One-Handed Angioplasty Steering Device and Method

The present invention relates to steering or torquing devices for manipulating or guiding a guidewire, catheter, fiber optic bundle or the like in percutaneous or intraoperative medical procedures such as percutaneous transluminal angioplasty.

Percutaneous transluminal angioplasty has recently become well known in the art as a delicate and artful procedure which has revolutionized medical treatment of atherosclerotic stenosis in arteries. The use of a catheter to dilate an atherosclerotic stenosis in blood vessels was first disclosed in 1964 by Dotter and Judkins. These investigators reported the development of a series of coaxial tapered dilating catheters that could be placed percutaneously through femoral artery atherosclerotic obstructions. The technique was subsequently modified by Gruntzig, who developed the balloon catheter concept. Today, balloon angioplasty is widely used to treat arterial stenosis or arterial blockages in lieu of more invasive procedures such as coronary artery bypass grafting, vascular surgery and the like.

Coronary angioplasty is now a very well known procedure. The utility of the present invention will be described in relation to coronary angioplasty although it has applications as a steering device for angioplasty of any vessel, as well as for other medical procedures involving steering a distal end of an elongated wire or strand by manipulating a proximal portion of the strand.

In the initial stages of a coronary angioplasty, a guiding catheter is inserted into the femoral artery in the groin. The guiding catheter is subsequently passed through the femoral artery into the aorta and over the aortic arch, and then maneuvered into the ostium of the coronary artery under fluoroscopic guidance. In order to dilate a coronary artery stenosis, a balloon catheter is directed through the guiding catheter and into the coronary artery until the deflated balloon is positioned across the stenosis. The balloon is then briefly inflated, thereby expanding the stenosis and relieving the blood vessel of the obstruction.

In order to guide the balloon catheter to the location of the stenosis, the balloon catheter is equipped with a guidewire which extends well beyond the distal end of the balloon catheter. The initial step in inserting the balloon catheter into the coronary artery involves advancing the guidewire beyond the guiding catheter and into the coronary artery under fluoroscopic guidance. After the guidewire is in place in the coronary artery, it is used to guide the balloon catheter into position by sliding the balloon catheter along the guidewire. In order to direct the guidewire successfully into position within the coronary artery without causing injury to the lining thereof, precise control of the guidewire is required. To provide such precise control, steering devices have been developed which allow precise rotational control of a J-tip which is generally provided at the distal end of the guidewire. Because the guidewire has extremely limited rotational flexibility, rotation of the steering device will generally result in a corresponding rotation of the J-tip. Because the guidewire must have considerable linear flexibility in spite of the need for limited rotational flexibility, workers in the field note that one may retain good control of the forward movement of the guidewire during insertion into the coronary artery by limiting the distance between the location of the steering device on the guidewire and the hub at the proximal end of the balloon catheter. If the distance between the steering device and the hub of the balloon catheter is relatively large, the control afforded the operator will be diminished because of the increased tendency for the guidewire to bend in a position between the steering device and the hub of the balloon catheter. Therefore, it is important that the distance between the steering device and the hub of the balloon catheter always be minimized. Preferably, this distance will be limited to 2-3 centimeters. Therefore, when the guidewire is being inserted into the coronary artery, the steering device must be repositioned on the guidewire as the guidewire is inserted further and further into the artery. Because this is a very delicate and artful procedure, it is very important for the operator to have as much control of the guidewire as possible. Furthermore, as the operator advances the guidewire, he or she must simultaneously watch a fluoroscopic monitor. Most operators have also found that they must hold the hub of the balloon catheter with one hand as they grasp the steering device with the other hand in order to direct the guidewire. Although the prior art steering devices which are presently available to workers in the field provide for adequate rotational control of the guidewire, it is tedious and distracting to advance the guidewire using these devices because it is necessary to use two hands to reposition them on the guidewire, and the operator's attention is necessarily diverted away from the monitor at a time when the operator needs to be particularly attentive.

The prior art steering devices generally used in the field of angioplasty today comprise a two-piece disposable plastic device having a collet-type gripping mechanism wherein a cap is screwed down over a plurality of flanges which are thereby tightened down upon the guidewire providing a tight grip thereof. Unfortunately, in order to loosen the grip of the steering device, the operator must use two hands. One hand is required to grasp the main body portion of the steering device, while the other hand unscrews the cap portion to loosen the collet-type mechanism. When the steering device is repositioned on the guidewire, both hands are again required to tighten the screw cap so that the manipulation of the guidewire may be continued. It will be appreciated that using both hands to loosen and then tighten the steering device on the guidewire every time the guidewire is advanced 2-3 centimeters can become a very tedious and cumbersome requirement.

The present invention addresses these and other problems associated with the use of a steering device for percutaneous transluminal angioplasty and related medical procedures requiring control of a guidewire or other elongated strand-like tools. The present invention also offers other advantages over the prior art and solves other problems associated therewith.

Accordingly, it is an object of the present invention to provide an improved guidewire steering device for percutaneous transluminal angioplasty and other related medical procedures which enables operators to fully control the repositioning of the steering device at various positions along a guidewire using one hand. The present invention provides a steering device for manipulating or directing passage of a remote portion of an elongated member, said steering device comprising releasable gripping means for releasably gripping a proximate portion of the elongated member. Said gripping means including opposing gripping surfaces which cooperate to grip the proximate portion of the elongated member therebetween when said gripping means are manipulated by the exertion of force upon said steering device so that said steering device is manipulated into a gripping position. Preferably, said steering device includes locking means for locking said steering device in a gripping position. In preferred embodiments, said locking means includes a releasable locking mechanism. Preferably, the steering device of the present invention includes living hinge means interconnecting opposing portions of said steering device, wherein said living hinge means includes a resilient portion biasing said opposing gripping surfaces to a non-gripping position.

