CA1265012A - Multiple probe angioplasty apparatus and method - Google Patents
Multiple probe angioplasty apparatus and methodInfo
- Publication number
- CA1265012A CA1265012A CA000533916A CA533916A CA1265012A CA 1265012 A CA1265012 A CA 1265012A CA 000533916 A CA000533916 A CA 000533916A CA 533916 A CA533916 A CA 533916A CA 1265012 A CA1265012 A CA 1265012A
- Authority
- CA
- Canada
- Prior art keywords
- port
- exit port
- access
- elongated element
- guiding catheter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
Abstract
ABSTRACT
Hemostatic valve and method for positioning a plurality of elongated elements such as dilatation catheters and guide wires in the cardiovascular system. The hemostatic valve has two or more separately sealable access ports through which the elongated elements can be inserted and manipulated independently of each other.
Hemostatic valve and method for positioning a plurality of elongated elements such as dilatation catheters and guide wires in the cardiovascular system. The hemostatic valve has two or more separately sealable access ports through which the elongated elements can be inserted and manipulated independently of each other.
Description
MULTIPLE PROBE ANGIOPLASTY APPARATUS AND METHOD
This inven~ion pertains generally to coronary angioplastv, and more particularly to apparatus and a method for positioning a plurality of elongated elements in the cardiovascular system.
In percutaneous transluminal coronary angioplasty, catheters are inserted into the cardiovascular system through the femoral or brachial arteries under local anesthesia. A preshaped guiding catheter is positioned in the coronary artery, and a dilatation catheter having a distensible balloon portion is advanced through this catheter into the branches of the coronary artery until the balloon portion;traverses or~crosses a stenotic lesion. The balloon por~ti`on is then inflated with a fluid to compress the atherosclerosis in a direction generally perpendicular to the wall of~the artery, thereby dilating the lumen of~the artery.
A guide wire~is often employed to facilitat0 placement of the~dilatation catheter beyond the distal end of the gu~iding~catheter. The guide wire is inserted through the quiding cathete~r, and the dilatation catheter is advanced 5~
along the guide wire to the desired position in the vascular system.
In some procedures, it is desirable to utilize more than one dilatation catheter and/or guide wire at a time. In one such procedure, for example, dilatation catheters are positioned adjacent to separate lesions and inflated to dilate the two lesions either simultaneously or in sequence. Another instance in which the use of two dila-tation catheters is desirable is when a lesion is located near or involves a branch of two vessels and there is a possibility that dilation of one branch will cause the other to close off or occlude. To prevent such closure, or to treat it if it occurs, a second dilatation catheter can be inserted into the branch not being immediately treated. In the event that the luminal opening of the guiding catheter is not large enough to accommodate the two dilatation catheters at the same time, a guide wire is positioned in the branch not being immediately treated so that the second dilatation catheter can be advanced along the wire and positioned quickly if the need should arise.
In these procedures, it is essential that the two guide wires and the two dilatation catheters be movable freely and independently of each other.
At times, it may be desirable to use three or more elongated elements, such as a diIatation catheter and two guide wires in a procedure at a vessel trifurcation, or a dilatation probe, a guide wire and a velocity probe, for example.
To control h~mostasis, guide wires and catheters have been introduced into the body through a hemostatic valve. The hemostatic valves heretofore provided have had only one access port through which the guide wires and catheters can be introduced. When more than one guide wire or catheter is employed, it is virtually impossible to move them independently in a single access port. The port is :
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sealed, and it is necessary to loosen the seal in order to move the element(s) passing therethrough. ~hen more than one guide wire or catheter is employed, loosening the seal for one also loosens the seal for the other(s).
It is in general an object of the invention to provide a new and improved hemostatic valve and method for positioning elements in the cardiovascular system.
The invention provides in a hemostatic valve: an exit port adapted for connection to a yuiding catheter or the like~ an instrumentation port in fluid communication with the exit port, a first access port in communication with the exit port and adapted to receive a first elongated element which passes ~hrough the guiding catheter, means for sealing the first access port about the first elongated element, a second access port in communication with the exit port and adapted for receiving a second elongated element which passes through the guiding catheter and can be manipulated independently of the first element, and means for sealing the second access port about the second elongated element.
