WO2020044130A1

WO2020044130A1 - Tapered coronary sinus vein balloon

Info

Publication number: WO2020044130A1
Application number: PCT/IB2019/052843
Authority: WO
Inventors: Abdollah HABIBI KOUSHA; MohammadSadegh GHANI; Moharram KAZEMI; Seyedmehdi MOSUAVI
Original assignee: Habibi Kousha Abdollah; Ghani Mohammadsadegh; Kazemi Moharram; Mosuavi Seyedmehdi
Priority date: 2018-08-29
Filing date: 2019-04-06
Publication date: 2020-03-05

Abstract

The embodiments herein provide the taper balloon of coronary sinus vein.it is a percutaneous transluminal balloon catheter with a fixed distal wire at its end, which is fixed to the end of a balloon followed by a taper balloon with inflation/deflation potential. There is one or two markers at the proximal and distal or middle of the balloon, which is opaque and visible with the x-ray, the shaft of the balloon catheter only has a single lumen, and there is a hub at the beginning of the balloon catheter.

Description

Tapered Coronary Sinus Vein Balloon

The taper balloon of coronary sinus vein has the technical field of health and medical equipment. In Cardiac Resynchronization Therapy (CRT), after insertion of the coronary sinus lead and lead analysis, the guide wire and sheathe must be removed. However, sometimes, when removing the guide wire and sheathe, the lead is displaced or removed that it is important to put it in the right place. The taper balloon of the coronary sinus vein has a fixed distal wire that passes through sheathe. According to the operator’s opinion and using the maneuver, the balloon is inflated at the proximal or distal lead to jail the lead at the balloon site and prevent it from displacement. Then the guide wire and sheathe are removed by ensuring the lead analysis. Using the taper balloon of coronary sinus vein, the procedure time, X-rays and costs are reduced.

Cross Reference to Related Application

This application claims the benefit of priority to an Iran patent application having serial number 139750140003004780 filed on Aug. 29, 2018, which is incorporated by reference herein in its entirety.

The innovation refers to an advantageous technology in a dilatation balloon assembly and particularly to a novel improvement in variable distention angioplasty balloon assembly.

The first pacemakers made, had the size of a table-clock and a service life shorter than 12 months. However, the idea of using an electrical device to provide for a regular heart beat was suggested by Paul Zoll in 1952.

The initial design of this system represented a device with two wires to be connected to the patient's belt. The device would be connected to an electricity socket and therefore, heart of the person having suffered a cardiac attack would be stimulated by electrical shock. This would often result in resumption of normal activity of the heart. This almost effective device would initially be used under emergency conditions; until batteries were added to the systems in 1958 and this converted the pace-makers into portable systems which facilitated mobility of the patient. The first implantable pacemaker was invented by William Cardac and Willson Gretback and used for a living person in 1960. Its battery had a service life of 12-18 months.

The modern technique for implanting a pacemaker into the heart was innovated by Simon Foreman in 1960. Instead of opening the patient's Chest he passed the leads through the veins and guided toward cardiac ventricles. Placement of the leads into ventricles reduced the voltage needed for adjustment of heart beats and this provided for a longer utilization of the pacemaker. Though this method was not utilized broadly at first, cardiologists started using the method later in 1960's. Along with the advancement made in respect of regulating leads, which consist of some wires depending on kind of lead covered with multiple layers of insulating materials and placed in heart through a vein, substituted the primary leads that would be connected to the outer surface of heart. Nowadays, pacemakers and leads are implanted without the requirement of opening the chest. Some pacemakers are temporary and they are normally used for an immediate establishment of hemodynamic stability of heart; or they may be used where a probability exists for arising of a brachycardia amidst the surgical Operation.

