Device for treating a patent foramen ovale

A device for treating a patent foramen ovale has a first part having a predetermined length; a second part having a predetermined length; a third part having a predetermined length; and a pulling member which penetrates into the second part from a side face of a distal portion of the second part, crosses the second cylindrical part obliquely and extends from a side face of a proximal portion of the second part and penetrates into the third part from a side face of a distal portion of the third part, with one end of the pulling member held by a proximal portion of the first part. A part of a locking mechanism provided at other end of the pulling member and a part of the locking mechanism provided at the third part are locked to each other, when the pulling member is pulled to allow the first part and the second part proximate to each other and the second part and the third part to be proximate to each other.

BACKGROUND OF THE INVENTION

The present invention relates to a device and an apparatus for treating a patent foramen ovate by preventing an over-flap of the patent foramen ovate of a heart septum.

The foramen ovale is present in the interatrial septum. The foramen ovale works as a valve in a fetal heart Under normal conditions, the foramen ovale closes a few months after birth. The case in which the foramen ovate does not close after birth is called the patent foramen ovate. About 20% of adults have the patent foramen ovale. In a normal heart the internal pressure of the left atrium of heart is higher than that of the right atrium of heart, and the septum primum covers the foramen ovale as a valve. Therefore blood does not flow from the left atrium of heart to the right atrium of heart However, when the internal pressure of the right atrium of heart becomes higher than that of the left atrium of heart when a person becomes tense, the septum primum opens toward the left atrium of heart Thereby the blood flows from the right atrium of heart to the left atrium of heart When a thrombus is contained in venous blood flowing from the right atrium of heart to the left atrium of heart, the thrombus flows in the order of left atrium of heart→left ventricle→main artery→brain. Therefore the patent foramen ovale is said to be a cardiogenic factor of cerebral stroke and migraine.

The following treatments for the patent foramen ovate are performed: medicinal therapy (aspirin, warfarin), sealing surgery to be performed by using percutaneous catheter procedure, and open heart surgery to be performed by using extracorporeal circulation.

The medicinal therapy is the first-choice treatment for the patent foramen ovale. But it is difficult to control a dose and stop bleeding during administration. The percutaneous catheter procedure and the open heart surgery are invasive, but radical, thus giving no anxiety for a return. In the present stage, the open heart surgery is more reliable than the percutaneous catheter procedure in terms of the procedure of sealing the patent foramen ovale. But considering risks in performing the extracorporeal circulation and an invasion in incising skin, the percutaneous catheter procedure is more desirable than the open heart surgery if the percutaneous treatment provides an effect similar to that provided by the open heart surgery.

The device, for sealing the patent foramen ovale, which uses the percutaneous catheter procedure is retained at the portion of a congenital septal defect More specifically, to seal a hole in the septum, the procedure of retaining two disk-shaped films at the left atrium of heart and the right atrium of heart is adopted to sandwich the hole.

In the case of the cerebral stroke and the migraine, it is unnecessary to use the film to seal the septum primum which is usually sealed. In this case, it is possible to simplify the construction of the device. Retaining the device to cover the defect at the left atrium of heart and the right atrium of heart causes the thrombus to attach to the left atrium of heart and the like because the device has a large area. Thereby there is a possibility that the thrombus formed at the left atrium of heart causes a patient to have the cerebral stroke and that the device damages the thin septum primum. Thus there is a demand for development of a device of specific use.

To seal a hole of congenital diseases such as atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA), the material for sealing septal defect is disclosed in EP1222897. The material for sealing septal defect is applicable to the patent foramen ovale. In using the material for sealing septal defect, the member is inserted into the hole by passing the member through the flap which is usually sealed. Thus there is a possibility that the frail septum primum is broken. Further because the member has a large area, there is a possibility that the thrombus attaches to the left atrium of heart or is discharged therein. Thus it is necessary to perform antiplatelet treatment to prevent the generation of the thrombus. As another problem of the method of using the material for sealing septal defect a large catheter is used because the disk-shaped material is accommodated in the catheter by folding it The device developed for carrying out this method is used specifically for a flap-shaped patent foramen ovale. Thus the risk of forming the thrombus is decreased by reducing the size of the member to be retained in a portion to be cured. When this method is used to perform antiplatelet treatment, effects such as reduction of a treatment period of time and a dose can be expected. Further it is possible to reduce the size of the catheter.

The clip-type device for sealing the patent foramen ovale for locking the flap is disclosed in U.S. patent Publication No. 2003/225421. In this device, the member shaped by using the material having a spring action is accommodated in the catheter by folding it. Folding the member to make the catheter small causes an excessive load to be applied to a bent portion. Thereby there is a possibility that the member loses the spring action and gives damage to the flap.

The device for sealing the patent foramen ovate is disclosed in WO2002/098298. The device nay also give damage to the flap.

It is an object of the present invention to provide an apparatus including a device, for treating a patent foramen ovate, which little damages a septum primum (flap) usually sealing the foramen ovale and little applies a load thereto, restrains the flap from opening toward the left atrium of heart, and is capable of preventing blood from flowing from the right atrium of heart to the left atrium of heart in spite of a patent foramen ovale.

SUMMARY OF THE INVENTION

The object described above is attained by the following a centrifugal fluid pump apparatus.

A device for treating a patent foramen ovale comprises a first part having a predetermined length, a second part having a predetermined length, a third part having a predetermined length, a pulling member penetrating into said second part from a side face of a distal portion of said second part, crossing said second cylindrical part obliquely and extends from a side face of a proximal portion of said second part, and penetrating or being penetrable into said third part from a side face of a distal portion of said third part, with one end of said pulling member held by said first part, and a pair of a locking mechanism provided at other end of said pulling member and said third part being locked to each other, when said pulling member is pulled to allow said first part and said second part to proximate to each other and said second part and said third part to be proximate to each other.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The embodiments of a device of the present invention for treating a patent foramen ovale and an apparatus of the present invention for treating the patent foramen ovale will be described below with reference to drawings.

FIG. 1is an outlook view of one embodiment of an apparatus, for treating a patent foramen ovale, including a device of the present invention for treating the patent foramen ovale.FIG. 2is a partly omitted enlarged sectional view of the apparatus shown inFIG. 1.FIG. 3is a partly enlarged sectional view of the apparatus shown inFIG. 1.

A device1for treating the patent foramen ovale (hereinafter often referred to as merely device1) formed on a septum in an organism (in other words, a heart of human) has a first part2having a predetermined length; a second part3having a predetermined length; a third part4having a predetermined length; and a pulling member5which penetrates into the second part3from a side face of a distal portion of the second part3, crosses the second cylindrical part3obliquely and extends from a side face of a proximal portion of the second part3, and penetrates or is penetrable into the third part4from a side face of a distal portion of the third part4, with one end of the pulling member5held by the first part2. A part of a locking mechanism provided at other end of the pulling member5and a part of the locking mechanism provided at the third part4are locked to each other, when the pulling member5is pulled to allow the first part2and the second part3to be proximate to each other and the second part3and the third part4to be proximate to each other. In other words, the device1for treating the patent foramen ovale has a pair of the locking mechanism provided at other end of the pulling member5and the third part4. The locking mechanism of the pulling member5and the locking mechanism of the third part4are locked to each other. Further in other words, the device1for treating the patent foramen ovale has a pair of the locking mechanism which comprises one of a part provided at the end of the pulling member5and the other of a part provided at the third part4.

It is preferable that the first part is a first cylindrical or columnar part that the second part is a second cylindrical or columnar part, and that the third part is a third cylindrical or columnar part.

It is preferable that the device1has a first connection portion21bendably connecting a proximal end of the first part2and a distal end of the second part3to each other; and a second connection portion22bendably connecting a position, located at a proximal end of the second part3, which confronts the first connection portion21obliquely and a distal end of the third part4to each other. It is preferable that with one end of the pulling member5held at a position of the first part2in the vicinity of the first connection portion21, the pulling member5penetrates into the second part3from a position of the side face of the distal portion of the second part3in the vicinity of the first connection portion21, extends from a position of the side face of the proximal portion of the second part3in the vicinity of the second connection portion22, and penetrates into the third part4from a position of the side surface of the distal portion of the third part4in the vicinity of the second connection portion22.

The apparatus10of the present invention has an outer tube6, the device1accommodated inside a distal portion of the outer tube6with the device1kept almost straight an inner tube7for pressing the device1out of a distal end of the outer tube6, and a pulling wire8for pulling the pulling member5separably from the pulling wire8.

The apparatus10of the embodiment shown inFIGS. 1 through 3will be described below.

The apparatus10of the embodiment has the outer tube6, the device1, the inner tube7, and the pulling wire8for pulling the pulling member5.