The invention also provides in apparatus for use in angioplasty: a valve having an exit port, an instrumentation port in fluid communication with the exlt port, and first and second separately sealable access ports; a guiding catheter having a luminal openlng connected to the exit port; a first elongated element passing through the first access port and the lumlnal open-ing of the guiding catheter; and a second elongated element passing through the second access port and the luminal opening of .
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- 3a - 62948-113 the guiding catheter and being movable independently of the first element.
The invention further provides in a hemostatic valve:
an exit port adapted for connection to a guiding catheter or the like, an instrumentation port in fluid communication with the exit port, at least three access ports in communication with the exit port and adapted to receive elongated elements which pass through the guiding catheter and can be moved independently of each other, and separate means for sealing each of the access ports independently of the other ports.
The invention permits a plurality of guide wires and/or dilatation catheters to be manipulated and positioned independently of each other.
Figure l is an exploded elevational view of one embodi-ment of a hemostatic valve according to the invention.
Figure 2 is an enlarged fragmentary sectional view of a portion of the hemostatic valve of Figure l.
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Figure 3 is a schematic view illustrating the use of the hemostatic valve of Figure 1 with a plurality of elongated probes to dilate lesions on opposite sides of a bifurcation in the vascular system.
Figure 4 is a view similar to Figure 2 of a modified embodiment of a hemostatic valve according to the invention Figure 5 is an elevational view of another embodiment of apparatus according to the invention.
Figures 6 and 7 are side elevational views of additional embodiments of hemostatic valves according to the invention.
Figure 8 is an isometric view of another embodiment of another hemostatic valve according to the invention.
As illustrated in Figures 1 and 2, the hemostatic valve comprises a body 11 having a central arm 12 and a pair of side arms 13, 14 in which passageways 16, 17 and 18 are formed. The side arms extend at an angle relative to the central arm and intersect the central arm near its distal 20 end, with passageways 17, 18 intersecting passageway 16 at the junction of the arms. The side arms flank the central arm in a common plane, and passageways 17, 18 intersect the distal end of passageway 16 at an obtuse angle which permits a smooth transition between these portions of the passageways. If desired, the corners or points 21 between the intersecting passageways can be rounded to provide an even smoother~transi*ion. Generally triangular gusset plates 23 extend between the central arm and the two side arms, with flanges 24 along the free edges of the gusset plates.
An exit port 26 is formed at the distal end of passageway 16 for connection to a guiding catheter (not shown) or the like, and means is provided for rotatively connecting the guiding catheter to the exit port. This means comprises a rotator 27 which is mounted on the distal end portion of the central arm and has a male Luer fitting 28 for connec-tion to a corresponding connector at the proximal end ofthe guiding catheter. The rotator can be of a suitable known design, and it maintains a ~luid-tight seal while permittlng the Luer fittlng to rotate about the axis of the central arm. If rotational capability is not desired, the rotator can be omitted and a stationary connector can be af~ixed to the distal end of the central arm.
An instrumentation port 29 is provided at the distal end of side arm 13 in fluid communication with exit port 26 through passageways 17 and 16. Means is provided for connecting this port to instrumentation such as a pressure monitor or a source of pressurized fluid. ~n the embodi-ment illustrated, this means comprises a female Luer fitting 31 which is formed as an integral part of side arm 13.
A first access port 33 is formed at the proximal end of central arm 12 in axial alignment with exit port 26 for receiving an elongated element such as a guide wire or a dilatation catheter (not shown). Means is provided for sealing the access port to control hemostasis. This means includes a sealing ring or gland 34 mounted in a bore 36 of enlarged diameter at the proximal end of passageway 16 and an end cap 37 threadedly mounted on the distal end of central arm 12. A radially extending shoulder 38 forms a seat for the sealing gland at the inner end of the bore, and in the embodiment illustrated, this seat is conically tapered. The end cap has an axially extending stem or post 39 which engages the sealing gland and compresses against the seat as the cap is tightened. The elongated element passes through an axial opening 40 in the end cap, and compression of the seali~g gland forms a fluid-tight seal between this element and the valve body.
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A second access port 41 is formed in side arm 14 for receiving a second elongated element. This port is similar to the first access port, but it is separately sealed, and elements inserted into the two ports can be manipulated and positioned independently of each other~
Port 41 includes a bore and seat (not shown~ similar to bore 36 and seat 38, a sealing gland 42 similar to sealing gland 34, and an end cap 43 similar to end cap 37.