It will be appreciated that because one hand is generally required to grasp the hub of the balloon catheter or the guide catheter during manipulation of the guidewire, the present invention will present significant advantage over the prior art because one can control the gripping mechanism of the present steering device with a single hand. The user is not required to remove his or her hand from the hub of the balloon catheter in order to engage a portion of the steering device so that the device may be repositioned or so that the device may be manipulated to grip the guidewire firmly. Furthermore, one's gaze is not distracted from the video monitor while repositioning the steering device.

In another embodiment of the present invention, a percutaneous transluminal angioplasty (PTA) steering device for directing passage of a remote portion of an elongated member or a length of wire is provided. The device comprises releasable gripping means for releasably gripping a proximate portion of the length of wire. The gripping means includes opposing gripping surfaces which cooperate to grip the proximate portion of the length of wire therebetween when the surfaces are manipulated so that they are in a gripping position. Said gripping means further include manipulation means for manipulating the surfaces into the gripping position. The manipulation means include releasable locking means for locking the gripping surfaces in the gripping position when opposing portions of said locking means are engaged. The gripping faces occupy a non-gripping position when the opposing portions of said locking means are disengaged. Preferably, said manipulation means includes means for engaging and disengaging said releasable locking means. Said gripping means preferably include opposing gripping members, each opposing gripping member including one of said opposing gripping surfaces. Preferably, the device further comprises lateral engaging means for engaging the length of wire by slipping the device laterally onto the length of wire.

In another embodiment, the PTA steering device of the present invention comprises opposing gripping members. Each gripping member includes a body member and a gripping flange. Each of the gripping flanges have gripping surfaces which cooperate to releasably grip a proximate portion of a length of wire when the opposing gripping members are manipulated so that the opposing gripping surfaces are in a gripping position. The gripping members include releasable locking means for locking said opposing gripping surfaces in the gripping position when opposing portions of said locking means are engaged. The opposing gripping surfaces occupy a non-gripping position when the opposing portions of said locking means are disengaged. When the opposing portions of said locking means are disengaged, the length of wire slides freely within said steering device, and when the opposing surfaces are in the gripping position and said locking means are engaged, the length of wire is substantially bound in an engaged position with respect to the device.

Further features provide additional advantages. These and various other advantages and features of novelty which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages, and the objects obtained by its use, reference should be made to the drawings which form a further part hereof, and to the accompanying descriptive matter, in which there are illustrated and described preferred embodiments of the invention.

In the drawings, in which like reference numerals and letters indicate corresponding parts throughout the several views,

FIG. 1 is a schematic view of a steering device of the present invention in connection to equipment commonly used in percutaneous transluminal angioplasty;

FIG. 2 is a schematic sectional view of a coronary artery with a portion of a guiding catheter and a guidewire and other equipment commonly used in angioplasty, and shown in FIG. 1, inserted therein;

FIG. 3 is a side elevational view of the steering device of FIG. 1;

FIG. 4 is an end view of the steering device shown in FIG. 3;

FIG. 5 is an enlarged cross-sectional view of the steering device as seen from line 5--5 of FIG. 4 showing the device in a non-gripping position;

FIG. 6 is an enlarged cross-sectional view similar to that in FIG. 5 showing the device in a gripping position;

FIG. 7 is a transverse cross-sectional view of the device as seen from the line 7--7 of FIG. 3 showing a locking mechanism in a locked position;

FIG. 8 is a transverse cross-sectional view of the device as seen from the line 8--8 of FIG. 3;

FIG. 9 is a side elevational view of another embodiment of the steering device of the present invention;

FIG. 10 is an end view of the steering device shown in FIG. 9 as seen from left to right;

FIG. 11 is an enlarged cross-sectional view of the steering device as seen from line 11--11 of FIG. 10 showing gripping members in a non-gripping position;

FIG. 12 is an enlarged cross-sectional view similar to the view shown in FIG. 11, but showing the gripping members in a gripping position;

FIGS. 13 and 14 are transverse cross-sectional views as seen from lines 13--13 and 14--14 of FIGS. 11 and 12, respectively;

FIGS. 15 and 16 are transverse cross-sectional views as seen from lines 15--15 and 16--16 of FIGS. 11 and 12, respectively;

FIGS. 17 and 18 are transverse cross-sectional views as seen from lines 17--17 and 18--18 of FIGS. 11 and 12, respectively;

FIG. 19 is a plan view of a preferred steering device of the present invention in a fully open position;

FIG. 20 is an end elevation of the steering device shown in FIG. 19;

FIG. 21 is an elevational view of the steering device shown in FIGS. 19 and 20 while in use;

FIG. 22 is an enlarged side elevational view of the preferred steering device shown in FIG. 21;

FIG. 23 is an end elevational view of the steering device shown in FIG. 22;

FIG. 24 is a view similar to that of FIG. 23, but showing the steering device in a different position adapted to laterally receive an elongated member such as a guidewire;

FIG. 25 is a sectional view as seen from the line 25--25 of FIG. 22 and showing the respective end portions in a partially engaged non-gripping position wherein the elongated member can slide freely through the center of the device;