As shown inFIGS. 2 and 3, in the device1of this embodiment, the first part2, the second part3, and the third part4are constructed of a cylindrical part respectively and connected with each other. Therefore the device1of this embodiment has a first cylindrical part2; a second cylindrical part3; a third cylindrical part4; a first connection portion21bendably connecting a proximal end of the first cylindrical part2and a distal end of the second cylindrical part3to each other; and a second connection portion22bendably connecting a position, located at a proximal end of the second cylindrical part3, which confronts the first connection portion21obliquely and a distal end of the third cylindrical part4to each other. With one end of the pulling member5held at a position of the first cylindrical part2in the vicinity of the first connection portion21, the pulling member5penetrates into the second cylindrical part3from a position of the side face of the distal portion of the second cylindrical part3in the vicinity of the first connection portion21, extends from a position of the side face of the proximal portion of the second cylindrical part3in the vicinity of the second connection portion22, and penetrates into the third cylindrical part4from a position of the side surface of the distal portion of the third cylindrical part4in the vicinity of the second connection portion22. In other words, with one end of the pulling member5held at the proximal portion of the first cylindrical part2, the pulling member5penetrates into the second cylindrical part3from the side face of the distal portion of the second cylindrical part3, crosses the second cylindrical part3obliquely and extends from the side face of the proximal portion of the second cylindrical part3, and penetrates into the third cylindrical part4from the side face of the distal portion of the third cylindrical part4. A part of the locking mechanism provided at the other end of the pulling member5and a part of the locking mechanism provided at the third cylindrical part4are locked to each other, when the pulling member5is pulled to allow the first cylindrical part2and the second cylindrical part3to be proximate to each other and the second cylindrical part3and the third cylindrical part4to be proximate to each other.

More specifically, as shown inFIGS. 2 and 3, the first cylindrical part (first part)2has a side hole23disposed at its proximal portion. A slip-off prevention portion52provided at one end of the pulling member5is formed larger than the side hole23. Thus when the pulling member5is pulled, the slip-off prevention portion52is held by an inner peripheral edge of the side hole23. Regardless of whether the slip-off prevention portion52is provided at the one end of the pulling member5, it may be fixed to the proximal portion of the first cylindrical part2.

As shown inFIGS. 2 and 3, the second cylindrical part (second part)3has a side hole31provided at its distal portion and a side hole32provided at its proximal portion. The position of the side hole32and that of the side hole31are opposed to each other obliquely with respect to approximately the center of the second cylindrical part3.

As shown inFIGS. 2 and 3, the third cylindrical part (third part)4has a side hole41formed at its distal portion and a locking side-hole42formed at a position opposed to the side hole41.

The first cylindrical part2, the second cylindrical part3, and the third cylindrical part4have passageways2a,3a,and4arespectively penetrating through the inside thereof These cylindrical parts2,3, and4may have any desired configurations. They may be circular, elliptic, square pillar-shaped, and the like. It is preferable that a guide wire can be inserted into the first cylindrical part2, the second cylindrical part3, and the third cylindrical part4when the pulling member5is present therein.

The outer diameter of each cylindrical part of the device1is favorably in the range from 0.1 mm to 5.0 mm and more favorably in the range from 1.0 mm to 3.0 mm. The inner diameter of each cylindrical part is favorably in the range from 0.02 mm to 4.9 mm and more favorably in the range from 0.4 mm to 2.8 mm. The length of each cylindrical part is favorably in the range from 5 mm to 50 mm and more favorably in the range from 7 mm to 35 mm.

As the material for forming each cylindrical part (first part, second part, and third part) of the device, in consideration of properties (flexibility, hardness, strength, sliding property, kink resistance, and stretching property) demanded therefor, it is preferable to selectively use polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, fluorine-containing polymers (for example, PTFE, and ETFE); and thermoplastic elastomers. The thermoplastic elastomer includes synthetic resin of nylon family (for example, polyamide elastomer), urethane family (for example, polyurethane elastomer), polyester family (for example, polyethylene terephthalate elastomer), olefin family (for example, polyethylene elastomer, polypropylene elastomer); metals highly compatible with organisms such as titanium, titanium alloy, stainless steel, gold, and platinum.

It is preferable to treat the inner surface of each cylindrical part and particularly the inner surface of the second cylindrical part to enhance the sliding property of the pulling member. As such treatment, it is possible to adopt a method of applying or fixing the following hydrophilic polymers to the inner surface thereof: poly(2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride copolymer, polyethylene glycol, polyacryl amide, and polyvinyl pyrrolidone. To enhance the sliding property of the inner surface of the outer tube and/or the outer surface of the inner tube, these hydrophilic polymers may be applied or fixed thereto.

In the device1of this embodiment a part of the locking mechanism provided at the proximal portion of the pulling member5and a part of the locking mechanism provided at the third part4are locked to each other, when the pulling member5is pulled to allow the first part2and the second part3to be proximate to each other and the second part3and the third part4to be proximate to each other. More specifically, the locking mechanism is constructed of a to-be-locked anchoring portion of the pulling member5and the side hole42of the third cylindrical part4for locking the to-be-locked anchoring portion.

As shown inFIG. 3, the pulling member5has a linear portion51; a holding portion52formed at the distal end of the linear portion51to hold the pulling member5at the first cylindrical part2; and to-be-locked anchoring portions53,54, and55disposed at a proximal portion of the linear portion51along the linear portion51. The linear portion51extends to the outside from the side hole23of the first cylindrical part2, penetrates into the second cylindrical part3from the distal-side side hole31of the second cylindrical part3, extends inside the second cylindrical part3, and extends to the outside from the proximal-side side hole32of the second cylindrical part3. The to-be-locked anchoring portions53,54, and55provided at the proximal portion of the pulling member5are disposed outside the third cylindrical part4or a part thereof penetrates into the third cylindrical part4from the distal-side side hole41of the third cylindrical part4. As shown inFIG. 3, the proximal end of the pulling member5may penetrate into the third cylindrical part4from the distal-side side hole41of the third cylindrical part4or may be disposed on the outer surface of the third cylindrical part4.

As the material for forming the linear portion of the pulling member and the to-be-locked anchoring portion thereof, it is possible to use metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum; comparatively rigid polymeric materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, fluororesin; and a combination of these materials. As the linear portion51, a wire or a plurality of twisted wires can be preferably used. Although not specifically limited, the diameter of the linear portion is favorably in the range from 0.01 mm to 1.3 mm and more favorably in the range from 0.1 mm to 0.3 mm.

In this embodiment, the locking mechanism of the embodiment is composed of a plurality of the to-be-locked anchoring portions53,54, and55provided at the other end portion (proximal portion) of the pulling member5and the locking side-hole42provided at the third cylindrical part4. The locking side-hole42has a small portion permitting a forced passage of the anchoring portion and locking the anchoring portion thereto after the anchoring portion passes therethrough More specifically, the locking side-hole42has a small diameter portion whose inner diameter is smaller than the outer diameter of the anchoring portion. The inner diameter of the locking side-hole42is smallest at its central portion to form the small-diameter portion. The inner diameter of both sides inward and outward from the small-diameter portion becomes gradually larger. Thereby the locking side-hole42facilitates the forced passage of the anchoring portion therethrough and holds the anchoring portion securely. Although it is preferable that the small diameter portion has the above-described construction, the small-diameter portion may be composed of an annular rib or ribs annularly dotted. The small-diameter portion may be disposed on the inner side of the locking side-hole42or on the outer side thereof.

In this embodiment the to-be-locked anchoring portions53,54, and55are provided at the proximal portion of the linear portion51of the pulling member5along the linear portion51. The to-be-locked anchoring portions53,54, and55can be locked to the locking side-hole42. Thereby by locking the to-be-locked anchoring portion54to the locking side-hole42, it is possible to shorten the distance between the first cylindrical part2and the second cylindrical part3and the distance between the second cylindrical part3and third cylindrical part4, compared with the case where the to-be-locked anchoring portion53is locked to the locking side-hole42. Similarly by locking the to-be-locked anchoring portion55to the locking side-hole42, it is possible to shorten the distance between the first cylindrical part2and the second cylindrical part3and the distance between the second cylindrical part3and third cylindrical part4to a higher extent, compared with the case where the to-be-locked anchoring portion54is locked to the locking side-hole42. Therefore the device of this embodiment allows adjustment of the distance between the first cylindrical part2and the second cylindrical part3and the distance between the second cylindrical part3and third cylindrical part4by selectively locking the to-be-locked anchoring portion to the locking side-hole in dependence on the thickness of the flap of the septum primum or the configuration of the foramen ovale.

As shown inFIGS. 1,2, and3, the outer tube6is tubular. The outer tube6is open at its distal and proximal ends. The opening formed at the distal end of the outer tube6functions as a release opening when the device1is retained in a foramen ovale. The distal portion of the outer tube6serves as an accommodation portion for accommodating the device1therein when the device is straight.

The outer diameter of the outer tube6is favorably in the range from 0.3 mm to 7.0 mm and more favorably in the range from 1.2 mm to 5.0 mm. The inner diameter of the outer tube6is favorably in the range from 0.2 mm to 6.5 mm. The length of the outer tube6is favorably in the range from 300 mm to 2000 mm and more favorably in the range from 700 mm to 1500 mm.

