KR20220156546A - Intravascular delivery systems and methods for percutaneous coronary intervention - Google Patents

Abstract

The subject guide catheter expansion/pre-inflation system includes an outer delivery sheath, an inner member that extends within the sheath, and a mechanism for engaging/disengaging the inner member to/from the sheath. The inner member consists of a tapered distal tip with a delivery microcatheter and a pre-inflation balloon member attached to the tapered distal tip proximate to the microcatheter. The outer delivery sheath and inner member are modified for different engagement/disengagement mechanism operation. The delivery microcatheter provides improved crossover of the balloon member to the treatment site in a non-traumatic, quick and convenient manner. During a cardiac procedure, a guide wire and guide catheter are advanced into the vicinity of the treatment site in the blood vessel. The inner member and outer delivery sheath are then advanced in a combined configuration along the guide wire inside the guide catheter towards the treatment site. Upon arrival at the treatment site, the balloon member is inflated for pre-inflation treatment. Subsequently, the inner member is disengaged and retracted from the outer delivery sheath and the stent is delivered to the treatment site inside the outer delivery sheath.

Description

Intravascular delivery systems and methods for percutaneous coronary intervention

REFERENCE TO RELATED APPLICATIONS

This PCT patent application is a continuation-in-part of the pending U.S. Utility Patent Application No. 15/899,603, filed on February 20, 2018, currently pending, dated September 17, 2018. Priority is claimed to pending U.S. Utility Patent Application #16/793,120, filed February 18, 2020, which is a continuation-in-part (CIP) of U.S. Utility Patent Application #16/132,878, filed with

Integration by reference

Currently pending US patent applications Ser. Nos. 16/793,120, 16/132,878 and 15/899,603 are incorporated herein by reference.

The present invention relates to a minimally invasive device used for treatment within the human vasculature, such as, for example, the coronary artery, in particular percutaneous coronary intervention, particularly suitable for endovascular balloon angioplasty and coronary stent delivery enhanced by the pre-expansion guide catheter dilatation function. It is about a delivery system for

The present invention also relates to the non-traumatic, convenient and rapid delivery of various intervening devices such as pre-expanded balloons or stents to the patient's body to facilitate, for example, percutaneous revascularization and catheter replacement of coronary arteries (or other blood vessels). It relates to a medical device designed for.

The present invention also further relates to an intravascular delivery system with a small tapered soft distal tip that allows superior delivery of the present interventional device superior to conventional balloon angioplasty catheters with virtually non-traumatic crossover to the site of the lesion for treatment. deal with

The present invention also relates to an intravascular guide catheter expansion/pre-dilation system using an inner member (intervention device delivery catheter sub-system) positioned at a predetermined position inside an outer member (external delivery catheter sub-system), comprising: Here the inner member is formed from a distal coil-reinforced tapered portion that interfaces with the slightly tapered distal end of the outer member. This creates a compact profile and substantially "seamless" transition at the interface between the distal end of the inner member (inner catheter) and the outer member (outer catheter) at the transition point where the distal portion of the inner catheter engages or enters the outer member. Dimensions are set so that This structure is very useful for atraumatic smooth passage of the inner and outer members as a single unit along the diseased vessel.

The present invention also relates to an intravascular guide catheter expansion/pre-inflation system comprising an outer catheter (member) and an inner catheter (member) displaceable inside and along the outer catheter, wherein the outer catheter is distal to the tapered end of the outer catheter. The soft tip is formed in its reduced configuration as an expandable, flexible, low durometer elastomeric member having an inner diameter at its junction with the outer catheter that is smaller than the outer diameter of the distal portion of the inner catheter. This arrangement achieves a reversible elastic coupling between the outer and inner catheters at the distal end, which ensures return of the enlarged distal end of the outer catheter to its reduced outer diameter when the inner catheter is removed from the outer catheter; As it progresses around the curvature of the vessel, it reduces (or eliminates) “fish mounting” at the distal junction of the outer and inner members.

The present invention also relates to an endovascular guide catheter expansion/pre-expansion system consisting of an outer and inner catheter displaceable relative to each other, wherein the proximal end of the outer catheter provides improved strengthening, improved mid-shaft stent entry, stent embolization. prevention, increased flexibility and flow rate improvement for contrast injection fluids.

In addition, the present invention can (1) controllably engage the inner and outer members for integrated motion within the guide catheter along the guide wire or (2) remove the inner catheter from the outer member (catheter), as required by an endovascular procedure. An intravascular guide catheter expansion/pre-expansion system designed with a mid-shaft interconnection (locking) mechanism that is actuated/disengaged by a physician to disengage the inner and outer catheters for retraction of the blood vessel. The inner member may carry an intervening device (such as a pre-inflated balloon member or stent) attached to the tapered coil reinforced distal end, and the locking mechanism provides a smooth and reversible engagement/disengagement procedure. This mid-shaft reversible locking also prevents any forward movement of the inner member relative to the outer member during system advancing or withdrawing, and the position of the distal "seamless" transition of the inner and outer catheters is axial during movement of the present system. ensures that it remains essentially fixed in place.

In addition, the present invention provides a "seamless" entry and smooth transfer of a balloon element comprising a coil-reinforced shaft tapered at the distal end for mounting and carrying the balloon element and integrated with the coil-reinforced delivery sheath of the external catheter to the desired treatment site. An intravascular guide catheter dilation/pre-dilation system that provides an achievement.

The present invention also addresses an intravascular guide catheter expansion/pre-inflation system featuring a monorail microcatheter embodiment with a rapid exchange (RX) feature for applications with short guide wires, wherein the distal end of the inner catheter is The tapered soft end consists of a coil-reinforced microcatheter that provides additional kink resistance and "pushability" while still maintaining flexibility for navigating tortuous vascular structures.

Coronary artery occlusive disease or other diseases of the peripheral vascular system are often treated with balloon angioplasty and/or stent placement. Advancement of a revascularization device, such as a balloon or stent delivery system, within a blood vessel to a treatment site can be difficult for a physician if tortuosity and/or calcification of the vessel is found.

A coronary stent is a device placed in a coronary artery that supplies blood to the heart to keep the artery open for the treatment of coronary heart disease, commonly used in a procedure called Percutaneous Coronary Intervention (PCI). It is a tube-shaped device. Stents have been shown to improve coronary blood flow, help reduce chest pain, and improve survival in the event of an acute myocardial infarction.

Treating a blocked coronary artery with a stent follows virtually the same steps as any other angioplasty procedure, but with important differences. Compressed stents placed in the balloon significantly reduce the flexibility of the balloon and impede its smooth passage through the coronary artery. This can make delivery of the stent to the treatment site difficult or impossible, and risks dislodging the undeployed stent from the delivery balloon.

Intravascular imaging can be used to assess the thickness and hardness (calcification) of the lesion, which will affect the delivery potential of the stent. The cardiologist uses this information to decide whether to treat the lesion with a stent and, if so, what type and size of stent to use. Stents, both bare metal and drug-eluting, are most often sold as a unit, with the stent in a folded (pre-expanded) form often attached to the outside of a balloon catheter.

The surgeon may perform "direct stenting", where the stent is threaded through the blood vessel and into the lesion and expanded. However, it is common to pre-expand the occlusion prior to stent delivery to facilitate stent delivery in more difficult lesions.

Pre-expansion is achieved by threading the lesion with a regular balloon catheter and dilating it to increase the diameter of the lesion. A balloon catheter is a type of “soft” catheter with an inflatable balloon at the tip used during a catheterization procedure to dilate a narrow opening or passage in the body. After pre-expansion, the pre-inflation balloon is removed and the stent catheter is threaded through the blood vessel into the lesion and expanded to remain a permanent implant to "scaffold" open the blood vessel at the lesion site.

Balloon catheters used in angioplasty have either an over-the-wire (OTW) or rapid exchange (RX) design. The balloon catheter slides into position over a guide wire that can be filled with the balloon catheter through the hub (in over-the-wire modifications) or through the RX port (for rapid exchange modifications of the balloon catheter). In an over-the-wire balloon catheter, a concentric lumen for passing the guide wire extends from the proximal hub to the balloon within the catheter, while in a rapid exchange (RX) balloon catheter, the lumen for passing the guide wire is inside the catheter. It extends from the RX port into the balloon to allow passage of the guide wire.

Revascularization devices generally use a guiding (or guide) catheter to deliver these devices to the treatment site. The use of a guide catheter alone to “back up” the advancement of a revascularization device into a coronary artery can be limited and difficult, particularly when stents are deployed using radial access guiding catheters.

To facilitate delivery of the revascularization device to the site of interest, a guide catheter expansion system has been designed and used during cardiac procedures.

