HK1237688B - Guidewire fixation - Google Patents

Description

Guidewire fixation

Priority claim

Priority benefit is hereby claimed to U.S. Provisional Patent Application Serial No. 62/166,259, filed on May 26, 2015, and entitled “GUIDEWIRE FIXATION,” and U.S. Provisional Patent Application Serial No. 62/190,879, filed on July 10, 2015, and entitled “GUIDEWIRE FIXATION,” the entireties of which are incorporated herein by reference.

Technical Field

This patent document relates to medical devices. More particularly, but not by way of limitation, this patent document relates to transcutaneous devices and methods suitable for minimally invasive treatment of various conditions and diseases.

Background of the Invention

Minimally invasive medicine, the practice of gaining access to blood vessels or other hollow body structures for the subsequent introduction and placement of catheters or other interventional medical devices, has been evolving since the invention of the Seldinger technique in the early 1950s.

An important advancement in this evolutionary process is the ability to replace a catheter or other interventional medical device on a single indwelling guidewire without the need to displace the guidewire proximally or distally, where proximally displacing the desired lesion would prevent access, while displacing the guidewire distally would risk perforation or other guidewire-induced patient damage. This "over the wire" (OTW) or "long wire" replacement technology requires a long guidewire length so that the guidewire can be handled and stabilized from the outside of the patient's body during surgery. The portion of the guidewire extending out of the patient must be at least slightly longer than the full-length lumen of the catheter (or other interventional medical device) to be used. In this way, the proximal end of the guidewire can protrude from the proximal end of the catheter and can be held by an operating physician or his/her assistant to maintain the indwelling positioning of the guidewire.

To exchange one catheter for another using the OTW technique, the physician and assistant must perform a series of well-coordinated, one-to-one movements between the guidewire and each catheter. The assistant pushes the guidewire the same amount the physician pulls back on the first catheter, until the first catheter is completely outside the patient and the physician has gained control of the guidewire at the point of entry. The assistant then pulls the first catheter off the guidewire and loads a second catheter back onto the guidewire into the patient to perform the second procedure, which in turn requires the same push-pull technique. Once the second catheter is fully loaded onto the guidewire, the proximal end of the guidewire protrudes beyond the proximal end of the catheter and can be grasped by the assistant, who typically stands farther away from the physician. These exchange maneuvers must be guided by fluoroscopy to monitor distal guidewire position, thereby increasing the radiation dose to which the patient, physician, and assistant are exposed during the procedure. Furthermore, these exchange maneuvers are prone to error, resulting in loss of indwelling guidewire position.

A technique has been developed that allows the use of shorter guidewire lengths and more control by the physician over the guidewire to simplify catheter replacement. It is known as "rapid exchange," "monorail," or "short-line" technology and is used in conjunction with a rapid exchange, monorail, or short-line catheter that includes a shortened guidewire channel that extends only along a portion of the catheter's length. The rapid exchange technique differs from the OTW technique in that the guidewire is fed into the shortened channel and exits at a point between the distal and proximal ends of the catheter via a port or channel formed on the side of the catheter. The physician can perform short-line catheter replacement by manipulating a guidewire portion that is slightly longer than the length of the shortened channel (instead of the guidewire being slightly longer than the entire catheter, as in the case of the OTW technique). This allows the physician to maintain control of the guidewire at all times and reduces the need for x-ray-guided push-pull replacement movements coordinated with an assistant.

SUMMARY OF THE INVENTION

As the complexity of vascular interventions increases, dedicated over-the-wire (OTW) catheters with full-length guidewire lumens are becoming increasingly available; however, physicians often prefer the convenience of short, quick-exchange guidewires to the more cumbersome OTW-length guidewires.

The present inventors have recognized that when an OTW catheter is used in combination with a rapid-exchange guidewire, the operating physician may not be able to maintain control of the guidewire throughout the catheter exchange process. When the guidewire can no longer be held, it can be easily lost as the OTW catheter is withdrawn, pulling it back along with it. Similarly, when attempting to advance the OTW catheter over the rapid-exchange guidewire, while the proximal end of the guidewire cannot be grasped by the physician or their assistant, the guidewire can be inadvertently pushed distally by the catheter. This advancement of the guidewire carries the potential risk of vessel perforation or other damage, as the distal tip of the guidewire may be advanced into a small or diseased vessel that the physician did not intend to cannulate. Alternatively, a redundant loop of the guidewire may form in front of the advancing OTW catheter, resulting in loss of wire control and inability to position the catheter. Any uncontrolled guidewire movement caused by movement of the OTW catheter over the rapid-exchange guidewire can lead to procedural inefficiencies, surgical failure, and/or patient complications.

The inventors have further recognized that, particularly when using over-the-counter (OTW) catheters and rapid-change length guidewires, there is a need for devices and methods for securing the position of an indwelling guidewire during percutaneous procedures. The present devices and methods include a means for engaging the intermediate or distal portion of a guidewire with the inner surface of a tubular member. Once the guidewire position is locked by engagement with the inner surface of the tubular member, it is possible to withdraw the first OTW catheter and subsequently introduce a second OTW catheter over the guidewire without causing the guidewire to move longitudinally relative to the tubular member.