As shown inFIGS. 1 through 3, the inner tube7is tubular. The inner tube7is open at its distal and proximal ends. The guide wire can be inserted through the inner tube7. The inner tube7is accommodated in the outer tube6. The distal portion71of the inner tube7is capable of contacting the proximal portion of the device1. Thus the inner tube7is capable of pressing the device1from the distal end of the outer tube6. As shown inFIG. 2, in the apparatus10of this embodiment, the diameter of the distal portion71of the inner tube7becomes gradually smaller toward its distal end to allow the distal portion71of the inner tube7to penetrate into the proximal portion of the device1. Provided at the distal portion71of the inner tube7is a slit72into which an unlocking wire is inserted. The unlocking wire constructs an unlocking mechanism for releasing locking performed by the locking mechanism (described later) of the device1.

The outer diameter of the inner tube7is favorably in the range from 0.1 mm to 5.0 mm and more favorably in the range from 1.0 mm to 3.0 mm. The inner diameter of the inner tube7is favorably in the range from 0.05 mm to 4.8 mm. The length of the inner tube7is favorably in the range from 300 mm to 2000 mm and more favorably in the range from 700 mm to 1500 mm.

As the material for forming the outer tube6and the inner tube7, in consideration of properties (flexibility, hardness, strength, sliding property, kink resistance, and stretching property) demanded for them, it is preferable to selectively use polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, fluorine-containing polymers (for example, PTFE, and ETFE); and thermoplastic elastomers. The thermoplastic elastomer includes synthetic resin of nylon family (for example, polyamide elastomer), urethane family (for example, polyurethane elastomer), polyester family (for example, polyethylene terephthalate elastomer), olefin family (for example, polyethylene elastomer, polypropylene elastomer).

It is preferable to treat the outer surface of the outer tube6to enhance the sliding property thereof. As such treatment it is possible to adopt a method of applying or fixing the following hydrophilic polymers to the inner surface thereof: poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate, hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride copolymer, polyethylene glycol, polyacryl amide, and polyvinyl pyrrolidone. To enhance the sliding property of the inner surface of the outer tube and/or the outer surface of the inner tube, these hydrophilic polymers may be applied or fixed thereto.

The apparatus10has a pulling wire8for pulling the pulling member. The pulling wire8extends from the proximal side of the apparatus10between the inner tube7and the outer tube6. The distal portion of the pulling wire8penetrates into the third cylindrical part4from the locking side-hole42of the third cylindrical part4. The proximal portion of the pulling wire8extends to the outside from the proximal end of the outer tube6. The pulling wire8is separable from the pulling member. As shown inFIG. 3, the pulling member5of the device1has an annular portion56at its proximal end. The pulling wire8is folded back after it penetrates through the annular portion56. That is, a looped portion81of the pulling wire8is in penetration through the annular portion56. By pulling the pulling wire8(exactly, two wires), the pulling member5is pulled to the proximal side of the apparatus10. An operation portion82is mounted at the proximal end (proximal end of two wires) of the pulling wire8. The pulling wire8is made of a material which can be cut Alternatively the operation portion82can be removed from the pulling wire8. Therefore by cutting the pulling wire8or removing the operation portion82from the pulling wire8, the end of the pulling wire8is formed or exposed. By pulling the pulling wire8, the pulling wire8can be separated from the pulling member5. Instead of the annular portion56, the pulling member5may have a hole through which the pulling wire8can be inserted.

The apparatus10has the unlocking mechanism for releasing locking performed by the locking mechanism of the device1. The unlocking mechanism of the apparatus10is composed of the unlocking wire9, having a loop91, which is disposed in the apparatus10. The pulling member5of the device1or the pulling wire8thereof is in penetration through the loop91of the unlocking wire9. Thus by pulling the unlocking wire9toward the proximal side of the device1, with the anchoring portion53being locked to the locking side-hole42, the anchoring portion53is forcibly passed through the locking side-hole42and is returned to the inside of the third cylindrical part4. Thereby the anchoring portion53and the locking side-hole42are unlocked from each other. An operation portion92is mounted at the proximal end (proximal end of two wires) of the unlocking wire9. The unlocking wire9is made of a material which can be cut Alternatively the operation portion92can be removed from the unlocking wire9. Therefore by cutting the unlocking wire9or removing the operation portion92from the unlocking wire9, the end of the unlocking wire9is formed or exposed. By pulling the unlocking wire9, the unlocking wire9can be separated from the pulling member or the pulling wire.

As the pulling wire and the unlocking wire, a wire or a plurality of twisted wires can be preferably used. Although not specifically limited, the diameter of the pulling wire and the unlocking wire is favorably in the range from 0.1 mm to 1.3 mm and more favorably in the range from 0.1 mm to 0.3 mm. As the material for forming the pulling wire and the unlocking wire, it is possible to use metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum; comparatively rigid polymeric materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, fluororesin; and a combination of these materials.

As shown inFIGS. 2,3,16, and17, a contrast portion61is formed at the distal portion of the first cylindrical part2. A contrast portion62is formed at the proximal portion of the first cylindrical part2. A contrast portion63is formed at the distal portion of the second cylindrical part3. A contrast portion64is formed at the proximal portion of the second cylindrical part3. It is preferable to provide both the contrast portions62and63, but the formation of one of the contrast portion62and the contrast portion63may be omitted. A contrast portion65is formed at the distal portion of the third cylindrical part4. A contrast portion66is formed at the proximal portion of the third cylindrical part4. It is preferable to provide both the contrast portions64and65, but the formation of one of the contrast portion64and the contrast portion65may be omitted. In the examples shown inFIGS. 2,3,16, and17, the contrast portions are formed at positions a little inward from the distal or proximal ends of the cylindrical parts, but may be formed at the distal or proximal ends of the cylindrical parts.

The positions of these contrast portions can be checked by X-ray contrast and ultrasonic wave contrast. It is preferable to compose the contrast portion of a ring-shaped wire or a coiled linear wire. As the material of the contrast portion, gold, platinum, tungsten, and alloys of these metals, a silver-palladium alloy can be preferably used. The contrast portion may be made of the same material as that used for the cylindrical members or a combination of a contrast substance and a material compatible therewith. As the contrast substance, it is possible to use X-ray unpermeable materials such as barium sulfate, bismuth oxide, and tungsten. A contrast portion (not shown) may be formed at the distal portion of the outer tube6. It is possible to form the contrast portion at the distal portion of the outer tube6by a method similar to the method of forming the above-described contrast portions.

An embodiment of an apparatus20for treating the patent foramen ovale having a device for treating the patent foramen ovale shown inFIG. 4is described below.

FIG. 4is a partly omitted enlarged sectional view of another embodiment of an apparatus, for treating the patent foramen ovale, including a device of the present invention for treating the patent foramen ovale.FIG. 5is a partly enlarged sectional view of the apparatus shown inFIG. 4.

In the above-described device1, the first part (first cylindrical part)2and the second part (second cylindrical part)3are connected to each other with the first connection portion, and the second part (second cylindrical part)3and the third part (third cylindrical part)4are connected to each other with the second connection portion. The apparatus20is different from the above-described apparatus10in that in a device11of this embodiment, the first part (first cylindrical part)2, the second part (second cylindrical part)3, and the third part (third cylindrical part)4are not connected to one another. In other words, the first part (first cylindrical part)2, the second part (second cylindrical part)3, and the third part (third cylindrical part)4are separately provided. The other constructions of the device11are similar to those of the device1of the above-described embodiment. Thus the same parts of this embodiment as those of the above-described embodiment are denoted by the same reference numerals as those of the above-described embodiment, and the above-described descriptions are referred to. In the device11of this embodiment, the first cylindrical part2has an inclined face27formed on a bottom surface of the proximal end thereof in the vicinity of the proximal-side side hole23. The second cylindrical part3has an inclined face37formed on an upper surface of the distal end thereof in the vicinity of the distal-side side hole31and an inclined face38formed on a bottom surface of the proximal end thereof in the vicinity of the proximal-side side hole32. The third cylindrical part4has an inclined face47formed on an upper surface of the distal end thereof in the vicinity of the distal-side side hole41. The first cylindrical part2and the second cylindrical part3are so disposed that the inclined face27of the first cylindrical part2and the inclined face37of the second cylindrical part3confront each other. The second cylindrical part3and the third cylindrical part4are so disposed that the inclined face38of the second cylindrical part3and the inclined face47of the third cylindrical part4confront each other. Therefore when the pulling member5is pulled, each cylindrical member can be inclined easily.

An embodiment of an apparatus30for treating the patent foramen ovale having a device for treating the patent foramen ovale shown inFIG. 6is described below.

FIG. 6is a partly omitted enlarged sectional view of another embodiment of an apparatus, for treating the patent foramen ovale, including a device of the present invention for treating the patent foramen ovale.FIG. 7is a partly enlarged sectional view of the apparatus shown inFIG. 6.

A device12of the apparatus30is different from the device I of the apparatus10in the inner configuration of the third cylindrical part4, the locking mechanism for locking a pulling member15including the form of an anchoring portion17to a locking portion of the third cylindrical part4, and the unlocking function. The other constructions of the device12are similar to those of the device1of the above-described embodiment Thus the same parts of this embodiment as those of the above-described embodiment are denoted by the same reference numerals as those of the above-described embodiment and the above-described descriptions are referred to.