Guide extension systems such as the "Guideliner ^TM ", for example, are produced by Teleflex. Such a guide extension system is described in U.S. Patent #8,292,850 to Root et al. Root et al. (US Pat. No. 8,292,850) describe a coaxial guide catheter passed through the lumen of the guide catheter for use with an interventional cardiac device that can be inserted into a branch artery branching off from a major artery.

A root coaxial guide catheter extends beyond the distal end through the lumen of the guide catheter and is inserted into the branch artery. Root uses a guide extension supported by a tapered internal catheter. The purpose of the internal catheter is to provide an atraumatic tip to prevent vessel injury while advancing guide expansion into the proximal portion of the coronary vessel to provide additional “backup” support for delivery of the stent or balloon.

Another guide extension system, such as “Guidezilla ^™ ”, was designed and manufactured by Boston Scientific. Such a guide extension system is described in US Pat. No. 9,764,118 to Anderson et al. Anderson's guide extension system uses a push member with a proximal portion having a proximal stiffness, a distal portion having a distal stiffness different from the proximal stiffness, and a transition portion providing a smooth transition between the proximal and distal portions. . The distal tubular member is attached to the push member and has an outer diameter greater than the outer diameter of the push member.

US Patent Application Publication No. 2017/0028178, authored by Ho, describes a guide expansion system that uses an expandable slit catheter for insertion of a balloon or stent delivery system. Ho's guide extension also uses a rigid push rod to assist delivery of the guide extension to the treatment site.

Ho's system, as well as the "Guideliner ^TM " and "Guidezilla ^TM " systems, supports the concept of advancing a guide extension system through a guide catheter and partially lowering the coronary artery to achieve additional "backup" support to achieve balloon inflation. Catheter and/or stent delivery The catheter is delivered to the intended treatment site.

The function of these guide extensions is to allow closer access to the lesion to provide additional support over the lesion to be treated with the intervention device. However, despite additional support, the lesion to be treated may still be difficult or nearly impossible to pass with a pre-expanding balloon catheter or stent delivery system due to fibrosis, calcification, previous stent support in the lumen and/or curvature of the lesion site. .

One of the limitations of currently used guide extension devices is the use of a relatively blunt, large bore cylindrical distal end. The relatively high profile distal edge in many cases limits the delivery potential of the guide extension and allows advancement only into the proximal or middle portion of the coronary artery to be treated. Very rarely, if at all, guide dilatation can be delivered to the actual lesion to be treated with angioplasty or stenting, even after balloon pre-expansion of the lesion. These "blunt-ended" tubular guide extension devices can fail relatively frequently and can cause severe incisional complications. Published data demonstrates that “blunt-ended” tubular guide expansion systems can fail in up to 20% of cases and can cause severe coronary artery transection in up to 3% of cases.

US Patent Application Publication #2011/0301502, authored by Gill, describes a catheter with longitudinal expansion that allows the positioning device to be smaller in diameter than the stent delivery system. However, the Gill device does not envisage an internal catheter allowing easy and non-traumatic crossing of the lesion to be treated. The Gill system merely serves as a sheath for the stent delivery system, which can be removed after advancement of the stent delivery system due to longitudinal expansion.

Although the concept of a tapered piece inside the guide expansion catheter can be seen in the Root device, prior art systems use a very short taper and do not design the taper as a long integral part of the overall system, and the pre-inflation balloon is used for tapered delivery. It does not devise anything that can be attached to a microcatheter and delivered to the target treatment area. Also, the prior art does not devise a substantially "flush" interface between the inner catheter and the outer guide extension inside the vessel, or the inner and outer catheter elements can be easily moved as the entire system as one integrated device. It is not possible to devise anything that can be reversibly fitted or locked together.

Root or other prior art systems describe a balloon (and/or stent) delivery system with a very low profile long tip that is advantageous for achieving coaxial delivery of the guide catheter expansion/balloon system to and beyond the lesion of interest; do not anticipate or invent This embodiment has not been commercialized, and the description of the device inside the tapered tip is meant only as a mechanism for proximal delivery of the blunt tip of the guide catheter extension from the guiding catheter, into and beyond the target treatment area within the blood vessel, the balloon ( and/or stents), nor is it intended that the integral nature of the inner and outer members and the "flush" interconnection would permit the passage of an external delivery "sheath" member to cross the lesion of interest. don't

Thus, a device and method capable of delivering the distal portion of a tubular guide extension system to or ideally beyond the lesion to be treated is comparable to conventional guide extension devices such as “Guideliner ^™ ” (Teleflex) or “Guidezilla ^™ ” (Boston Scientific). will have significant advantages over

None of the conventional balloon catheters (over-the-wire or rapid exchange) are integrated with an external delivery sheath, and none of these allow an intervening device (such as a balloon or stent) to pass from inside the blood vessel to the lesion site and beyond, non-traumatically. Do not use a tapered delivery microcatheter with the distal end of the catheter anchored for enemy advancement. Further, any of the conventional balloon catheters are operated to allow integrated motion of the conventional balloon catheter and external delivery sheath as a single unit, preventing forward displacement of the balloon catheter relative to the external delivery sheath while retracting the balloon catheter from the external delivery sheath. It is not interconnected with the external delivery sheath (guide catheter expansion sub-system) via an interconnection mechanism that is deactivated to allow for

Providing an intravascular delivery system that can deliver an intervention device (eg, a pre-inflated balloon) into and beyond a lesion in a substantially non-traumatic and convenient manner, along with a guide catheter expansion sub-system (such as an external delivery sheath). Doing so would be very desirable and efficient.

Additionally, an external catheter and an internal catheter featuring both a reinforced distal end with a compact tapered distal tip profile with a “seamless” distal interface to ensure non-traumatic crossover potential of the system to the lesion for treatment. It would be highly desirable to provide an intravascular delivery system having

It would also be desirable to facilitate percutaneous revascularization procedures using a balloon attached to the coil-reinforced, tapered distal tip of an internal balloon catheter that is fitted within the external delivery sheath of the external catheter, wherein the internal balloon catheter has a path to the lesion to be treated. A distal long tapered coil reinforced microcatheter is then mounted at the distal tapered tip to deliver the intervening device (pre-inflated balloon and/or stent) past it. This would represent a substantial improvement over conventional guide catheter expansion and pre-inflation systems.

Accordingly, it is an object of the present invention to provide a medical device for endovascular applications capable of delivering an interventional device (such as a balloon or stent) into and beyond a coronary artery occlusive lesion in an efficient and minimally traumatic manner.

Another object of the present invention is to achieve a "crossability" of the pre-inflated balloon (or other intervening device) distal end in a "seamless" manner with a compact profile that enhances the efficient and safe distal delivery of the guide expansion device. It is to provide an intravascular delivery system using a coaxial, highly flexible delivery catheter arrangement having an outer catheter and an inner catheter interfacing with each other.

A further object of the present invention is a highly flexible, coil-reinforced device for delivery of a pre-inflated balloon (or other interventional device) to and/or beyond a targeted lesion in the coronary artery of a patient to be treated with angioplasty (or stenting). The distal tapered long microcatheter tip is used.

A further object of the present invention is an external catheter (external delivery sheath sub-system) and an internal catheter (intervention device) interchangeably connected and fitted within an external sheath of the external catheter, which can both be delivered to and beyond the lesion area of intravascular treatment. delivery sub-system) to provide a guide catheter expansion/pre-inflation system, wherein the inner catheter has a delivery tapered microcatheter at the distal end and a pre-inflation balloon that slides along the guide wire in a substantially atraumatic manner. A member (or other intervening device) is attached to it.

A further object of the present invention is to provide a guide catheter expansion sub-system (outer member) integrated with a pre-inflation balloon (or other intervening device) sub-system (inner member), wherein the outer member and inner member guide wires. are coupled to each other (through a locking mechanism) so that they are displaced integrally (as a "whole system") to the lesion site along the way. After the pre-inflation procedure, the guide catheter expansion sub-system (consisting of an external delivery sheath) is unlocked from the inner member and can be advanced over the lesion if desired. Subsequently, the inner member (the intervening device delivery sub-system) can be withdrawn. The external delivery sheath of the external member may remain in the guide catheter when required for a surgical procedure to enhance delivery of the stent (or other interventional device) to the lesion site inside the external delivery sheath. The external delivery sheath can be subsequently withdrawn after the stent (or other interventional device) has been delivered to the lesion and deployed for final treatment.

It is also an object of the present invention to provide a guide catheter expansion/pre-inflation system equipped with a “locking mechanism” operatively coupled between an inner member and an outer member (outer sheath) to allow pre-inflation balloon into and beyond the treatment site. and to provide an integrated passageway for both the inner and outer members as a single unit for the possibility of convenient and safe delivery of the outer sheath.