A percutaneous device used in conjunction with a guide catheter and a guidewire, particularly a quick-change length guidewire, can include a relatively flexible, elongated tubular member, a pushing member, and a fixing mechanism such as a fixed balloon. The tubular member can define an inner cavity of a size and shape that can accommodate one or more interventional medical devices and can have an outer diameter that is smaller than the inner cavity of the guide catheter. In this way, a portion of the tubular member can extend inside and outside the distal end of the guide catheter to facilitate deeper delivery of the one or more interventional medical devices to a desired target vessel or other hollow structure. The pushing member can be attached to the tubular member and can extend proximally therefrom to slidably position the tubular member relative to the guide catheter. The pushing member can include an inner cavity that is in fluid communication with the interior of the fixed balloon to deliver an inflation fluid to the balloon or remove fluid therefrom. The fixed balloon can be positioned on a portion of the pushing member near or within the tubular member and can include a size and shape that, when expanded, engages or locks the guidewire onto the inner surface of the guide catheter or the tubular member. This engagement or locking can facilitate replacement of the OTW catheter while maintaining the position of the guidewire within the desired target vessel or other hollow structure.

A method for inserting an OTW catheter or other interventional medical device into a patient's body using an in-situ rapid length change guidewire as a track can include advancing the distal end of a guide catheter over the guidewire to a position adjacent to the mouth of a desired vessel or other hollow structure. A percutaneous device comprising a pushing member, a relatively flexible elongated tubular member, and a fixing mechanism such as a fixing balloon can be advanced into the guide catheter and onto the guidewire. The tubular member can be positioned coaxially aligned with the guide catheter, with its distal end portion extending beyond the distal end of the guide catheter. The longitudinal movement of the guidewire relative to the guide catheter or the tubular member can be suppressed by inflating the fixing balloon, thereby engaging the guidewire with the inner surface of the guide catheter or the tubular member. After the fixing balloon is inflated, the OTW catheter can be loaded onto the proximal end of the locked guidewire and advanced distally to a position close to the fixing balloon. When the proximal end of the guidewire becomes accessible outside of the proximal end of the OTW catheter, the physician can grasp the proximal end of the guidewire and can then deflate the fixation balloon so that the OTW catheter can be further advanced into the desired vessel or other hollow structure.

These and other embodiments and features of the apparatus and methods of the present invention are at least partially described in the following detailed description. This summary is intended to provide non-limiting examples of the present subject matter - it is not intended to provide an exclusive or exhaustive explanation. The following detailed description is included to provide further information about the apparatus and methods of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference numerals may be used to describe similar features and components throughout the several views.The drawings illustrate generally by way of example and not limitation, the various apparatus and method embodiments discussed in this patent document.

1 depicts a plan view of a guide catheter advanced through the aorta to the coronary ostia, constructed in accordance with at least one embodiment.

2 depicts a plan view of a percutaneous device for use in conjunction with a guide catheter constructed in accordance with at least one embodiment.

3 depicts an exploded view of a percutaneous device for use in conjunction with a guide catheter and guidewire, constructed in accordance with at least one embodiment.

4 depicts a front view of a transcutaneous device constructed in accordance with at least one embodiment.

5 depicts a side cross-sectional view of a transcutaneous device, eg, along line 5 - 5 of the embodiment of FIG. 4 .

6 depicts a side cross-sectional view of a percutaneous device constructed in accordance with at least one embodiment for use in conjunction with a guide catheter, a guidewire, and an OTW catheter.

7-8 depict cross-sectional views of a percutaneous device, a guide catheter, and a guidewire, eg, along lines 7-7 and 8-8 of FIG. 6, respectively.

9 depicts a method for using a percutaneous device to exchange a first OTW catheter or other interventional medical device for a second OTW catheter or other interventional medical device using a guidewire as a track, constructed in accordance with at least one embodiment.

The drawings are not necessarily drawn to scale. Certain features and components may be shown exaggerated in scale or in simplified form, and some details may not be shown for the sake of clarity and conciseness.

Detailed description

Typically, after a catheter or other interventional medical device is inserted into a patient's body, it is necessary to withdraw the catheter or device to replace it with a catheter or device of a spare size. For example, the profile of the deflation balloon of a dilatation catheter may sometimes be too large to pass through the lesion to be treated (such as stenosis); or the profile of the balloon may be so small that the lesion cannot be fully expanded when the balloon is inflated. When this happens, the dilatation balloon catheter needs to be replaced with a different (smaller or larger) size so that the lesion can be crossed and properly treated after the balloon is inflated. The catheter or device may also or alternatively have poor controllability or low flexibility, resulting in an inability to track anatomical landmarks away from the lesion. In this case, the catheter or device must be replaced with a catheter or device with better tracking properties so that the anatomical landmarks can be reached. These replacements are completed during catheter or device replacement.

The percutaneous devices and methods of the present invention allow for reliable insertion and removal of OTWs and rapid-exchange catheters or other interventional medical devices over any length of guidewire, including rapid-exchange guidewires having a length of about 190 centimeters (cm) or less, while maintaining the position of the guidewire relative to tubular members or anatomical landmarks within the vasculature. Maintaining the guidewire's indwelling position during insertion and removal of such interventional medical devices reduces the need for coordinated x-ray-guided push-pull exchange movements that would otherwise be required.

It is believed that the apparatus and method of the present invention will have great application value in percutaneous coronary intervention procedures performed by interventional cardiologists using rapid exchange length guidewires, particularly when an OTW catheter is employed or anticipated. The apparatus and method of the present invention may also allow the position of the guide catheter to be maintained relative to the port of a target vessel or other hollow structure in which anatomical landmarks are placed by utilizing the deep vessel seatability of its tubular member. While the remainder of this patent document generally discusses and illustrates the use of the apparatus and method of the present invention with reference to the treatment of coronary vessels, it should be understood that the apparatus and method may also be used to treat other diseased or obstructed vessels or other hollow structures (e.g., bile ducts, ureters, etc.) throughout the body of a patient using a guidewire.