The locking mechanism of the device30of this embodiment is constructed of an anchor17of a pulling member15and a locking portion43provided on a side face of a second passageway4bof the third cylindrical part4.

As shown inFIGS. 6 and 7, in the device12of the apparatus30, the third cylindrical part4has two lumens extending in parallel with each other. As described above, a first passageway4aserves as a guide wire insertion passageway. Inside the distal portion of the second passageway4b,the second passageway4bhas a locking portion43to which the anchoring portion17of the pulling member15is locked. In this embodiment, locking portions43a,43b,and43care formed at certain intervals along the axial direction of the second passageway4b.The locking portions43a,43b,and43care constructed of an annular rib respectively. Each of the locking portions43a,43b,and43chas an annular inclined face for guiding the anchoring portion17whose inner diameter becomes gradually shorter from its distal side to its proximal side; and an annular face disposed at the rear end of the annular inclined face and being orthogonal to the second passageway4b.The annular face and the anchoring portion17are locked to each other.

As in the case of the above-described embodiment, the pulling member15has a holding portion formed at the distal end thereof to hold the pulling member15at the first cylindrical part2. As shown inFIGS. 6 and 7, the pulling member15extends to the outside from the distal-side side hole23of the first cylindrical part2, penetrates into the second cylindrical part3from the distal-side side hole31of the second cylindrical part3, extends inside the second cylindrical part3, extends to the outside from the proximal-side side hole32of the second cylindrical part3, penetrates into the third cylindrical part4from the distal-side side hole41of the third cylindrical part4. The proximal portion of the pulling member15is disposed inside the second passageway4b.The proximal portion of the pulling member15may not penetrate into the third cylindrical part4but may be disposed on the outer surface of the third cylindrical part4. The anchoring portion17of this embodiment has a construction similar to that of an umbrella rib. More specifically, the proximal end of the anchoring portion17is fixed to the pulling member, and the distal end thereof is formed as a free end. That is, the anchoring portion17is constructed of a plurality of rod-shaped members that can be folded back toward its distal side. The rod-shaped members extend radially and obliquely from a given position of the pulling member15toward the distal end thereof. Therefore by folding the anchoring portion17toward the distal side thereof, it is capable of passing through the locking portions43a,43b,and43c.After passing through the locking portions43a,43bor43c,the anchoring portion17opens (in other words, returns to the open configuration), and the distal end thereof is locked to the annular face of the locking portion. An annular portion18is provided at the proximal portion of the pulling member15. Instead of providing the pulling member15with the annular portion56, the pulling member15may be so constructed that the anchoring portion17thereof has a hole into which the pulling wire8can be inserted or the anchoring portion17is pulled by the pulling wire8. The locking portion43may be constructed of an annular groove instead of the annular rib.

Similarly to the above-described apparatus10, the apparatus30of this embodiment has a pulling wire8for pulling the pulling member. In correspondence with the inner construction of the third cylindrical part4, the inner tube7has two lumens extending therein in parallel. A guide wire is inserted through a first lumen corresponding to the first passageway4aof the third cylindrical part4. An unlocking wire19and the pulling wire8are inserted through a second lumen corresponding to the second passageway4bof the third cylindrical part4. The pulling wire8extends inside the second lumen of the inner tube7and penetrates into the third cylindrical part4from the distal end of the second passageway4bof the third cylindrical part4. The proximal portion of the pulling wire8extends to the outside from the proximal end of the inner tube7. The pulling wire8is separable from the pulling member15. As shown inFIG. 6, the pulling member15of the device12has the annular portion18at its proximal end. The pulling wire8is folded back after it penetrates through the annular portion18. That is, the looped portion81of the pulling wire8is in penetration through the annular portion18. By pulling the pulling wire8(exactly, two wires), the pulling member15is pulled to the proximal side of the apparatus30. An operation portion82is mounted at the proximal end (proximal end of two wires) of the pulling wire8. The pulling wire8is made of a material which can be cut Alternatively the operation portion82can be removed from the pulling wire8. Therefore by cutting the pulling wire8or removing the operation portion82from the pulling wire8, the end of the pulling wire8is formed or exposed. By pulling the pulling wire8, the pulling wire8can be separated from the pulling member15.

The apparatus30has also the unlocking mechanism for releasing locking performed by the locking mechanism of the device12. The unlocking mechanism of the apparatus30is constructed of an unlocking shaft19. The unlocking shaft19extends inside the second lumen of the inner tube7, and penetrates into the third cylindrical part4from the distal end of the second passageway4bof the third cylindrical part4. The pulling wire8is in penetration through the inside of the unlocking shaft19. To unlock the anchoring portion17of the pulling member15from the locking portion43, the pulling wire is pulled to some extent with the distal portion of the unlocking shaft19disposed at the rear end (proximal side) of the anchoring portion17to decrease the diameter of the anchoring portion17. Thereafter the unlocking shaft19is pressed toward the distal side of the device12to some extent Thereby the anchoring portion17and the locking portion can be unlocked from each other. The unlocking shaft19is removed when there is no need of unlocking the anchoring portion from the locking portion.

Similarly to the embodiment described above with reference toFIGS. 4 and 5, in the device12of this embodiment each cylindrical part does not necessarily have to be provided with the connection portion. In this case, it is preferable to form opposed inclined faces at portions of opposed end faces of each cylindrical part, similarly to the above-described embodiment described above with reference toFIGS. 4 and 5.

An embodiment of an apparatus40for treating a patent foramen ovale having a device for treating the patent foramen ovale shown inFIG. 8is described below.

FIG. 8is a partly omitted enlarged sectional view of another embodiment of an apparatus, for treating the patent foramen ovale, including a device of the present invention for treating the patent foramen ovale.FIG. 9is a partly enlarged outlook view of the device shown inFIG. 8.FIG. 10is a sectional view taken along a line A-A ofFIG. 9.

A device13of the apparatus40is different from the device1of the apparatus10in the configuration of the third cylindrical part4, the locking mechanism for locking a pulling member25including the form of an anchoring member28to a locking portion of the third cylindrical part4, and the unlocking function. The other constructions of the device13are similar to those of the device1of the above-described embodiment Thus the same parts of this embodiment as those of the above-described embodiment are denoted by the same reference numerals as those of the above-described embodiment, and the above-described descriptions are referred to.

The locking mechanism of the device40of the embodiment is constructed of the anchor28of the pulling member25and a locking portion formed on a groove provided at the side face of the third cylindrical part4.

In a device13of the apparatus40, as shown inFIGS. 8,9, and10, the third cylindrical part4has a groove4dformed on its side face from its distal portion to its proximal end thereof with the groove4dextending axially. In this embodiment a plurality of locking portions43a,43b,and43care axially provided on the inner side face of the groove4dat certain intervals. Each of the locking portions43a,43b,and43cis constructed of a pair of opposed ribs. Each of the locking portions43a,43b,and43chas an inclined face for guiding the anchoring portion28that increases in its projected width from its distal side to its proximal side; and an orthogonal face disposed at the rear end portion of the annular inclined face and being orthogonal to the groove. The orthogonal face and the anchoring portion28are locked to each other.

The pulling member25has a linear portion26. As in the case of the above-described embodiment the linear portion26has a holding portion formed at the distal end thereof to hold the pulling member25at the first cylindrical part2. As shown inFIG. 8, the linear portion26of the pulling member25extends to the outside from the side hole23of the first cylindrical part2, penetrates into the second cylindrical part3from the distal-side side hole31of the second cylindrical part3, extends inside the second cylindrical part3, extends to the outside from the proximal-side side hole32of the second cylindrical part3, and penetrates into the third cylindrical part4from the distal-side side hole41of the third cylindrical part4. The proximal portion of the pulling member25(linear portion26) extends to the outside of the third cylindrical part4from the distal-side side hole42of the third cylindrical part4and penetrates into the groove4dformed on the side face of the third cylindrical part4. The anchoring portion28is mounted at the proximal end of the pulling member25(linear portion26). An annular portion29to be connected to the pulling wire8is provided on the anchoring portion28.

As shown inFIGS. 9 and 10, the groove4dformed on the side faces of the third cylindrical part4has axially extending linear ribs4eformed on opposed portions of an outer surface of the third cylindrical part4. As shown inFIGS. 9 and 10, the anchoring portion28has a base portion28awhich is slidable inside the groove4d of the third cylindrical part4and is restrained from being separated from the groove4dby the rib4eand an anchor-constructing portion28bformed on the outer surface of the base portion28a.In this embodiment the anchor-constructing portion28bis constructed of a rib circularly projected. The anchor-constructing portion28bdoes not necessarily have to be circular but may be elliptic or polygonal.