A further object of the present invention is to achieve easy passage of a balloon (or other interventional device) and guide expansion system therethrough, so that percutaneous coronary intervention is performed with lower radiation dose exposure than is achieved using conventional systems. To provide a guide expansion system consisting of a pre-inflated balloon (or other intervening device) delivery catheter that can be delivered to a treatment site inside a vasculature in a non-traumatic manner to facilitate cardiac procedures that allow for stent embolization risk. It has the added advantage of having little or no drug loss from the stent delivery system (using a drug eluting stent).

A further object of the present invention is an intravascular guide consisting of coaxial inner and outer catheters displaceable relative to each other, improved by coil reinforcement along its length, but increasingly flexible, capable of achieving improved contrast infusion flow rates and anti-embolic. A catheter expansion/pre-inflation system is provided wherein the tapered outer end of the outer catheter is elastically stretched to form a firm contact with the distal portion of the inner catheter and is substantially flush with the outer surface at the interface between the inner catheter and the outer catheter. It is high (smooth).

The present systems and methods address an intravascular delivery system configured for controllable displacement along a guide wire in a vessel of interest. The system is formed of a proximal section, a distal section and a mid section portion located between the proximal section and the mid section. Current systems include an outer member formed by a flexible, substantially cylindrically contoured, elongated external delivery sheath defining a sheath lumen having a proximal end and a distal end. The outer delivery sheath consists of an outer tip extending between the middle section and the distal section and tapering at the distal end of the sheath lumen. The tapered outer tip of the outer member at the distal end of the outer delivery sheath consists of a wall extending in a cylindrical fashion between the proximal and distal edges of the tapered outer tip. The wall of the tapered outer tip has an inner diameter and an outer diameter. The inner and outer diameters of the walls of the tapered outer tip progressively decrease in dimension from the proximal edge to the distal edge of the tapered outer tip. The proximal (wire or hypo-tube) element (pushing or pulling) connected to the tubular structure of the outer member may be low profile and "flexible" (not "rigid"), thus replacing conventional guided expansion catheters. Allows for improved compliance and a lower profile inside the guiding catheter than the rigid "pushing" elements of (to the Root). This is made possible due to the "push ability" of the "whole system" achieved through the locking and integrated connection between the outer catheter (hypo-tube pushing/pull element) and the inner catheter (guide extension tube).

The system further includes an inner member (inner catheter) having an elongated body defining an inner channel extending along a longitudinal axis. The inner member extends internally along the sheath lumen of the outer member (external catheter) in controllable relationship with the outer delivery sheath. The elongate body of the inner member has an outer diameter and a tapered distal portion configured as a tapered delivery catheter having an elongated body of a predetermined length. The tapered delivery catheter of the inner member may be displaced beyond the distal end of the outer sheath. It is important that the inner diameter of the wall of the tapered outer tip of the outer member is smaller than the outer diameter of the tapered distal portion of the inner member in the region where the two elements form the distal junction.

The interconnection mechanism is operatively coupled between the inner and outer members and controllably actuated to operate the guide catheter expansion/pre-expansion sub-system in an engaged or disengaged mode of operation. In the combined mode of operation, the inner and outer members of the guide catheter expansion sub-system are coupled for a common controllable displacement along the guide wire. It is also a connected pusher (pushing/pulling element) of the outer member that has a small profile and is flexible (as flexible as or more flexible than the outer tubular sheath of the outer catheter) (with the outer member connected and locked to the inner member). Allows for improved "push ability" of the present system. In the disengaged mode of operation, the inner and outer members are disengaged for retraction of the inner member from the outer member following delivery of the pre-expansion treatment, or stent.

The distal end of the inner member interfaces at its outer surface with the inner surface of the tapered outer tip of the sheath lumen. A dimensional transition between the outer diameter of the outer tip of the sheath lumen and the outer diameter of the distal tip of the inner member forms a substantially equal-height interface transition therebetween.

The tapered outer tip of the outer member has a resiliently expandable configuration. At its proximal end (also referred to herein as the mid-shaft portion of the outer member), the outer sheath is configured with an entry opening that at its circumference exceeds the circumference of the tubular body of the outer sheath. In some embodiments, the entry opening at the proximal end of the outer sheath is funnel shaped.

The outer sheath is preferably reinforced along its length. The outer member includes a distal soft tip encapsulating material surrounding the reinforced sheath of the outer member at the distal end. The distal soft tip encapsulating material is a flexible, low durometer elastomeric material with a sloping durometer value that increases from the distal end of the sheath toward the proximal end.

The outer member also includes a distal lubrication liner sandwiched between an outer surface of the outer sheath and an inner surface of the distal soft tip encapsulating material.

The delivery catheter is preferably a micro catheter. The microcatheter may be formed of a flexible material and have differential flexibility along its length, where the microcatheter's flexibility increases towards its distal end.

A balloon member is attached to the distal tapered portion of the inner member proximate to the tapered delivery microcatheter; An inflation lumen extends within the inner member between the proximal section and the balloon member at the distal section to provide a fluid passageway between the external balloon inflation system and the balloon member. The inflatable member may assume an inflated or deflated configuration. In the deflated configuration, the balloon member is displaced from the vessel. The balloon member is placed in at least alignment with the treatment site for the pre-inflation procedure and then controllably deformed into an inflated configuration.

The long body of the inner member and the microcatheter are coil-reinforced along its length.

A pusher/puller element of the outer catheter consisting of a flat portion at the distal end is secured to the proximal end of the outer sheath of the outer catheter. Preferably, the pusher/puller of the outer member is configured with a channel extending along its length in fluid communication with the sheath lumen to prevent embolism. These proximal (pushing and pulling) elements connected to the outer sheath tubular structure of the outer catheter allow better conformability and lower profile inside the guiding catheter than the rigid "pushing" elements of conventional guided expansion catheters (such as the root). It can be low profile and "flexible" (not "rigid") for use.

The interconnection mechanism includes a snap-fit locking mechanism consisting of a proximal coupler disposed at the proximal end of the sheath of the outer member (catheter) and a cooperating element disposed on the outer surface of the elongated body of the inner member (catheter). can do. The proximal coupler may include a distal solid ring and an intermediate split ring positioned at a predetermined distance from the solid ring, with cooperating members including mid-shift locking rings, square annular rings, snap-fit cages, and other similar members. It may include members selected from the containing group. The cooperating member is attached to the outer surface of the elongated body of the inner member. When the cooperating member is snap-fitted and locked between the distal solid ring and the middle split ring, a locking fit between the outer and inner members is achieved. The outer catheter and proximal pusher/puller element of the coupler resists deformation during forward or backward movement of the outer member and the mid-shaft coupler (also referred to herein as proximal coupler) during passage of a stent or other device through the mid-shaft portion of the outer catheter. memory metal (eg, such as nitinol) to prevent any deformation of the

The proximal coupler further comprises a proximal beveled split ring at the proximal end, which reinforces the funnel-shaped proximal entrance of the outer member and provides a funnel-shaped proximal opening caused by displacement of the stent delivery system at the inner member or funnel entrance. Prevent damage or permanent deformation of the inlet. The coupler and mid-shaft inlet may have an inlet opening (or "mouth"), the circumference of which is greater than the circumference of the flexible tubular outer sheath structure of the outer member.

The present endovascular system further includes a guide wire advancing from a vessel of interest to at least a treatment site, and the guide catheter dilation sub-system is configured for controllable displacement along the guide wire. In one embodiment of the present system, an elastic outer jacket surrounds the inner member at least at the proximal end and surrounds the pusher/puller of the inner member along at least the distal end. The proximal end of the inner member is connected to the pusher/puller by fusing the elastic outer jacket to the length of the inner member's proximal end and snugly supporting the inner member's pusher/puller to the elastic outer jacket.

The pushing-pull element of the outer catheter (or its outer jacket) may be color coated to have an identifying color to distinguish it from the normal gray or silver coronary guide wire as well as the pushing/pull element of the inner catheter. Alternatively, the elastic outer jacket of the inner member may be color coated to identify the pusher/puller of the inner member from the color(s) of the other elements of the present system for the convenience of the surgeon.

These and other objects and advantages of the present invention will become apparent to those skilled in the art upon reading the detailed description of the present invention in conjunction with the patent drawings.