Minimally invasive cardiac interventions, such as percutaneous transluminal coronary angioplasty procedures, are used throughout the world and typically include the use of a guide catheter 102, as depicted in FIG1 . The guide catheter 102 is an elongated tubular member that defines a guide catheter lumen 104 along its entire length. The guide catheter 102 can be formed of, for example, polyurethane and can be shaped to facilitate its access to a coronary ostium 106 or other relevant area within a patient's body. In the embodiment of FIG1 , a 6 French (F), 7 French, or 8 French guide catheter 102 can be inserted into the femoral artery and advanced through the aorta 108 to a position adjacent to the ostium 106 of a coronary artery 110. The diameter and rigidity of the guide catheter 102 generally do not allow it to be advanced beyond the ostium 106 into the coronary artery 110 to be treated, and therefore, a dilatation balloon catheter must be advanced independently of the guide catheter 102 to reach the lesion 112.

Maintaining the position of the distal end of the guide catheter 102 at the port 106 may be desirable to facilitate successful delivery of the dilatation balloon catheter to the lesion 112. When resistance is encountered in attempts to deliver the dilatation balloon catheter, the guide catheter 102 may be withdrawn or retracted from the port 106. The intrinsic pulsation of the heart may also cause the distal end of the guide catheter 102 to lose its position or otherwise become displaced such that it is no longer positioned to guide the dilatation balloon catheter to the lesion 112. Due to this displacement from the port 106, access to the coronary artery 110 and the lesion 112 may require repeated repositioning of the guide catheter 102 to reengage its distal end with the port 106.

The percutaneous device 200 of the present invention can improve access to the coronary artery 210 and anatomical landmarks typically located distal to the lesion 212, and comprises a relatively flexible, elongated tubular member 214, a pusher member 216, and a fixation mechanism (e.g., a fixation balloon as depicted in FIG3 ). FIG2 depicts a portion of the tubular member 214 extending through the guide catheter 202 and beyond its distal end 218 into the coronary artery 210. By extending into the coronary artery 210, the tubular member 214 can stabilize the positioning of the guide catheter 202 relative to the ostium 206 of the artery and can allow for improved access to the lesion 212, where a dilatation balloon catheter can be used to perform an appropriate intervention. The tubular member 214 can define an inner lumen 220 to accommodate the dilatation balloon catheter and can have an outer diameter smaller than that of the inner lumen 204 of the guide catheter 202.

The pushing member 216 can be attached to at least the proximal end of the tubular member 214 and extend proximally from this attachment, such that its proximal portion 242 is accessible to an operating physician outside the patient's body. The pushing member 216 allows the physician to position the tubular member 214 between a first position (in which the tubular member 214 is completely positioned within the guide catheter 202) and a second, extended position (as depicted) in which a portion of the tubular member 214 extends beyond the distal end 218 of the guide catheter 202. In various embodiments, the pushing member 216 can include a hypotube ( FIG. 3 ) capable of delivering inflation fluid to or removing fluid from the fixation balloon, and its proximal portion 242 can include an inflation manifold 222 that can be coupled to an inflation device, such as a Luer fitting 224.

The distal end portions of the guide catheter 302 and the percutaneous device 300 are positioned adjacent the ostium 306 and within the coronary artery 310, respectively, wherein an in situ guidewire 326 (e.g., a rapid-change length guidewire) can be freely positioned therein and can be rotated and controlled at its proximal end 330, as shown in FIG3 . For anatomical orientation and relative positioning, a dose of contrast agent can be provided through the guide catheter 302 and the tubular member 314 of the percutaneous device 300. When the guidewire 326 has passed through the lesion 312 in the coronary artery 310 to be treated, its distal tip 332 can be positioned distal to an anatomical landmark adjacent to the lesion.

Next, the size of the securing mechanism of the percutaneous device 300 can be increased so that the guidewire 326 engages the inner surface 338 of the middle or distal portion 328 of the guide catheter 302. The securing mechanism can take various forms, including, for example, expandable, extendable, or elastic arms, fingers, latches, or expandable members. As depicted in the embodiment of FIG3 , the securing mechanism can be a securing balloon 334 positioned on the distal portion 336 of the pushing member 316 adjacent to the tubular member 314, and can include an expanded size and shape so that the guidewire 326 engages the inner surface 338 of the middle or distal portion 328 of the guide catheter 302. The expansion of the securing balloon 334 can inhibit the longitudinal movement of the guidewire 326 relative to the guide catheter 302, the tubular member 314, or the anatomical landmark, while providing sufficient force to advance or withdraw the OTW catheter or other interventional medical device without causing the guidewire 326 to move. Based on clinical bench testing, the force sufficient to secure a 0.014 inch (in) (0.0356 cm) guidewire is believed to be approximately 30 grams (g) to 60 g.

The fixation balloon 334 or other fixation mechanism may alternatively be positioned within the tubular member 314 and may comprise an enlarged size and/or shape to engage the guidewire 326 on the inner surface of the tubular member 314. This fixation balloon 334 position provides direct and localized control of the position of the guidewire 326 near its distal portion.

Inflation of the fixed balloon 334 can be accomplished by connecting the tip of a syringe or a dedicated inflation device 340 to an inflation manifold 322 coupled to the proximal portion 342 of the push member 316. By depressing the plunger of the syringe 340, an inflation fluid or gas can be pushed through the lumen of the push member 316 into the fixed balloon 334. The inflation fluid typically comprises a sterile saline solution or a sterile solution consisting of saline and a contrast agent. A contrast agent solution can be used when it is desired to observe the expansion of the fixed balloon 334 using fluoroscopy. Once the fluid is pushed into the fixed balloon 334 and the tip of the syringe is withdrawn from the inflation manifold 322, the valve or stopcock 323 within the manifold can be closed or is closed to keep the balloon 334 in an inflated state.

