DE202017106887U1 - Catheter with asymmetrical cross section - Google Patents

Abstract

A catheter comprising a hollow tube comprising a first inner diameter (10) and a second inner diameter (20), said hollow tube comprising a wall made of a flexible material and having a proximal end, a distal end and a longitudinal axis characterized in that said first inner diameter is substantially parallel to said longitudinal axis and surrounded by said wall, and wherein said second inner diameter is spirally disposed about said first inner diameter and located within said wall.

Description

Field of the invention

The present invention relates generally to a catheter having an asymmetrical cross-section. In particular, it relates to a catheter comprising an outer shaft and a smaller inner shaft spirally disposed about the longitudinal axis of the outer shaft.

Background of the invention

Catheters are often used in the practice of medical procedures such as coronary angiography for injecting a dye or the like into the cardiovascular system for diagnosis, and angioplasty for expanding the lumen of the coronary artery, which has been at least partially blocked by a stenotic lesion, which causes an abnormal narrowing of the artery due to injury or illness. In these techniques, the distal end of the catheter is inserted into the aorta via the femoral artery. The proximal end of the catheter is then manipulated so that its distal end is inserted into the lumen of a selected coronary artery branching from the aorta. A typical angioplasty procedure initially involves inserting a leading catheter into the cardiovascular system in the above manner, followed by a dilating catheter, a laser catheter, an atherectomy catheter or the like passed through the leading catheter until its distal end region within the catheter stenotic lesion is positioned in the coronary artery to reduce the blockage in the artery. A diagnostic catheter would be used in the same way. Further details are in US 5,445,625 . US 6,083,213 and WO 02 / 32495A1 which are incorporated herein by reference. For leading catheters, see the following citations, which are incorporated herein by reference: Meier B .; "Percutaneous coronary intervention"; In: Topol EJ (ed.), Textbook of Cardiovascular Medicine, 2nd Edition 2002, pages 1665-1676 ; Kiemeneij F, Laarman GJ, de Melker E .; "Transradial artery coronary angioplasty", Am Heart J. 1995; 129: 1-7 ; and Campeau L. "Percutaneous Radial Artery Approach to Coronary Angiography", Cathet. Cardiovasc. Diagn, 1989; 16: 3-7 ,

The introduction of guide catheters and the like in body cavities including nonuniform body cavities such as branched arteries during coronary angioplasty and the like involves a considerable risk, even a risk of death, such as that in US Pat WO 2008/005388 A2 . US 6,960,222 . US 6,936,060 . US 6,908,474 . US 6,905,490 . US 6,682,505 . US 6,645,222 . US 6,632,236 . US 6,582,396 . US 6,540,712 US 6,423,032 . US 6,413,235 and US 6,206,868 which are all incorporated herein by reference.

Current catheters such as urinary catheters, Foley catheters, etc. are characterized by a large diameter (e.g., about 9 mm) relative to the urethral lumen. This is a cause of discomfort, anxiety, pain and trauma to the patient while at the same time introducing such a wide and flexible catheter is a difficult procedure for less experienced physicians.

There is a long-felt and unmet need for an improved catheter that is easy to insert yet has a sufficiently wide inside diameter. Moreover, simple procedures and devices for introducing catheters and similar inserts from within body cavities, namely non-uniform body cavities such as branched arteries, which simultaneously reduce the risk of injury to body tissue, are still a long-felt and unmet need.

Summary of the invention

It is an object of the present invention to provide a catheter having at least one property that is asymmetrical with respect to at least one plane of said catheter, said feature providing the catheter with maneuverability within a body cavity.

It is therefore an object of the present invention to provide a catheter comprising a hollow tube having a first inner diameter 10 and a second inner diameter 20 wherein said hollow tube is made of a flexible material and characterized by a proximal end, a distal end and a longitudinal axis, said first inner diameter being substantially parallel to said longitudinal axis, and wherein said second inner diameter is spiral is arranged around the said first inner diameter.

It is a further object of this invention to provide a catheter comprising a hollow tube having a first inner diameter 10 and a second inner diameter 20 wherein said hollow tube is made of a flexible material and characterized by a proximal end, a distal end and a longitudinal axis, said first inner diameter being substantially parallel to said longitudinal axis, and wherein said second inner diameter is spiral disposed about said first inner diameter and disposed within said wall.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said second inner diameter is characterized by a diameter smaller than that of said first inner diameter.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said catheter is characterized by a transverse cross-section in which said first inner diameter is meniscus-shaped, and said second inner diameter is opposite a concave portion of said inner diameter Meniscus is arranged.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said second inner diameter has a substantially circular cross-section.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said flexible material is selected from the group consisting of latex, polypropylene, polyethylene, polyethylene terephthalate, silicone plastic, shape memory materials, electroactive materials, and any combination from that.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said catheter is characterized by a compressive force versus compression displacement curve equivalent to that of an elastomer having a Shore A hardness of between 45 and 45 ° 65 has.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said first inner diameter encloses said longitudinal axis.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said second inner diameter is spirally disposed about said first inner diameter in a spiral passing through a pitch of between 0.25 and 1.5 turns is marked per 2.54 cm.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said first inner diameter and said second inner diameter are open at both ends of said catheter.

It is another object of the present invention to provide a catheter as defined in any of the above, wherein said catheter is configured to be connectable to a tip at said distal end.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a sagittal cross-section, wherein at least a portion of said sagittal cross-section is characterized by at least one asymmetric property and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a corneal cross-section, wherein at least a portion of said corneal cross-section is characterized by at least one asymmetric property and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a transverse cross-section, at least a portion of said transverse cross-section passing through at least one asymmetric property, and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open internal diameter shaft, said sheath being characterized by a major longitudinal axis and a (i) sagittal cross section, (ii) corneal cross section, (iii) transversal A cross section or any combination thereof, wherein at least a portion of either said (i) sagittal cross section, (ii) corneal section, (iii) transverse section or any combination thereof is characterized by at least one asymmetric property, and further wherein the asymmetric property is along the extending said main longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide the catheter as defined above, wherein said predetermined pattern is selected from a group consisting of parallel or non-parallel.