The locking portion43to which the anchor-constructing portion28bof the anchoring portion28is locked is formed on the groove4dof the third cylindrical part4. In this embodiment, the locking portions43a,43b,and43care provided at certain intervals along the axial direction of the groove4d.Each of the locking portions43a,43b,and43cis constructed of opposed ribs. In this embodiment, each of the locking portions43a,43b,and43cis constructed of opposed ribs approximately triangular. The rib constructing the locking portions is formed integrally with the rib4e.In this embodiment, each of the locking portions43a,43b,and43chas an inclined portion, for guiding the anchor-constructing portion28b,which inclines in a central direction of the groove from its distal side to its proximal side; and a locking/unlocking-guiding inclined portion which is continuous with the rear end of the annular inclined surface and inclines in the direction of the side face of the groove from its distal side to its proximal side. The locking/unlocking-guiding inclined surface and the anchor-constructing portion28bare locked to each other.

The pulling wire8extends between the inner tube7and the outer tube6. The proximal portion of the pulling wire8extends to the outside from the proximal end of the outer tube6. The pulling wire8is separable from the pulling member. More specifically, as shown inFIG. 9, the pulling member25of the device13has the annular portion29at its proximal portion. The pulling wire8is folded back after it penetrates through the annular portion29. That is, the looped portion81of the pulling wire8is in penetration through the annular portion29. By pulling the pulling wire8(exactly, two wires), the pulling member25is pulled to the proximal side of the apparatus40. The operation portion82is mounted at the proximal end (proximal end of two wires) of the pulling wire8. The pulling wire8is made of a material which can be cut Alternatively the operation portion82can be removed from the pulling wire8. Therefore by cutting the pulling wire8or removing the operation portion82from the pulling wire8, the end of the pulling wire8is formed or exposed. By pulling the pulling wire8, the pulling wire8can be separated from the pulling member25.

The apparatus40has the unlocking mechanism for releasing locking performed by the locking mechanism of the device13. In the apparatus40, a groove extending axially is formed on the side face of the inner tube7in correspondence with the groove4dof the third cylindrical part4. Similarly to the groove4d,this groove has axially extending linear ribs formed on opposed portions of the outer surface of the inner tube7. The linear ribs may be composed of dotted ribs. The unlocking mechanism is constructed of the unlocking shaft29. The unlocking shaft29extends through the groove formed on the side face of the inner tube7and penetrates into the groove4dfrom the proximal portion of the third cylindrical part4. The distal portion of the unlocking shaft29is disposed in the vicinity of the locking portion43. To unlock the anchoring portion28of the pulling member25from the locking portion43, the unlocking shaft29is pressed to press the anchoring portion28toward the distal side. The unlocking shaft29is removed when there is no need of unlocking the anchoring portion28from the locking portion43.

In the apparatus40of this embodiment as shown inFIG. 18, after the device13is disposed at the foramen ovale, the pulling member25is pulled. Thereby the first connection portion21and the second connection portion22are bent Consequently the proximal portion of the first cylindrical part2and the distal portion of the second cylindrical part3become proximate to each other, and the proximal portion of the second cylindrical part3and the distal portion of the third cylindrical part4become also proximate to each other. As a result, the device13deforms into a configuration similar to a letter Z. By further pulling the pulling member25, the anchoring portion28passes through the locking portion43(for example, locking portion43a) and is locked thereto, as shown inFIG. 9. Thereby the device13keeps the configuration similar to the letter Z. In this manner, as shown inFIG. 18, the first cylindrical part2and the second cylindrical part3hold a distal portion102of the flap of the septum primum, and the second cylindrical part3and the third cylindrical part4hold an upper portion103of the interatrial septum where the foramen ovale is present Thereby the flap102is restrained from opening toward the left atrium of heart.

Similarly to the embodiment described above with reference toFIGS. 4 and 5, in the device13of this embodiment, each cylindrical part does not necessarily have to be provided with the connection portion. In this case, it is preferable to form opposed inclined faces at portions of opposed end faces of each cylindrical part, similarly to the above-described embodiment described above with reference toFIGS. 4 and 5.

Like an apparatus50shown inFIG. 11, the apparatus having the locking mechanism whose construction is as shown inFIGS. 8 through 10may have an unlocking mechanism of the apparatus shown inFIGS. 1 through 3. The unlocking mechanism of the apparatus50is constructed of the unlocking wire9having a loop91disposed in the apparatus50. The pulling member25of the device or the pulling wire8thereof is in penetration through the loop91of the unlocking wire9. Thus by pulling the unlocking wire9toward the proximal side of the device, with the anchoring portion28being locked to the locking portion43, the anchoring portion28is forcibly passed through the locking portion43and is returned to the distal side of the third cylindrical part4. Thereby the anchoring portion53and the locking side-hole42are unlocked from each other. The operation portion92is mounted at the proximal end (proximal end of two wires) of the unlocking wire9. The unlocking wire9is made of a material which can be cut Alternatively the operation portion92can be removed from the unlocking wire9. Therefore by cutting the unlocking wire9or removing the operation portion92from the unlocking wire9, the end of the unlocking wire9is formed or exposed. By pulling the unlocking wire9, the unlocking wire9can be separated from the pulling member or the pulling wire.

The method of using the apparatus having the device of the present invention is described below with reference toFIGS. 12 through 17.

As shown inFIG. 12, the apparatus10is inserted into the femoral vein. Thereafter a guide wire100is inserted into the apparatus10to insert the apparatus10into the lower large vein and the right atrium of heart along the guide wire100. Then the distal portion of the guide wire100is passed through a foramen ovale101of the interatrial septum. Thereafter as shown inFIG. 13, the device1is pressed out of the distal end of the outer tube6of the apparatus10along the guide wire100to dispose the first cylindrical part2at the left atrium of heart with respect to the septum primum and dispose the second cylindrical part3at the foramen ovale. Then with the inner tube7maintained at its original position, the outer tube6is pulled toward its proximal side to expose the third cylindrical part4inside the right atrium of heart as shown inFIG. 14. After the entire device1is exposed in the heart the pulling wire8is pulled. As a result as shown inFIG. 15, the proximal portion of the first cylindrical part2and the distal portion of the second cylindrical part3become proximate to each other, and the proximal portion of the second cylindrical part3and the distal portion of the third cylindrical part4become also proximate to each other. Consequently the device1deforms into a configuration similar to the letter Z. More specifically describing, as shown inFIG. 16, by pulling the pulling wire8toward the proximal side of the apparatus10, the pulling member5is pulled. Thereby the first connection portion21and the second connection portion22are bent Consequently the proximal portion of the first cylindrical part2and the distal portion of the second cylindrical part3become proximate to each other, and the proximal portion of the second cylindrical part3and the distal portion of the third cylindrical part4become also proximate to each other. As a result, the device1deforms into the configuration similar to the letter Z. By keeping pulling the pulling member8, the anchoring portion53passes through the locking side-hole42and is locked thereto, as shown inFIG. 16. Thereby the device1keeps the deformed configuration similar to the letter Z. In this manner, the first cylindrical part2and the second cylindrical part3hold a distal portion102of the flap of the septum primum, and the second cylindrical part3and the third cylindrical part4hold an upper portion103of the interatrial septum where the foramen ovale is present Thereby the flap102is restrained from opening toward the left atrium of heart When the operator desires to decrease the distance between the distal portion of the first cylindrical part2and the proximal portion of the second cylindrical part3and the distance between the distal portion of the second cylindrical part3and the proximal portion of the third cylindrical part4, the pulling wire8is pulled further. Thereby the anchoring portions54and55pass through the locking side-hole42and are locked thereto. Thereby the device1keeps the deformed configuration similar to the letter Z.

When the anchoring portion (for example, the anchoring portion53) is desired to be unlocked from the locking side-hole42, the unlocking wire9is pulled to the proximal side of the apparatus10. Thereby as shown inFIG. 17, the proximal portion of the pulling member5is pulled toward the third cylindrical part4, and the anchoring portion (for example, the anchoring portion53) passes through the locking side-hole42, thus penetrating into the third cylindrical part4. Thereby both are unlocked from each other.

When an object is achieved because the anchoring portion53has been locked to the locking side-hole42and because the deformed state of the device1similar to the letter Z has been obtained, the pulling wire8is cut at a position outward from the proximal end of the apparatus10and pulled out. The unlocking wire9is also cut at a position outward from the proximal end of the apparatus10and pulled out Thereafter the apparatus10(outer tube6and inner tube7) is pulled out of the organism, together with the guide wire100.

The device of the present invention for treating the patent foramen ovale has the first part having the predetermined length; the second part having the predetermined length; the third part having the predetermined length; and the pulling member whose proximal end penetrates into the second part from the side face of the distal portion of the second part crosses the second cylindrical part obliquely and extends from the side face of the proximal portion of the second part and penetrates or is penetrable into the third part from the side face of the distal portion of the third part with the distal end of the pulling member held by the proximal portion of the first part A part of the locking mechanism provided at the proximal portion of the pulling member and a part of the locking mechanism provided at the third part are locked to each other, when the pulling member is pulled to allow the first part and the second part to be proximate to each other and the second part and the third part to be proximate to each other.