1 schematically shows a subject guide catheter expansion/pre-inflation system advanced to a target site within a coronary artery.
2A-2C schematically illustrates a subject guide catheter expansion/pre-inflation system, where FIG. 2A shows assembled inner and outer catheters, FIG. 2B shows the inner catheter in detail, and FIG. 2C shows the subject system The middle section is shown in detail.
Figures 3a-3d show a mid-section of an internal catheter, Figure 3a shows a longitudinal section of an expandable lumen hypo-tube interconnected with an expandable lumen distal shaft at the inner catheter, and Figure 3b shows a longitudinal section of an expandable lumen hypo-tube. Show in detail the longitudinal section of the skived part. 3C is a longitudinal section of the inner catheter showing the RX guide wire (GW) port formed on the distal shaft of the inflation lumen, and FIG. 3D is an isometric view of the RX port portion of the inner catheter shown in FIG. 3C. do.
4 shows a longitudinal section of the inner catheter detailing the distal end of the inflation hypo-tube at its junction with the inflation lumen distal shaft.
5A-5C show a distal section of the subject system, FIG. 5A shows an inflated balloon member, FIG. 5B shows a deflated balloon member, and FIG. 5C shows details of the inflation lumen/balloon junction.
6A and 6B show longitudinal sections of the distal section of the subject internal catheter detailing the 3 mm distal and proximal tapers of the balloon ( FIG. 6A ) and the 6 mm distal and proximal tapers of the balloon ( FIG. 6B ).
7 shows the distal tip of an external catheter.
8A and 8B show details of the interfacing of the inner and outer catheters at the distal end, where FIG. 8A shows the tapered distal end of the inner catheter and FIG. 8B shows a slightly enlarged view of the connection point between the inner and outer catheters. shown to scale.
9A-9D show an alternative embodiment of an elastically extensible distal tip of an external catheter consisting of an expandable split ring ( FIG. 9A ), an expandable tip scaffold ( FIG. 9B ) and a slit ( FIGS. 9C and 9D ). indicates
10A-10G show side views ( FIGS. 10A , 10B , 10D , 10F ) and isometric views ( FIGS. 10C , 10E , 10G ) of alternative embodiments of a proximal portion of an external catheter.
11A-11C detail the design of the coupler at the proximal end of the outer catheter, where FIG. 11A shows an isometric view of a flat hypo-tube pusher and FIG. 11B is an isometric view of the proximal end of the outer catheter; 11C shows a side view of a coupler at the proximal end of an external catheter featuring a snap-fit locking mechanism.
12A-12C show alternative embodiments of a proximal portion of an external subject catheter, FIG. 12A is an isometric view of a proximal coupler, FIG. 12B is an isometric view of an encapsulated proximal coupler, and FIG. 12C is an encapsulated proximal coupler. is a side view of
13A and 13B show an isometric view ( FIG. 13A ) in a side view ( FIG. 13B ) of another embodiment of a proximal coupler at the proximal end of an external catheter.
14A and 14B show a welded ring embodiment of the proximal entrance of an external catheter, FIG. 14A shows a welded ring coupler and FIG. 14B shows an encapsulated welded ring coupler.
15A-15D show further alternative embodiments of a proximal coupler of an external catheter, FIGS. 15A-15B are side and isometric views of a circularly contoured funnel puncture, respectively, and FIGS. 15B-15D are respectively a triangular funnel puncture. It is a side view and an isometric view of
16A-16C show the hypo-tube pusher flush lumen concept, FIG. 16A shows an isometric view of the proximal coupler of the external catheter coupled with the pusher, and FIG. 16B shows the flow channels within the pusher. 16A is an isometric cross-sectional view, and FIG. 16C illustrates the procedure for injecting flushing fluid between the inner and outer catheters.
17a to 17c show the object intermediate shaft annular circular ring locking mechanism, FIG. 17a shows the “disengage lock” mode of operation, FIG. 17b shows the “lock engaged” mode of operation, and FIG. 17c shows the object Represents the annular circular ring of the locking mechanism.
18a and 18b detail the corresponding annular ring locking mechanism shown in FIGS. 17a and 17b, where FIG. 18a shows a proximal coupler configured with a locking pocket for engagement with an annular ring (of FIG. 17c); , FIG. 18B is a longitudinal cross-sectional view of inner/outer catheters locked relative to each other.
19A-19C show an alternative subject embodiment of a locking mechanism featuring an intermediate shaft “square” annular ring, with FIG. 19A showing an inner catheter equipped with a ring shaped locking mechanism, and FIG. 19B showing an outer catheter. Showing the ring of the inner catheter snapped to the proximal coupler of the catheter, Figure 19C shows a cross-sectional view of the square annular ring.
20A-20C show an alternative “snap-fit cage” locking mechanism, FIG. 20A shows an inner catheter with a welded cage lock, and FIG. 20B shows an inner catheter snapped to the proximal coupler of the outer catheter. A welded cage lock is shown, and FIG. 20C is an isometric view of a welded cage element.
21 is a side view of another embodiment of an external catheter proximal coupler featuring two locking slots.
22A and 22B show a monorail microcatheter embodiment of the subject system, with FIG. 22A showing an isometric view of the monorail microcatheter embodiment and FIG. 22B showing a side view taken along line AA.
23A-23C detail a subject monorail microcatheter embodiment, with FIG. 23A showing an isometric view of the proximal portion of the inner catheter connected with the inner catheter hypo-tube pusher, and FIG. 23B showing a slightly enlarged proximal end of the pusher. 23C is a side view of the proximal portion of the inner catheter associated with the hypo-tube pusher.
24A and 24B show isometric and side views, respectively, of a coil-reinforced balloon catheter embodiment of the present system.

A subject comprising a guide catheter expansion sub-system (also referred to herein as an external catheter or external member) and an intervention device delivery sub-system (also referred to herein as an internal catheter or internal member) that cooperate under the control of a physician during a cardiac procedure. An intravascular delivery system 10 is shown in FIGS. 1-24B. Although the interventional device delivery sub-system may be used for delivery of a variety of cardiac interventional devices in one of the implementations by way of example only and without limiting the scope of the invention to this specific embodiment, the subject interventional device delivery sub-system may be pre- It will be further described as configured for delivery of a balloon member to perform an inflation procedure.

In the exemplary embodiments described herein, subject system 10 may be referred to herein as a guide catheter expansion/pre-expansion system that may be used for cardiac procedures with guide wire 12 and guide catheter 14. have. As shown in FIG. 1 , the guide wire (GW) 12 is moved to the blood vessel 16 by the surgeon at the initial stage of the heart procedure. Guide catheter 14 is advanced along guide wire 12 through blood vessel 16 (eg, such as the aorta) to a position adjacent to ostium 18 of coronary artery 20 . The guide wire 12 may be used to guide the guide catheter 14 during cardiac procedures, and subsequently the subject guide catheter expansion/pre-expansion system 10 (inside the guide catheter 14) is detailed in the following paragraphs. As described, it may extend toward a target location 22 within the artery 20 .

2A-2C, subject guide catheter expansion/pre-inflation system 10 includes balloon catheter sub-system 34 (also referred to herein as an internal catheter, internal member or pre-inflation sub-assembly). referred to herein) and a guide catheter expansion sub-system 36 (also referred to herein as an external catheter). The inner catheter 34 interacts with the outer catheter 36 and can be coupled or disengaged from the outer catheter 36 as required by the cardiac procedure.

The subject system 10 includes a proximal section 38 , a distal section 40 , and an intermediate section 42 extending between and interconnecting the proximal and distal sections 38 , 40 . A pre-inflated balloon member 44 is delivered in the distal section 40 of the inner catheter 34 . The distal section 40 of the inner catheter 34 may also consist of a long tapered micro catheter 46, as detailed in the next paragraph.

As shown in FIG. 1 , the subject guide expansion/pre-inflation system 10 is expanded within the lumen (internal channel) 48 of the guide catheter 14 . In order to reliably reach the target location 22 and, in some cases, to pass beyond the target location 22, the subject guide expansion/pre-expansion system 10 passes through the guide catheter 14 to the guide catheter ( 14) and is advanced deep into the coronary artery 20. The subject system 10 extends beyond the distal end 50 of the guide catheter 14 to provide adequate reachability of the pre-inflation balloon 44 to the target location 22 and to the stoma of the coronary artery 20. Extending beyond 18 stabilizes the positioning of guide catheter 14 and allows improved access of subject system 10 to coronary artery 20 and target site 22 .

As shown in FIGS. 1, 2A and 2B, 3D and 3D, 4, 5A-5C and 6A, the guide wire 12 is inside the guide catheter expansion/pre-expansion system 10. , and exits system 10 with the distal end of GW 12 beyond the outermost end 52 of distal section 40 and the proximal end of GW 12 in intermediate section 42 .

In operation, the inner catheter 34 and the outer catheter 36 are coupled together to be advanced (as a single unit) along the guide wire 12 inside the guide catheter 14 located within the blood vessel 16, and to target the lesion. It extends beyond the distal end 50 of the guide catheter 14 to reach the site 22 . Once the targeted balloon catheter sub-system (inner member) 34 has reached the lesion site 22 and the balloon member 44 has been positioned in alignment with the lesion site 22, the intended pre-inflation procedure can be performed. have. Once pre-inflation is performed, the outer catheter (also referred to herein as an outer member) 36 may be advanced across the lesion as an integral unit with the inner catheter (also referred to herein as an inner member) 34 and , the inner catheter 34 is disengaged from the outer catheter 36 for subsequent withdrawal of the inner catheter from the outer catheter.

