandable balloon <NUM> thus obtained will comprise at least one convex barrel-like surface as a result of the flow of material out of the mold cavity during the forming by molding.

In accordance with an embodiment, the die <NUM> substantially forms the core for at least one concave balloon portion <NUM> of an expandable balloon <NUM>.

In accordance with an embodiment, said counter-die <NUM> comprises a first channel wall delimiting the inlet of a first blowing channel 122b. In accordance with an embodiment, said first channel wall is connected to said second tapered surface <NUM>. In accordance with an embodiment, said die <NUM> comprises a second channel wall delimiting the inlet of a second channel 122a. In accordance with an embodiment, said second channel of channel 122a is made inside said protrusion <NUM>. In accordance with an embodiment, the first channel 122a and the second channel 122b are configured to accommodate the intraluminal element <NUM> on which the parison <NUM> is mounted to form the expandable balloon <NUM>.

The mold <NUM> as well as the die <NUM> and the counter-die <NUM> can be provided with heating elements to heat the parison <NUM>.

In accordance with a general embodiment, an expandable balloon <NUM> suitable for medical-surgical applications comprising a concave portion <NUM> is provided. Preferably, the expandable balloon <NUM> is suitable for intraluminal applications, such as the sclerosing treatment of the varices of a blood vessel <NUM>.

Said expandable balloon <NUM> is made using a die <NUM> according to any one of the previously described embodiments.

Preferably, said expandable balloon <NUM> is made using a mold <NUM> according to any one of the previously described embodiments.

The inclusion of said concave portion <NUM> of the expandable balloon <NUM> allows performing a collection of material <NUM>, for example debris <NUM>, from a lumen <NUM> of a patient's body, such as a lumen <NUM> of a blood vessel. For example, material <NUM> removed from the internal wall of a blood vessel <NUM> can be collected from the concave portion <NUM> of the expandable balloon <NUM>. The collection can occur by translating, in other words by advancing, the expandable balloon <NUM> inside the lumen <NUM> of a blood vessel, taking care to face the concave portion <NUM> towards the advancement direction of the expandable balloon <NUM> inside the lumen <NUM>.

In accordance with an embodiment, said expandable balloon <NUM> comprises at least one first surface <NUM> adapted to face said intraluminal element <NUM>. The at least one first surface <NUM> is adapted to face a fluid inside the blood vessel. The at least one first surface <NUM> at least in said expanded configuration, forms said at least one concave portion <NUM>.

In accordance with an embodiment, said expandable balloon <NUM> comprises at least one contact portion <NUM> adapted to remove material <NUM> from an internal wall <NUM> of a stretch of the blood vessel lumen <NUM>.

In accordance with an embodiment, said expandable balloon <NUM> is configured to expand with respect to said intraluminal element <NUM> at least in a radial direction RO transverse to the longitudinal extension direction of the vessel between at least one rest configuration and at least said expanded configuration. Said radial direction RO being transverse to the longitudinal extension direction of the intraluminal element <NUM>.

In accordance with an embodiment, between said contact configuration and said rest configuration, said contact portion <NUM> approaches said intraluminal element <NUM> closing said concave portion <NUM> in the direction of said intraluminal element <NUM> so as to retain the removed material <NUM>.

In accordance with an embodiment, said expandable balloon <NUM> comprises an attachment portion circumferentially connectable to the intraluminal element <NUM>, in which said first surface <NUM> extends between said attachment portion and said contact portion <NUM>.

In accordance with an embodiment, said first surface <NUM> is substantially frustoconical.

The contact portion <NUM> is preferably a surface having a substantially circumferential extension. For example, the contact portion <NUM> can be formed by a circumferential edge. In accordance with an embodiment, the contact portion <NUM> comprises a circumferential edge of the expandable balloon <NUM>.

In accordance with an embodiment, said contact portion <NUM> can have an increased section <NUM> with respect to the rest of the expandable balloon <NUM> and the increased section forms a reinforcing element <NUM>. In accordance with an embodiment, said reinforcing element <NUM> comprises a sharp edge. In accordance with an embodiment, said expandable balloon <NUM> comprises a sharp edge comprising said contact portion <NUM>.