It is another object of the present invention to provide the catheter as defined above, wherein said predetermined pattern is a spool-like or helical pattern in either clockwise or counterclockwise fashion.

It is another object of the present invention to provide the catheter as defined above, wherein said catheter is insertable into a non-uniform body cavity.

It is another object of the present invention to provide the catheter as defined above, wherein said part of said cross-section has at least one protrusion protruding either inwardly or outwardly from said sheath, or any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said bulge projects within a range of about 0.01 millimeter to about 2.5 millimeters.

It is another object of the present invention to provide the catheter as defined above, wherein the thickness of said at least one protrusion is substantially different from the thickness of said sheath.

It is another object of the present invention to provide the catheter as defined above, wherein said bulge is disposed on the periphery of said sheath.

It is another object of the present invention to provide the catheter as defined above, wherein the part of said sheath is made of a material having a predetermined property Y1 while said sheath is made of a material having a predetermined property Y2 has, where Y1 is distinctly different from Y2.

It is another object of the present invention to provide the catheter as defined above, wherein said property is selected from a group consisting of Young's modulus, stiffness, flexibility, shear modulus G, compression modulus K, Poisson's number ν , spring modulus, flexural stiffness EI, thickness, texture, composition, electrical conductivity, density, composition and elasticity.

It is another object of the present invention to provide the catheter as defined above, wherein said Young's modulus is in the range of about 0.01 to about 0.05 GPa.

It is another object of the present invention to provide the catheter as defined above, wherein said material is selected from a group consisting of latex, silicone plastic, shape memory materials, electroactive materials, or any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said sheath is made of at least one material selected from a group consisting of latex, silicone plastic, shape memory materials, electroactive materials, or any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said portion of said cross-section comprises at least one balloon-like bulge such that said asymmetric property is provided by further inflation or contraction of the balloon.

It is another object of the present invention to provide the catheter as defined above, wherein said asymmetrical property is either automatically controlled or manually controlled by the user.

It is another object of the present invention to provide the catheter as defined above, wherein said portion of said cross-section comprises either at least one balloon-shaped bulge or at least one bulge or any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said asymmetric property is provided by means of a predefined microstructure texture.

It is another object of the present invention to provide the catheter as defined above, wherein said at least one property is selected from a group consisting of size, texture, material from which said shell is made, mechanical properties, mechanical properties selected from a group consisting of stiffness, flexibility, Young's modulus E, modulus of shear G, modulus of compression K, Poisson's number ν, spring modulus, flexural stiffness EI, thickness, texture, composition, electrical conductivity, density, composition, elasticity, and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, translating a linear reciprocating motion and / or a rotatable maneuver of the proximal end of said shaft into movement of said catheter in said body cavity.

• a. Erhalten eines Katheters, der eine kontinuierliche Hülle hat, die einen länglichen Schaft mit offenem Innendurchmesser ausbildet;
• b. asymmetrisches Modifizieren von zumindest einer Eigenschaft in zumindest einem Teil des besagten Sagittalquerschnitts;
• c. Hinausgehen über den besagten Schnitt entlang des besagten Schafts gemäß einem vorbestimmten Muster; und
• d. Einführen des besagten Katheters in eine Körperhöhle; und
• e. Behandeln des besagten Patienten.

It is another object of the present invention to provide a method for treating a patient, said method comprising the step of:

• a. Obtaining a catheter having a continuous sheath forming an elongated shaft of open inner diameter;
• b. asymmetrically modifying at least one property in at least part of said sagittal cross-section;
• c. Going beyond said section along said shaft according to a predetermined pattern; and
• d. Inserting said catheter into a body cavity; and
• e. Treating the said patient.

It is another object of the present invention to provide a method of treating a patient, said method comprising the steps of: obtaining a catheter having a continuous sheath forming an elongated shaft of open inner diameter, said sheath being characterized by a main longitudinal axis and a corneal cross section; asymmetrically modifying at least one property in at least a part of said corneal cross section; Going over said section along said shaft according to a predetermined pattern; Inserting said catheter into a body cavity; and treating said patient.

It is another object of the present invention to provide a method of treating a patient, said method comprising the steps of: obtaining a catheter having a continuous sheath forming an elongated shaft of open inner diameter, said sheath being characterized by a main longitudinal axis and a transverse cross section; asymmetrically modifying at least one property in at least a portion of said transverse section; Going over said section along said shaft according to a predetermined pattern; Inserting said catheter into a body cavity; and treating said patient.

It is another object of the present invention to provide a method of treating a patient, said method comprising the steps of: obtaining a catheter having a continuous sheath forming an elongated shaft of open inner diameter, said sheath being characterized by a main longitudinal axis and a (i) transverse cross section; (ii) sagittal cross section; (iii) sagittal cross section; asymmetrically modifying at least one property in at least a part of either the (i) transverse cross-section; (ii) said sagittal cross section; (iii) said sagittal cross section; or any combination thereof; Going over said section along said shaft according to a predetermined pattern; Inserting said catheter into a body cavity; and treating said patient.

It is another object of the present invention to provide the methods as defined above, further comprising the step of selecting said predetermined pattern from a group consisting of parallel or non-parallel.

It is another object of the present invention to provide the methods as defined above, further comprising the step of selecting said predetermined pattern as a coil-like or helical pattern in either clockwise or counterclockwise fashion.

It is another object of the present invention to provide the methods as defined above additionally comprising the step of inserting said catheter into a non-uniform body cavity.

It is another object of the present invention to provide the methods as defined above, additionally comprising the step of providing said catheter having at least one bulge in said part of said cross section, said bulge either inwardly or outwardly of said one Shell protrudes, or any combination thereof.