The most simple kind of pacemakers is referred to as single chamber pacemaker as this is connected to only right atrium or right ventricle by a lead. A dual Chamber pacemaker has two leads, one of which is placed into right atrium and the other one into right ventricle. This kind of pacemaker can stimulate two chambers. An ICD (Implantable Cardioverter Defibrillator) has a wire which is placed into right ventricle and it is principally used for quick ventricular arrhythmia. There are also more recent pacemakers which are Wireless and they are placed into the heart through feet veins in the way similar to angiography. Currently the aforesaid pacemakers (wireless) are supplied in the form of single chamber pacemakers only.

There is some kind of double ventricle, triple chamber pacemakers referred to as cardiac resynchronization therapy defibrillator (CRT-D) or Cardiac resynchronization therapy pacemaker (CRT-P) which are used in treatment of Cardiac insufficiency.

A lead is placed into right ventricle with another lead placed into right atrium. These are mostly active- fixation and steroid-eluting leads. A third lead is placed at Coronary sinus. This latter lead is curved, tined or steroid-eluting to pace the left ventricle.

Description or the related art including information disclosed. examples of such assemblies are disclosed in the following U.S. pat. Nos.:

U.S. pat. No. 5273536A, discloses a Taper Balloon Catheter. It is a modified and advanced balloon for use in coronary artery angioplasty through a transparent subcutaneous tract. The modified and advanced balloon has a work section of more than 30 millimeters, and when it is inflated, it has a sharp taper form. The balloon less than 30 millimeters is tapered. However, a taper balloon catheter is invented with the length of six to thirty millimeters fixed in distal guide wire and used in the trap technique.

U.S. pub. No. 20080045928A1 discloses a Taper shaft of balloon catheter with high strength and flexibility and similar manufacturing method. A catheter has a long shaft with a tubular member that forms at least part of the shaft. It is formed of a double-sided thermoplastic polymer material. In a catheter shaft forming method with radial and longitudinal extension of the tube section is directed to double-sided polymer material in one of the embedded and tapered parts if the tubular member to create a rigid and curved transmission. An innovative catheter that combines advanced flexural stiffness with low curvature, high failure pressure and tensile strength to improve catheter performance. However, a taper balloon catheter is invented with the length of six to thirty millimeters fixed in distal guide wire and used in the trap technique.

U.S. pat. No. 5702364A, discloses a Balloon catheter dilatation with fixed wire. A fixed balloon catheter that extends for use in angioplasty includes a metal tube with a flexible and thin wall that has an inflated distal balloon. The main metal part with a smaller outer diameter of the metal tube connects to the distal tube to provide support and guidance to the balloon section. The balloon proximal is connected to the distal tube of middle tube with the expansion of central distal between the metal tube and the balloon. The distal balloon is tightly fastened to the center. A good ventilation system is installed to deflate the gases before using the catheter. While our invention is a taper balloon catheter with dissimilar ends and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve that is mostly used in trap technique in the coronary sinus vein.

U.S. pat. No. 5593419A, discloses a Catheter dilatation with fixed wire with distal rotating part. A type of balloon catheter dilatation with fixed wire has a small diameter and it can be led toward or through the narrow tracts.

The catheter has a balloon at the distal that can be placed in a cut site to allow it to pass through a narrow tract. The catheter includes a connection between the distal balloon and the central wire, which shows the minimum resistance to torsion in the central wire when the central wire is rotated towards the balloon and the balloon is inflated. As a result, any catheter rotation around the wire occurs at distal balloon, which prevents the flow of fluid from the balloon. While our invention is a taper balloon catheter with dissimilar ends and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve that is mostly used in trap technique in the coronary sinus vein.