In accordance with an embodiment, said contact portion <NUM> preferably has a surface treatment aimed at increasing the roughness thereof. For example, the contact portion <NUM> can be corrugated or pleated, to favor the abrasive power on the internal wall <NUM>. For example, the contact portion <NUM> can comprise surface knurling processing.

In accordance with a preferred embodiment, the expandable balloon <NUM> is fitted on the intraluminal element <NUM>, and the intraluminal element <NUM> comprises at least one inflation opening <NUM> in fluid communication with the inside of the expandable balloon <NUM> to introduce in or extract from the expandable balloon <NUM> the inflation fluid <NUM> so as to reversibly expand or contract the expandable balloon <NUM> between the rest configuration and the contact configuration.

In accordance with an embodiment, the expandable balloon <NUM> has a longitudinal balloon extension axis around which the balloon extends. In accordance with an embodiment, said balloon <NUM> extends with cylindrical symmetry around said balloon longitudinal extension axis. In accordance with an embodiment, said radial direction RO is transverse with respect to said balloon longitudinal extension axis.

In accordance with an embodiment, the expandable balloon <NUM> is tightly fastened on said intraluminal element <NUM> with a first fastening element <NUM> and a second fastening element <NUM>' so as to define a fluid-tight chamber in fluid connection with said inflation opening <NUM> between an internal surface of the expandable balloon <NUM> and a surface of the intraluminal element <NUM> between the first fastening element <NUM> and the second fastening element <NUM>', in which said concave portion <NUM> extends from said first fastening element <NUM> to said contact portion <NUM>. In accordance with an embodiment, said expandable balloon <NUM> has a first attachment portion and a second attachment portion configured to be connected to said intraluminal element <NUM> by means of said first fastening element <NUM> and said second fastening element <NUM>', in which said first attachment portion and said second attachment portion are circumferential, preferably cylindrical portions adapted to accommodate the intraluminal element <NUM>, in which said first attachment portion and said second attachment portion are spaced apart by an attachment distance D along a longitudinal extension direction of the intraluminal element <NUM> or along said balloon longitudinal extension axis around which the balloon extends. In accordance with an embodiment, said attachment distance D is between <NUM> and <NUM>.

In accordance with an embodiment, in which said concave portion <NUM>, at least in said contact configuration, has an at least partially conical shape. In accordance with an embodiment, the collection portion <NUM> is joined to the contact portion <NUM> so that the material <NUM> removed from the contact portion <NUM> is directed in the collection portion avoiding interfering with the contact portion <NUM>. In accordance with an embodiment, at least in the contact configuration, the collection portion <NUM> forms a funnel-shaped portion configured to facilitate the collection of the removed material <NUM> advancing said expandable balloon <NUM> inside the blood vessel along an advancement direction X. In accordance with an embodiment, the collection portion <NUM> and the contact portion <NUM> are seamlessly integrated.

In accordance with an embodiment, when said balloon is in said expanded configuration, a projection of the concave portion <NUM> on the longitudinal extension axis of the balloon defines a segment having a concave portion length C. In accordance with an embodiment, said concave portion length is between <NUM> and <NUM>, preferably between <NUM> and <NUM>. In accordance with an embodiment, said concave portion length is the height of the truncated cone delimiting the concave portion <NUM>. In accordance with an embodiment, said concave portion length C is between <NUM>/<NUM> and ½ of the attachment distance D.

In accordance with an embodiment, said intraluminal element <NUM> comprises a drug dispensing opening <NUM>.

Preferably, such an expandable balloon <NUM> is intended for the sclerosing treatment of varices.

A manufacturing method of an expandable balloon <NUM> for medical-surgical applications having at least one concave portion <NUM> will be described below.

A manufacturing method of an expandable balloon <NUM> for medical-surgical applications having at least one concave portion <NUM> comprises the steps of:.

In accordance with a preferred operating mode, the method comprises the step of overturning the parison <NUM> on the protrusion <NUM> of the die <NUM>.

In accordance with a preferred operating mode, the method comprises the step of inserting the parison <NUM> in the mold cavity <NUM>.

In accordance with a preferred operating mode, the method comprises the step of expanding the parison <NUM> in the concave portion <NUM> of the mold cavity <NUM>.

In accordance with a preferred operating mode, the method comprises the step of abutting the counter-die <NUM> against the die <NUM>. If necessary, this allows closing the mold and firmly interposing a portion of the parison between the die <NUM> and the counter-die <NUM>.