FIG. 26 is a sectional view as seen from the line 26--26 of FIG. 22, but showing the steering device in the position shown in FIG. 25;

FIG. 27 is a sectional view as seen generally from the line 27--27 of FIG. 22, but showing the respective end portions and the respective ratchet mechanisms in a fully engaged position and the steering device in a gripping position;

FIG. 28 is a sectional view similar to that shown in FIG. 8, but showing the steering device in the position shown in FIG. 27;

FIG. 29 is a sectional view of the preferred steering device as seen from the line 29--29 of FIG. 23;

FIG. 30 is a sectional view of an alternate embodiment similar to the view of the preferred embodiment shown in FIG. 26;

FIG. 31 is a sectional view of the alternate embodiment shown in FIG. 30, but similar to the view of the preferred embodiment shown in FIG. 25; and

FIG. 32 is a sectional view similar to FIG. 27, but showing an alternate embodiment having a modified lower ratchet mechanism.

Referring now to the drawings, and specifically to FIGS. 1 and 2, the steering device 2 of the present invention is used to manipulate or direct a guidewire 4 used in various medical procedures, preferably percutaneous transluminal coronary angioplasty. The steering device 2 grips the guidewire 4 so that the guidewire 4 may be advanced or withdrawn within a guiding catheter 6 which provides a passage for the guidewire 4 and a balloon catheter 8 which may be advanced along the guidewire 4, through the guiding catheter 6 and into the coronary artery 16. A rounded rubberized tip 10 of the guiding catheter 6 is engaged in the ostium 14 of the coronary artery 16 to be sure that the passage provided by the guiding catheter 6 directs the guidewire 4 and, therefore, the balloon catheter 8 into the coronary artery 16 where the balloon catheter 8 may be used to dilate regions of the coronary artery which may be partially obstructed. The steering device 2 is very critical in providing the operator with sufficient control of the guidewire 4 and its tip 5 which is in the shape of a "J". It is believed that the present steering device 2 will provide great advantages over the prior art because it can be manipulated with one hand and does not require a second hand to reposition the device 2 along the guidewire 4. When the guidewire 4 is engaged in a bore 3 (shown in FIGS. 4-7) of the steering device 2 and the steering device 2 grips the guidewire 4, the J-tip 5 can be rotated, as shown by the arrow in FIG. 2, by rotating the steering device 2 along an axis which runs through the center of the bore 3 which is occupied by a proximal portion of the guidewire 4. The J-tip 5 is located at the distal end of the guidewire 4. It is made of extremely flexible material which will bend easily along its axis in a lateral direction, but will not readily twist or provide a high degree of torsional flexibility. The guidewire 4, and its J-tip 5 are designed to allow for lateral flexibility, especially in the J-tip portion 5, while substantially limiting torsional flexibility. In this way, the J-tip 5 of the guidewire 4 may be easily manipulated by rotating the steering device 2 when it is engaged with the guidewire 4 proximate to the J-tip which is inserted into the arterial passageways of the body. With the help of a fluoroscope, the guidewire 4 may be manipulated or directed so that it will extend into areas within the coronary artery 16 which may be partially blocked by a stenosis 18 as is shown in FIG. 2.

Although the present steering device 2 may be used for a wide variety of medical operations involving directing an elongated strand such as the guidewire 4 or other medical tools such as fiber optic cables and the like, it is most preferably used for percutaneous transluminal angioplasty (PTA), especially coronary angioplasty, which is generally carried out in the following manner. The first step is to position the rubberized tip 10 of the guiding catheter 6 in the ostium 14 of the coronary artery. The guiding catheter 6 is a relatively large catheter having a diameter of about 3 millimeters such that the rubberized tip 10 will fit within the ostium 14, but slide no further into the coronary artery 16. The guiding catheter 6 is inserted into the femoral artery near the groin of a patient undergoing angioplasty and is passed from there under fluoroscopic guidance into the aorta, up over the aortic arch, and then maneuvered into the ostium 14 of the coronary artery 16. Once the rubberized tip 10 of the guiding catheter 6 is in place in the ostium 14, its location is confirmed by injecting a small amount of radio-opaque dye so that the dye may be observed fluoroscopically as it passes into the coronary artery 16.

It will be appreciated that fluoroscopic guidance is X-ray guidance. This method of monitoring internal operations within the body employs a low energy radiation which allows workers to see the movement of radio-opaque objects on a video monitor. A radio-opaque dye can be used to visualize the passageway in the coronary artery 16 and to identify a blockage or stenosis 18 in the artery.

It is very important that the guiding catheter 6 is positioned carefully in the ostium 14 of the coronary artery 16 under fluoroscopic guidance. Once it is there, the shape of the guiding catheter 6 is such that it tends to stay in place within the ostium 14 unless it is specifically withdrawn or advanced to another area.