U.S. pat. No. 5441484A, discloses a Catheter dilatation with open central wire. The catered without fixed wire in angioplasty has a central wire that extends and spreads from the distal side to the outside of the distal tubular section. The pipe section defines an internal lumen that connects the fluid to an inner lumen of the distal middle tube that extends to the central wire. The inflatable section of the balloon expands and spreads in the central wire range, and connects the fluid to an inner lumen of the distal middle tube. A rigid component is connected to the balloon section. The rigid component provides the possibility of rotation of the central wire relative to the balloon section, so that the applied torque applied to the tube section and transmitted to the central wire cannot easily be transmitted to the balloon section. A compressive section is connected to the central wire of the lateral rigid and axial component. The compressive section prevents longitudinal displacement of the inner line tube, which in its turn prevents the longitudinal collapse of the balloon and middle tubes when the catheter passes through a coronary system of the patient. While our invention is a taper balloon catheter that enters the patient body through the coronary system of the patient and subclavian, radial, or femoral lumen. The ends are dissimilar and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve that is mostly used in trap technique in the coronary sinus vein.

U.S. pat. No. 4616653A, discloses a Balloon catheter dilatation with advanced non-displaceable guide wire. Balloon catheter dilatation with advanced non-displaceable advanced guide wire has a flexible tube section with the first and second tracts that passes through them. A dilatable balloon is mounted on the distal tube section, so that the first tract extends into the balloon and is not associated with the interior of the balloon and the second tract connected to the inner balloon is dilated. A guide wire is set in the first tract in sliding mode. The coil-like end is attached to distal guide wire and has a cross-sectional area that is larger than the cross-sectional area of the first tract and prevents the guide wire from being removed from the first tract. The guide wire is capable of moving along the first tract so that the coil end such as the guide wire advances ahead of the balloon to facilitate the balloon positioning. While our invention is a taper balloon catheter with dissimilar ends and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve. The guide wire moves the balloon catheter without the need for another guide wire. The distal balloon guide wire prevents trauma to the vessel wall during the balloon catheter movement in the vessel that is mostly used in trap technique in the coronary sinus vein.

U.S. pub. No. 20060282110A1, discloses a Balloon catheter transmission system with advanced non-displaceable guide wire for stenting method. A balloon catheter transmission system with advanced non-displaceable guide wire for stenting includes a balloon catheter dilatation including a balloon specified with inner and an outer tube sections and a mounted guide wire. It has a limited range of longitudinal motion relative to the inner tube and expandable stent mounted on the balloon. While our invention is a taper balloon catheter with dissimilar ends and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve that is mostly used in trap technique in the coronary sinus vein.

U.S. pub. No. 20030139762A1, discloses an Angioplasty balloon with thin wall taper needle and similar manufacturing method. There is an angioplasty balloon and its construction method. The balloon has a functional length and a tapered needle, each of which has a thickness equivalent to its length. This shape allows the balloon to be easily led through the coronary system to the blockage site before dilation during an angioplasty method. The tapered needle thickness is achieved, in particular, by the use of a multi-tube designed rod that is molded for the formability of angioplasty balloon of this invention. While our invention is a taper balloon catheter with dissimilar ends and it has a distal hydrophilic or hydrophilic guide wire coated with tip straight or fixed curve. The guide wire moves the balloon catheter without the need for another guide wire. The distal balloon guide wire prevents trauma to the vessel wall during the balloon catheter movement in the vessel that is mostly used in trap technique in the coronary sinus vein.

E.P. pat. No. 2389974A1, discloses a Balloon catheter for entering the body vessels especially the coronary sinus. A balloon catheter for entering a body vessel, in particular the coronary sinus and for an intermittent blockage vessel, comprises a catheter shaft that has a dilated balloon on the distal end of the vessel. It also includes a number of tracts expanded by the catheter shaft, a pressure sensor tract developed from the catheter shaft to the distal mouth. It has at least one distal mouth distally inserted on the balloon for fluid communication in the body vessel. Additionally, a dilated tract is fitted to inflate and deflate the balloon, while the catheter comprises a hardening component that extends throughout the catheter shaft. The hardener has a distal region adjacent to the proximal balloon and has less flexural strength relative to the remainder of the hardening region. While our invention is a taper balloon catheter with a distal guide wire that the guide wire moves the balloon catheter without the need for another guide wire. The has a separate tract to inflate and deflate the balloon and the balloon catheter is used for trap technique in the coronary sinus vein.