Alternatively, after the pre-expansion procedure has been performed, the inner catheter 34 can be disengaged from the outer catheter 36, and the outer catheter 36 is advanced across the inflated lesion. Additionally, the outer catheter 36 can be left in the vicinity of the lesion after pre-inflation has been performed and the inner catheter 34 has been removed.

In any case scenario, the external member (catheter) 36 remaining proximal to the pre-expanded lesion may be used to deliver the stent inside the external member (catheter) 36 to the lesion site. The outer member 36 is removed from the guide catheter 14 once the stent is installed (placed) at the lesion site.

As will be presented in further paragraphs, in the subject system, the inner catheter 34 is prevented from anterior displacement inside the outer catheter 36. A posterior or ablating displacement of the inner member 34 exclusively relative to the outer member 36 is allowed to assist in retraction of the inner member from the outer member following pre-expansion of the lesion.

Referring to FIGS. 2A-2C , the proximal section 38 of the subject guide expansion/pre-inflation system 10 includes the proximal end 58 of the outer member 36 and the balloon inflation hub 56 of the inner member 34. ) (best shown in Figure 2b).

Referring to FIGS. 2B, 3A-3D, 4, and 5C , an inner member (also intermittently referred to herein as a balloon catheter sub-system or a pre-inflation balloon delivery sub-system) 34 is an inflation hub (56) and an internal inflation channel (60) extending between the pre-inflated balloon member (44). Internal inflation channel 60 is provided between balloon inflation system 62 (shown schematically in FIG. 2B ) and balloon member 44 for controlled inflation/deflation of balloon member 44 as defined by cardiac procedures. It serves as a passage for the expansion air.

The inner inflation channel 60 is formed by an inflation lumen hypo-tube 64 and an inflation lumen distal shaft 66 interconnected in a fluid sealed fashion overlapping each other.

An inflation hub 56 located at the proximal end 68 of the inner member 34 has an internal conical channel 70 connected to a balloon inflation system 62 (shown schematically in FIG. 2B ) by a proximal opening 72. consists of

Balloon inflation system 62 may be a manual or automatic system. In the preferred automated embodiment, balloon inflation system 62 includes an electronic sub-system, a pneumatic sub-system and control software with a corresponding user interface. Under the control of the control software, the electronic sub-system powers the solenoid pressure valve (fluidically coupled to the balloon inflation hub 56) to control the inflation/decompression of the balloon member 44 with fluid or air flow.

As shown in FIG. 2B , the inner conical channel 70 of the balloon inflation hub 56 consists of a distal opening 74 coupled to an inflation lumen hypo-tube 64 . The proximal end of the inflation lumen hypo-tube 64 is a fluid-sealed manner to assist the passage of inflation air between the balloon members 44 in the inflation system 62 and the inner conical channel of the balloon inflation hub 56. coupled to the distal opening 74 of (70).

Expanding lumen hypo-tube 64 extends through the length of a portion of proximal section 38 and middle section 42 of subject system 10 and distal section 40, as shown in FIGS. 2B and 4 . terminates at its distal end 78.

2B, a flexible serrated member 80 is provided at the proximal end 76 of an inflation lumen hypo-tube 64 coupled to the distal end 82 of the balloon inflation hub 56. . A serrated flexible member 80 supports the proximal end 76 of the inflation lumen hypo-tube 64 and provides flexible bending of the structure when manipulated by the surgeon.

As shown in FIGS. 2A-2C , 3A-3D , 4 and 5C , the inflation lumen distal shaft 66 extends along the middle section 42 between the proximal section 38 and the distal section ( 40) ends. 3A details the junction between the expansion lumen hypo-tube 64 and the expansion lumen distal shaft 66 . The expandable lumen hypo-tube 64 does not always extend through the inner member 34 and terminates at its distal end 78 (as shown in FIGS. 2B and 4 ).

Referring to FIGS. 3B-3D , the expansion lumen hypo-tube 64 has a skived distal portion 90 coaxially surrounded by a wall of the expansion lumen distal shaft 66 to form an expansion lumen distal shaft 66. The inflation lumen hypo-tube 64 with the interior of the balloon member 44, as shown in FIGS. 5A-5C, for controlled inflation/deflation of the balloon member 44 as required by cardiac procedures. Provides sealed fluid communication between chamber 92 and balloon inflation system 62 .

2b and 3c and 3d show that the inflation lumen distal shaft 66 consists of a rapid exchange (RX) guide wire (GW) port 94 where the GW lumen 96 begins at its proximal end 98. show The GW lumen 96 extends between the RX GW port 94 inside the inflation lumen distal shaft 66 through the entire length of the distal section 40 of the inner catheter 34 . The GW lumen 96 has a distal end 100 corresponding to the outermost distal end 52 of the distal section 40 of the inner member 34 and a proximal end 98 corresponding to the RX GW port 94. form internal channels. As shown in FIGS. 6A and 6B , in the distal section 40 , the GW lumen 96 extends beyond the distal end 102 of the inflation lumen distal shaft 66 . The distal end 100 of the GW lumen 96 constitutes a progressively tapered portion 104 that may be in the form of a delivery microcatheter 46 .

2A and 2B, 5A-5C, 6A and 6B, 24A and 24B, an internal catheter (also referred to herein as a balloon catheter sub-system) 34 is tapering at the distal section 40. It consists of a distal portion (also intermittently referred to herein as a tapered distal tip). Mounted to the distal tapered portion 162 is a pre-inflated balloon member 44 secured to the distal tapered portion 162 in close proximity to the microcatheter 46 . The pre-inflation balloon member 44 is secured to the tapered distal portion (tip) 162 of the inner member to assist in pre-inflation/stenting procedures, as required for cardiac treatment of a patient.

Balloon member 44 has a proximal portion 112 and a distal portion 114 . The balloon member (44) is attached (secured) to the distal section (40) proximate to the delivery microcatheter (46) and its proximal portion (112) is coupled to the distal end (102) of the inflation lumen distal shaft (66). , the distal portion 114 of the balloon 44 has a microcatheter 46 coupled to its outer surface.

As shown in FIGS. 5A-5C , the pre-inflation balloon 44, together with its proximal portion 112, has a proximal portion of the distal tip 162 at the boundary juxtaposed with the outer tip 164 of the sheath 120. 204 and, together with its distal portion 114 , is attached to the distal end 166 of the distal portion (tip) 162 of the inner member 34 .

Inflatable member 44 may intermittently assume a deflated (collapsed) and an inflated (expanded) configuration. The retracted (collapsed) configuration is used during insertion and/or withdrawal of the subject system to and from the vessel. Inflate (expand) the balloon to widen the blood vessels while in place (at the target site 22) and remove plaque for pre-dilation procedures, or for stenting procedures (when the stent is delivered to the treatment site on the balloon). Compress. When inflated, balloon 44 is in the inflated/open configuration shown in FIGS. 2A and 2B, 5A, 5C, 6A and 6B and 24A and 24B for pre-dilation of diseased blood vessels. take When deflated, the balloon member 44 assumes the deflated configuration shown in FIG. 5B.

The balloon 44 may have a smooth surface, or "chocolate" configuration. The “chocolate” balloon catheter is an over-the-wire balloon inflation catheter with a braided shaft and an atraumatic tapered tip. The balloon is constrained by a nitinol structure that creates small "pillows" and grooves in the balloon when inflated.

2a, 2c, 5a to 5c, 7, 8a and 8b, 9a, 9c and 9d, 10a to 10g, 11c, 12b and 12c, 13a and 13b, 14b, 15a to 15d, 16a and 16b, 17a and 17b, Referring to 18a and 18b, 19b, 20a and 20b, 21, and 24a and 24b, the outer catheter (also referred to as the guide catheter extension sub-system) 36 has an inner channel 122 extending along the interior. It is formed with a cylindrical external delivery sheath 120 . The coupler mechanism 130 is formed in enclosing relationship with the proximal end 132 of the cylindrical sheath 120 .

At the proximal end 58, the outer catheter 36 includes an outer member pusher (also referred to herein as a pusher/puller) 134, which is shown in FIGS. , 14a and 14b, 15a-15d, 16a and 16b, 17a and 17b, 18a and 18b, 19b, and 22, in one embodiment a circular wire proximal section 136, and welded or otherwise sheath 130 ) can be a solid wire that can have a flat distal portion 138 that can be fixedly attached to the proximal end 132 of . In another embodiment, the pushing and pulling element 134 may be constructed as a hypo-tube.

Alternatively, a circular pusher wire can be welded to a flat wire, which in turn has sheath 120 welded or otherwise rigidly secured to proximal end 132 .