The next step is to insert a guidewire 4 having a very small diameter, preferably about 0.016 to 0.018 inches in diameter, into a passageway created by the guide catheter 6. The guidewire 4 is typically provided with a small J-tip 5 at its distal end. The J-tip 5 is generally made of a very delicate and flexible material, whereas the remainder of the wire 4, although also quite flexible, has virtually no torsional flexibility such that when the guidewire 4 is rotated about its longitudinal axis by an engaged steering device 2 at one position, there is a substantially one-to-one torsional response at the distal end. Once the wire 4 is pushed beyond the tip 10 of the guide catheter 6, it is very easy to monitor by watching the fluoroscope. It is then cautiously maneuvered down the coronary artery 16 past any obstruction or stenosis 18 which may exist therein. Once the wire 4 is in place beyond the obstruction, the very slender balloon catheter 8, which generally has a deflated cross-sectional diameter of about 1.5 mm, is slipped over the wire and through the guiding catheter 6 until it advances coaxially over the wire and into the coronary artery. The balloon catheter 8 has a first lumen which provides a passageway for the guidewire 4, and a second lumen, separate from the first lumen, which connects a compression device to a balloon incorporated in the leading end of the catheter 8 (elements of 8 not shown). The center of the balloon is generally marked by radio-opaque material which can be easily observed on the fluoroscope so that the position of the balloon may be determined. In this way, the balloon may be centered over a lesion in the artery which is to be dilated, and the compression device can then be used to dilate the balloon to accomplish this task.

The balloon catheter 8 is advanced over the guidewire 4 very cautiously. As the balloon catheter 8 is advanced, the guidewire 4 also advances so that each time the balloon catheter 8 is advanced, the guidewire 4 must be withdrawn in a corresponding increment so that the guidewire 4 does not extend too far into the coronary artery 16. This requires that the steering device 2 be manipulated to release the guidewire 4 so that the steering device 2 can be repositioned on the guidewire 4 after the guidewire has been withdrawn an increment corresponding to the increment which the balloon catheter 8 has been advanced. Because the operator is holding a hub 12 of the balloon catheter 8 when the steering device 2 is manipulated, it is extremely advantageous to be able to alternately release and grip the guidewire 4 with the steering device 2 by manipulating the steering device 2 with one hand.

Once the distal end of the balloon catheter 8 is in the desired position, the balloon is inflated with the compression device for a period of typically about 30-60 seconds, during which time the flow of blood through that particular portion of the artery 16 is totally blocked and the plaque in the artery is compressed. The balloon is then deflated and withdrawn back into the guiding catheter 6 leaving the guidewire 4 in the coronary artery 16.

When the prior art steering devices are used, it generally takes two people to properly position the balloon catheter 8 in the coronary artery 16. One person watches the monitor and pulls back on the guidewire 4, and the other person gently pushes the balloon catheter 8 forward. Although the inventive steering device 2 may be used during this operation, it is especially useful for advancing the guidewire 4 into the coronary artery 16 which is an extremely delicate operation and requires great care to avoid injuring the internal lining of the coronary artery 16 with the tip 5 of the guidewire 4. If one wants to maneuver the guidewire 4 past a stenosis, and then through another branch of the artery, one needs to have very good control and a minimum of distraction. If the steering device is locked onto the guidewire 4 in a position which is 6 or 7 cm. back from the hub 12 of the balloon catheter 8 one will have torqueability, but it will be difficult to exert the forward pushing motion on the wire 4 when holding the steering device 2 without flexing the wire in a position between the steering device 2 and the hub 12. It is for this reasons that the steering device 2 must grip the guidewire 4 in a position which is only 2 or 3, or preferably 1 or 2 cm. in back of the hub 12 so that there will be minimal lateral deflection of the guidewire 4' in positions between the steering device 2 and the hub 12. Therefore, advancing the guidewire 4 into the coronary artery requires a great deal of finesse. It must be advanced very gently. The worker must watch the fluoroscopic monitor to see where the wire 4 is going and hold the steering device 2 in one hand and the hub 12 in the other. It will be appreciated that it would be very distracting and time consuming to look down at the steering device and remove the one hand from the hub 12 in order to use that hand to loosen a screw cap on the forward end of a prior art steering device such as are presently used in the art. In such a situation, the prior art steering device would need to be loosened with two hands, and then moved back 2 or 3, preferably 1 or 2 cm., tightened down again in order to grip the guidewire 4 in a different position. One would then repeat the process of grasping the hub 12, reestablishing visual contact with the monitor, and advancing the guidewire 4 by gently pushing the prior art steering device toward the hub 12 before repeating the repositioning of the prior art steering device again.

If one is not cautious enough when advancing the guidewire 4, the J-tip 5 at the distal end of the guidewire 4 can find its way under the plaque on the inner surface of the artery even if the tip 5 is pushed gently. The plaque can be lifted and may inadvertently cause a serious dissection of the artery which has the potential for severe complications. A great deal of finesse is required as the operator delicately probes his or her way through the narrowing in the arteries. Similarly, when one comes to a branch point in the arteries as the wire is extended further into the vessel, one does not want to make abrupt or gross movements. In addition to pushing under plaque on the inner surface of the vessels, the wire 4 may lift up the thin, delicate inner membrane lining of the vessel called the intima. It is possible that this membrane may be injured and may flop into the lumen of the vessel and obstruct flow.

The present steering device 2 is preferably a disposable device which will preferably be sterilized prior to sale and delivery to an end user. It is designed to move freely up and down an angioplasty guidewire 4 without encountering substantial resistance when it is in a non-gripping position, and it may be locked into a gripping position by using translational force exerted by a single hand.

Referring now also to FIGS. 3-8, one embodiment of the steering device 2 of the present invention employs a single gripping member 20 which forces the wire 4 against gripping face 30b of an interior surface 21 of the main body 22 of the steering device 2 proximate the bore 3 when the gripping member 20 is in a gripping position as shown in FIGS. 6-8.