This summary is intended to provide an overview of the subject matter of the present disclosure, and is not intended to identify essential elements or key elements of the subject matter, nor is it intended to be used to determine the scope of the claimed implementations. The proper scope of the present disclosure may be ascertained from the claims set forth below in view of the detailed description below and the drawings.

According to some exemplary embodiments, the taper balloon of coronary sinus vein has the technical field of health and medical equipment. In Cardiac Resynchronization Therapy (CRT), after insertion of the coronary sinus lead and lead analysis, the guide wire and sheathe must be removed. However, sometimes, when removing the guide wire and sheathe, the lead is displaced or removed that it is important to put it in the right place. The taper balloon of the coronary sinus vein has a fixed distal wire that passes through sheathe. According to the operator’s opinion and using the maneuver, the balloon is inflated at the proximal or distal lead to jail the lead at the balloon site and prevent it from displacement. Then the guide wire and sheathe are removed by ensuring the lead analysis. Using the taper balloon of coronary sinus vein, the procedure time, X-rays and costs are reduced.

Some kind of pacemakers known as double atrium triple chamber pacemakers or Cardiac resynchronization therapy (CRT) pacemakers, are used in treatment of Cardiac insufficiency. A lead is placed in right ventricle, another lead in right atrium and the third lead in Coronary Sinus. Much progress has taken place in designing leads to substitute the straight and curved tip leads.

Modern leads are tined or active stabilization leads and they are more commonly used nowadays. They provide for a more reliable connection to cardiac tissue so that dislocation of the lead is prevented.

This kind of active leads are used in right atrium and ventricle. However Coronary Sinus lead cannot be activated in the same way as those of atrium and ventricle. Coronary Sinus leads are mostly curved and only some of those leads are tined or steroid-eluting to pace left ventricle.

To place a Coronary Sinus lead, a sheath is required to be placed first. In case the tip of sheath rests on the proper location, then 0.014-in guide-wire is placed at the proper point on a branch of Coronary Sinus and subsequently the lead runs over the guide-wire. Sometimes the guide-wire is dislocated when the lead is running over the guide-wire whereupon it should be retried or instead, one may displace or even substitute the guide-wire with another one so that the lead is properly located with the help of guide-wire. There are accessions when the lead is displaced at the moment of removing the sheath after the coronary sinus lead has been properly placed and it has been checked by using an analyzer. There are even the occasions when tip of the lead is displaced when removing the sheath after we have properly placed the coronary sinus lead and have checked it by using an analyzer, and there are even the occasions when tip of the lead is displaced after the sheathe has been removed and we are trying to remove the guide (Stylet) . The aforesaid displacements make us place the sheathe again with the help of guide-wire and repeat the procedures completely.

Purpose: It is to prevent displacement of lead or tip of coronary sinus lead when removing the sheath or guide (Stylet) and hence to prevent repetition of sheath placement and other procedures.

Tapered coronary sinus vein balloon is a catheter balloon with a length of 70 to 135 cm made of a polymer-polyethylene-polypropylene-polyurethanes-nylon-silicon-pebax or a combination of it, which has a hydrophilic or non-hydrophilic guidewire at the distal end with a straight or cure or shapeable head with a length of five to twenty mm and a diameter of 0.014 or 0.010 inches, and there are two types of (Compliance) balloon or (semi or non-compliance) balloon with a pressure of 6 to 24 atmospheres and length of the balloon is 6 to 30 mm and a diameter of 1.50 to 8.00 mm, which have no the same diameter (Tapered) at the proximal end and the distal end, and they are different in the lower diameters from 0.125 mm (such as 1.50 in the distal and 1.75 in the proximal) and in the higher diameter to 0.05 mm (such as 6.00 in the distal and 6.50 in the proximal), and always the Proximal part of the balloon is more than the Distal part of the balloon.