It is another object of the present invention to provide the methods as defined above, wherein said protrusion protrudes in a range of about 0.01 millimeter to about 2.5 millimeters.

It is another object of the present invention to provide the methods as defined above, further comprising the step of providing said catheter such that the thickness of said at least one protrusion is substantially different from the thickness of said sheath.

It is another object of the present invention to provide the methods as defined above, further comprising the step of providing said catheter, wherein said bulge is disposed on the periphery of said sheath.

It is another object of the present invention to provide the methods as defined above, further comprising the step of providing said catheter such that the part of said sheath is made of a material having a predetermined property Y1 while said sheath is made of a material having a predetermined property Y2, where Y1 is distinctly different from Y2.

It is another object of the present invention to provide the methods as defined above, further comprising the step of selecting said property from a group consisting of the Young's modulus, the stiffness, the flexibility, the shear modulus G, the compression modulus K, the Poisson's number ν, the spring modulus, the bending stiffness EI, the thickness, the texture, the composition, the electrical conductivity, the density, the composition, the elasticity.

It is another object of the present invention to provide the methods as defined above, wherein said Young's modulus is in the range of about 0.01 to about 0.05 GPa.

It is another object of the present invention to provide the methods as defined above, further comprising the step of selecting said material from a group consisting of latex, silicone plastic, shape memory materials, electroactive materials, or any combination thereof.

It is another object of the present invention to provide the methods as defined above, further comprising the step of providing said shell of at least one material selected from a group consisting of latex, silicone plastic, shape memory materials, electroactive materials, or any combination thereof.

It is another object of the present invention to provide the methods as defined above, additionally comprising the step of providing said part of said cross-section with at least one balloon-like bulge such that said asymmetrical property is provided by further inflation or contraction of the balloon ,

It is another object of the present invention to provide the methods as defined above, wherein said asymmetrical property is either automatically controlled or manually controlled by the user.

It is another object of the present invention to provide the methods as defined above, additionally comprising the step of providing said part of said cross-section with either at least one balloon-shaped bulge or at least one bulge or any combination thereof.

It is another object of the present invention to provide the methods as defined above, additionally comprising the step of providing said asymmetric property by means of a predefined microstructure texture.

It is another object of the present invention to provide the methods as defined above, further comprising the step of selecting said at least one property from a group consisting of size, texture, material of which said shell is made, mechanical properties, mechanical Properties selected from a group consisting of stiffness, flexibility, Young's modulus E, shear modulus G, compression modulus K, Poisson's number ν, spring modulus, flexural stiffness EI, thickness, texture, composition, electrical conductivity, density, composition, elasticity, and any combination thereof.

It is another object of the present invention to provide the methods as defined above, further comprising the step of activating the proximal end of said shaft such that within a branched and / or non-linear body cavity of defined internal diameter and structure, branches and branches thereof said activation towards and within said ramifications and branches progresses.

It is another object of the present invention to provide the methods as defined above, wherein said step of activating the proximal end of said shaft additionally comprises a cautious linear reciprocation and / or a rotatable maneuver or any combination thereof.

It is another object of the present invention to provide the methods as defined above additionally comprising the step of inserting said catheter into a body cavity.

It is another object of the present invention to provide the methods as defined above wherein said body cavity is a non-uniform body cavity.

Moreover, it is further within the scope of the invention to describe a novel catheter provided with reversibly collapsible and expandable configurations. The catheter has, among other things, at its distal part, a continuous sheath which forms an elongate, open-ended shaft which is insertable within a body cavity. At least a cross section of this stem and / or tip, d. H. at least a portion along the length of the shaft or along its entire length comprises at least one reversibly recessed portion. This one or more invaginated sections provide the catheter with the required (i) at least one collapsible configuration characterized by a relatively rigid shaft and a small cross-section, and (ii) at least one expandable configuration characterized by a flexible shaft and / or tip and a larger cross-section.

It is also within the scope of the invention that in the predicted collapsible configuration, at least a portion is reversibly retained in its collapsed (inverted) configuration by means of at least one insert. For example, the insert is adapted to mechanically couple to the inverted sheath, to connect to or otherwise to reversibly attach to the sheath wall in the invaginated, encapsulated, sunken or contracted state.

It is further within the scope of the invention to describe a novel method of treating a patient by means of the catheter as defined and described in the present invention. The method includes steps of obtaining a catheter having a continuous sheath forming an elongated shaft of open inner diameter; Providing at least one cross section of the stem with one or more reversibly recessed portions; Maintaining the catheter in its at least one collapsible configuration within a body cavity while maintaining the shaft with a relative rigidity and a small cross-section; and then, if necessary and still in the cavity, expanding the cross-section of at least a portion of the catheter to its expanded configuration and having a larger cross-section while maintaining the flexibility of the shaft.

It is further within the scope of the invention to disclose the method as defined above, which method additionally comprises steps selected from (i) maintaining the shaft and / or tip in a collapsible configuration by providing an insert to secure the invaginated sheath within the Effectively coupling the section, and (ii) expanding the shaft to its expanded configuration by manipulating the insert to disengage from the invaginated sleeve so as to obtain a flexible shaft of large cross-section.

It is further within the scope of the invention to disclose a catheter having a continuous sheath forming an elongated open-ended shaft and / or a tip insertable within a body cavity. The cross-section of the stem is reciprocally maneuverable from at least one collapsible configuration of diameter d to at least one expandable configuration of diameter D, where D> d. The diameters d and D can range from about 0.01 mm to about 25 mm and from about 0.05 mm to about 50, respectively. In latex urine catheters, as defined in the present invention, d ranges from, for example, about 2 to about 6 mm and D ranges, for example, from about 6 to about 13 mm.