First and second body members 22a and 22b are joined together to form the main body 22. The body members 22a and 22b may be made of any suitable polymeric material that would be selected by one skilled in the art for the present purpose. The two body members 22a and 22b are joined together by suitable means known to those skilled in the art for joining such material together such that the device 2 comprises an integral article of manufacture. The gripping member 20 is preferably made of a somewhat more flexible polymeric material than the material used to make the body member 22. This material may also be selected from materials which one skilled in the art would find to be suitable for this purpose. The gripping member 20 is preferably integrally molded of a suitable polymeric material and includes a body portion 24 and flange portions 26. The ends of each of the flange portions 26 distal to the body portion 24 are bifurcated into two wedge members 28, each having gripping faces or surfaces 30a which form a part of a gripping mechanism 31 which also includes gripping faces or surfaces 30b on an internal surface 21 of the main body 22 substantially in the geometric center of a transverse cross section of the steering device 2. The gripping member 20 is supported by a leaf spring 32 which pushes the gripping member 20 away from the guidewire 4, which runs through the bore 3 in the center of the steering device 2. When the gripping member 20 is in a non-gripping position as shown in FIG. 5, the gripping member 20 and the gripping faces 30a are disengaged from the wire 4. When the gripping member 20 is depressed toward the center of the steering device 2, the gripping faces 30a of the gripping member 20 engage the guidewire 4 and press it against the internal surface 21 of the main body 22, especially in the vicinity of the gripping faces 30b of the main body 22, so that the gripping faces 30a and 30b grip the wire 4 and hold it in place. The gripping faces 30b of the main body 22 correspond to, and are located directly opposite to and directly opposed to, the gripping faces 30a of the gripping member 20. The gripping mechanism 31, therefore, includes all of the gripping faces 30a and 30b and also includes recesses 34 in the main body 22 and the walls of the main body 22 which define the recess 34 which force the wedge members 28 against the guidewire 4 when the gripping member 20 is depressed toward the center of the steering device 2. The gripping mechanism also includes the gripping member 20 and the internal surface 21 of the main body 22. When the gripping member 20 is depressed sufficiently, and the gripping faces 30a and 30b grip the guidewire 4, an upper surface 36 of the gripping member 20 will be flush with the rounded outer surface 38 of the steering device 2. Furthermore, the gripping member 20 will depress the leaf spring 32 and a locking mechanism 39 including two latching members 40 will become engaged within the steering device 2 so as to lock the gripping member 20 in a gripping position as shown in FIGS. 6-8. When the gripping member 20 is in the gripping position, the locking mechanism 39 is in a locked position. It will be appreciated, however, that the gripping mechanism 31 can be partially actuated to provide some frictional gripping force without actuating the locking mechanism 39, and thereby locking the device 2 in the locked position.

Referring now specifically to FIG. 7, when the gripping member 20 is in the gripping position and the locking mechanism is in the locked position, the latching members 40 are engaged in latch recesses 42 in the main body 22. In order to release the gripping member 20 so that it will be forced away from the center of the steering device 2 by the leaf spring 32 and disengaged from the wire 4, there are release levers 44 on each side of the steering device 2. The release levers 44 form an integral portion of the main body 22. Because the main body 22 is made of a somewhat flexible material, the integral connection between the release levers 44 and the main body 22 acts as a "living hinge" which permit the release levers 44 to be depressed. When they are depressed simultaneously, by exerting translational forces toward the center of the device 2 from both sides, the flexible latching members 40 are forced toward the center of the steering device 2 so that the latching members 40 are pushed out of the latch recesses 42 and the gripping member 20 is released and pushed upward away from the center of the steering device 2, by the resilient leaf spring 32. Therefore, it is possible to depress the gripping member 20 when it is in the non-gripping position shown in FIG. 5, so that it will occupy the gripping position shown in FIGS. 6-8, where the locking mechanism 39 is shown in a locked position. In order to release the gripping member 20 from the gripping position shown in FIGS. 6-8, the release levers 44 on both sides of the steering device are depressed toward the center of the device 2 to push the latching members 40 away from their corresponding latch recesses 42 so that the locking mechanism 39 will disengage, thereby freeing the gripping member 20 to become disengaged from the guidewire 4 under the biasing force of the leaf spring 32. It will be appreciated that these operations can be accomplished when the steering device 2 is grasped by a single hand and that none of these operations would require the assistance of another hand during maneuvering of the guidewire 4 in the various operations required during an angioplasty procedure.

Referring now also to FIGS. 9-18, which show a second embodiment 2' of the present invention which includes two opposing gripping members 20a and 20b. The main body 22' of the steering device 2' includes two body members 22a' and 22b' which are joined together in a manner similar to that described for the steering device 2 shown in FIG. 3. Two end caps 46 are rotatably connected to the respective extremities of the main body 22. The end caps 46 may be rotated 90.degree. in order to provide for the alignment of radial channels 50 and 52 in the end caps 46 and the main body 22', respectively. When the respective radial channels 50 and 52 are aligned, as is shown in FIGS. 14, 16 and 18, a length of the guidewire 4' may be inserted transversely into the steering device 2'. In order to prevent the guidewire 4' from coming out of the steering device 2' the end caps 46 can be rotated 90.degree. so that the radial channels 50 and 52 are no longer in alignment. The rotation of the end caps 46 is permitted by indexing recesses 54 in the main body 22' which permits indexing pins 56, which are integral parts of each of the end caps 46, to slide within the respective indexing recesses 54 as the respective end caps 46 are rotated axially with respect to a transverse cross-section of the main body 22'.