The tapered balloon has at least one marker in the middle of the balloon or two markers at the proximal and the distal ends of the balloon that the markers are opaque and approximately one to two millimeters in diameter, indicating position of the Proximal end and the Distal end or the middle of the balloon at the time of fluoroscopy. The balloon (Shaft) has a (Lumen), associated with a (Hub) at the Proximal end and with a balloon at the Distal end.

(Hub) is embedded at the Proximal part of the balloon, which is connected through the lumen inside the catheter shaft to the balloon's lumen, and balloon's inflation/deflation can be done with the help of a syringe or special medical instruments (Inflator) through the connection to the Catheter Hub.

1- A better body balloon support for lead when passing beside the balloon.

2- Prevention of movement of guide-wire when passing the lead under the conditions that the balloon in inflated and guide-wire is jailed.

3- Prevention of displacement of lead when the lead is jailed and we intend to remove sheath and guide-wire.

4- Reduction in procedure time because of prevention of probability of displacement of lead and due to prevention of a repeated procedure for placement of sheath.

5- Reduction in fluoroscopy time, X-ray and sometimes in costs

The drawing figures depict one or more implementations in accord with the present teachings, by way of example only, not by way of limitation. In the figures, like reference numerals refer to the same or similar elements.

The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

Fig.1

is a Schematic view of coronary sinus balloon, consistent with one or more exemplary embodiments of the present disclosure.

Fig.2

is a Schematic view of double marker balloon with high diameter (usually used in the proximal coronary sinus vein), consistent with one or more exemplary embodiments of the present disclosure.

Fig.3

is a Schematic view of single marker balloon with low diameter (usually used in the middle to distal indication), consistent with one or more exemplary embodiments of the present disclosure.

Fig.4

is a The Schematic view of two markers with guide wire - j tip or shapeable, consistent with one or more exemplary embodiments of the present disclosure.

Fig.5

is a The Schematic view of single marker balloon coronary sinus vein (with cs lead), consistent with one or more exemplary embodiments of the present disclosure.

Fig.6

is a The Schematic view of two markers balloon coronary sinus vein (with cs lead), consistent with one or more exemplary embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE DRAWINGS

In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent that the present teachings may be practiced without such details. In other instances, well known methods, procedures, components, and/or circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.

The following detailed description is presented to enable a person skilled in the art to make and use the methods and devices disclosed in exemplary embodiments of the present disclosure. For purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the present disclosure. However, it will be apparent to one skilled in the art that these specific details are not required to practice the disclosed exemplary embodiments. Descriptions of specific exemplary embodiments are provided only as representative examples. Various modifications to the exemplary implementations will be readily apparent to one skilled in the art, and the general principles defined herein may be applied to other implementations and applications without departing from the scope of the present disclosure. The present disclosure is not intended to be limited to the implementations shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.

For purposes of reference, it should be understood that the techniques and systems disclosed herein are applicable to coupled motion in a wrist; however, the techniques and systems may be adapted to a number of other applications.

To Place the coronary sinus lead, one should first place a sheath the sheathe is to be placed at the beginning of coronary sinus vein with the help of a 0.033 in guide-wire and a catheter while contrast material is injected as well.

When sheath tip has been placed at the proper point, first the 0.014-in guide-wire is placed in a branch of coronary sinus with the help of catheter. In case the operator intends to jail the distal part by the balloon, then tapered coronary sinus vein balloon should be guided by support from the guide-wire so that it is placed beside guide-wire. Then; the balloon is to be inflated while it jails the guide-wire. After we have ensured that the guide-wire has been jailed by the balloon, we may pass the coronary sinus lead over the jailed guide-wire until it is guided to the intended point. Most often it is happened that the guide is dislocated when we are passing the lead through the curve or bifurcation of the vein.

However, there is no possibility for us to displace the guide-wire under these circumstances because of jailing of the guide-wire. Therefore, the lead is guided to the end of balloon, when we may guide the deflated balloon and lead with the support of guide and balloon to the intended point and after all, we way inflate the balloon when every analysis has been made on the lead by the system in the may thut the balloon is jailed. Under these conditions, we way first remove the sheathe and then the guide (stylet).