By pulling the pulling member, the proximal portion of the first cylindrical part and the distal portion of the second cylindrical part become proximate to each other, and the proximal portion of the second cylindrical part and the distal portion of the third cylindrical part become also proximate to each other. As a result the device deforms into the configuration similar to the letter Z. The locking mechanism maintains the configuration. In this manner, the first cylindrical part and the second cylindrical part hold the distal portion of the flap of the septum primum, and the second cylindrical part and the third cylindrical part hold the upper portion of the interatrial septum where the foramen ovale is present Thereby the flap is restrained from opening toward the left atrium of heart, and blood is prevented from flowing from the right atrium of heart to the left atrium of heart in spite of the patent foramen ovale. In the device of the present invention, a spring action is not utilized, but the straight members are mechanically bent or folded to hold the distal end of the flap of the septum primum and the open portion of the foramen ovale. Therefore they are little damaged and a load is applied little thereto.

A device and an apparatus of another embodiment of the present invention for treating the patent foramen ovale are described below with reference to the drawings.

FIG. 19is a front view of a device of another embodiment of the present invention for treating the patent foramen ovale.FIG. 20is a rear view of the device shown inFIG. 19.FIG. 21is a right side view of the device shown inFIG. 19.FIG. 22is a side view of a device of another embodiment of the present invention for treating the patent foramen ovale.FIG. 26is an explanatory view for explaining an example of a deformed state holding member of the device of the present invention for treating the patent foramen ovale.FIG. 27is an explanatory view for explaining another example of the deformed state holding member of the device of the present invention for treating the patent foramen ovale.

A device200of this embodiment for treating the patent foramen ovale is used to treat the foramen ovale formed on the septum in the organism. As shown inFIGS. 19 through 21and25, the device200includes a first part201having a predetermined length and a through-passageway121provided at a proximal side thereof; a second part202having a predetermined length and a through-passageway122; a third part203having a predetermined length and a through-passageway123provided at a distal side thereof; a pulling member104, one end of which is held by the first part201and which is extended sequentially in penetration through the through-passageway121of the first part201, the through-passageway122of the second part202, and the through-passageway123of the third part203; and a deformed state holding member105, provided at other side of the pulling member104, for holding the device200deformed into an approximately Z configuration, in a side view, which is formed by approach or contact of a side face of a proximal portion of the first part201to or with a side face of a distal portion of the second part202at one side thereof and approach or contact of a side face of a proximal portion of the second part202at other side thereof to or with a side face of a distal portion of the third part203owing to pulling of the pulling member104.

An apparatus110of this embodiment for treating the patent foramen ovale has an outer tube140, the device200, an inner tube141, and a pulling wire148.

In the device200of this embodiment the second part202can be bent at the proximal portion of the first part201, and the third part203can be bent at the proximal portion of the second part202. Although the above-described construction is preferable in this embodiment, the first part, the second part, and the third part may be separate like the device1of the above-described embodiment

More specifically, as shown in the drawings, the device200of this embodiment has an integrally formed body member having the first part201, the second part202, and the third part203. The body member has a first connection portion131abendably connecting the first part201and the second part202with each other and a second connection portion132abendably connecting the second part202and the third part203with each other.

It is preferable that the first part201branches with two branched portions spread out toward its distal side and that the two branched portions can be approached to each other. More specifically, as shown inFIG. 19, the first part201branches at a portion of its proximal side to form a shape similar to that of a letter “Y”. The branched portion of the first part201is made of an elastically deformable material. Thereby the first part201can be accommodated in the outer tube140with the two branched portions proximate to each other. After the first part201is discharged from the outer tube140, it is capable of returning to the original shape similar to that of the letter “Y”. The first part201may be entirely made of the elastically deformable material or only the branched portion may be made of the elastically deformable material. Instead of making the branched portion of the elastically deformable material, the branched portion may be opened and closed mechanically.

Similarly to the first part201, it is preferable that the third part203branches with two branched portions spread out toward its proximal side and that the two branched portions can be approached to each other. More specifically, as shown inFIG. 19, the third part203branches at a portion of its distal side to form a shape similar to that of the inverted letter “Y”. The branched portion of the third part203is made of the elastically deformable material. Thereby the third part203can be accommodated in the outer tube140with the two branched portions proximate to each other. After the third part203is discharged from the outer tube140, it is capable of returning to the original shape similar to that of the inverted latter “Y”. The third part203may be entirely made of the elastically deformable material or only the branched portion may be made of the elastically deformable material. Instead of making the branched portion of the elastically deformable material, the branched portion may be opened and closed mechanically.

As shown inFIG. 19 and 21, the device200of this embodiment has a slit131forming a boundary between the first part201and the second part202. As shown inFIGS. 19 and 21, the slit131is extended from a front surface of the device200toward a rear surface thereof and does not reach the rear surface thereof. Therefore a slit-unformed position of the slit-formed portion constructs a connection portion131aconnecting the first part201and the second part202with each other. Similarly, as shown inFIGS. 20 and 21, a slit132is extended from the rear surface of the device200toward the front surface thereof and does not reach the front surface thereof. Therefore the slit-unformed position of the slit-formed portion constructs a connection portion132aconnecting the second part202and the third part203with each other.

Therefore as shown inFIG. 25, in the device200of this embodiment, by pulling the pulling member104, the first part201bends about the second part202at the slit131, and the third part203bends about the second part202at the slit132in a direction opposite to the bent direction of the first part201. As a result, the device200forms a shape similar to that of a letter “N” in a side view. The device200may be so constructed that when the device200is bent, the first part may be fractured from the second part and that the third part may be fractured from the second part In this case, the connection portion is not formed.

As shown inFIGS. 21 and 25, it is preferable to chamfer a corner201cof the portion in which the slit131is formed (the corner of the portion in which the slit131of the first part201is formed) and a corner202a(the corner of the portion in which the slit131of the second part202is formed) confronting the corner201c.It is also preferable to chamfer a corner202bof the portion in which the slit132is formed (the corner of the portion in which the slit132of the second part202is formed) and a corner203c(the corner of the portion in which the slit132of the third part203is formed) confronting the corner202b.Thereby as shown inFIG. 25, the exposed corners are not edged when the pulling member is pulled. Thus it is possible to restrain the device200from damaging an inner wall of the organism.

In this embodiment, the first part201, the second part202, and the third part203are pillar-shaped. Although it is preferable that they are pillar-shaped, they may be cylindrical like the first part201, the second part202, and the third part203of the above-described embodiment.

It is preferable that the through-passageway122of the second part202is disposed at the central side of the second part202in its longitudinal direction.

The pulling member104is held at its one end by the first part201and extended sequentially through the through-passageway121of the first part201, the through-passageway122of the second part202, and the through-passageway123of the third part203.

In this embodiment, one end of the pulling member104is held by the first part201at its distal portion. In this embodiment, the pulling member104is constructed of a first pulling member111held at the distal portion of each of the two branched portions of the first part201, and a second pulling member112which is capable of pulling the proximal side of the first pulling member111and extended sequentially in penetration through the through-passageway121of the first part201, the through-passageway122of the second part202, and the through-passageway123of the third part203.

The first pulling member111is a linear wire having two distal portions each of which is held by the distal portion of the each of the two branched portions of the first part201. This construction allows the branched configuration of the first part201to be securely accomplished by pulling the first pulling member111. In this embodiment, distal portions of the first pulling member111penetrate through holes201a,201brespectively formed at distal portions of the first part201. Anchoring portions109a,109bare fixed to the distal portions of the first pulling member111respectively. Thereby each distal portion of the first pulling member111is held by the first part201.

The second pulling member112is a looped linear wire. The looped distal portion of the second pulling member112is positioned in proximity to the proximal portion of the first part and the first pulling member111, penetrates through the through-passageway121of the first part201, is extended to the proximal side of the second part202along the rear surface of the device, penetrates through the through-passageway122of the second part202, appears on the front surface of the device, penetrates through the through-passageway123of the third part203, and is extended to the rear surface of the device.

The proximal side of the first pulling member111can be pulled by pulling the second pulling member112. The pulling member104has a linking member106linking the first pulling member111and the second pulling member112with each other. As the linking member106, a material having a through-passageway through which the first pulling member111and the second pulling member112penetrate is used. More specifically, the linking member106is composed of a bead member having a through-passageway. The linking member106may be composed of members having any configurations cylindrical, ring-shaped, and the like provided that they have a through-passageway. Instead of providing the pulling member104with the linking member, the first pulling member111and the second pulling member112may be intersected with each other at the proximal portion of the first pulling member111or the first pulling member111and the second pulling member112may be joined with each other at the proximal portion of the first pulling member111.

The pulling member104may be composed of one member instead of being composed of the first pulling member111and the second pulling member112

It is preferable that in this embodiment, as shown inFIG. 19, the third part203has a second through-passageway124disposed at the proximal side thereof with respect to the through-passageway123formed at the distal side of the third part203. It is preferable that the device200has a linear wire113for said third part having a distal-side portion looped at a portion, of said pulling member, which is disposed between the through-passageway123of the third part203and the deformed state holding member and a proximal side portion which penetrates through the second through-passageway124of the third part203and is held at a proximal portion of the third part203. The pulling member104(the second pulling member112) may be so constructed that the two linear wires constructing the pulling member104pass through the looped distal portion of the linear wire113for the third part203or only one of the two linear wires constructing the pulling member104(the second pulling member112) passes through the looped distal portion of the linear wire113for the third part203. In this embodiment the proximal portions of the linear wire113for the third part penetrate through holes203a,203brespectively formed at the proximal portions of the third part203. Anchoring portions107a,107bare fixed to the proximal portions of the linear wire113for the third part respectively. Thereby each distal portion of the linear wire113for the third part is held by the third part203. A ring-shaped member is used for the anchoring portions107a,107b.