When the guidewire 4 is inserted in the steering device 2' as shown in FIG. 11, the gripping members 20a and 20b can be depressed toward the center of the steering device 2' so that the gripping members 20a and 20b engage and grip the guidewire 4. When the opposing gripping members 20a and 20b are depressed, the respective opposing flange portions 26a and 26b, and particularly the wedge members 28a and 28b, which form the bifurcated end portions of the respective flange portions 26a and 26b, are forced downward and outward toward the respective axial extremities of the steering device 2' and as the respective wedge members 28a and 28b are forced up again bosses 58 in each respective end cap 46 which define conical recesses 60 in the respective end caps 46. When the respective opposing gripping members 20a and 20b are depressed, upper and lower latching members 40a and 40b on each side of the steering device 2' engage so that a locking mechanism 39' is in a locked position. When the locking mechanism 39' is in a locked position, the upper and lower gripping members 20a and 20b are in a gripping position wherein gripping faces 30a of the upper gripping member 20a and 30c of the lower gripping member 20b are engaged with and grip the guidewire 4'. In order to disengage the upper and lower latching members 40a and 40b respectively, which are located on each side of the steering device 2' and, therefore, latch the respective gripping members 20a and 20b on both sides of the guidewire 4', release levers 44' are squeezed to force the lower latching members 40b on each side inward toward bore 3' in the center of the steering device 2'. When the lower latching members 40b are forced inward, they are individually disengaged from the upper latching members 40a, thereby releasing the opposing gripping members 20a and 20b which are then forced away from each other and away from the center of the steering device 2' by the biasing affect of the resilient flange portions 26a and 26b of the respective gripping members 20a and 20b, which are made of a resilient, flexible polymeric material as previously described with respect to the gripping member 20 of the device 2 shown in FIG. 3.

The steering device 2' shown in FIGS. 9-18 is an integral unit and is preferably made of suitable polymeric materials that would be selected by one of skill in the art for such a device. Preferably, these materials include resilient, flexible, polymeric materials which are biocompatible with the intended use. This device 2' is preferably disposable and is preferably sterilized prior to distribution to its end user.

The gripping mechanism 31' of the device 2' includes the opposing gripping members 20a and 20b and their various parts including the opposing gripping faces 30a and 30c. Also included in the gripping mechanism 31' are the bosses 58 in each respective end cap 46 which define the conical recesses 60 in the respective end caps. The bosses 58 wedge the wedge members 28a and 28b against the guidewire 4' when the respective gripping members 20a and 20b are depressed toward the center of the device 2'.

It will be appreciated that the respective gripping mechanisms 31 and 31' and the respective locking mechanisms 39 and 39' which include their respective release levers 44 and 44', may all be actuated using direct translational force exerted by a single hand grasping the respective steering devices 2 and 2'. The translational movement of the respective elements of the respective devices 2 and 2', which results from the translational force applied to these elements is sufficient to actuate respective changes in the various positions occupied by the respective devices 2 and 2'. Translational force, as used herein, means a linear force as opposed to a rotational force.

The present invention enables one of skill in the art to releasably engage a length of wire so as to direct passage of a remote portion of the length of wire during percutaneous transluminal angioplasty and related medical procedures.

As used herein, wire means any elongated strand-like member, such as a PTA guidewire, a fiber optic bundle or strand, a catheter, or the like.

Referring now to FIGS. 19-29, and specifically to FIGS. 19-24, another embodiment of the present steering device to 2" is shown. The steering device 2" is an integral unit, preferably made from suitable polymeric materials which provide for sufficient durability, strength, flexibility and shape retention. The steering device 2" includes a flexible center portion 68 which acts as a "living hinge" between opposing midsections 70a and 70b and between opposing end portions 72a and 72b. This steering device 2" is preferably made by a molding process, preferably an injection molding process or the like. After the device 2" is made in the molding process, it will have a fully open configuration as shown in FIGS. 19 and 20. In order to complete the manufacture of the steering device 2", the manufacturer will preferably manipulate the steering device 2" to a partially open position shown in FIG. 24. The respective end portions 72a and 72b are manipulated into opposing positions, as shown in FIG. 24, by bending the flexible center portion 68. Preferably, the polymeric material used to make the steering device 2" of the present invention is such that it permits the device 2" to have both flexibility and memory or resilience. In preferred embodiments, however, the steering device 2" will be fixed or cured, preferably by treating it with heat in a location proximate the flexible center portion 68, so that the steering device 2" will "remember" or retain the shape it is in such that it will return to the partially open position shown in FIG. 24, and will not return to the fully open position shown in FIG. 20 when no force is exerted upon the steering device 2" and the end portions 72a and 72b are unrestrained.