Operation and use of the hemostatic valve, and therein the method of the invention, are illustrated in Figure 3. In this embodiment, the obstruction to be cleared comprises lesions 46, 47 in the two branches 48, 49 of a bifurcation in the left anterior descending artery (LAD) 51. A
guiding catheter 52 is connected to exit port 26 and advanced to the osteum of the heart. A guide wire 53 is inserted into the guiding catheter through access port 33 and advanced down the LAD across lesion 46 in branch 48 of the bifurcation. A second guide wire 54 is inserted into the guiding catheter through access port 41 and advanced down the LAD across lesion 47 in branch 49. End caps 37, 43 are tightened to compress sealing glands 34, 42 and form fluid-tight seals about the respective guide wires.
The two guide wires can be moved and positioned indepen-dently of each other, and either end cap can be loosened to permit movement of a guide wire without disturbing the seal for the other guide wire.
A dilatation catheter 56 is inserted over the guide wire 53, through access port 33 and advanced along guide wire 53 until the balloon portion 57 of the catheter crosses lesion 46. End cap 37 is adjusted to provide a ~luid-tight seal about the catheter, and the balloon is inflated to dilate the lesion. If the guiding catheter is large enough, a second dilatation catheter (not shown) can be inserted through access port 41 and advanced along guide wire 54 to dilate lesion 47 simultaneously with the dila-tion of lesion 46. Otherwisej diIatation catheter 56 is :
:
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: 7 removed after the first lesion is dilated, and the second dilatation catheter is then inserted over guide wire 54 to dilate the second lesion. With guide wire 54 already in position, the second dilatation catheter can be positioned quickly in the event of a spontaneous occlusion of lesion 47 while lesion 46 is being dilated.
Instrumentation port 29 is connected to the desired instrumentation by a line 5a having a connector 59 which mates with Luer fitting 31. In one presently preferred embodiment, the instrumentation port is connected to a manifold (not shown) to which a source of pressurized fluid and a pressure monitor are also connected.
The modified embodiment illustrated in Figure 4 is similar to the embodiment of Figures 1-2 except the two side arms 61, 62 are offset longitudinally along central arm 63 so that side arm passageways 66, 67 are not directly opposite each other where they intersect passageway 68 in the central arm. Even with the passageways directly opposite each other, as in the embodiment of Figures 1-2, there is little chance that an element inserted in one of the passageways will inadvertently enter the other. However, with the passageways offset, the possibility of an element inadvertently entering passageway 66 from passageway 67 is even more remote.
The valve assembly can be fabricated of any suitable material such as a suitàble plastic, and it can be formed by a suitabIe process such as molding.
The apparatus illustrated in Figure 5 includes a three-arm adapter 71 having a body portion 72 with a central arm 73 and side arms 74, 76. A syringe 78 for injecting pressurized fluids is connected to side arm 74 by a connector 79, and the proximal ends of the passageways in central arm 73 and side arm 76 are sealed by valve assemblies 81, 82 similar to the means by which access ports 33, 41 are sealed in the embodiment of Figures 1-2.
The valve assemblies are connected to the adapter arms by connectors 83, 84.
The tubular body of a catheter 86 is connected to the distal end of central arm 73 by connectors 87, 88, a first elongated element 91 passes through valve assembly 81 into this catheter, and a second elongated element 92 passes through valve assembly 82 to the catheter. A control knob 93 is connected to the proximal end of element 91 to aid in steering this element during placement in the cardio-vascular system. Elements 91, 92 are separately sealed by valve assemblies 81, 82, and element 92 can be manipulated and positioned independently of element 91.
Catheter 86 and elements 91, 92 can be any suitable elements for insertion into the cardiovascular system.
Catheter 86 can be a guiding catheter, and elements 91, 92 can, for example, be guide wires and dilatation catheters as discussed above. In the embodiment disclosed in Serial No. 522,835, now U.S. Patent No. 4,582,181 , catheter 86 is a dilatation catheter, element 91 is a guide wire to which the distal end of the catheter is sealed, and element 92 is a vent tube which is inserted into the balloon portion of the catheter to remove trapped air.
The proximal end portion of the vent tube can be folded back on itself and sealed by valve assembly 82, as indicated by dotted line 92a.
The embodiments illustrated in Figures 6 and 7 are generally similar to the embodiments of Figures 1 and 2, with additional access ports for receiving additional elongated elements. The embodiment of Figure 6 has three separately s~eaIable~access ports, and the emhodiment of Figure 7 has four.