In another alternative embodiment of the outer member 36, the circular wire may be welded or otherwise rigidly secured to two flat wires, which in turn may be welded or otherwise fixed to the proximal end 132 of the sheath 120. fixed in a fixed way

The flat profile of the pusher wire portion is welded to the proximal coupler 130 of the outer sheath 120 so that when the inner member 34 is inserted into the outer member (catheter) 36, as required by the procedure, the pusher wire The outer member 36 does not create an obstruction to rotational or longitudinal motion of the inner catheter 34 inside the sheath 120 and the proximal coupler 130 . The proximal pushing-pull element 134 advances or withdraws with the outer tubular sheath 120 and is preferably flexible (not rigid). The pusher/puller 134 may be flexible (not rigid) with flexibility along its longitudinal axis comparable to or exceeding that of the tubular external delivery sheath 120 of the external catheter 36 .

The pusher 134 of the external catheter requires manipulation of the external member 36 to position the external delivery sheath 120 with the balloon delivery sub-system 34 at a desired position relative to the lesion 22 in the diseased vessel. A proximal handle 140 shown in FIG. 10F may be mounted on its proximal end for the convenience of a surgeon performing a coronary intervention procedure for a coronary artery intervention.

The proximal (wire or hypo-tube configuration) pushing/pulling element 134 connected to the tubular structure 120 of the outer member has a small profile and is flexible (not "rigid"), providing improved conformability inside the guiding catheter and It achieves a lower profile (relative to the Root) compared to the rigid "pushing" element of conventional guided expansion catheters. This is made possible due to the "pushing ability" of the "whole system" achieved through the locking integral connection between the outer catheter (with hypo-tube pushing element) and the inner catheter (guide extension tube).

In addition, the inner catheter (inner member) 34 has these for various stages of cardiac procedures as well as facilitating withdrawal of the inner member 34 from the outer member 36 as required by coronary intervention procedures. A pusher (also referred to herein as a pusher/puller) 142 (shown in FIG. 2A ) of the inner member may be mounted which may be attached to the expansion hub 56 to control engagement/disengagement between the members. The inner member pusher/puller 142 may be formed as a handle of the inner member pusher/puller for the convenience of a surgeon performing the procedure.

The handles of the pushers of the inner and outer members are a mechanism that permits additional releasable locking of the inner and outer members to each other to enhance their integrated cooperation in a combined mode of operation (U.S. Patent Application #15, incorporated herein by reference). /899,603).

The inner member 34 can be either an over-the-wire configuration or an RX configuration. In one of the embodiments detailed herein, the guide wire 12 is an RX GW port 94 made at the proximal end of the tubular expansion lumen distal shaft 66, as shown in FIGS. 3C and 3D and 4 . through to and along the inner channel 146 of the GW lumen 96. At the distal section 40 of the subject system 10, the guide wire 12 is provided (at the tapered portion 104), as shown in FIGS. 2A and 2B, 5A and 5B, and 6A and 6B. ) extends into the GW lumen along the delivery tapered microcatheter 46 and exits the distal end 100 of the GW lumen 96 at the outermost end 52 of the inner member 34.

The outer delivery sheath 120 of the outer member 36 is made of a flexible, cylindrically shaped tubular body 150 that substantially extends the length of the middle section 42 of the subject system 10 . By manipulating the outer member pusher 134, the surgeon activates the integrated advancement of the outer delivery sheath 120 and the inner member 34 along the guide catheter 14. When the pre-inflation procedure has been performed (described in detail in a further paragraph), the surgeon manipulates the outer member pusher 134 and/or the inner member pusher 142 relative to the sheath 120 of the outer member 36. Controls the required linear rearward displacement of the inner member 34.

8A-8B and 9A-9D, the interface between the outer tip 164 of the sheath 120 and the distal tip 162 of the inner member 34 is the outer tip of the sheath 120. Distal tip 162 relative to outer tip 164 of sheath 120 to facilitate displacement of distal tip 162 of inner member 34 relative to 164, essentially as required by cardiac procedures. facilitates the displacement of

The distal end 160 as well as the outer tip 164 of the sheath 120 are formed from a flexible material that allows for simplified retraction of the distal tip 162 of the inner member 34 therethrough. A flat wire helical coil may be used for the outer tip 164 and distal end 160 of sheath 120 .

At its proximal end 132, the sheath 120 of the outer catheter 36 has an entry “opening” of circumference that exceeds that of the outer member flexible tubular sheath 120, as shown in FIGS. 10A-10G. (or “mouse”) 210. The inlet 210 (also referred to herein as a "mouse") into the inner channel 122 of the sheath 120 may be configured with various modifications. For example, as shown in FIG. 10A, inlet 210 may be an eccentric opening (shown in FIG. 10A), or a concentric blunt contour (shown in FIGS. 10B and 10C), or a concentric bevel (shown in FIGS. 10D and 10E). ) or alternatively has a funnel shape 211 with concentric concave contours (shown in FIGS. 10F and 10G ). The pusher 134 is attached to a predetermined point on the proximal entrance 210 of the funnel-shaped external catheter.

As shown in FIGS. 2A, 2C, 7 and 8A and 8B, the external delivery sheath 120 of the external catheter 36 connects with the proximal end 132 of the intermediate section 42 of the subject system 10. It extends between distal end 160 of distal section 40 . In the distal section 40 of the subject guide catheter expansion/pre-inflation system 10, the inner member 34 is shown in FIGS. 2A and 2B, 5A and 5B, 6A and 6B, 8A, 22A and 22B, and FIGS. 24A and 24B, consisting of a tapered configuration 104 having a distal tapered portion (also referred to herein as a distal tapered tip) that may be formed into a microcatheter 46 do. The microcatheter 46 has the configuration of a tapered conical contour with a diameter not exceeding 1 mm at the distal end 52 . The microcatheter 46 may be integrally formed with the tapered distal tip 162 of the inner member 34 .

At the distal end 160, the outer delivery sheath 120 interacts with the distal tip 162 of the inner member 34, as shown in FIGS. 2A, 5A-5C, 7 and 8A-8B. It is formed with an outer tip 164 having the configuration of a tapered conical contour that can be connected. The outer tip 164 of the outer member 36 provides a smooth distal tapered transition between the distal end 160 of the sheath 120 and the distal section 40 .

2A , 5A and 5B , 6A and 6B , 8A and 8B , 22A and 22B and 24A and 24B , the distal tip 162 of the inner catheter 34 is connected to the sheath 120 It is shown as having a tapered configuration that gradually changes from the point of interconnection with the outer tip 164 of the distal tip 162 to the distal end 166 of the distal tip 162 . The microcatheter 46 is integrally connected and extends from the distal end 166 of the distal tapered portion 162 of the inner member 34 (approximately 1 to 3 cm in length) and terminates at the outermost distal end 52. .

The targeted guide catheter expansion/pre-inflation system 10 measures the durometer of the plastic (polymer) component from the proximal portion to the distal portion of the external delivery sheath (i.e., the higher durometer of the proximal portion when taken for the distal portion). and/or change the winding frequency (pitch) of the helical coil of wire of the microcatheter 46 in the direction from the proximal portion to the distal portion, thereby providing differential microcatheter flexibility with greater flexibility at the distal portion. The distal portion of the microcatheter 46 is more flexible and trackable than the proximal portion of the microcatheter delivery device, has a substantially lower profile, and distal portion of the guide catheter expansion sub-system (external delivery sheath). more flexible than parts.

System 10 may also include wires that are radiopaque so that balloon member 44, microcatheter 46, and external delivery sheath 120 are easily visualized using fluoroscopy. Distal tip 162 (shown in FIGS. 5A, 6A and 6B ) is provided with radio-opaque markers 264, 266 proximal to proximal portion 112 and distal portion 114 of balloon 44. is envisioned as Radio-markers 264 and 266 allow the surgeon (operator) to visualize the positioning of balloon member 44 relative to lesion location 22 .

In addition, the outermost distal tip 52 of the microcatheter delivery portion 46 and the tip 160 of the sheath 120 allow the surgeon to pass the obstructive lesion by the microcatheter and the balloon member carried proximate to the microcatheter. It may have one or more radio-opaque markers 268, 270 (shown in FIGS. 2B and 5A) to be able to differentiate between radio-markers of particular importance because they are fixed in place.

As shown in detail in FIG. 7 , in one embodiment thereof, the outer catheter 36 is a system of catheter shaft coil reinforcements 170 disposed on (or embedded in) the inner surface 152 of the sheath 120. It consists of Preferably, a lubricating liner 172 is positioned inside the shaft 120 . The shaft reinforcing coil 170 may be installed within the shaft 120 in contact with the lubrication liner 172, that is, in a relationship surrounding the surface of the lubrication liner 172 covering the inner surface 152 of the shaft 120. can A distal soft tip jacket 174 is attached to the distal end of the outer catheter shaft 120 along the longitudinal axis 176 of the outer catheter 36 .