This method doesn't require to passing of a second guide-wire for guiding the balloon. At the same time, the balloon's shaft provides a better support for passing the coronary sinus lead over the guide-wire. Furthermore, when the operator intends to jail proximal (beginning) part of the lead, the balloon my be guided through the sheath to the beginning of the vein after the lead has been passed and positioned appropriately.

Then, after lead analysis we may inflate the balloon. We may then remove the sheath and stylet and finally remove the deflated balloon slowly. After analysis of coronary sinus lead, we may fix the same at the point of incision with the help of Anchored-sleeve.

According to an exemplary embodiment herein, FIG. 1 illustrates a Schematic view of coronary sinus balloon, Inflation port 1, Female lure connection 2, Hub 3, Proximal shaft balloon catheter (PTFE coated king resistant) 4, Inner line balloon catheter (the inner line balloon catheter which is connected to the hub proximally and the balloon holes distally) 5, Distal shaft balloon catheter 6, Proximal radiopaque marker 7, Proximal balloon with a greater diameter than its distal 8, Proximal lumen balloon hole 9, Middle lumen balloon hole 10, Distal lumen balloon hole 11, The distal balloon, which has a smaller diameter than the proximal balloon 12, Distal radiopaque marker 13, Guide wire to distal balloon connection 14, Guide wire attached to the end of the balloon, which is non-thermostatically fixed with maximum diameter of 0.014 "(0.36mm) 15, Distal guide wire 16, and Single lumen from hub to balloon 30 .

In FIG. 2 , Outer line balloon, which can be a combination of the above-mentioned materials depending on the function of the balloon (polymer-polyethylene-polypropylene-polyurethanes-nylon-silicon-pebax) 18, Non hydrophilic tip straight guide wire 20 .

In FIG. 3, Middle radiopaque marker 17, Hydrophilic or hydrophilic coated guide wire with tip straight 19,

In FIG. 4, Non hydrophilic J tip or shapeable guide wire 21,

In FIG. 5, Schematic view of coronary sinus vein 22, Lead CS 23, The connection between the balloon and coronary sinus vein wall (endothelium wall) 24, The connection between the lead and coronary sinus vein wall (endothelium wall) 25, The connection between the lead and balloon in coronary sinus vein (trap technique) 26, Coronary sinus lead’s electrode 27, Distal coronary sinus lead 28, Coronary sinus vein’s side branch 29.

Tapered coronary sinus vein balloon is a catheter balloon with a length of about 50 to about 135 cm made of a polymer-polyethylene-polypropylene-polyurethanes-nylon-silicon-pebax or a combination of it, which has a hydrophilic or non-hydrophilic guidewire at the distal end with a straight or cure or shapeable head with a length of 5 to 30 mm and a diameter of about 0.014 or about 0.010 inches, and there are two types of (Compliance) balloon or (semi or non-compliance) balloon with a pressure of 6 to 24 atmospheres and length of the balloon is 6 to 30 mm and a diameter of about 1.50 to about 8.00 mm, which have no the same diameter (Tapered) at the proximal end and the distal end, and they are different in the lower diameters from about 0.125 mm (such as 1.50 in the distal and 1.75 in the proximal) and in the higher diameter to 0.05 mm (such as 6.00 in the distal and 6.50 in the proximal), and always the Proximal part of the balloon is more than the Distal part of the balloon.

While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that the teachings may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all applications, modifications and variations that fall within the true scope of the present teachings.

Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

The scope of protection is limited solely by the claims that now follow. That scope is intended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows and to encompass all structural and functional equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 202, 204, or 206 of the Patent Act, nor should they be interpreted in such a way. Any unintended embracement of such subject matter is hereby disclaimed.

Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.