Optionally, the percutaneous device 300 can further include an inflation indicator bulb 344 positioned on the proximal portion 342 of the push member 316. The indicator bulb 344 can be in fluid communication with the interior of the fixation balloon 334 and can provide an external (outside the patient's body) indication of the inflation status of the fixation balloon 334 to the operating physician.

For example, after the guidewire 326 is engaged with the inner surface 338 of the distal portion 328 of the guide catheter 302 using the fixation balloon 334, the proximal end 330 of the guidewire 326 can be introduced into the OTW dilation balloon catheter 346, for example, using a backloading technique. Without a torquer on the guidewire 326, the proximal end 330 of the guidewire 326 can be inserted in a rearward direction through the tip and axial lumen of the dilation balloon catheter 346. The guidewire 326 can be advanced rearward by holding the distal portion 348 of the dilation balloon catheter 346 with one hand and advancing the guidewire 326 rearward with the other hand. As the dilation catheter 346 is advanced distally into the coronary artery 310, the proximal end 330 of the guidewire 326 exits through the opening 350 at the proximal portion 352 of the catheter and can be grasped by the physician.

The fixation balloon 334 can then be deflated, releasing the guidewire 326 from its captured or fixed position relative to the guide catheter 302 or the anatomical landmark. The dilation balloon catheter 346 can then be advanced further distally along the guidewire 326, beyond the guide catheter 302 and the distal end 318 of the tubular member 314, and through the coronary artery 310 to the anatomical landmark. This occurs while the proximal end 330 of the guidewire 326 extends beyond the proximal portion 352 of the dilation balloon catheter 346 and is grasped by the physician to prevent advancement within the coronary artery 310. The balloon 356 of the dilation balloon catheter 346 can be positioned over the lesion 312 such that, upon expansion, the lesion 312 is dilated.

4 depicts a front view of an exemplary percutaneous device 400 for use with a guide catheter and guidewire. The percutaneous device 400 can include a relatively flexible elongated tubular member 414, a pushing member 416, and a securing balloon 434, and can have a collective length 482 of, for example, 120 cm-180 cm.

The markings on the percutaneous device 400 can allow the operating physician to identify the positioning of the components of the device relative to the patient's anatomy, the guide catheter, and any interventional medical devices used during the procedure. For example, one or more depth markings 484 can be printed on the pushing member 416 and can be positioned at a first 486 (e.g., approximately 105 cm) and a second 488 (e.g., approximately 95 cm) length from the distal end of the tubular member 414. A radiopaque marker 494 can be positioned within the fixed balloon 434 and can be formed by gold plating around a portion of the pushing member 416. Furthermore, one or more radiopaque marker bands 496 can be positioned on the tubular member 414 and can be made of tungsten, platinum, or an alloy thereof. The first marker band 496 can be positioned at a length 498 slightly away (e.g., about 4 mm away) from the full-circular entrance of the tubular member 414, and the second marker band 496 can be positioned near the distal end of the tubular member.

The fixation balloon 434 can be positioned on the distal portion 436 of the pushing member 416 , for example, at a length 490 proximate (eg, approximately 5 cm) to the fully circular entrance of the tubular member 414 .

The tubular member 414 can extend a length 492 of approximately 6-30 cm and can define a lumen 420. The lumen 420 can be larger than the outer diameter of the pushing member 416 and within one or two French sizes of the inner diameter of the guide catheter to allow passage of dilatation balloon catheters, stents, and other interventional medical devices.

FIG5 depicts a side cross-sectional view of the percutaneous device 500, for example, along line 5-5 of FIG4 . Describing the illustration in a proximal-to-distal direction, the pushing member 516 can define or otherwise include a lumen 564. The lumen 564 can be in fluid communication with the interior of the fixed balloon 534 to deliver inflation fluid to or remove fluid from the balloon. In various embodiments, the pushing member 516 can include a hypotube having a port 566 in its sidewall to fluidically couple the lumen 564 and the fixed balloon 534. The lumen 564 can be blocked or otherwise sealed at the distal end of the fixed balloon 534 to form a closed inflation system.

The fixing balloon 534 can be positioned on the distal portion 536 of the pushing member 516 adjacent to the tubular member 514 and wrapped around the port 566. The fixing balloon 534 can be laser welded or otherwise bonded to the pushing member 516 at the proximal annular connector 568 and the distal annular connector 570. The center of the fixing balloon 534 can be vertically offset 574 and/or radially offset 575 relative to the axial (horizontal and vertical) center plane of the pushing member 516. The radial offset 575 can help the balloon avoid inhibiting the delivery of an interventional medical device into the tubular member 514, while the vertical offset 574 can, for example, effectively push the guidewire against the inner surface of the guide catheter when expanded. In various embodiments, the expanded outer diameter of the fixing balloon 534 is slightly larger than the inner diameter of the guide catheter in which the percutaneous device 500 is used. The fixing balloon 534 can have an effective locking length of approximately 10-12 mm, and the marker 594 can extend along a portion of this effective length.