It is further within the scope of the invention to disclose a catheter having a continuous sheath forming an elongated open-ended shaft and / or a tip insertable within a body cavity. The cross section of the stem is reciprocally maneuverable from at least one collapsible configuration having a cross-sectional area a to at least one expandable configuration having a cross-sectional area A, where A> a. For example, in a latex urine catheter as defined in the present invention, a is about 30 mm ² and A is about 201 mm ² .

It is also to be disclosed within the scope of the invention, wherein the at least one part of the shaft, which is characterized by a collapsible cross section, is reversibly held in its collapsed / expanded configuration by means of at least one insert.

It is also within the scope of the invention to disclose a method of treating a patient. The method includes a step of obtaining a catheter having a continuous sheath forming an elongate shaft of open inner diameter and / or a tip; Providing at least a portion of the stem and / or the tip with a maneuverability to change from at least one collapsed configuration to at least one expanded configuration by providing the at least one portion having at least one collapsible configuration defined by a cross-sectional area a, and with at least one expandable configuration characterized by a cross-sectional area A; A>a; Maintaining the catheter in its at least one collapsible configuration within a body cavity while maintaining the shaft with a relative rigidity and a small cross-section; and then, still in the cavity, expanding the cross-section of at least part of the catheter to its expanded configuration and larger cross-section while keeping the shaft flexible.

It is further within the scope of the invention to disclose a method as defined above, wherein the method additionally comprises steps selected from (i) maintaining the shaft and / or tip in a collapsed configuration by providing an insert to effectively engage the portion of the shaft and (ii) expanding the shaft and / or the tip to the expanded configuration by manipulating the insert to stop the coupling so as to obtain a flexible shaft of large cross-section.

It is further within the scope of the invention to disclose a method of treating a patient. The method includes a step of obtaining a catheter having a continuous sheath forming an elongate shaft of open inner diameter and / or a tip; Providing at least a portion of the shaft and / or the tip with a maneuverability to change from at least one collapsed configuration to at least one expanded configuration by providing the at least one portion having at least one collapsible configuration defined by a diameter d, and having at least one expansible configuration characterized by a diameter D; D> d; Maintaining the catheter in its at least one collapsible configuration within a body cavity while maintaining the shaft with a relative rigidity and a small cross-section; and then, still in the cavity, expanding the cross-section of at least part of the catheter to its expanded configuration and larger cross-section while keeping the shaft flexible.

It is further within the scope of the invention to disclose a method as defined above, wherein the method additionally comprises steps selected from (i) maintaining the shaft and / or tip in a collapsed configuration by providing an insert to effectively engage the portion of the shaft and (ii) expanding the shaft and / or the tip to the expanded configuration by manipulating the insert to stop the coupling so as to obtain a flexible shaft of large cross-section.

Brief description of the drawings

The objects and advantages of the various embodiments of the invention will become apparent from the following description when read in conjunction with the accompanying drawings, wherein:

1a and 1b schematically and not to scale illustrate a distal portion of a commercially available and known in the prior art catheter and a cross section A: A of the aforementioned commercially available catheter;

2a - 2h and 3 schematic and not to scale transversal cross sections ( 2a - 2f ) and a sagittal cross section ( 3 ) of various embodiments of the novel catheter as defined in the present invention;

4 schematically and not to scale illustrates a side view of a distal portion of a catheter;

5 schematically and not to scale illustrates a cross-section of a commercially available catheter;

6a - 6d schematic and not to scale transversal cross sections ( 6a - 6c ) and a sagittal cross section ( 6d ) of the novel catheter as defined in the present invention;

7a - 7b illustrate schematically and not to scale an embodiment of the novel catheter as defined in the present invention;

8a - 8b illustrate a transverse cross-section and side views of an embodiment of the novel catheter as defined in the present invention;

9 presents a graph showing the measure of compressive force as a function of the amount of compression of a catheter according to one embodiment of the present invention;

10a and 10b presents graphs of resistance as a function of catheter elongation according to one embodiment of the present invention;

11 illustrates a device for measuring the pushability of the catheters of the invention disclosed herein; and

12a and 12b present graphs showing results of cathodic pushability tests of the invention disclosed herein which were made on the device disclosed in U.S. Patent Nos. 3,846,074; 11 is illustrated.

Detailed description of preferred embodiments

The following description is provided to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the invention for carrying out this invention. Various modifications will, however, be apparent to those skilled in the art, as the generic principles of the present invention have been specifically defined to provide a catheter with reversibly provided collapsible and expanded configurations as defined and described herein.

It is therefore an object of the present invention to provide a catheter having at least one property that is asymmetrical with respect to at least one plane of said catheter, said feature providing the catheter with maneuverability within a body cavity.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a sagittal cross-section, wherein at least a portion of said sagittal cross-section is characterized by at least one asymmetric property and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a corneal cross-section, wherein at least a portion of said corneal cross-section is characterized by at least one asymmetric property and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open-ended shaft, said sheath being characterized by a major longitudinal axis and a transverse cross-section, at least a portion of said transverse cross-section passing through at least one asymmetric property, and further wherein the asymmetric property extends along said major longitudinal axis according to a predetermined pattern.

It is another object of the present invention to provide a catheter comprising a continuous sheath forming an open internal diameter shaft, said sheath being characterized by a major longitudinal axis and a (i) sagittal cross section, (ii) corneal cross section, (iii) transversal A cross section or any combination thereof, wherein at least a portion of either said (i) sagittal cross section, (ii) corneal section, (iii) transverse section or any combination thereof is characterized by at least one asymmetric property, and further wherein the asymmetric property is along the extending said main longitudinal axis according to a predetermined pattern.

As used herein, the term "catheter" refers to any catheter used medically or veterinarily and to any tube or the like that can be inserted into a body cavity, passage or vessel, and drainage, injection of fluids or access by surgical instruments allowed. The catheter is made, at least in part, of a flexible material such as but not limited to latex, silicone plastic, rubber, polymers, Gor-tex ^™ or any other polytetrafluoroethylene (PTFE) or the like, and any combination and mixtures thereof. The catheter may be made of radiopaque dyes or agents thereof.