Distal soft tip jacket 174 may be adhered to shaft 120 at end 175 (as shown in FIG. 7 ) or may cover a portion of the length of outer surface 173 of shaft 120 .

A distal soft tip jacket 174 extends from the distal end 160 of the shaft 120 beyond the coil reinforcement 170 and lubrication liner 172 and has a distal edge 184 and a proximal edge 182 tapering. It terminates at section 178.

Lubrication liner 172 may be formed from a PTFE material. The distal soft tip jacket 172 may be formed from a highly flexible low durometer elastomeric Pebax material that transitions to high durometer along the longitudinal axis 176 towards the proximal end 132 of the sheath 120 .

7 and 8A and 8B, in one preferred embodiment, the inner diameter of sheath 120 at its inner surface 152 is approximately 0.048", while at its outer surface 173 the shaft The outer diameter of 120 is 0.058". The inside diameter of the tapered portion 178 of the outer catheter 36 at its distal edge 184 is -0.045", while the outside diameter of the tapered portion 178 at its distal edge 184 is -0.047". The slope between the outer diameter of the sheath 120 (0.058") and the outer diameter of the taper 178 (0.047") defines the outer surface tapering, at its distal edge 184 the inner diameter of the taper 178 (0.045"). ") to the inner diameter (0.048") of the sheath 120 defines the tapering of the inner surface. The distal wall 180 of the tapered portion 178 is the outermost edge of the tapered portion 178 of the soft tip jacket 174 distal from the interface 182 (between the sheath 120 and the tapered portion 178). (184).

As shown in FIG. 7 in conjunction with FIGS. 8A and 8B , the outer diameter of the tapered element 104 of the inner catheter at its outermost distal edge 184 is approximately 0.001" greater than the inner diameter of the distal tip of the outer catheter (0.045"). This difference between the outer diameter of the tapered element 104 of the inner catheter 34 and the inner diameter at the distal edge 184 of the outer tip 164 of the outer catheter results in stretching of the distal soft tip jacket 174 at its tapered portion 178 when it interferes with the tapered element 104 of the inner catheter. 36), as well as a small size of the distal end due to squeezing of the distal tip of the inner catheter 34 by the tapered element 178 of the outer catheter 36. Upon removal of the inner catheter 34, the elastomeric distal tip of the distal soft tip jacket 174 of the outer catheter 36 has a tapered portion 178 to its original inner diameter (0.045"). allow to return

In the disengaged mode of operation, the inner diameter of the wall 180 of the tapered outer tip 164 of the outer member 36 is smaller than the outer diameter of the inner member 34 . In the combined mode of operation, the outer diameter of the tapered outer tip 164 of the sheath lumen 120 and the inner member 34 interact with the outer diameter of the tapered outer tip 164 of the outer member 36 and the inner member 34. ) form a substantially equal-height interface transition between them.

With further reference to FIGS. 9A-9D , tapered portion 178 is contemplated in some embodiments of an expandable tapered design. As shown in FIG. 9A , the elasticity of the outer catheter 36 at its distal tapered portion 178 (when interfaced with the inner catheter 34) allows the distal outer tip 164 to expand at the tapered portion. augmented by an expandable split ring 190 attached to (178). Expandable split ring 190 has a slit 192 at its distal end that allows ring 190 to expand and contract upon interference between the inner and outer catheters. This structure provides additional reinforcement to prevent permanent deformation of the tapered portion 178 during internal catheter 34 removal and delivery of the stent (or balloon).

Referring to FIG. 9B , in an alternative embodiment of external catheter 36, tapered portion 178 may consist of an expandable tip scaffold 194, which may be made of NiTi wire, and distal end 196. It may consist of a proximal end 198 and a distal end 196 having a diameter greater than the diameter of . Due to its flexibility, the expandable scaffold 194 expands and contracts when necessary to resist permanent deformation of the jacket 174 at the tapered portion 178 during internal catheter removal and delivery of the stent or balloon member. provide additional support.

Another alternative embodiment of a tapered portion 178 at the distal end of sheath 120 is shown in FIGS. 9C and 9D , wherein walls 180 of tapered portion 178 are spaced along its circumference. It is shaped as a slit 200 extending longitudinally along the length of the tapered portion 178 . When tapered portion 178 interfaces with the distal end of inner member 34 , slit 200 is temporarily widened to enclose distal tip 162 of inner catheter 34 . This design can prevent permanent deformation of the jacket 174 at its tapered portion 178 that can be caused by internal catheter 34 removal or during stent/balloon number delivery.

An important "seamless" aspect of the subject system is the distance between the outer diameter of the outer tip 164 of the sheath 120 (at its tapered portion 178) and the outer diameter of the distal tip 162 of the inner member 34. A transition is one that forms a substantially gradual (smooth) transition between them.

As shown in Figs. 2c, 10a-10g, 11a-11c, 12a-12c, 13a-13b, 14a-14b, 15a-15d, the subject system has a middle section ( Interconnection mechanism 220 comprising a proximal coupler 130 formed at proximal end 132 of sheath 120 of outer member 36 at 42 and ( FIGS. 17A and 17B , 18B , 19A and FIGS. 19B and FIGS. 20A-20C ) with a cooperating mechanism 222 formed on the outer surface of the inner member 34 .

The subject guide catheter expansion/pre-inflation system 10 can operate in an internal/external catheter engagement mode and an internal/external catheter disengagement mode achieved by controlling the interconnection mechanism 220 . The object interconnection mechanism 220 engages/disengages the inner and outer catheters 34, 36 (as required by cardiac procedures) as well as the undesired movement of the inner member 34 inside the outer delivery sheath 120. It is configured to prevent undesirable forward displacement. The combined mode of operation is with a flexible element (which is as flexible as or more flexible than the outer tubular sheath 120 of the outer catheter 36) and a connected pushing/pull element 134 of the outer member 36 composed of a low profile. It also allows for improved "pushability" of the "whole system" (with the outer catheter 36 connected to and locked to the inner catheter 34).

The interconnection unit 220 is such that the inner surface 152 of the tubular body 150 of the sheath 120 (at its proximal end 132) interfaces with the outer surface of the cooperating mechanism 222 (on the inner member 34). When engaged, it operates based on interference between the cooperating mechanism 222 configured on the outer surface 224 of the inner member 34 and the proximal coupler 130 configured on the proximal end 132 of the sheath 120.

By way of example, a number of interconnection mechanisms are envisioned applicable to the subject guide catheter expansion/pre-expansion system 10 . The target engagement mechanism is intended for controllable engagement/disengagement between the inner member 34 and the outer member 36 as well as to prevent forward motion of the inner member 34 relative to the outer delivery sheath 120 beyond a predetermined position. is composed for

For example, as shown in FIGS. 11A-11C , laser cut coupler 130 may include a pair of distal rings comprising a solid distal ring 242 and an open (split) distal ring 244 and a proximal open (split) distal ring 244 . ) ring 240. Proximal open ring 240 as well as distal rings 242 , 244 are integrally formed into coupler base 246 . The coupler 130 may be formed of stainless steel or thermosetting NiTi. The pusher/puller element 134 of the outer catheter 36 and the mid-shift coupler (also referred to herein as the proximal coupler) 130 prevent deformation during forward or backward movement of the outer member and the middle of the outer catheter 36. It may be made of a memory metal (eg, Nitinol) to prevent any deformation of the intermediate shaft coupler 130 during passage of the stent (or other device) through the shaft portion.

Open ring 240 correlates with proximal entry opening (eg, funnel-shaped) 211 of external catheter 36 (shown in FIGS. 10A , 10D-10E and 11C ). Proximal opening ring 240 allows expansion of inlet 211 into funnel 210 as needed for entry/removal of inner catheter 34 as required by the surgical procedure. As shown in FIGS. 10A , 10D-10E and 11A-11C , proximal open ring 240 provides support for proximal opening 210 at the funnel-shaped proximal end of seat 120 . The proximal ring 240 supports the elastic properties of the sheath 120 at the entry aperture 210 by strengthening the entry aperture ("mouse") 211 and preventing damage or permanent deformation of the entry aperture. The distal rings 242 and 244 create a snap-fit locking mechanism separate from the proximal opening ring 240 of the funnel. While the distal ring 242 does not expand (closed circular contour), the opening of the split ring 244 expands during displacement of the inner catheter 34 relative to the proximal coupler 130 of the outer catheter 36.

The base 246 of the coupler 130 may be flat, preferably flat or (in the cross direction) crescent contoured distal end of the cooperating distal end of the pusher 134, as shown in FIGS. 11B and 11C . It is slightly arched (in cross section) to match (250). Pusher 134 may be made of stainless steel or NiTi. The distal end 250 of the pusher 134 is welded (bonded, glued or otherwise secured) to the base member 246 of the coupler 130 . A PTFE liner (also shown in FIG. 7 ) 172 may encapsulate the coupler 130 as shown in FIG. 11C .