In the embodiment of Figure 6, the hemostatic valve has two side arms 101, 102 on one side of a central arm 103 :: :
_g_ and one side arm 104 on the other side. An exik port 106 is provided at the distal end of the central arm, and access ports 107-109 are provided at the proximal ends of side arms 102, 104 and central arm 103. An instrumenta-tion port 111 is provided at the proximal end of side arm101. Each of the access ports is separately sealable and similar to access ports 33, 41, and instrumentation port 111 is similar to instrumentation port 29. The side arms are offset longitudinally along central arm 103 such that the passageways in side arms 101, 102 are not directly opposite the passageway in side arm 104 where they intersect the passageway in the central arm.
In the embodiment of Figure 7, the hemostatic valve has two side arms on each side of a central arm 112. The side arms on one side of the central arm are designated by the reference numerals 113, 114, and the side arms on the other side are designated by the reference numerals 116, 117. An exit port 119 is provided at the distal end of the central arm, and access ports 121-124 are provided at the proximal ends of side arms 114, 116, 117 and central arm 112. An instrumentation port 126 is provided at the proximal end of side arm 113. Each of the access ports is separately sealed and similar to access ports 33, 41, and instrumentation port 126 is similar to instrumentation port 29. The side arms are offset longitudinally along central arm 112 such that the passageways in side arms 113, 114 are not directly opposite the passageways in side arms 116, 117 where they intersect the passageway in the centraI arm.
In the embodiment of Figure 8, four side arms 131-134 are spaced radially in~quadrature about a central arm 136. An exit port 137 is provided at the distal end of central arm 136 and access ports 141-144 are provided at the proximal ends of side arms 131-133 and central arm 136. An ~` 35 instrumentation port 146 is provided at the proximal end of side arm 134. Each of the access ports is separately sealed and similar ~o access ports 33, 41, and instrumen-tation port 146 is similar to instrumentation port 29.
Side arms 141-144 are illustrated as intersecting the central arm in a common radial plane, but they can be offset longitudinally along the cen~ral arm so that none of the passageways are directly opposite each other at the intersections with the passageway in the central arm.
Operation and use of the embodiments of Figures 6-8 is generally similar to that of the other embodiments heretofore described, except that additional elements can be introduced through the additional access ports. Each of the access ports is separately sealed, and an element introduced through any of these ports can be moved without disturbing the other ports.
It is apparent from the foregoing that a new and improved apparatus for positioning a plurality of elongated elements in the cardiovascular system have been provided.
While only certain presently preferred embodiments have been described in detail, as will be apparent to those familiar with the art, certain changes and modifications can be made without departing from the scope of the invention as defined by the following claims.
This inven~ion pertains generally to coronary angioplastv, and more particularly to apparatus and a method for positioning a plurality of elongated elements in the cardiovascular system.
In percutaneous transluminal coronary angioplasty, catheters are inserted into the cardiovascular system through the femoral or brachial arteries under local anesthesia. A preshaped guiding catheter is positioned in the coronary artery, and a dilatation catheter having a distensible balloon portion is advanced through this catheter into the branches of the coronary artery until the balloon portion;traverses or~crosses a stenotic lesion. The balloon por~ti`on is then inflated with a fluid to compress the atherosclerosis in a direction generally perpendicular to the wall of~the artery, thereby dilating the lumen of~the artery.
A guide wire~is often employed to facilitat0 placement of the~dilatation catheter beyond the distal end of the gu~iding~catheter. The guide wire is inserted through the quiding cathete~r, and the dilatation catheter is advanced 5~
along the guide wire to the desired position in the vascular system.
In some procedures, it is desirable to utilize more than one dilatation catheter and/or guide wire at a time. In one such procedure, for example, dilatation catheters are positioned adjacent to separate lesions and inflated to dilate the two lesions either simultaneously or in sequence. Another instance in which the use of two dila-tation catheters is desirable is when a lesion is located near or involves a branch of two vessels and there is a possibility that dilation of one branch will cause the other to close off or occlude. To prevent such closure, or to treat it if it occurs, a second dilatation catheter can be inserted into the branch not being immediately treated. In the event that the luminal opening of the guiding catheter is not large enough to accommodate the two dilatation catheters at the same time, a guide wire is positioned in the branch not being immediately treated so that the second dilatation catheter can be advanced along the wire and positioned quickly if the need should arise.