In accordance with a possible operating mode, the step of providing a mold cavity <NUM> is performed by including a mold <NUM> according to any one of the embodiments described above. In accordance with a possible operating mode, the step of providing a mold cavity <NUM> is performed by including a die <NUM> according to any one of the embodiments described above.

The parison <NUM> comprises an internal parison surface <NUM> delimiting an internal parison cavity <NUM> and an external parison surface <NUM> opposite said internal parison surface <NUM> facing the internal cavity <NUM>.

In accordance with an embodiment, the parison <NUM> extends longitudinally between a first parison end and a second parison end which define, respectively, an inlet opening and an outlet opening, preferably circular, with respect to the internal cavity <NUM>. In accordance with an embodiment, said parison <NUM> has a substantially cylindrical shape.

The step of fitting the parison <NUM> on the protrusion includes at least partially making a first parison surface portion <NUM> adhere to said protrusion. In accordance with an embodiment, said internal parison surface <NUM> or said external parison surface <NUM> comprises said first parison surface portion <NUM>. In accordance with an embodiment, said first parison surface portion <NUM> is near said inlet opening or said outlet opening.

In accordance with an operating mode, the method comprises the step of fitting the parison <NUM> on the protrusion <NUM>. In accordance with an operating mode, the fitting step includes approaching the protrusion <NUM> with the external parison surface <NUM> of the parison <NUM>, as shown for example in <FIG> In accordance with an operating mode, the fitting step includes approaching the protrusion <NUM> with the internal parison surface <NUM> of the parison <NUM>, as shown for example in <FIG>and <FIG>as well as in <FIG>.

In accordance with an operating mode, the method comprises the step of overturning the parison <NUM> on the protrusion <NUM> of the die <NUM> of the mold <NUM>, as shown for example in <FIG>and <FIG>By virtue of the overturning step, the same surface <NUM> or <NUM> of the parison <NUM> approaching the protrusion <NUM> of the die <NUM> is allowed to face the mold cavity <NUM> of the mold <NUM>.

In accordance with an operating method shown for example in <FIG>the parison <NUM> approaches the die <NUM>, then the parison <NUM> receives the die <NUM> in the cavity <NUM> thereof so that the parison <NUM> is fitted on the first surface <NUM> of the die <NUM>. Thereby, the internal parison surface <NUM> of the parison <NUM> faces the first surface <NUM> of the die <NUM>. Subsequently, the counter-die <NUM> approaches the external parison surface <NUM> of the parison <NUM> fitted on the die <NUM>. The counter-die <NUM> is thus abutted against the die <NUM>. Preferably, the second tapered surface <NUM> of the counter-die <NUM> is abutted against the first tapered surface <NUM> of the die <NUM>, so that a portion of the parison <NUM> is interposed therebetween and substantially locked. Subsequently, the parison <NUM> is overturned, bringing a free edge thereof on the counter-die <NUM>. Thereby, the external parison surface <NUM> of the parison <NUM> faces the counter-die <NUM>. Thereby, due to the effect of overturning the parison <NUM>, it is possible to make an expandable balloon <NUM> having a concave portion <NUM>.

In accordance with an operating mode shown for example in <FIG>, the parison <NUM> approaches the protrusion <NUM> of the die <NUM> with a closed margin thereof, i.e., unable to allow access to the cavity <NUM> and the parison <NUM> is shaped to the protrusion <NUM>. The counter-die <NUM> is thus abutted against the die <NUM>. The parison <NUM> is subsequently expanded by inflating through the channel <NUM>. The shape of the concave portion <NUM> of the mold cavity <NUM> allows making an expandable balloon <NUM> having a concave portion <NUM>.

In accordance with an operating mode shown for example in <FIG>the parison <NUM> approaches the protrusion <NUM> of the die <NUM>, then the parison <NUM> receives the protrusion <NUM> in the cavity <NUM> thereof, so that the parison <NUM> is fitted on the first surface <NUM> of the die <NUM>. Thereby, the internal parison surface <NUM> of the parison <NUM> faces the first surface <NUM> of the die <NUM>. Subsequently, the parison <NUM> is overturned. Subsequently, the parison <NUM> is overturned, bringing a free edge thereof on the protrusion <NUM>, facing the internal parison surface <NUM> of the parison <NUM> to the mold cavity <NUM>. The counter-die <NUM> is thus abutted against the die <NUM>. The parison <NUM> is subsequently expanded by inflating through the channel <NUM>. The shape of the concave portion <NUM> of the mold cavity <NUM> allows making an expandable balloon <NUM> having a concave portion <NUM>.