It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study, except where specific meanings have otherwise been set forth herein. Relational terms such as “first” and “second” and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof, as used herein and in the appended claims are intended to cover a non-exclusive inclusion, encompassing a process, method, article, or apparatus that comprises a list of elements that does not include only those elements but may include other elements not expressly listed to such process, method, article, or apparatus. An element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is not intended to be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various implementations. Such grouping is for purposes of streamlining this disclosure, and is not to be interpreted as reflecting an intention that the claimed implementations require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed implementation. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separately claimed subject matter.

While various implementations have been described, the description is intended to be exemplary, rather than limiting and it will be apparent to those of ordinary skill in the art that many more implementations are possible that are within the scope of the implementations. Although many possible combinations of features are shown in the accompanying figures and discussed in this detailed description, many other combinations of the disclosed features are possible. Any feature of any implementation may be used in combination with or substituted for any other feature or element in any other implementation unless specifically restricted. Therefore, it will be understood that any of the features shown and/or discussed in the present disclosure may be implemented together in any suitable combination. Accordingly, the implementations are not to be restricted except in light of the attached claims and their equivalents. Also, various modifications and changes may be made within the scope of the attached claims.

Examples

According to one or more exemplary embodiments of the present disclosure:

1- The balloon catheter in addition to the coronary sinus can be used as a trap technique in the cardiovascular and peripheral vessels.

2- in another example, When, after passing the guide wire to the desired area, the guide wire does not provide the necessary support for the passage of the lead to the intended point, it is possible to lead the taper balloon to the end of the branch and then conduct the guide wire and lead with balloon catheter support easily to the point where the balloon catheter is located.

3- in another example, Fixing or trapping the lead occurs when the lead is trapped by the taper balloon. In this case, after temporary fixing or trapping of the lead, sheathe and guide wire can be removed without displacing the lead from the point it is trapped and finally, the balloon catheter is removed.

Tapered coronary sinus vein balloon has its application in cardiac resynchronization therapy defibrillator (CRT-D) or Cardiac resynchronization therapy pacemaker (CRT-P) where it prevents displacement or removal of the lead upon removing the sheath and guide-wire (stylet) after the lead has been jailed.

Citation List follows:

Patent US5273536A

Patent US20080045928A1

Patent US5702364A

Patent US5593419A

Patent US5441484A

Patent US4616653A

Patent US20060282110A1

Patent US20030139762A1

Patent EP2389974A1

Claims

A taper balloon of coronary sinus vein that is a percutaneous transluminal balloon catheter comprising:
a fixed distal guide wire at its end, which is fixed to the end of a balloon catheter followed by a taper balloon with inflation/deflation potential.
a marker in the balloon, which is opaque; and
a shaft of the balloon catheter only has a single lumen.
The taper balloon as claimed in Claim 1, wherein the guide wire is hydrophilic or non-hydrophilic and opaque.
The taper balloon as claimed in Claim 1, wherein the guide wire is straight, cure or shapeable with a length of about 5 to about 30 mm and a diameter of about 0.10 to about 0.014 inches.
The taper balloon as claimed in Claim 1, wherein the balloon catheter is of compliance, semi compliance or noncompliance type with a length of about 6 to about 30 mm and a diameter of about 1.5 to about 8 mm.
The taper balloon as claimed in Claim 1, wherein the balloon diameter is not identical at the beginning and the end of it and balloon diameter is greater at the proximal point than the distal area.
The taper balloon as claimed in Claim 1, wherein the balloon is inflated or deflated only by the proximal hub, which is connected to the balloon catheter by medical inflator devise.
The taper balloon as claimed in Claim 1, wherein there is at least one marker in the middle or two markers in the proximal and distal parts that the markers are opaque and visible with the x-ray.
The taper balloon as claimed in Claim 1, wherein the balloon's shaft body only has a single lumen and this lumen is connected to the hub in the proximal and balloon lumen is connected in the distal points.
The taper balloon as claimed in Claim 8, wherein the balloon lumen has one to several holes in terms of the balloon length and these holes are connected to the balloon distal wall through which the balloon is inflated or deflated.