The fixation balloon 534 can comprise one or more polymer layers. In one embodiment, the fixation balloon 534 comprises a single polymer layer formed from nylon, polyether block amide, polyethylene terephthalate (PET), or polyurethane. In another embodiment, the fixation balloon 534 comprises an inner polymer layer and an outer polymer layer; the inner polymer layer can comprise a high-durometer polymer to increase rupture resistance and provide enhanced outward force, and the outer polymer layer can comprise a lower-durometer polymer to provide flexibility and conformity to the vessel wall.

The proximal portion 558 of the tubular member 514 can be coupled to the distal portion 536 of the pushing member 516. The arrangement or configuration of this coupling can vary. For example, the tubular member 514 can have an opening formed in its wall, and the pushing member 516 can be disposed within the opening. Inserting the pushing member 516 into the opening can result in mechanical coupling between the members, and additional or alternative bonding (e.g., adhesive bonding, thermal bonding, welding, brazing, etc.) can be utilized. The distal portion 536 of the pushing member 516 can be flattened to provide a larger surface area to be fixed to the tubular member 514. A coupling mechanism is also contemplated that is achieved by bonding between or integrating a third component (e.g., a metal or polymer collar or concave track) of the proximal portion 558 of the tubular member 514 and the distal portion 536 of the pushing member 516. The polymer forming the third component decreases in hardness and increases in flexibility in the proximal-to-distal direction to provide a gradual transition in flexibility between the more rigid pusher member 516 and the more flexible tubular member 514 .

In the embodiment shown, the proximal portion 558 of the tubular member 514 includes a concave track 501 that is accessible from a longitudinal side defined transverse to the longitudinal axis of the tubular member 514. The area provided by this concave track 501 for accommodating a balloon catheter, stent, or other interventional medical device into the tubular member 514 is larger than the area associated with an opening oriented perpendicular to the longitudinal axis of the tubular member. The skeleton support structure 503 of this concave track 501 can transition from the relatively rigid propulsion member 516 in the form of a hypotube to a more flexible structure 560 without an inner cavity embedded in the tubular member 514. The distal portion 536 of the hypotube 516 can have an outer diameter that gradually decreases in its distal direction, wherein it can be welded to a metal (such as stainless steel) band member 560 whose size can also gradually decrease in its distal direction. At the weld region 505 between the distal end of the hypotube 516 and the proximal end of the metal strip 560, each component may be cut at a mating angle 507 to provide a controlled and gradual transition to a larger weld surface area.

This tubular member 514 can be formed by inner polymer layer 509, outer polymer layer 511 and the reinforcing member 513 that is arranged between this polymer layer.This inner polymer layer 509 can be made up of silicone resin, polytetrafluoroethylene (PTFE) or other lubricating materials or use it to coat, think that the interventional medical device that is housed provides smooth surface.This outer polymer 511 layers can comprise one or more soft flexible materials that hardness reduces successively along the length of this tubular member 514, for example polyurethane, polyethylene or polyolefin, and it can be coated with antifriction material (as hydrophilic or organosilicon coating), so that the insertion that is carried out by vascular system and guiding catheter and tracking.Alternatively, this outer polymer layer 511 can be loaded with one or more radiopaque elements, so that can be observed under fluoroscopy.Reinforcement braid or coil 513 can be by, for example stainless steel or platinum alloy form, and can extend between this polymer layer along at least a portion of the length of this tubular member 514. In one embodiment, the reinforcing coil 513 is formed from 304 stainless steel having cross-sectional dimensions of 0.0015 in and 0.0080 in and is coupled to the distal end of the concave track's skeletal support structure 503 .

FIG6 depicts a percutaneous device 600 disposed within the guide catheter 602 and used in conjunction with the guidewire 626 and an OTW dilation balloon catheter 646. The tubular member 614 of the percutaneous device 600 can be loaded back from its distal end onto the proximal end of the guidewire 626 and advanced through a hemostatic valve into the guide catheter 602. As shown, the tubular member 614 of the percutaneous device 600 can be advanced beyond the distal end 618 of the guide catheter 602 under fluoroscopy, for example, approximately 10 cm or less beyond the distal end. When so disposed, a portion of the tubular member 614 can engage a port and extend within a portion of a coronary artery to help maintain the position of the guide catheter 602 and improve access to the artery.

Once the fixing balloon 634 of the percutaneous device 600 is positioned within the guide catheter 602 as desired, it can be expanded (as shown in phantom) to limit the movement of the guide wire 626 (e.g., a quick-change length guide wire). The fixing balloon 634 can be expanded to a diameter that fills the inner diameter of the guide catheter 602 (see Figures 7 and 8) and can engage the guide wire 626 on the inner surface 638 of the guide catheter 602, thereby inhibiting longitudinal movement of the guide wire 626 relative to the guide catheter 602 and the anatomical landmark (assuming that the guide catheter 602 is stationary relative to the anatomical landmark). When the position of the guide wire 626 is locked by the expansion of the fixing balloon 634, the proximal end of the guide wire 626 can be released by the operating physician, and the OTW dilation balloon catheter 646 can be loaded back onto the guide wire 626 and advanced distally through the guide catheter 602.

7 and 8 are cross-sectional views of the percutaneous device 700, 800; the guide catheter 702, 802, and the guidewire 726, 826, for example, taken along lines 7-7 and 8-8 of FIG. 6, respectively. It can be seen that the use of an eccentrically positioned push member 716, 816 and a skeletal support structure 703, 803 to adjust the position of the tubular member 714, 814 of the percutaneous device 700, 800 provides several advantages. The relatively small diameter of the push member 716, 816 creates low surface friction during its longitudinal movement within the guide catheter 702, 802. The low friction allows for easy extension and retrieval of the tubular member 714, 814. Furthermore, the small cross-sectional size of the push member 716, 816 does not significantly interfere with the delivery of dilatation balloon catheters, stents, and other interventional medical devices or fluids through the guide catheter 702, 802.