It is within the scope of the invention that the term "catheter" or "leading catheter", as used interchangeably herein, refers to catheters, tubes, guide wires, trocars, intravenous tubing, inserts, needles, endoscopes, and sheaths thereof used in human or veterinary surgery, such as percutaneous coronary intervention (PCI), percutaneous transluminal coronary angiography (PTCA), coronary artery bypass graft (CABG), balloon angioplasty, urological procedures, etc.

The term "body cavity" herein interchangeably refers to both natural body cavities and openings such as the circulatory system, blood vessels such as arteries, branches of the aorta such as the atrial artery, the collarbone aorta, the celiac trunk, the intestinal arteries, etc. the renal artery and pelvic artery, arteries, coronary Circulation, blood vessels of the coronary circulation, the urethra, the vagina, the anus, the respiratory tract or other NOTS openings, as well as on unnatural orifices such as supportive provided openings as in laparascopic surgery procedures, intravascular cannulas, etc.

The term "non-uniform body cavity" refers to a body cavity as defined above that has at least one irregular shape, such as branches, junctures, cavities, one or more narrowing or constricting portions, strictures; or, alternatively, widening or widening sections, enlargements, expansions, dilatations, deployments, expansionism, expansiveness, extensiveness, elevations, spaciousness, dilations, etc .; or alternatively curved, staggered or bent sections.

The term "latex" herein refers to either natural or synthetic stable dispersions (emulsions) of polymer microparticles in an aqueous medium, such as a rubber latex. In a broader range, the term refers to any biocompatible material such as rubber, polyamide (Nylon ^™ ), polyalkene or the like, silicone, etc.

As used herein, the term "asymmetric cross-section" refers to an asymmetry provided in the catheter, inter alia, in one or more of its following cross-sections, namely, sagittal, corneal, or transverse plan views. The term also refers to any asymmetry provided in other plan views of the stem. The asymmetry of the catheter is provided by various means, such as by constructing at least a portion of the catheter with a material characterized by at least one property, which is at least one property different from at least one property of other portions of the catheter. Thus, for example, the at least one property is selected from a group consisting of stiffness, flexibility, Young's modulus E, shear modulus G, compression modulus K, Poisson's number ν, spring modulus, flexural stiffness EI, thickness, texture , the composition, the electrical conductivity, the density, the method of preparation and any combination thereof.

The term "about" herein refers to a value that is + 25% of the defined measure.

It will be up now 1a Reference is made showing a side-by-side and not to scale illustration of a distal portion of a commercially available catheter known in the art having an insertion tip 2 has at its extreme distal end and an elongated shaft part (neck) 1 , Transverse section A: A defines at least a portion along the shaft or tip. The main elongated axis of the shaft is marked in dashed line B: B.

It will be up now 1b Reference is made, which illustrates the cross section A: A of the aforementioned commercially available catheter. This view, which is provided here in a manner not to scale, schematically presents a portion of the aforesaid elongate shaft. The cross section shows a relatively larger open inner diameter 4 , The thickness of the shell (walls, 3 ) of the catheter is essentially smooth, flexible, single-layered, homogeneous and thinner catheter.

It will now be on the 2a to 2h and 3 With reference to the drawings, which are schematic and still not to scale true transverse cross-sections ( 2a to 2f ) and a sagittal cross section ( 3 ) of various embodiments of the novel catheter as defined in the present invention.

2a therefore illustrates a cross-section of a non-limiting embodiment 101 of the catheter according to the present invention. The shaft includes a relatively larger open inner diameter 4 which is suitable for providing a fluid. As in the prior art, the thickness of most of the envelope (walls, 3 ) of the catheter is substantially smooth, single-ply, homogenous and thin so as to provide the catheter with flexibility. The catheter further includes a bulge 10 Here is a section of a relatively thick wall that protrudes inwards, ie in the inner diameter 4 into it. Said at least one less flexible section 10 is located somewhere along the circumference of the envelope. The section 10 is less flexible than the shell 3 and therefore provides a structural element. A coiled elevation (see eg Part 17 in 3 ) of the bulge 10 , which surrounds the main elongated axis B: B of the shaft, constitutes a rotation of the tip part 2 and / or the shaft part 1 the catheter ready when the catheter is linearly maneuvered within the body cavity.

The catheter of the present invention is characterized by a tip portion 2 and / or at least one shaft part 1 which have either a continuous or controlled asymmetry or tendency (flexibility) to break out of the given boundary of the envelope. By way of example and not limitation, the bulge is circumferentially protruding in the range of about 0.01 and less than millimeters to about 2.5 and more millimeters. The asymmetry as provided, among others and according to yet another embodiment, by means of a predefined microstructured texture.

Thus, within a branched and / or non-linear body cavity having a defined size of inner diameter and structure, junctions and branches thereof, a cautious linear reciprocating motion and / or a rotatable maneuver of the shaft 1 at its proximal end, tip part 2 and / or at least one shaft part 1 advanced towards and within said junctions or junctions.

It will be up now 2 B Reference is made, which is a cross section of another non-limiting embodiment 102 of the catheter of the present invention. The catheter here includes more than one bulge, here two bulges 11 and 12 with relatively thick walls that protrude inwards.

It will be up now 2c Reference is made, which is a cross section of another non-limiting embodiment 103 of the catheter of the present invention. The catheter includes a bulge here 13 with relatively thick walls that project inwards and outwards. It is well within the scope of the invention that more than one type of bulge ( 13 ) is used, and that the bulge protrudes only outside the circumference of the shell.