In these procedures, it is essential that the two guide wires and the two dilatation catheters be movable freely and independently of each other.
At times, it may be desirable to use three or more elongated elements, such as a diIatation catheter and two guide wires in a procedure at a vessel trifurcation, or a dilatation probe, a guide wire and a velocity probe, for example.
To control h~mostasis, guide wires and catheters have been introduced into the body through a hemostatic valve. The hemostatic valves heretofore provided have had only one access port through which the guide wires and catheters can be introduced. When more than one guide wire or catheter is employed, it is virtually impossible to move them independently in a single access port. The port is :
,: . . i ' ;5~
sealed, and it is necessary to loosen the seal in order to move the element(s) passing therethrough. ~hen more than one guide wire or catheter is employed, loosening the seal for one also loosens the seal for the other(s).
It is in general an object of the invention to provide a new and improved hemostatic valve and method for positioning elements in the cardiovascular system.
The invention provides in a hemostatic valve: an exit port adapted for connection to a yuiding catheter or the like~ an instrumentation port in fluid communication with the exit port, a first access port in communication with the exit port and adapted to receive a first elongated element which passes ~hrough the guiding catheter, means for sealing the first access port about the first elongated element, a second access port in communication with the exit port and adapted for receiving a second elongated element which passes through the guiding catheter and can be manipulated independently of the first element, and means for sealing the second access port about the second elongated element.
The invention also provides in apparatus for use in angioplasty: a valve having an exit port, an instrumentation port in fluid communication with the exlt port, and first and second separately sealable access ports; a guiding catheter having a luminal openlng connected to the exit port; a first elongated element passing through the first access port and the lumlnal open-ing of the guiding catheter; and a second elongated element passing through the second access port and the luminal opening of .
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5~
- 3a - 62948-113 the guiding catheter and being movable independently of the first element.
The invention further provides in a hemostatic valve:
an exit port adapted for connection to a guiding catheter or the like, an instrumentation port in fluid communication with the exit port, at least three access ports in communication with the exit port and adapted to receive elongated elements which pass through the guiding catheter and can be moved independently of each other, and separate means for sealing each of the access ports independently of the other ports.
The invention permits a plurality of guide wires and/or dilatation catheters to be manipulated and positioned independently of each other.
Figure l is an exploded elevational view of one embodi-ment of a hemostatic valve according to the invention.
Figure 2 is an enlarged fragmentary sectional view of a portion of the hemostatic valve of Figure l.
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Figure 3 is a schematic view illustrating the use of the hemostatic valve of Figure 1 with a plurality of elongated probes to dilate lesions on opposite sides of a bifurcation in the vascular system.
Figure 4 is a view similar to Figure 2 of a modified embodiment of a hemostatic valve according to the invention Figure 5 is an elevational view of another embodiment of apparatus according to the invention.
Figures 6 and 7 are side elevational views of additional embodiments of hemostatic valves according to the invention.
Figure 8 is an isometric view of another embodiment of another hemostatic valve according to the invention.
As illustrated in Figures 1 and 2, the hemostatic valve comprises a body 11 having a central arm 12 and a pair of side arms 13, 14 in which passageways 16, 17 and 18 are formed. The side arms extend at an angle relative to the central arm and intersect the central arm near its distal 20 end, with passageways 17, 18 intersecting passageway 16 at the junction of the arms. The side arms flank the central arm in a common plane, and passageways 17, 18 intersect the distal end of passageway 16 at an obtuse angle which permits a smooth transition between these portions of the passageways. If desired, the corners or points 21 between the intersecting passageways can be rounded to provide an even smoother~transi*ion. Generally triangular gusset plates 23 extend between the central arm and the two side arms, with flanges 24 along the free edges of the gusset plates.
An exit port 26 is formed at the distal end of passageway 16 for connection to a guiding catheter (not shown) or the like, and means is provided for rotatively connecting the guiding catheter to the exit port. This means comprises a rotator 27 which is mounted on the distal end portion of the central arm and has a male Luer fitting 28 for connec-tion to a corresponding connector at the proximal end ofthe guiding catheter. The rotator can be of a suitable known design, and it maintains a ~luid-tight seal while permittlng the Luer fittlng to rotate about the axis of the central arm. If rotational capability is not desired, the rotator can be omitted and a stationary connector can be af~ixed to the distal end of the central arm.