In order to laterally engage the guidewire 4", the respective end portions 72a and 72b and midsections 70a and 70b are allowed to rest in opposing positions similar to those shown in FIG. 24 when the device 2" is in the partially open position. In this position, generally opposing lower centering pins 76a and 76b each break a plane 78 between the respective halves 80a and 80b of the steering device 2" and cross each other to form a cradle to receive the guidewire 4" as shown in FIG. 24. The steering device 2" has two pairs of upper centering pins 75a and 75b and two pairs of lower centering pins 76a and 76b, one of each in general proximity to each of the lateral ends 82 and 84 of the steering device 2". Each pair of centering pins 75a, 75b 76a, 76b straddle a respective midsections 70a and 70b. The guidewire 4" or any other elongated member such as a catheter, fiber optic bundle, or the like, can then be inserted laterally into the steering device 2" as shown in FIG. 24 and it will be supported by the respective lower centering pins 76a and 76b at each lateral end 82 and 84 of the steering device 2". When the guidewire 4" is resting upon opposing lower centering pins 76a and 76b, which break or intersect the plane 78 between the respective halves 80a and 80b of the steering device 2", the respective end portions 72a and 72b can be engaged so that the guidewire 4" or the like is retained within the steering device 2". Referring now also to FIGS. 25-29, when the steering device 2" is compressed transversely by exerting force upon the respective halves 80a and 80b of the device 2" to engage the respective end portions 72a and 72b, the second end portion 72b overrides the first end portion 72a such that an upper ratchet mechanism 85 engages a lower ratchet mechanism 86. In addition to the lower ratchet mechanism 86 in the center of the first end portion 72a, a pair of channel-like recesses 87 are located on an upper surface 88 of the first end portion 72a, one toward each of the respective lateral ends 82 and 84 of the device 2". When the upper and lower ratchet mechanisms 85 and 86 are engaged, a pair of lateral locking teeth 90, one in relative proximity to each of the respective lateral ends 82 and 84 of the second end portion 72b, are received in the channel-like recesses 87 in general proximity to each of the respective lateral ends 82 and 84 of the first end portion 72a. The lateral locking teeth 90 interact with the distal edges 91 of the respective channel-like recesses 87 to provide a catch mechanism which prevents the end portions 72a and 72b from disengaging. This is demonstrated in FIG. 25 where the lateral locking tooth 90 in general proximity to the second lateral end 84 is shown in contact with the distal edge 91 of the channel-like recess 87 in general proximity to the second lateral end 84 of the first end portion 72a. When the respective end portions 72a and 72b of the steering device 2" are engaged in this manner, the steering device 2" is in a partially engaged position and the guidewire 4" can slide freely in the axial bore or center of the steering device 2" (see FIG. 25).

In order to grip the guidewire 4" with the steering device 2", force is exerted on the respective outer surfaces 74a and 74b of the midsections 70a and 70b such that the upper and lower ratchet mechanisms 85 and 86 are further engaged and two pairs of gripping surfaces 30a" and 30b", each pair straddling a respective midsection 70a or 70b of the device 2", cooperate to grip the guidewire 4" in opposition to one another. Each pair of gripping surfaces 30a" and 30b" are forced inwardly toward the center of the steering device 2" in order to more fully engage the respective end portions 72a and 72b as shown in FIG. 27. When the respective end portions 72a and 72b are engaged, as shown in FIGS. 23 and 27, the steering device 2" is in a gripping position and the guidewire 4" is unable to slide through the center of the steering device 2" because it is gripped between the opposing gripping surfaces 30a" and 30b". The respective ratchet mechanisms 85 and 86 cooperate to provide a locking mechanism capable of locking the gripping surfaces 30a" and 30b" in the gripping position shown in FIGS. 23 and 27.

The first end portion 72a of the steering device 2" includes a release pad 94 which is interconnected with the upper surface 88 by a pair of connecting members 92. In order to partially disengage the upper or lower ratchet mechanisms 85 and 86 when they are engaged as shown in FIGS. 23 and 27, so as to permit the guidewire 4" to slide freely within the center of the steering device 2", downward force is exerted upon the release pad 94 such that the first end portion 72a is lowered slightly, permitting the respective ratchet mechanisms 85 and 86 to disengage sufficiently to allow the lateral locking teeth 90 to slide through the respective channel-like recesses 87 until the lateral locking teeth 90 engage the distal edges 91 of the channel-like recesses 87 in the position shown in FIG. 25. A gap 95 exists between the release pad 94 and the upper surface 88 of the first end portion 72a which receives the second end portion 72b and permits the ratchet mechanisms 85 and 86 to disengage. Because the flexible center portion 68 is resilient and always attempts to return the device 2" to the position shown in FIG. 24, the steering device 2" is biased toward disengagement. In order to completely disengage the respective ratchet mechanisms 85 and 86 and the respective end portions 72a and 72b, additional downward force is placed upon the release pad 94, so as to force the first end portion 72a downward, in relation to the second end portion 72b, thereby lowering the channel-like recesses 87 in relation to the lateral locking teeth 90 so as to remove the lateral locking teeth 90 therefrom and thereby disengage them from the distal edges 91 of the channel-like recesses 87. This will allow the second end portion 72b and the first end portion 72a to disengage under the biasing effect of the resilient flexible hinge or center portion 68, and the steering device 2" will return to the partially open position shown in FIG. 24, unless it is otherwise restrained in some manner.

As shown in FIGS. 19 and 27, and in phantom in FIGS. 25, 26 and 28, the steering device also includes a pair of lower centering pin recesses 96 in the first half 80a of the steering device 2" for receiving lower centering pins 76b which straddle the midsection 70b of the second half 80b of the steering device 2". When the respective ratchet mechanisms 85 and 86 are engaged as shown in FIGS. 27 and 28, the lower centering pins 76b of the second half 80b straddle the lower centering pins 76a of the first half 80a and are respectively received in the lower centering pin recesses 96. The steering device 2" also includes a plurality of bump-like protrusions on the outer surfaces 74a and 74b of the respective midsections 70a and 70b, and on an engaging surface 99 of the release pad 94 in order to provide for demarcation of these respective surfaces and to provide a surface which is easier to engage or grip with one's finger or fingers.