It will be up now 2d Reference is made, which is a cross section of another non-limiting embodiment 104 of the catheter of the present invention. The catheter here comprises at least one section 14 from a relatively flexible or relatively rigid wall section. This section protrudes neither inwards nor outwards. For example, the shell 3 made of a material, eg. At least a first latex having a predetermined Young's modulus, and the part 14 is made of at least a second latex or a silicone plastic having a different Young's modulus. Thus, by way of non-limiting example, the at least one first latex is characterized by a Young's modulus ranging from, for example, about 1500 to about 7000, and a modulus ranging from, for example, about 0.01 to about 0, GPa, and the second latex or silicone-containing material is characterized by a Young's modulus ranging from, for example, about 7500 to about 15000, and a modulus ranging from, for example, about 0.05 to about 0, 01 GPa, and vice versa.

It will be up now 2e Reference is made to a cross section of another embodiment 105 of the catheter disclosed herein. The catheter includes at least one inflatable / contractible balloon-like bulge 15 that has at least one open inside diameter 6 Has. Here, the asymmetrical proportions of the cross section are controlled by the operator. Inflating the balloon increases the asymmetry. It is within the scope of the invention that more than one type of controllable lobes 15 is used, and that the bulge protrudes only outside the circumference of the shell.

It should be emphasized that due to the above-mentioned asymmetry characteristic, the catheter tip has a tendency to one side, which favor one of the directions (left, right, up, down).

Each time the operator wishes to reverse the catheter tendency, he inflates the balloon or pulls the balloon together, directing the catheter tip to the opposite side.

It will be up now 2f Reference is made, which is a cross section of another non-limiting embodiment 106 illustrated by the thus patented catheter. The catheter is characterized by heterogeneous asymmetric properties. The catheter 106 includes, inter alia, (a) at least one inflatable / contractible balloon-like bulge 15 that has at least one inflatable volume 6 Has; and (b) at least one section 14 from either relatively flexible or rigid wall sections compared to the wall 3 , Again, the asymmetrical proportions of the cross-section are controlled by the operator.

It will be up now 2g Reference is made, which is a cross section of another non-limiting embodiment ( 107 ) of the patented catheter. The shaft includes a relatively large open inner diameter 4 , which is suitable for a fluid supply, and a smaller inner diameter 5 which is particularly adapted to inflate or contract a balloon placed at the tip of the catheter, as in urine catheters. Here is in the catheter 107 the continuous shell 16 that the inner diameter 5 surrounds, designed to provide the required asymmetric properties. Again referring to 3 is the inner diameter 5 that from the shell 16 is not parallel to the major longitudinal axis B: B, but is coiled along the axis in a helically wound fashion, such as through the line 17 is defined.

It will be up now 2g Reference is made, which is a cross section of another non-limiting embodiment ( 108 ) of the catheter disclosed thereby. The shaft is characterized by asymmetric proportions provided by the use of shape memory materials, in particular Nitinol ^™ and electroactive polymers arranged along the circumference of the shaft, in particular along its major longitudinal axis of one or more parts of the shaft, for example see a herringbone design with sections 17 and 18 which comprises one or more rib-like structures made from Nitinol ^™ .

It will be up now 3a Reference is made to a three-dimensional, not to scale, simplified presentation of a portion of the catheter 109 which has an asymmetric configuration, the asymmetry being particularly in the sagittal and coronal planes and cross-sections thereof. Again referring to the stem 104 , is the wall 3 made of a flexible material, eg. At least one first latex or one or more silicone plastics having a defined Young's modulus, wherein the portion 14 made of a different material or a mixture of materials. The section 14 goes along the shaft in a coiled way (see line 17 ) so that it turns clockwise over the main longitudinal axis B: B.

According to one embodiment of the invention, the section 14 Made from at least a second latex or silicone plastic, compared to the wall 3 has a different Young's modulus. Thus, by way of example and not limitation, the at least one first latex is characterized by a Young's modulus ranging from, for example, about 1500 to about 7000, and a modulus ranging from, for example, about 0.01 to about 0, GPa, and the at least one second latex or silicone-containing material is characterized by a Young's modulus ranging from, for example, about 7500 to about 15000, and a modulus in a range of, for example, about 0.05 to about 0.01 GPa, and vice versa. According to yet another embodiment of the invention, as described above, the section comprises 14 one or more shape memory alloys or electroactive polymers. Thus, by applying an electric current to the section 14 a rotational movement 20 provided here a clockwise rotation ( 20 ) above the main longitudinal axis B: B.

It will be up now 3b Reference is made to a three-dimensional, not to scale, simplified presentation of a portion of the catheter 110 illustrated, which has a complicated asymmetric configuration. The wall 3 is made of a flexible material, for. At least one first latex or one or more silicone plastics having a defined Young's modulus, wherein the portion 14 for example, made of still another material or a mixture of materials. The section 14 goes along the shaft in a coiled way (see line 17 ) so that it turns clockwise over the main longitudinal axis B: B, and further where the section 17 made of, for example, another material or a mixture of materials. The section 17 goes along the shaft in a coiled way (see line 19 ) so that it turns clockwise ( 21 ) over the main longitudinal axis B: B

According to one embodiment of the invention, the section 19 Made from at least a second latex or silicone plastic, compared to the wall 3 has a different Young's modulus. Thus, by way of non-limiting example, the at least one first latex is characterized by a Young's modulus ranging from, for example, about 1500 to about 7000, and a modulus ranging from, for example, about 0.01 to about 0, GPa, and the at least one second latex or silicone-containing material is characterized by a Young's modulus ranging from, for example, about 7500 to about 15000, and a modulus in a range of, for example, about 0.05 to about 0.01 GPa, and vice versa. According to yet another embodiment of the invention, as described above, the section comprises 19 one or more shape memory alloys or electroactive polymers. Thus, by applying an electric current to the section 19 a rotational movement 21 provided, here a rotation in the counterclockwise direction over the main longitudinal axis B: B. The shaft 110 is thus maneuverable to rotate (i) counterclockwise and / or (ii) clockwise.