An instrumentation port 29 is provided at the distal end of side arm 13 in fluid communication with exit port 26 through passageways 17 and 16. Means is provided for connecting this port to instrumentation such as a pressure monitor or a source of pressurized fluid. ~n the embodi-ment illustrated, this means comprises a female Luer fitting 31 which is formed as an integral part of side arm 13.
A first access port 33 is formed at the proximal end of central arm 12 in axial alignment with exit port 26 for receiving an elongated element such as a guide wire or a dilatation catheter (not shown). Means is provided for sealing the access port to control hemostasis. This means includes a sealing ring or gland 34 mounted in a bore 36 of enlarged diameter at the proximal end of passageway 16 and an end cap 37 threadedly mounted on the distal end of central arm 12. A radially extending shoulder 38 forms a seat for the sealing gland at the inner end of the bore, and in the embodiment illustrated, this seat is conically tapered. The end cap has an axially extending stem or post 39 which engages the sealing gland and compresses against the seat as the cap is tightened. The elongated element passes through an axial opening 40 in the end cap, and compression of the seali~g gland forms a fluid-tight seal between this element and the valve body.
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A second access port 41 is formed in side arm 14 for receiving a second elongated element. This port is similar to the first access port, but it is separately sealed, and elements inserted into the two ports can be manipulated and positioned independently of each other~
Port 41 includes a bore and seat (not shown~ similar to bore 36 and seat 38, a sealing gland 42 similar to sealing gland 34, and an end cap 43 similar to end cap 37.
Operation and use of the hemostatic valve, and therein the method of the invention, are illustrated in Figure 3. In this embodiment, the obstruction to be cleared comprises lesions 46, 47 in the two branches 48, 49 of a bifurcation in the left anterior descending artery (LAD) 51. A
guiding catheter 52 is connected to exit port 26 and advanced to the osteum of the heart. A guide wire 53 is inserted into the guiding catheter through access port 33 and advanced down the LAD across lesion 46 in branch 48 of the bifurcation. A second guide wire 54 is inserted into the guiding catheter through access port 41 and advanced down the LAD across lesion 47 in branch 49. End caps 37, 43 are tightened to compress sealing glands 34, 42 and form fluid-tight seals about the respective guide wires.
The two guide wires can be moved and positioned indepen-dently of each other, and either end cap can be loosened to permit movement of a guide wire without disturbing the seal for the other guide wire.
A dilatation catheter 56 is inserted over the guide wire 53, through access port 33 and advanced along guide wire 53 until the balloon portion 57 of the catheter crosses lesion 46. End cap 37 is adjusted to provide a ~luid-tight seal about the catheter, and the balloon is inflated to dilate the lesion. If the guiding catheter is large enough, a second dilatation catheter (not shown) can be inserted through access port 41 and advanced along guide wire 54 to dilate lesion 47 simultaneously with the dila-tion of lesion 46. Otherwisej diIatation catheter 56 is :
:
5()~
: 7 removed after the first lesion is dilated, and the second dilatation catheter is then inserted over guide wire 54 to dilate the second lesion. With guide wire 54 already in position, the second dilatation catheter can be positioned quickly in the event of a spontaneous occlusion of lesion 47 while lesion 46 is being dilated.
Instrumentation port 29 is connected to the desired instrumentation by a line 5a having a connector 59 which mates with Luer fitting 31. In one presently preferred embodiment, the instrumentation port is connected to a manifold (not shown) to which a source of pressurized fluid and a pressure monitor are also connected.
The modified embodiment illustrated in Figure 4 is similar to the embodiment of Figures 1-2 except the two side arms 61, 62 are offset longitudinally along central arm 63 so that side arm passageways 66, 67 are not directly opposite each other where they intersect passageway 68 in the central arm. Even with the passageways directly opposite each other, as in the embodiment of Figures 1-2, there is little chance that an element inserted in one of the passageways will inadvertently enter the other. However, with the passageways offset, the possibility of an element inadvertently entering passageway 66 from passageway 67 is even more remote.
The valve assembly can be fabricated of any suitable material such as a suitàble plastic, and it can be formed by a suitabIe process such as molding.