Delivery of a dilatation balloon catheter, stent, or other interventional medical device into the tubular member 714, 814 through the guide catheter 702, 802 can be accomplished by a concave track 701, 801 defining a partially cylindrical opening and having a length of approximately 1 cm to 18 cm. The concave track 701, 801 can be positioned adjacent to or distal to the anchoring balloon 734, 834 of the percutaneous device 700, 800. In one embodiment, the first segment 778 of the concave track 701 can have an arcuate cross-sectional shape extending at least 0.5 cm in length and radially extending 25% to 40% of the cross-sectional circumference of the guide catheter 702 or tubular member 714. The second segment 880 of the concave track 801 can have a semi-cylindrical cross-sectional shape extending at least 0.5 cm in length and radially extending 40% to 70% of the cross-sectional circumference of the guide catheter 802 or tubular member 814.

The pushing members 716, 816 and the fixing balloons 734, 834 can extend along the sides of the guidewires 726, 826 within the guide catheters 702, 802 and can remain there throughout the interventional procedure. The fixing balloons 734, 834 can provide sufficient engagement to secure the position of the guidewires 726, 826 within the guide catheters 702, 802 when, for example, the dilation balloon catheter is advanced or withdrawn, and can be deflated to allow the dilation balloon catheter to continue to be advanced relative to anatomical landmarks while the proximal end of the guidewire can be grasped by the operating physician.

FIG. 9 depicts an exemplary method 917 for using a percutaneous device to exchange a first OTW catheter or other interventional medical device for a second OTW catheter or other interventional medical device using a guidewire as a track.

The first OTW catheter can be initially removed from the patient. At 919, the first OTW catheter to be removed can be withdrawn over the guidewire and into the guide catheter until its distal end is positioned proximate to a fixation mechanism. This positioning can be confirmed using fluoroscopy and radiopaque markers on or within the fixation mechanism. The fixation mechanism can then be increased in size (e.g., expanded) at 921 to engage the guidewire on the inner surface of the guide catheter, thereby preventing longitudinal movement of the guidewire during catheter removal. At 923, the first OTW catheter can be completely withdrawn from the patient and removed.

The second OTW catheter can then be inserted into the patient. At 925, the second OTW catheter can be loaded onto the locked guidewire and advanced distally toward the fixation mechanism until the proximal end of the guidewire becomes accessible outside the proximal end of the second OTW catheter. At 927, the physician can grasp the proximal end of the guidewire and can then reduce the size of the fixation mechanism (e.g., shrink it). At 929, the second OTW catheter can be further guided into the desired target vessel or other hollow structure to provide treatment.

Conclusion

In minimally invasive surgery, it is often necessary to replace one catheter or other interventional medical device with another while maintaining the guidewire's indwelling position relative to the guide catheter or anatomical landmark. Maintaining the position of the guide catheter relative to the port of the target vessel or other hollow structure in which the anatomical landmark is placed is also beneficial during this replacement. To maintain this position of the guidewire, guidewire lengths of approximately 270 cm or longer were previously used, requiring two operators—the physician and his/her assistant—to handle the process, particularly when an over-the-counter catheter was intended to be used. One operator manipulated the long guidewire and held it in place while the other operator replaced the catheter. The operators had to communicate with each other during this replacement process, which increased the surgical time, and the tip of the guidewire had to be monitored under fluoroscopy, which exposed the operator and patient to increased radiation. In addition, the long length of the guidewire was difficult to handle and occasionally came into contact with the operating room floor or otherwise became contaminated, requiring disposal.

The percutaneous devices and methods of the present invention allow for the maintenance of a guidewire's indwelling position relative to a guide catheter, tubular member, or anatomical landmark of the percutaneous device during catheter exchange without the previously required task of manually holding the guidewire outside the patient's body. Because the guidewire no longer needs to be continuously held outside the body to be distally secured, the guidewire can be shorter in length and the hazardous, prolonged use of fluoroscopy to continuously monitor the guidewire position is no longer required. The shorter guidewire allows a single operator to efficiently perform an OTW dilatation balloon catheter exchange. The devices and methods further allow for the maintenance of the guide catheter's position relative to the ostium of a target vessel or other hollow structure in which the anatomical landmark is positioned by using the tubular member and extending a portion thereof beyond the distal end of the guide catheter.

The above detailed description of the invention contains references to the accompanying drawings, which form a part of the detailed description of the invention. The detailed description of the invention should be read with reference to the accompanying drawings. The accompanying drawings show, by way of illustration, specific embodiments in which the apparatus and method of the invention may be practiced. These embodiments are also referred to herein as "embodiments."

The above detailed description of the invention is intended to be illustrative and not restrictive. For example, the above embodiments (or one or more features or components thereof) can be used in combination with each other. For example, after reading the above detailed description of the invention, a person of ordinary skill in the art can use other embodiments. In addition, various features or components have been or can be combined together to simplify the present disclosure. This should not be interpreted as intending that the disclosed features that are not claimed are essential to any claim. On the contrary, the subject matter of the present invention has fewer than all the features of the embodiments of the particular disclosure. Therefore, the following claimed embodiments are hereby incorporated into the detailed description of the invention, wherein each embodiment independently serves as a separate embodiment:

In embodiment 1, the percutaneous device used together with the guide catheter and the guide wire can include an elongated tubular member, a pushing member and a fixing mechanism. The tubular member can be limited in size to accommodate the lumen of one or more interventional medical devices passing therethrough, and the outer diameter it has can be smaller than the lumen of the guide catheter. The pushing member can be attached to the tubular member to slidably position the tubular member in the guide catheter or partially exceed the guide catheter. The fixing mechanism can be positioned on a part of the pushing member and can be configured to engage the guide wire on the inner surface of the guide catheter or the tubular member when moving or increasing in size.