It will be up now 4 Reference is made, which presents a lateral and not to scale illustration of a distal portion of a catheter having an insertion tip 2 at its outermost distal end, and an elongate shaft portion 1 (Neck).

It will be up now 5 Reference is made, which illustrates a cross section of a commercially available catheter. This view, which is provided here in a manner not to scale, schematically presents a portion of the aforesaid elongate shaft. The cross-section shows a relatively larger open inner diameter suitable for providing fluid and a smaller inner diameter (see at the bottom of the cross-section) which is particularly adapted to inflate and contract a balloon at the apex the catheter is arranged. The structure of the sheath (walls) of the catheter is substantially smooth, single-layered, homogeneous and thin so that the catheter is flexible and characterized by a large diameter.

It will now be on the 6a to 6d Referring to the schematic and not to scale transverse cross-sections ( 6a to 6c ) and a sagittal cross section ( 6d ) of some embodiments of the novel catheter as defined in the present invention. 6a illustrates the patented catheter in its collapsed configuration. Its smaller diameter and relative stiffness make it easy for the physician to insert the catheter into a cavity of the body. 6a therefore shows the two sections of the lumen of the catheter, namely the relatively large first inner diameter 10 which is suitable for incomplete provision of fluid, and a smaller second inner diameter 20 which is adapted to inflate and contract a balloon located at the tip of the catheter. The structure of the sheath (walls) of the catheter in its collapsed configuration is textured (see the invaginated section 30 ), has different layers, is heterogeneous and respectfully thick, so that the catheter is reasonably stiff and characterized by a small diameter.

Reference will now be made to a preferred embodiment of the invention, a transverse cross-section, as in 6b is shown. In this embodiment, a small inner diameter 20 spiral around the central large inner diameter 10 arranged. The small inner diameter may be completely within the wall of the catheter. In preferred embodiments of the invention, the diameter of the small inner diameter is sufficiently large that it causes a protuberance in the wall of the catheter inwardly. The inner large inner diameter thereby assumes a shape that appears in transverse cross section as a meniscus, wherein the inner inner diameter is opposite to the convex part of the meniscus. A transverse cross-section of a catheter constructed in accordance with this embodiment of the catheter is shown in FIG 8a While side views of catheters according to this embodiment of the invention are shown with varying pitches of the spiral small inner diameter in FIG 8b are shown. In the 8th Imaged catheters are made of latex, but any suitable material can be used to make the catheter of the present invention.

The catheter may be made with any suitable outer diameter. As a non-limiting example has a small inner diameter 20 for a 16F catheter, typically a diameter of about 1 mm, while the large inside diameter 10 an inner diameter (the diameter of the circle of which the meniscus is a part) of about 2-3 mm.

The physical properties of the catheter, such as the pushability, flexibility, traceability, and traversability of the catheter, depend on the pitch of the small inner diameter spiral, as shown in the examples below. The slope can therefore be selected as any value that gives the catheter the characteristics appropriate for the particular application for which it is used. In typical embodiments of the invention, the slope is in the range of 0.25-1.5 turns per 2.54 cm.

It is within the scope of the invention for the catheter to comprise more than one invaginated section. Thus, by way of example and not by way of limitation, in accordance with one embodiment of the invention, a portion of the stem includes two inverted portions, the first at a 3 o'clock position and the second at a 9 o'clock position. Similarly, and in accordance with yet another embodiment of the invention, a portion of the stem may have three inverted portions, the first at a 9 o'clock position, the second at a 12 o'clock position and the third at a 3 o'clock position. According to another embodiment of the invention, a part of the shaft may have a recessed portion, for. B. in 12 o'clock position, and another part of the shaft may comprise two invaginated sections, z. B. in a 9 o'clock position and the third in a 3 o'clock position. The size of the invaginated sections, ie the length of the invaginated shell and thus the area of the encapsulated shell may vary. Thus, in at least a first part of the shaft, the number of invaginated portions is N and the surface of the encapsulated shell is M ^2, whereas in at least a second part of the shaft and the number of invaginated portions N'the surface of the encapsulated shell ^M'2 is; N is the same or different from N 'and M is the same or different from M'. It is therefore within the scope of the invention for the catheter to have two or more collapsed configurations and / or two or more expanded configurations.

It will now be on the 6c Reference is made, which schematically shows a catheter with a recessed portion 30 Illustrates that are effectively reversible through use 40 is coupled. The insert here comprises two wires that mechanically grasp the folded indentation in the collapsed configuration. According to one embodiment of the invention, the wires detach by pulling the wires or otherwise manipulating (physically, mechanically, electrically, etc.) or maneuvering the insert, and the catheter spontaneously turns into its expanded configuration. Still referring to a mechanical wire-based embodiment of the insert, the two wires in their coupled configuration can be secured in a locking pin lock mechanism provided on the outermost proximal portion of the catheter (see 41 in 6d ), by a zipper mechanism, by untying temporarily sawn sutures, or by any other suitable mechanical, chemical (peel, dissolve, etc.) or electrical mechanism (eg, compounds comprising shape memory alloys such as nickel titanium (Nitinol) and / or electroactive polymers such as ferroelectric polymers, conductive polymers, ionic polymer-metal compounds, electrorheological fluids, ionic polymer-metal compounds, etc.). It is therefore within the scope of the invention that the insert and its parts (see, for example, the wires 40 ) are at least partially made of polymers, metal materials, etc.

It will be up now 7a and 7b Referring now to Fig. 3, which illustrate schematically and still not to scale the novel catheter as defined in the present invention, wherein Figs 7a the collapsed configuration is presented, with two inserts 40a and 40b effective and continuous invagination 30 in strongly opposite directions 40c respectively. 40d fold. By unifying or opening the spring-like inserts the invagination disappears (see 7b ).