The method preferably comprises the step of heating the parison <NUM> as well.

In accordance with an operating mode, the method includes the step of cooling the parison <NUM> to obtain the expandable balloon <NUM>.

In accordance with an operating mode, the method includes overturning the parison <NUM> on the protrusion <NUM> so that said internal parison surface <NUM> has at least one portion of said first parison surface portion <NUM> fitted on said protrusion <NUM> and so that the remaining part of said internal surface <NUM> faces said mold cavity <NUM>.

In accordance with an operating mode, the method includes circumferentially fastening the first parison end <NUM> to an intraluminal element <NUM> facing the entire said internal parison surface <NUM> to the intraluminal element <NUM>. In accordance with an operating mode, the method includes overturning the parison <NUM> on the intraluminal element <NUM> so as to delimit the parison cavity <NUM> between the external parison surface <NUM> and the intraluminal element <NUM>, fastening the second parison end from the opposite part to the first parison end. In accordance with an operating mode, the step of overturning the parison <NUM> includes leaving said first parison surface portion <NUM> of said internal parison surface <NUM> facing said intraluminal element <NUM>, in which said fitting step of the parison <NUM> on the protrusion <NUM> includes at least partially fitting said first parison surface portion <NUM> on said protrusion <NUM>,.

In accordance with an operating mode, the step of heating the parison <NUM> includes heating at least the first parison surface portion <NUM> at least simultaneously with the step of expanding the parison <NUM> in the mold cavity <NUM>, by adhering said first parison surface portion <NUM> both on said protrusion <NUM> and on a first mold tapered surface <NUM> made integrally with said protrusion <NUM> so as to form the concave portion <NUM> of said expandable balloon <NUM>. In accordance with an operating mode, said method includes heating and expanding the parison <NUM>, by adhering a second parison surface portion <NUM> to an acute angle of the mold cavity <NUM> formed by the tapered surface <NUM> and the counter-die <NUM>. In accordance with an operating mode, said step of cooling the parison <NUM> includes cooling said parison <NUM> while keeping the parison <NUM> expanded in the mold cavity. In accordance with an operating mode, said step of cooling the parison <NUM> includes cooling the second parison surface portion <NUM> so as to form a sharp contact portion <NUM> of said expandable balloon <NUM>. In accordance with an operating mode, the first parison surface portion <NUM> comprises the second parison surface portion <NUM>. In accordance with an operating mode, before said step of inserting the parison in the mold cavity, the first parison surface portion <NUM> is formed by a parison flap facing the intraluminal element <NUM>.

In accordance with an operating mode, said method includes the step of stretching the parison (<NUM>), for example moving said die <NUM> away from said counter-die <NUM>.

In accordance with an operating mode, the step of expanding the parison includes inflating the parison with a fluid passing through the intraluminal element <NUM>.

In accordance with an operating mode, said parison <NUM> is an elastomer or an extensible polymer. In accordance with an operating mode, said parison <NUM>.

In accordance with an operating mode, said step of heating the parison <NUM> includes heating the parison <NUM> in a temperature range between a glass transition temperature of the extensible polymer of the parison and a softening temperature or a melting temperature of the extensible polymer of the parison.

In accordance with an operating mode, the step of cooling the parison <NUM> includes cooling the parison <NUM> to an ambient temperature between <NUM>° and <NUM>°.

In accordance with an operating mode, said extensible polymer is a thermoplastic elastomer.

In accordance with an operating mode, said extensible polymer comprises individually or in a mixture at least one of polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamides, polyvinyl chloride, latex, silicones, polyurethane copolymers, polyamide copolymers, copolymers of polyamide and polyethers.

In accordance with an operating mode, said parison <NUM> has a multilayer parison body, comprising a first elastomeric layer and a second thermoplastic layer. In accordance with an operating mode, said parison <NUM> comprises a non-compliant layer.