This construction allows the linear wire113for the third part to be pulled when the deformed state holding member105which is described later is operated. Thereby the branched configuration of the third part203can be securely accomplished.

As shown inFIG. 26, it is preferable that the deformed state holding member105has a through-passageway161through which the pulling member (the second pulling member112) can be slidably penetrated at a predetermined resistance. That is, the deformed state holding member105is capable of sliding along the second pulling member112by being pressed rearward or forward at a degree of force higher than the predetermined degree of force. In a normal state, the deformed state holding member105is not moved because it is subjected to the fictional resistance of the pulling member and that of the inner surface of the through-passageway. It is preferable that the through-hole161has a diameter-enlarged portion162into which the pulling member is inserted. It is preferable that the deformed state holding member105is composed of a sphere.

As shown inFIG. 27, the device200may have an anchoring portion114provided at the other side (proximal side) of the pulling member104(the second pulling member112). A deformed state holding member105amay have a through-hole161athrough which the pulling member104(the second pulling member112) penetrates and a locking portion163capable of locking the anchoring portion114thereto so that the pulling member is capable of sliding through the through-hole161a.In this embodiment the second pulling member112slides through the through-passageway161awithout being subjected to a resistance. In this embodiment the locking portion163is constructed of an annular rib formed inside the through-hole161a.The anchoring portion114is composed of a sphere. The anchoring portion114has an outer diameter a little larger than a minimum inner diameter of the annular rib163. The anchoring portion114and the locking portion (annular rib)163are locked to each other, when the pulling member (second pulling member112) is pulled and the anchoring portion114rides across the annular rib163. Thereby the anchoring portion114is restrained from moving to the distal side of the anchoring portion114, and a deformed state of the device is maintained. As shown inFIG. 27, it is preferable to form a plurality of the anchoring portions114. Thereby the deformed state of the device can be selected.

The first part201, the second part202, and the third part203of the device20may be circular, elliptic, polygonal, and the like in the sectional configuration thereof. The width and outer diameter of the material for forming each of the first part201, the second part202, and the third part203is favorably in the range of 0.1 to 5.0 mm and more favorably in the range of 1.0 to 3.0 mm. Tie longitudinal length of the first part201is favorably in the range of 5 to 50 mm. The longitudinal length of the second part202is favorably in the range of 5 to 50 mm. The longitudinal length of the third part203is favorably in the range of 5 to 50 mm. The distance between the distal ends of the branched portions of the first part201is favorably in the range of 10 to 40 mm. The distance between the proximal ends of the branched portions of the third part203is favorably in the range of 10 to 40 mm. In the device200of this embodiment, the longitudinal length of the third part203is set larger than that of the first part and that of the second part Thereby the flap of the septum primum can be held securely. It is preferable that the longitudinal length of the third part203is set longer than that of the second part.

As the material for forming each part (first part, second part, and third part) of the device, in consideration of flexibility, hardness, strength, sliding property, kink resistance, and stretching property, it is preferable to selectively use polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, fluorine-containing polymers (for example, PTFE, ETFE); and thermoplastic elastomers. The thermoplastic elastomer is used selectively from synthetic resin of nylon family (for example, polyamide elastomer), urethane family (for example, polyurethane elastomer), polyester family (for example, polyethylene terephthalate elastomer), and olefin family (for example, polyethylene elastomer, polypropylene elastomer). As described above, it is preferable that the branched portion of the first part201and that of the third part203are made of an elastically deformable material. As the elastically deformable material, the above-described resins can be used. The thermoplastic elastomer is most favorable. In the device, by using a two-color molding method, the branched portion of the first part201and that of the third part203of the body member may be made of the above-described elastomer, and the other parts may be made of resin compatible with the elastomer and having a hardness than that of the elastomer by using a two-color molding method. Although it is preferable that the branched portion of the first part201and that of the third part203are made of the elastically deformable material, the branched portions may be made of a plastically deformable material because when the first pulling member and the linear wire for the third part are pulled, the branched portion of the first part201and that of the third part203are restored to the original configuration thereof similar to that of Y.

It is preferable to treat the inner surface of the through-passageway of each of the first, second, and third parts to enhance the sliding property of the pulling member. As such treatment, it is possible to adopt a method of applying or fixing the following hydrophilic polymers to the inner surface thereof poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate, hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride copolymer, polyethylene glycol, polyacryl amide, and polyvinyl pyrrolidone. To enhance the sliding property of the inner surface of the outer tube and/or the outer surface of the inner tube, these hydrophilic polymers may be applied or fixed thereto.

As the material for forming the linear portion of the pulling member and the linear wire for the third part, it is possible to use metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum; comparatively rigid polymeric materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, fluororesin; and a combination of these materials. As the linear portion111,112,113, a wire or a plurality of twisted wires can be preferably used. Although not specifically limited, the diameter of the linear portion is favorably in the range from 0.01 mm to 1.3 mm and more favorably in the range from 0.1 mm to 0.3 mm.

Like a device210shown inFIG. 22, a through-hole formed in penetration through the first part201, second part202, and the third part203may be formed obliquely to reduce a resistance to the movement of the pulling member in the pulling direction. More specifically, a through-hole121aof the first part201is formed obliquely toward the proximal side of the first part201from the front surface of the body member of the device210to the rear surface thereof. A through-hole122aof the second part202is formed obliquely toward the proximal side of the second part202from the rear surface of the body member of the device210to the front surface thereof. A through-hole123aof the third part203is formed obliquely toward the proximal side of the third part203from the front surface of the body member of the device210to the rear surface thereof. A second through-hole124aof the third part203is formed obliquely toward the proximal side of the third part203from the rear surface of the body member of the device210to the front surface thereof.

An apparatus for treating the patent foramen ovale of another embodiment of the present invention is described below with reference toFIGS. 23 through 25.

FIG. 23shows an outlook of the apparatus having the device shown inFIG. 19.FIG. 24is a partly omitted enlarged sectional view of the apparatus shown inFIG. 23.FIG. 25is an explanatory view for explaining the operation of the apparatus shown inFIGS. 23 and 24.

The apparatus110of this embodiment for treating the patent foramen ovale is used to treat the foramen ovale formed on the septum in the organism. As shown inFIGS. 23 and 24, the apparatus110has an outer tube140, the device200accommodated inside a distal portion of the outer tube140with the device200kept almost straight, an inner tube141for pressing the device200out of the distal end of the outer tube140and operating the deformed state holding member105, and the pulling wire148which is capable of pulling the pulling member104and separable from the pulling member104.

As shown inFIGS. 23 and 24, the outer tube140is tubular. The outer tube140is open at its distal and proximal ends. The opening formed at the distal end of the outer tube140functions as a release opening when the device200is retained in a foramen ovale. The distal portion of the outer tube140serves as an accommodation portion for accommodating the device200therein when the device200is straight.

The outer diameter of the outer tube140is favorably in the range from 0.3 mm to 7.0 mm and more favorably in the range from 1.2 mm to 5.0 mm. The inner diameter of the outer tube140is favorably in the range from 0.2 mm to 6.5 mm. The length of the outer tube140is favorably in the range from 300 mm to 2000 mm and more favorably in the range from 700 mm to 1500 mm.

As shown inFIGS. 23 and 24, the inner tube141is tubular. The inner tube141is open at its distal and proximal ends. The inner tube141is accommodated in the outer tube140. The distal portion of the inner tube141is capable of contacting the proximal portion of the device200. Thus the inner tube141is capable of pressing the device200from the distal end of the outer tube140. As shown inFIG. 24, in the apparatus110of this embodiment, the distal portion of the inner tube141contacts the deformed state holding member105and the deformed state holding member105to be operated. The apparatus110has a pulled state release member for releasing a deformation state held by the deformed state holding member105of the device200.

The outer diameter of the inner tube141is favorably in the range from 0.1 mm to 5.0 mm and more favorably in the range from 1.0 mm to 3.0 mm. The inner diameter of the inner tube141is favorably in the range from 0.05 mm to 4.8 mm. The length of the inner tube141is favorably in the range from 300 mm to 2000 mm and more favorably in the range from 700 mm to 1500 mm.

As the material for forming the outer tube140and the inner tube141, in consideration of properties (flexibility, hardness, strength, sliding property, kink resistance, and stretching property) demanded for them, it is preferable to selectively use polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, fluorine-containing polymers (for example, PTFE, ETFE); and thermoplastic elastomers. The thermoplastic elastomer includes synthetic resin of nylon family (for example, polyamide elastomer), urethane family (for example, polyurethane elastomer), polyester family (for example, polyethylene terephthalate elastomer), olefin family (for example, polyethylene elastomer, polypropylene elastomer).