In Example 2, the transcutaneous device of Example 1 may optionally be configured such that the tube member is more flexible than the push member.

In Example 3, the transcutaneous device of any one of Examples 1 or 2 can optionally be configured such that the tube member comprises a length of at least 6 cm.

In Example 4, the percutaneous device of any one or any combination of Examples 1-3 can optionally be configured such that the diameter of the lumen of the tubular member is no more than one French size smaller than the diameter of the lumen of the guide catheter.

In Example 5, the percutaneous device of any one or any combination of Examples 1-4 can optionally be configured such that the tubular member is movable between a first retracted position in which the tubular member is fully positioned within the guide catheter and a second extended position in which a portion of the tubular member extends beyond the distal end of the guide catheter.

In Example 6, the transcutaneous device of any one or any combination of Examples 1-5 can optionally be configured such that the tube member comprises an inner polymer layer, an outer polymer layer, and a reinforcing member disposed between the inner and outer polymer layers.

In Example 7, the transcutaneous device of any one or any combination of Examples 1-6 can optionally be configured such that the pushing member is attached to the proximal portion of the tube member.

In Example 8, the transcutaneous device of any one or any combination of Examples 1-7 can optionally be configured such that the pushing member is positioned eccentrically relative to the cross-section of the tube member.

In Example 9, the percutaneous device of any one or any combination of Examples 1-8 can optionally be configured such that the fixation mechanism is a fixation balloon configured to engage the guidewire to the inner surface of the guide catheter or the tubular member when inflated.

In Example 10, the percutaneous device of Example 9 can optionally be configured such that the pushing member includes a lumen in fluid communication with the interior of the fixation balloon to deliver inflation fluid to or remove inflation fluid from the fixation balloon.

In Example 11, the transcutaneous device of Example 10 can optionally be configured such that the urged member comprises a hypotube.

In Example 12, the transcutaneous device of either Example 10 or 11 can optionally be configured such that the proximal portion of the push member includes an inflation manifold coupleable with a syringe or other inflation device.

In Example 13, the percutaneous device of any one or any combination of Examples 9-12 can optionally be configured such that the fixation balloon is positioned adjacent to the tubular member and wrapped around the pushing member.

In Example 14, the transcutaneous device of any one or any combination of Examples 9-13 can optionally be configured such that the fixation balloon comprises an inner polymer layer and an outer polymer layer.

In Example 15, the percutaneous device of any one or any combination of Examples 9-14 can optionally further include an inflation indicator bulb positioned on the proximal portion of the pushing member. The indicator bulb can be in fluid communication with the interior of the fixation balloon.

In Example 16, the transcutaneous device of any one or any combination of Examples 1-15 can optionally be configured such that the center of the securing mechanism is offset relative to the axial plane of the pushing member.

In Example 17, the transcutaneous device of any one or any combination of Examples 1-16 can optionally further comprise a radiopaque marker positioned on or within the securement mechanism.

In Example 18, the transcutaneous device of any one or any combination of Examples 1-17 can optionally further include a concave track defining a partially cylindrical opening to the fully circular portion of the tubular member.

In Example 19, the transcutaneous device of Example 18 can optionally be configured such that the first segment of the concave track comprises an arcuate cross-sectional shape.

In Example 20, the transcutaneous device of Example 19 can optionally be configured such that the arcuate cross-sectional shape extends for a length of at least 0.5 cm.

In Example 21, the transcutaneous device of any of Examples 19 or 20 can optionally be configured such that the arcuate cross-sectional shape radially extends 25% to 40% of the cross-sectional circumference of the tubular member.

In Example 22, the transcutaneous device of any one or any combination of Examples 19-21 can optionally be configured such that the second segment of the concave track comprises a semi-cylindrical cross-sectional shape.

In Example 23, the transcutaneous device of Example 22 can optionally be configured such that the semi-cylindrical cross-sectional shape extends for a length of at least 0.5 cm.

In Example 24, the transcutaneous device of either Example 22 or 23 can optionally be configured such that the semi-cylindrical cross-sectional shape radially extends 40% to 70% of the cross-sectional circumference of the tubular member.

In Example 25, the percutaneous device of any one or any combination of Examples 18-24 can optionally be configured such that the support structure of the concave track transitions from the pushing member in the form of a hypotube to a metal structure without an inner cavity.

In Example 26, the percutaneous device of Example 25 can optionally be configured such that the distal end of the hypotube and the proximal end of the non-lumen metal structure contain mating non-perpendicular cuts that are welded together.

In Example 27, a method may include advancing a percutaneous device into a guide catheter and inhibiting longitudinal movement of a guide wire relative to the guide catheter or a tubular member of the percutaneous device. The percutaneous device may include a pushing member, the tubular member, and a securing mechanism. Movement of the guide wire may be inhibited by increasing the size of the securing mechanism so that a portion of the guide wire engages an inner surface of the guide catheter or the tubular member.

In Example 28, prior to increasing the size of the fixation mechanism, the method of Example 27 may optionally further include withdrawing the interventional medical device over the guidewire until its distal end is positioned proximal to the fixation mechanism.

In Example 29, after increasing the size of the securement mechanism, the method of either Example 27 or 28 can optionally further include releasing contact with the proximal portion of the guidewire.