In accordance with an operating mode, said parison <NUM> is made of a material adapted to make a compliant or semi-compliant expandable balloon.

In accordance with an operating mode, the method comprises the step of making two convex balloons, and associating them with each other in a respective edge <NUM>, <NUM>' to form a single balloon having a concave portion <NUM>, avoiding providing a mold having a concave portion <NUM>. Preferably, the method comprises the step of providing two parisons <NUM>, <NUM>', each parison <NUM> and <NUM>' being arranged in a respective pre-mold <NUM> and <NUM>', and the step of expanding by inflating each parison <NUM> and <NUM>' in the respective pre-mold <NUM> and <NUM>', making two convex expandable balloons. Preferably, such pre-molds <NUM> and <NUM>' are both convex, i.e., they are intended to form a convex balloon.

The association between the edges <NUM> and <NUM>' of the convex balloons to form a balloon having a concave portion <NUM> preferably occurs by laser welding.

In accordance with an embodiment, such an association is performed by gluing. In accordance with an embodiment, such an association determines the formation of a concave portion <NUM> formed by one of the expandable balloons associated with each other in the respective edge <NUM>, <NUM>'.

Therefore, in accordance with a general embodiment, as shown for example in <FIG>a manufacturing method of an expandable balloon <NUM> for medical-surgical applications having at least one concave portion <NUM> comprises the steps of:.

The preforms can in turn be expandable balloons.

In accordance with an embodiment, the manufacturing method of an expandable balloon <NUM> for medical-surgical applications having at least one concave portion <NUM> comprises the steps of:.

A method for collecting material <NUM> from a lumen <NUM> of a patient's body will be described below.

A method for collecting material <NUM> from the lumen <NUM> of a patient's body, such as from the lumen <NUM> of a blood vessel, comprises the steps of:.

The method preferably comprises the further step of extracting the expandable balloon <NUM> from the lumen <NUM> of the patient's body. This step is preferably performed with the concave portion <NUM> facing proximally and filled with collected material <NUM>.

The advancing step is preferably performed by keeping the concave portion <NUM> facing proximally.

In accordance with a possible operating mode, the collection method is performed inside the lumen <NUM> of a blood vessel to collect material <NUM> which is formed as an effect of a pharmacological and/or abrasive treatment of the internal wall <NUM> of the blood vessel <NUM>.

For example, first a pharmacological treatment of the internal wall <NUM> of the blood vessel <NUM> is performed, subsequently or simultaneously an abrasive action is performed, for example mechanical, of the internal wall <NUM> of the blood vessel <NUM>, and subsequently the collection method is performed.

By virtue of the features described above included separately or jointly with each other in particular embodiments, it is possible to obtain a mold, as well as an expandable balloon, as well as a method which at the same time satisfy the above described requirements, contrasting each other, and the aforementioned desired advantages, and in particular:.

In order to meet contingent and specific needs, those skilled in the art may make several changes and adaptations to the above-described embodiments, without however departing from the scope of the following claims.

Claim 1:
A mold (<NUM>) for forming an expandable balloon (<NUM>) for medical-surgical applications adapted to be fitted on an intraluminal element (<NUM>) comprising a die (<NUM>) and at least one counter-die (<NUM>),
wherein said die (<NUM>) comprises a first wall (<NUM>) at least partially delimiting a concave portion (<NUM>) of a mold cavity (<NUM>) configured to form at least one concave portion (<NUM>) of the expandable balloon (<NUM>) adapted to face said intraluminal element (<NUM>);
said first wall (<NUM>) comprising:
- a protrusion (<NUM>) adapted to project cantilevered in said mold cavity (<NUM>) forming a protrusion free end (<NUM>) and a protrusion root (<NUM>) opposite said protrusion free end;
- a first mold tapered surface (<NUM>) tapering as it approaches said protrusion root (<NUM>),
wherein the protrusion (<NUM>) and the first tapered surface (<NUM>) are made in a single piece,
wherein said counter-die (<NUM>) at least partially delimits a convex portion (<NUM>) of said mold cavity (<NUM>),
characterized in that said protrusion (<NUM>) has a substantially cylindrical shape,
and in that said tapered surface (<NUM>) and said protrusion (<NUM>) are jointed forming an obtuse angle.