It is within the scope of the invention that the mechanical properties of said portion of the stem are selected from a group consisting of the Young's modulus ranging, for example, from about 1500 to about 15,000 lbf per in ² , and the shear modulus, for example from about 0.01 to about 0.1 GPa is sufficient.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed, but, on the contrary, that it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention as defined in the appended claims.

The following examples are presented solely as illustrations of features of some preferred embodiments of the catheter disclosed herein and will aid one skilled in the art to make and use the finished invention. They are therefore not to be construed as limiting in any way.

example 1

The flexibility of a typical embodiment of a catheter according to the in 8th The illustrated embodiment was tested by placing the catheter in a compression device. It will be up now 9 Reference is made, which shows a graph of the measured reaction force as a function of the displacement of the compression device along its x-axis (ie the axis of the catheter in its uncompressed state). As can be seen from the graph, the force-versus-compression behavior of the catheter is that of an elastomer having a Shore A hardness of between 45 and 65, ie, less soft than typical soft to medium sized rubbers covered by a Shore A. Hardness of about 40, but softer than typical hard rubbers, which are characterized by a Shore A hardness of about 80.

Example 2

Tests for the elasticity of the catheters disclosed herein according to the in 8th illustrated embodiment have been for a number of slopes of small inner diameter 20 between 0.25 and 1.5 turns per 2.54 cm.

It will be up now 10A Referring to Figure 4, which shows a graph of resistance force as a function of elongation for catheters of the present invention having different slopes (solid lines) compared to standard latex and silicone Foley catheters (dashed lines). As can be seen from the graph, the catheters of the present invention are generally less resilient than standard Foley catheters.

It will now be on the 10B Reference is made to the resistance to elongation and recovery for catheters of the same design as in 10A shows, however, for larger shifts. As can be seen from the graph, the catheters of the present invention (shown as solid lines for the results) are less elastic than typical Foley catheters (shown as dashed lines). In one case, the catheter of the present invention 20 characterized by a pitch of 1.5 turns per 2.54 cm and elongated to the point at which it underwent a permanent plastic deformation. The deformation is manifested by the inability of the catheter to regain its original length, as indicated by the double-sided arrow along the x-axis of the graph. This graph further illustrates that the catheters of the present invention are less elastic than typical Foley catheters, which can be stretched to a significantly greater extent without undergoing permanent plastic deformation.

Example 3

Slidability tests of the catheters of the present invention were made. It will be up now 11 Refer to, which represents the device on which the Schiebbarkeitstests were performed. The catheter was inserted into a straight tube with an inside diameter that matched the outside diameter of the catheter, and the catheter was forced through the tube by a force pulse from an Aikoh Engineering Model AEF-5 push-pull meter. The penetration depth after the impact was then measured.

It will be up now 12 Reference is made which presents two graphs showing the results of the test. 12A Figure 4 shows the depth of penetration as a function of slopes for specific slopes at different catheter diameters 12B shows the evolution of penetration depth as a function of slopes for different catheter diameters. As can be seen from the graphs, the tendency for greater depth of penetration at low slopes, approaching an asymptotic value, is maintained regardless of the catheter diameter. Therefore, the desired pushability for a particular application can be selected by choosing the pitch of the small inside diameter 20 to be obtained.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 5445625 [0002]
• US 6083213 [0002]
• WO 02/32495 A1 [0002]
• WO 2008/005388 A2 [0003]
• US 6960222 [0003]
• US 6936060 [0003]
• US 6908474 [0003]
• US 6905490 [0003]
• US 6682505 [0003]
• US 6645222 [0003]
• US 6632236 [0003]
• US 6582396 [0003]
• US 6540712 [0003]
• US 6423032 [0003]
• US 6413235 [0003]
• US 6206868 [0003]

Cited non-patent literature

• Meier B .; "Percutaneous coronary intervention"; In: Topol EJ (ed.), Textbook of Cardiovascular Medicine, 2nd edition 2002, pages 1665-1676 [0002]
• Kiemeneij F, Laarman GJ, de Melker E .; "Transradial artery coronary angioplasty", Am Heart J. 1995; 129: 1-7 [0002]
• Campeau L. "Percutaneous Radial Artery Approach to Coronary Angiography", Cathet. Cardiovasc. Diagn, 1989; 16: 3-7 [0002]

Claims (10)

A catheter comprising a hollow tube comprising a first inner diameter ( 10 ) and a second inner diameter ( 20 ), said hollow tube comprising a wall made of a flexible material and characterized by a proximal end, a distal end and a longitudinal axis, said first inner diameter being substantially parallel to said longitudinal axis, and of is surrounded by the said wall, and wherein said second inner diameter is arranged spirally around the said first inner diameter and is located within said wall.  The catheter of claim 1, wherein said second inner diameter is characterized by a diameter smaller than that of said first inner diameter.  The catheter of claim 1, wherein said catheter is characterized by a transverse cross-section in which said first inner diameter is meniscus-shaped and said second inner diameter is disposed opposite a concave portion of said meniscus.  The catheter of claim 1, wherein said second inner diameter has a substantially circular cross-section.  The catheter of claim 1, wherein said flexible material is selected from the group consisting of latex, polypropylene, polyethylene, polyethylene terephthalate, silicone plastic, shape memory materials, electroactive materials, and any combination thereof.  The catheter of claim 1, wherein said catheter is characterized by a compressive force versus compression displacement curve equivalent to that of an elastomer having a Shore A hardness of between 45 and 65.  The catheter of claim 1, wherein said first inner diameter encloses said longitudinal axis.  The catheter of claim 1, wherein said second inner diameter is spirally disposed about said first inner diameter in a spiral characterized by a slope of between 0.25 and 1.5 turns per 2.54 cm.  The catheter of claim 1, wherein said first inner diameter and said second inner diameter are open at both ends of said catheter.  The catheter of claim 1, wherein said catheter is configured to be connectable to a tip at said distal end.

Images