The apparatus illustrated in Figure 5 includes a three-arm adapter 71 having a body portion 72 with a central arm 73 and side arms 74, 76. A syringe 78 for injecting pressurized fluids is connected to side arm 74 by a connector 79, and the proximal ends of the passageways in central arm 73 and side arm 76 are sealed by valve assemblies 81, 82 similar to the means by which access ports 33, 41 are sealed in the embodiment of Figures 1-2.
The valve assemblies are connected to the adapter arms by connectors 83, 84.
The tubular body of a catheter 86 is connected to the distal end of central arm 73 by connectors 87, 88, a first elongated element 91 passes through valve assembly 81 into this catheter, and a second elongated element 92 passes through valve assembly 82 to the catheter. A control knob 93 is connected to the proximal end of element 91 to aid in steering this element during placement in the cardio-vascular system. Elements 91, 92 are separately sealed by valve assemblies 81, 82, and element 92 can be manipulated and positioned independently of element 91.
Catheter 86 and elements 91, 92 can be any suitable elements for insertion into the cardiovascular system.
Catheter 86 can be a guiding catheter, and elements 91, 92 can, for example, be guide wires and dilatation catheters as discussed above. In the embodiment disclosed in Serial No. 522,835, now U.S. Patent No. 4,582,181 , catheter 86 is a dilatation catheter, element 91 is a guide wire to which the distal end of the catheter is sealed, and element 92 is a vent tube which is inserted into the balloon portion of the catheter to remove trapped air.
The proximal end portion of the vent tube can be folded back on itself and sealed by valve assembly 82, as indicated by dotted line 92a.
The embodiments illustrated in Figures 6 and 7 are generally similar to the embodiments of Figures 1 and 2, with additional access ports for receiving additional elongated elements. The embodiment of Figure 6 has three separately s~eaIable~access ports, and the emhodiment of Figure 7 has four.
In the embodiment of Figure 6, the hemostatic valve has two side arms 101, 102 on one side of a central arm 103 :: :
_g_ and one side arm 104 on the other side. An exik port 106 is provided at the distal end of the central arm, and access ports 107-109 are provided at the proximal ends of side arms 102, 104 and central arm 103. An instrumenta-tion port 111 is provided at the proximal end of side arm101. Each of the access ports is separately sealable and similar to access ports 33, 41, and instrumentation port 111 is similar to instrumentation port 29. The side arms are offset longitudinally along central arm 103 such that the passageways in side arms 101, 102 are not directly opposite the passageway in side arm 104 where they intersect the passageway in the central arm.
In the embodiment of Figure 7, the hemostatic valve has two side arms on each side of a central arm 112. The side arms on one side of the central arm are designated by the reference numerals 113, 114, and the side arms on the other side are designated by the reference numerals 116, 117. An exit port 119 is provided at the distal end of the central arm, and access ports 121-124 are provided at the proximal ends of side arms 114, 116, 117 and central arm 112. An instrumentation port 126 is provided at the proximal end of side arm 113. Each of the access ports is separately sealed and similar to access ports 33, 41, and instrumentation port 126 is similar to instrumentation port 29. The side arms are offset longitudinally along central arm 112 such that the passageways in side arms 113, 114 are not directly opposite the passageways in side arms 116, 117 where they intersect the passageway in the centraI arm.
In the embodiment of Figure 8, four side arms 131-134 are spaced radially in~quadrature about a central arm 136. An exit port 137 is provided at the distal end of central arm 136 and access ports 141-144 are provided at the proximal ends of side arms 131-133 and central arm 136. An ~` 35 instrumentation port 146 is provided at the proximal end of side arm 134. Each of the access ports is separately sealed and similar ~o access ports 33, 41, and instrumen-tation port 146 is similar to instrumentation port 29.
Side arms 141-144 are illustrated as intersecting the central arm in a common radial plane, but they can be offset longitudinally along the cen~ral arm so that none of the passageways are directly opposite each other at the intersections with the passageway in the central arm.
Operation and use of the embodiments of Figures 6-8 is generally similar to that of the other embodiments heretofore described, except that additional elements can be introduced through the additional access ports. Each of the access ports is separately sealed, and an element introduced through any of these ports can be moved without disturbing the other ports.
It is apparent from the foregoing that a new and improved apparatus for positioning a plurality of elongated elements in the cardiovascular system have been provided.
While only certain presently preferred embodiments have been described in detail, as will be apparent to those familiar with the art, certain changes and modifications can be made without departing from the scope of the invention as defined by the following claims.