It is preferable to treat the outer surface of the outer tube140to enhance the sliding property thereof. As such treatment it is possible to adopt a method of applying or fixing the following hydrophilic polymers to the inner surface thereof: poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate, hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride copolymer, polyethylene glycol, polyacryl amide, and polyvinyl pyrrolidone. To enhance the sliding property of the inner surface of the outer tube and/or the outer surface of the inner tube, these hydrophilic polymers may be applied or fixed thereto.

The pulling wire148is folded back after it penetrates through a looped portion or an annular portion formed at the proximal portion of the pulling member104(the second pulling member112) of the device200. In this embodiment, as shown inFIG. 24, the distal portion of the pulling wire148is folded back inside the outer tube140after it penetrates through the looped portion or the annular portion formed at the proximal portion of the second pulling member112and is then penetrated into the inner tube141from the opening disposed at the distal end of the inner tube141. Thereafter the distal portion of the pulling wire148is exposed to the outside from the proximal end of the inner tube141. That is, the pulling wire148is extended to its proximal side with two wires kept in parallel after it (one wire) is folded back at its distal portion. By pulling the pulling wire148(exactly, two wires), the pulling member104(the second pilling member112) is pulled to the proximal side of the device200. An operation portion148ais mounted at the proximal end (proximal end of two wires) of the pulling wire148. The pulling wire148is made of a material which can be cut Alternatively the operation portion148acan be removed from the pulling wire148. Therefore by cutting the pulling wire148or removing the operation portion148afrom the pulling wire148, the end of the pulling wire148is formed or exposed. By pulling the pulling wire148, the pulling wire148can be separated from the pulling member104. An annular portion may be formed on the proximal end of the pulling member112by mounting an annular member thereon instead of forming the looped portion thereon.

The apparatus110of this embodiment has a pulled state release member108which is pulled to move the deformed state holding member105to the other side (proximal side) of the pulling member104.

The device200of the apparatus110of this embodiment has the second through-passageway124disposed at the proximal side of the third part203with respect to the through-passageway123formed at the distal side of the third part203, and the distal-side portion looped at the portion, of the pulling member104, which is disposed between the through-passageway123of the third part203and the deformed state holding member105. The device200further includes the linear wire113, for the third part203, which penetrates through the second through-passageway124of the third part203and has the proximal side portion held by the third part203at the proximal portion thereof. The pulled state release member108is constructed of a linear wire for pulling a portion, of the linear wire113for the third part, which is held by the third part203at the proximal portion thereof.

More specifically, as described above, in the device110of this embodiment, the third part203is provided with the linear wire113. The proximal portions of the linear wire113for the third part penetrate through the holes203a,203brespectively formed at the proximal portions of the third part203. The anchoring portions107a,107bare fixed to end portions of the linear wire113for the third part respectively. The ring-shaped member is used for the anchoring portions107a,107b.The linear wire113for the third part extends to the distal side of the device200in penetration through the second through-passageway124of the third part203. The distal portion of the linear wire113for the third part loops at the portion, of the pulling member104, which is disposed between the through-passageway123of the third part203and the deformed state holding member105.

In the apparatus110of this embodiment, the pulled state release member108is composed of the looped wire (pulled state release wire) penetrating through the ring-shaped anchoring portions107a,107bof the linear wire113for the third part.

More specifically, the pulled state release wire108is folded back after it penetrates through the ring-shaped anchoring portions107a,107bof the linear wire113for the third part of the device200. As shown inFIG. 19, in this embodiment the pulled state release wire108is folded back at its distal portion after it penetrates through the ring-shaped anchoring portions107a,107band is then penetrated into the inner tube141from the opening disposed at the distal end thereof. Thereafter the pulled state release wire108is exposed to the outside from the proximal end of the inner tube141. That is, the pulled state release wire108is extended to its proximal side with two wires kept in parallel after it (one wire) is folded back at its distal portion. By pulling the pulled state release wire108(exactly, two wires), the linear wire113for the third part is pulled. Thereby the deformed state holding member105can be moved to the proximal side of the pulling member104(second pulling member112) by means of the looped distal portion of the linear wire113for the third part Owing to the movement of the deformed state holding member105to the proximal side of the pulling member104(second pulling member112), the deformation-held state is released. An operation portion149is mounted at the proximal end (proximal end of two wires) of the pulled state release wire108. The pulled state release wire108is made of a material which can be cut Alternatively the operation portion149may be removed from the pulled state release wire108. Therefore by cutting the pulled state release wire108or removing the operation portion149from the pulled state release wire108, the end of the pulled state release wire108is formed or exposed. By pulling the pulled state release wire108, it can be separated from the pulling member104.

As the pulling wire and the unlocking wire, a wire or a plurality of twisted wires can be preferably used. Although not specifically limited, the diameter of the pulling wire and the unlocking wire is favorably in the range from 0.01 mm to 1.3 mm and more favorably in the range from 0.1 mm to 0.3 mm. As the material for forming the pulling wire and the unlocking wire, it is possible to use metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum; comparatively rigid polymeric materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, fluororesin; and a combination of these materials.

As shown inFIGS. 2,3,16, and17, like the device1of the above-described embodiment, a contrast portion may be formed at the distal portion of the first part201. A contrast portion may be formed at the distal portion of the second part and/or the proximal portion thereof A contrast portion may be formed at the distal portion of the third part203and/or the proximal portion thereof. In the examples shown inFIGS. 2,3,16, and17, the contrast portions are formed at positions a little inward from the distal or proximal ends of each of the first, second, and third parts, but may be formed at the distal or proximal ends thereof.

The positions of these contrast portions can be checked by X-ray contrast and ultrasonic wave contrast It is preferable to compose the contrast portion of a ring-shaped wire or a coiled linear wire. As the material of the contrast portion, gold, platinum, tungsten, and alloys of these metals, a silver-palladium alloy can be preferably used. The contrast portion may be made of the same material as that used for the cylindrical members or a combination of a contrast substance and a material compatible therewith. As the contrast substance, it is possible to use X-ray unpermeable materials such as barium sulfate, bismuth oxide, and tungsten. A contrast portion (not shown) may be formed at the distal portion of the outer tube140. It is possible to form the contrast portion at the distal portion of the outer tube140by a method similar to the method of forming the above-described contrast portions.

The method of using the apparatus having the device of the above-described embodiments is described below with reference toFIGS. 23 through 25.

As shown inFIGS. 12 through 15, the apparatus110is inserted into the femoral vein. Thereafter a guide wire (not shown) is inserted into the apparatus (between the outer tube140and the inner tube141)110to insert the apparatus110into the lower large vein and then the right atrium of heart along the guide wire. Then the distal portion of the guide wire is passed through a foramen ovale of the interatrial septum. Thereafter the device200is pressed out of the distal end of the outer tube140of the apparatus110to dispose the first part201at the left atrium of heart with respect to the septum primum and dispose the second part202at the foramen ovale. Then with the distal position of the inner tube141held at its original position, the outer tube140is pulled toward its proximal side to expose the third part203inside the right atrium of heart After the entire device200is exposed in the heart, the pulling wire148is pulled. As a result, as shown inFIG. 25, the deformed state holding member105contacts the distal portion of the inner tube141. By continuing to pull the pulling wire148, the deformed state holding member105moves to the distal side of the pulling member (second pulling member112). In a short time, the first part201bends. As a result the proximal portion of the first part201and the distal portion of the second part202become proximate to each other. Then the third part203bends. As a result, the distal portion of the third part203and the proximal portion of the second part202become proximate to each other. Consequently the body member of the device200deforms into a configuration similar to the letter “Z”. The deformed state holding member105remains disposed on the pulling member (second pulling member112), thereby keeping the device200deformed in the configuration similar to the letter “Z”. In this manner, the first part201and the second part202hold the distal portion of the flap of the septum primum, and the second part202and the third part203hold an upper portion of the interatrial septum where the foramen ovale is present Thereby the flap is restrained from opening toward the left atrium of heart.

When an object is achieved in the deformed configuration of the device200similar to the letter “Z”, the pulling wire148is cut at a position outward from the proximal end of the apparatus110and pulled out. Similarly, the pulled state release wire108is also cut at a position outward from the proximal end of the apparatus110and pulled out Thereafter the apparatus110(outer tube140and inner tube141) is pulled out of the organism, together with the guide wire.

The device of the present invention for treating the patent foramen ovale has the first part having the predetermined length; the second part having the predetermined length; the third part having the predetermined length; and the pulling member whose proximal end penetrates into the second part from the side face of the distal portion of the second part, crosses the second cylindrical part obliquely and extends from the side face of the proximal portion of the second part and penetrates or is penetrable into the third part from the side face of the distal portion of the third part, with the distal end of the pulling member held by the proximal portion of the first part A part of the locking mechanism provided at the proximal portion of the pulling member and a part of the locking mechanism provided at the third part are locked to each other, when the pulling member is pulled to allow the first part and the second part to be proximate to each other and the second part and the third part to be proximate to each other.