The steering device 2" shown in FIGS. 19-29 and a similar steering device 2"' shown in FIGS. 30-31, are believed, for a number of reasons, to be preferable to the steering devices 2 and 2' described hereinabove and shown in FIGS. 1-18. These reasons include, but are not limited to, the following. Because the steering device 2" is an integral unit, it can be made in a single mold by a process of injection molding. Therefore, it is believed that it can be manufactured at a cost which would be significantly lower than the cost necessary to make the steering devices 2 and 2' shown in FIGS. 1-18. It is also believed that this steering device 2" is easier to manipulate with a single hand during transluminal percutaneous procedures such as transluminal percutaneous angioplasty or the like. This is particularly because of the biasing effect of the living hinge 68 which allows the preferred device 2" to assume the partially engaged position shown in FIG. 25 by simply pressing downward on the release pad 94 when the device 2" is in the fully engaged position shown in FIGS. 23 and 27 and the elongated member 4" is being gripped. This makes it very easy to release the guidewire 4" from the grip of the device 2" so that the user can slide the steering device further up or down the length of the wire 4". It is also much easier to remove or insert the elongated member 4" laterally or from the side. When it is necessary to grip the guidewire 4" so as to manipulate it, it is a simple matter to force the opposing halves 80a and 80b together to more fully engage the ratchet mechanisms 85 and 86 to move the respective gripping surfaces into a gripping position so as to grip the guidewire 4". Utilization of the present steering device by a physician or the like to manipulate an elongated member such as a guidewire for a catheter, a fiber optic bundle or the like, must be susceptible to manipulation with a single hand in order to allow the operator to use the other hand to grip the hub of the catheter. The ease of manipulation is also critical so as to free the physician to concentrate on the fluoroscope or other monitor providing an image of the elongated member being percutaneously or intraoperatively manipulated within the body of the patient with the help of the steering device.

Another advantage of the preferred steering device 2" is that the guidewire 4" can be gripped gently by engaging the ratchet mechanisms 85 and 86 in one of several positions (not shown) depending on the cross-sectional diameter of the elongated member 4" which are intermediate positions between the partial engagement shown in FIG. 25 and the full engagement shown in FIGS. 23 and 27. This is particularly important if the elongated member is delicate, such as a fiber optic bundle or the like. It is also noted that it is possible to engage the ratchet mechanisms 85 and 86 beyond the full engagement shown in FIGS. 23 and 27. This allows for greater gripping power, because the midsections 70a and 70b can be further depressed than shown in FIGS. 27 and 28, and they can, therefore, have a greater biasing effect of pushing the respective gripping faces 30a" and 30b" together to grip the elongated member.

Referring now also to FIGS. 30 and 31, yet another embodiment of the present steering device 2"' is shown which is almost identical to the steering device 2" shown in FIGS. 19-28. The steering device 2"' differs from the steering device 2" shown in FIGS. 19-28 only in that the respective gripping surfaces 30a"' and 30b"' are located on special gripping pads 33a and 33b which are bonded to, adhered to, or integrally formed with the respective halves 80a' and 80b' of the steering device 2"', in order to provide gripping surfaces 30a"' and 30b"' made of a polymeric material which is preferably softer, and preferably more resilient than the polymeric material used to make the other portions of the steering device 2"'. This is especially desirable when the steering device 2"' is used to grip an elongated member such as a fiber optic bundle 3 which is more delicate than ordinary guidewires used for most transluminal percutaneous angioplasty procedures. The special gripping pads 33a and 33b are made of a suitable polymeric material or materials to provide the flexibility and resilience which may be desired to suit a specific application, and to allow the pads 33a and 33b to adhere, bond or become joined to the respective halves 80a' and 80b' of the steering device 2"'.

Referring now also to FIG. 32, yet another embodiment of the present steering device 2"" is shown which is almost identical to the steering device 2" shown in FIGS. 19-28. The steering device 2"" differs from the steering device 2" shown in FIGS. 19-28 only in that the lower ratchet mechanism 86"' has been modified to provide a smooth surface 93 in place of the first four ratchet teeth 89 of the lower ratchet mechanism 86 of the steering device 2" which is shown in FIG. 27. In other alternate embodiments, different numbers of ratchet teeth 89, starting from the distal end of the first end portion 72a, can be eliminated and replaced with a smooth surface which will allow the ratchet teeth of the upper ratchet mechanism 85 to slide smoothly thereover without engaging any portion of the lower ratchet mechanism 86. This feature is designed to permit the user to grip the elongated member by exerting a force sufficient to grip the elongated member between the respective gripping faces 30a" and 30b" without locking the respective ratchet mechanisms 85 and 86 into position relative to one another. The respective end portions 72a"' and 72b"' are partially engaged when the locking teeth 90"' are received in the channel-like recesses 87"', however, an enlongated member of a somewhat larger size (not shown) can be gripped in the alternate steering device 2"" without allowing the ratchet teeth 89 of the respective ratchet mechanisms 85 and 86 to become engaged. It will be appreciated that the number of ratchet teeth which are removed and replaced by a smooth surface 93 can be modified to suit a particular need respecting an elongated member having a specific cross-sectional diameter.

It will be appreciated that the steering devices of the present invention may be used to manipulate elongated members of many different kinds for many different purposes or procedures including, but not limited to, transluminal percutaneous or intraoperative angioplasty, other transluminal percutaneous or intraoperative procedures, percutaneous or intraoperative surgical procedures employing a fiber optic bundle, percutaneous or intraoperative observation procedures employing a fiber optic bundle, and the like.

It is to be understood, however, that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size, composition, and arrangement of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.