In Example 30, after increasing the size of the fixation mechanism, the method of any one or any combination of Examples 27-29 may optionally further include advancing an interventional medical device over the guidewire to a proximal position of the fixation mechanism.

In Example 31, the method of Example 30 can optionally be configured such that advancing the interventional medical device over the guidewire to the proximal position of the fixation mechanism includes exposing a proximal portion of the guidewire to a proximal portion of the interventional medical device.

In Example 32, the method of Example 31 may optionally further include grasping the proximal portion of the guidewire, reducing the size of the fixing mechanism to disengage the guidewire from the inner surface of the guide catheter or the tubular member, and advancing the interventional medical device over the distal portion of the guidewire and through the tubular member.

In Example 33, the method of Example 32 can optionally be configured such that reducing the size of the fixation mechanism includes deflation of the fixation balloon.

In Example 34, the method of any one or any combination of Examples 27-33 can optionally be configured such that advancing the percutaneous device into the guide catheter includes positioning the tubular member in coaxial alignment with the guide catheter with its distal portion extending beyond the distal end of the guide catheter.

In Example 35, the method of any one or any combination of Examples 27-34 can optionally be configured such that increasing the size of the fixation mechanism comprises inflating a fixation balloon.

In Example 36, the transdermal device or method of any one or any combination of Examples 1-35 can optionally be configured so that all listed elements or options are available for use or selection.

Certain terms are used in this patent document to refer to specific functional components or assemblies. As will be appreciated by those skilled in the art, different people may refer to the same functional component or assembly by different names. This patent document is not intended to distinguish between components or functional components that have different names but the same function.

For the terms defined below, specific definitions shall apply unless otherwise defined in other parts of this patent document. The terms "a", "an" and "the" are used to include one or more and are not affected by any other instances or uses of "at least one" or "one or more". The term "or" is used to indicate non-exclusivity; or "A or B" includes "A but not B", "B but not A" and "A and B". Whether explicitly stated or not, all numerical values are considered to be modified by the term "about". The term "about" refers to a numerical range that one skilled in the art would consider to be equivalent to the quoted value (e.g., having the same function or result). In many cases, the term "about" can include numerical values rounded to the nearest significant figure. The description of a numerical range by endpoints includes all numbers and subranges within and constraining the range (e.g., 1 to 4 includes 1, 1.5, 1.75, 2, 2.3, 2.6, 2.9, etc. and 1 to 1.5, 1 to 2, 1 to 3, 2 to 3.5, 2 to 4, 3 to 4, etc.). The terms "patient" and "subject" are intended to include, for example, mammals for human or veterinary applications. The terms "distal" and "proximal" are used to refer to a position or direction relative to a physician performing the procedure. "Distal" or "distally" refers to a position or direction away from the physician. "Proximal" and "proximally" refer to a position close to or a direction toward the physician.

The scope of the apparatus and methods of the present invention should be determined with reference to the appended claims, along with the full scope of equivalents to such claims. In the appended claims, the terms "including" and "in which" are used as the plain English equivalents of the terms "comprising" and "wherein," respectively. Moreover, in the claims that follow, the terms "including" and "comprising" are open-ended; that is, an apparatus or method that includes features or components in addition to those listed after the term in a claim is still considered to fall within the scope of the claim. Moreover, in the claims that follow, the terms "first," "second," and "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Claims (11)

1. A percutaneous device for use with a guiding catheter and guidewire, comprising: A distal, slender tubular member that defines an inner lumen and has an outer diameter smaller than that of the inner lumen of the conduit; A proximal actuating member, coupled to and extending proximally therefrom, to slidably position the tube member within or partially beyond the distal end of the guiding catheter; and A fixing mechanism is positioned on a portion of the actuating member and configured to engage the guide wire with the inner surface of the guiding conduit or the tube member when moved or enlarged. 2. The percutaneous device of claim 1, wherein the diameter of the lumen of the tubular member is smaller than the diameter of the lumen of the guiding catheter by no more than one French dimension. 3. The percutaneous device of claim 1 or 2, wherein the tubular member is movable between a first retracted position and a second extended position, wherein in the first retracted position the tubular member is fully positioned within the guiding catheter, and in the second extended position a portion of the tubular member extends beyond the distal end of the guiding catheter. 4. The percutaneous device of claim 1 or 2, wherein the tubular member comprises an inner polymer layer, an outer polymer layer, and a reinforcing member disposed between the inner polymer layer and the outer polymer layer. 5. The percutaneous device of claim 1 or 2, wherein the actuating member is eccentrically positioned relative to the cross-section of the tubular member. 6. The percutaneous device of claim 1 or 2, wherein the fixation mechanism is a fixation balloon configured to engage the guidewire with the inner surface of the guiding catheter or the tubular member upon inflatation. 7. The percutaneous device of claim 6, wherein the actuating member includes a cavity in fluid communication with the interior of the fixation balloon for delivering or removing inflatable fluid into or from the fixation balloon. 8. The percutaneous device of claim 7, wherein the proximal portion of the actuating member includes an expansion manifold that can be coupled to a syringe or other expansion device. 9. The percutaneous device of claim 6, wherein the fixation balloon is positioned adjacent to the tubular member and wraps around the actuating member. 10. The transdermal device of claim 1 or 2, further comprising a radiopaque marker positioned on or within the fixation mechanism. 11. The transdermal device of claim 1 or 2, wherein coupling between the actuating member and the tubular member is achieved by a concave track through a partially cylindrical opening leading to a fully circular portion of the tubular member.