Claims (15)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. In a hemostatic valve: an exit port adapted for connection to a guiding catheter or the like, an instrumentation port in fluid communication with the exit port, a first access port in communication with the exit port and adapted to receive a first elongated element which passes through the guiding catheter, means for sealing the first access port about the first elongated element, a second access port in communication with the exit port and adapted for receiving a second elongated element which passes through the guiding catheter and can be manipulated independently of the first element, and means for sealing the second access port about the second elongated element.
2. The hemostatic valve of claim 1 including means for rotatively connecting the guiding catheter to the exit port.
3. The hemostatic valve of claim 1 including at least one additional access port sealable independently of the other access ports for receiving at least one additional elongated element which passes through the guiding catheter and can be moved independently of the other elongated elements.
4. In apparatus for use in angioplasty: a valve having an exit port, an instrumentation port in fluid communication with the exit port, and first and second separately sealable access ports; a guiding catheter having a luminal opening connected to the exit port; a first elongated element passing through the first access port and the luminal opening of the guiding catheter; and a second elongated element passing through the second access port and the luminal opening of the guiding catheter and being movable independently of the first element.
5. The apparatus of claim 4 wherein the first elongated element comprises a dilatation catheter.
6. The apparatus of claim 5 wherein the second elongated element comprises a guide wire.
7. The apparatus of claim 4 including at least one addi-tional access port sealable independently of the other access ports, and an elongated element passing through each additional access port and the luminal opening of the guiding catheter and being movable independently of the other elongated elements.
8. In a hemostatic valve: a body having an exit port, a central arm aligned axially with the exit port and a pair of side arms intersecting the central arm at an angle; an instrumentation port formed in one of the side arms in fluid communication with the exit port; a first access port formed in the central arm and communicating with the exit port for receiving a first elongated element which passes through the exit port; means for sealing the first access port about the first elongated element; a second access port formed in the second side arm for receiving a second elongated element which passes through the exit port and can be manipulated independently of the first elongated element; and means for sealing the second access port about the second elongated element.
9. The hemostatic valve of claim 8 wherein the means for sealing the access ports comprise end caps threadedly mounted on the central arm and the second side arm with openings through which the elongated elements can pass, and sealing glands compres-sed about the elongated elements by rotation of the end caps.
10. The hemostatic valve of claim 9 wherein each of the access ports includes an axial bore with a radially extending shoulder forming a seat for one of the sealing glands, and each of the end caps has an axially extending system which extends into the bore and compresses the gland against the seat.
11. The hemostatic valve of claim 10 wherein the seat in each of the access ports is conically tapered.
12. The hemostatic valve of claim 8 including a rotary connector for attaching a guiding catheter to the exit port.
13. The hemostatic valve of claim 8 including at least one additional side arm which intersects the central arm, and a separately sealable access port formed in each additional side arm for receiving an elongated element which passes through the exit port and can be moved independently of the other elongated elements.
14. The hemostatic valve of claim 13 wherein the side arms lie in planes which extend radially from the central arm.
15. In a hemostatic valve: an exit port adapted for connection to a guiding catheter or the like, an instrumentation port in fluid communication with the exit port, at least three access ports in communication with the exit port and adapted to receive elongated elements which pass through the guiding catheter and can be moved independently of each other, and separate means for sealing each of the access ports independently of the other ports.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/848,776 US4730616A (en) | 1983-08-12 | 1986-04-07 | Multiple probe angioplasty apparatus and method |
| US848,776 | 1986-04-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1265012A true CA1265012A (en) | 1990-01-30 |
Family
ID=25304237
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000533916A Expired CA1265012A (en) | 1986-04-07 | 1987-04-06 | Multiple probe angioplasty apparatus and method |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US4730616A (en) |
| EP (1) | EP0244955A1 (en) |
| JP (1) | JPS6311169A (en) |
| CA (1) | CA1265012A (en) |
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-
1986
- 1986-04-07 US US06/848,776 patent/US4730616A/en not_active Expired - Lifetime
-
1987
- 1987-04-06 CA CA000533916A patent/CA1265012A/en not_active Expired
- 1987-04-06 JP JP62084506A patent/JPS6311169A/en active Pending
- 1987-04-06 EP EP87302996A patent/EP0244955A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| US4730616A (en) | 1988-03-15 |
| JPS6311169A (en) | 1988-01-18 |
| EP0244955A1 (en) | 1987-11-11 |
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