Sheath 120 is positioned in enclosing relationship with the coupler and PTFE liner 172. A Pebax encapsulation similar to the distal soft tip jacket 174 at the distal end 160 of the sheath 120 (shown in FIG. 7 ) may be used at the proximal end 132 of the sheath 120 . A catheter shaft coil reinforcement 170 (also shown in FIG. 7 ) at the distal end of the outer catheter 36 may extend its length to the proximal end of the outer catheter 36 .

As shown in FIGS. 11A-11C , 17A-17C , and 18A-18B , cooperating mechanism 222 for the particular embodiment shown in FIGS. 11A-11C is provided for snap-fit locking. It further includes an intermediate shaft locking ring 252 (shown in FIGS. 17B and 17C and 18B).

Another embodiment of the external catheter proximal entry structure shown in FIGS. 12A-12C is similar to that shown in FIGS. 11A-11C , with certain modifications including:

(a) thickness and additional material added around base 246 of coupler 130;

(b) modified surface treatment to improve bonding of the polymer encapsulation (eg, bead blasting); and

(c) Use of a hard polymer encapsulation (such as nylon) to provide additional support to the funnel to prevent damage that could interfere with stent passage.

A further embodiment of the coupler 130 at the proximal inlet 210 (as shown in FIGS. 13A and 13B ) features an open ring (rib) 256 reinforcing the inlet port 210 . Snap-fit lock 260 is indicated by at least two open rings 262 at the distal end of coupler 130 . As shown in the variant presented in FIGS. 13A and 13B , coupler 130 is preferably a laser cut coupler formed from either stainless steel or thermoset NiTi.

The hypo-tube pusher/puller 134 can be flattened at its distal end 250 and welded to the base 246 of the coupler 130 . A PTFE liner 172 extends under the coupler 130 and a Pebax encapsulation 174 surrounds the coupler 130 with a pusher 134 attached thereto. The catheter shaft coil reinforcement structure 170 extends along the shaft 120 of the outer catheter 36 from the distal end to the proximal end. Snap-fit lock 260 cooperates with the circular ring embodiment of cooperation mechanism 222 shown in FIGS. 17A-17C and 18B. In some embodiments, the encapsulation 174 and/or the pusher/puller 134 are color-coated in a distinct color, as shown in FIG. To be safe, it can be distinguished from other elements in the target array.

A further modification of coupler 130 is shown in FIGS. 14A and 14B , where coupler 130 has separate rings 266 and 268 welded to distal end 250 of pusher 134 . As shown, locking mechanism 260 is formed by solid distal ring 266 and middle split ring 268, each ring 266, 268 welded to pusher 134. A proximal bevel split ring 270 is also welded to the pusher 134 . This design provides increased flexibility in size and construction of each ring 266, 268 and 270 and supports the formation of different funnel shapes/dimensions unlike laser cut couplers which are limited to a single diameter.

15A and 15B show another modification of the proximal coupler 130 featuring funnel perforations that improve contrast injection flow rates by providing additional open cross sectional pathways for fluid flow. As shown in FIGS. 15A and 15B , circular openings 272 are formed in sheath 120 . Apertures 272 are positioned in a predetermined pattern in a non-closed manner with proximal split ring 274 and distal rings 276 and 278 of snap-fit locking structure 280 . 15C and 15D, coupler 130 is formed on sheath 120 in a non-closed manner with proximal ring 274 and distal rings 278, 276 of snap-fit fastener 280. It is formed with a triangular opening 282 .

Although only circular and triangular openings 272 and 282 are shown in FIGS. 15A-15D , respectively, other configurations of cutouts in the plastic encapsulation are also considered in the subject structure to allow passage of injected contrast fluid through the cutouts. do.

Referring to FIGS. 16A, 16B and 16C , another embodiment of the proximal end of the outer catheter 36 is shown, when air inadvertently enters the fluid injected between the inner and outer catheters 34, 36. It is specifically designed as a potential solution to prevent unwanted embolism situations. To prevent this, a flush lumen 290 is built into the pusher 134 via the flat hypo-tube. A luer hub is coupled to the proximal end of the hypo-tube (pusher 134) as shown in FIG. 16C, allowing the surgeon to pass fluid between the inner and outer catheters through the hypo-tube 134. can be injected. As fluid enters outer catheter lumen 292 through channel 290 of hypo-tube 134, entry of air bubbles between the inner and outer catheters is prevented.

In addition, referring to FIGS. 17A to 17C, between the proximal coupler 130 shown in FIGS. 11A to 11E, 12A to 12C, 13A and 13B, 14A and 14B, and 15A to 15D The interconnection unit 220 includes a cooperating member 222 in the form of an annular circular ring 252 (also referred to herein as an intermediate locking ring) formed on the outer surface 224 of the inner catheter 34 . The stainless steel annular ring 252 is contoured with a fully circular surface allowing minimal reversible engagement/disengagement from the required split-ring feature of the outer catheter coupler 130. The ring 252 shown in FIG. 17C has a circular outline on the outer surface 302 for a smooth locking/unlocking action. The inner surface 304 of the ring 252 is a smooth structure that also engages the outer surface 224 of the inner catheter 34 .

17A shows an uncoupled configuration of inner catheter 34 to outer catheter 36 . FIG. 17B shows that the inner catheter 34 is received and locked inside the opening 210 at the proximal end of the sheath 120 so that the ring 252 is a snap-fit formed by the distal solid ring 308 and the middle split ring 310. When coupled to the locking portion 306, it shows a locked-coupled configuration. While in place, the proximal bevel split ring 312 surrounds the inner catheter 34 and the ring 252 is locked in the snap-fit fastener 306 so as to allow for surgical manipulation, as required by the surgical procedure. for internal and external catheters.

During longitudinal motion of inner catheter 34 inside outer catheter 36, while ring 252 passes through proximal bevel split ring 312 and middle split ring 310, the arms of this ring 252 ) is extended from its original location to create enough space for the . When in place, that is, when ring 252 is received between rings 308 and 310, bevel split ring 312 and the arm of split ring 310 return to their original closed position. Ring 252, trapped between rings 308 and 310, is snap-fitted therebetween to prevent relative displacement of the inner and outer catheters.

18A and 18B , which show details of the structure shown in FIGS. 17A-17C , the intermediate shaft lock ring 252 is coupled to the intermediate split ring 310 of the snap-fit lock 306 and the solid distal ring ( Section (pocket) 316 of sheath 120 of external catheter 36 is shown deflected rather than reinforced by coil 170 when inserted between 308 . The biased portion 316 of sheath 120 between rings 308 and 310 provides additional retention to hold inner and outer catheters 34 and 36 in locking engagement.

The stainless steel annular ring 252 may be attached to the outer surface 224 of the inner catheter shaft 34 via adhesive. The locking ring geometry (perfect circular surface) allows smooth reversible engagement/disengagement from the laser cut features of the coupler 130 of the outer catheter. The distal ring 308 of the snap-fit lock 306 prevents further distal motion of the inner catheter 34, and the middle split ring 310 opens when it contacts the middle shaft lock ring 252 and provides a tactile snap. provides Proximal bevel split ring 312 allows funnel 211 to open with an inner diameter greater than the inner diameter of the rest of shaft 120 . This also allows smooth passage of the intermediate shaft locking ring 252.

Interference between the unreinforced shaft pocket 316 and the intermediate shaft locking ring 252 occurs when the user is ready to remove the inner catheter 34 from the outer catheter 36 and disengage the snap fit lock between them. to provide retention of the inner catheter 34 to the outer catheter 36. The force required to disengage the locking mechanism can be customized from 0.1 to 2.0 lbs.

Referring to Figures 19A-19C, another alternative embodiment of an intermediate shaft lock comprising a square annular ring (formed of metal or polymeric material) 320 is presented. Unlike ring 252 shown in FIGS. 17A-17C and 18B , ring 320 has a square cross-section 321 shown in FIG. 19C . A square annular ring 320 is attached to the outer surface 224 of the inner catheter 34 with a thermally fused Pebax encapsulation 322 . Alternatively, it may be adhered to the inner catheter outer surface 224. As shown in FIG. 19B , when the inner catheter is in the locked position, the square annular ring 320 snaps into the snap-fit lock 324 formed by the solid ring 326 and split ring 328 and , encapsulation 322 is in contact with inner surface 152 of sheath 120, and ring 320 is positioned between rings 326 and 328.

In a further alternative embodiment, as shown in FIGS. 20A-20C , the intermediate shaft locking mechanism 220 includes two (2) connected together via multiple (e.g., four) NiTi shape-set wires 336. It is formed of a cooperating member 222 in the form of a cage-shaped structure 330 having two NiTi rings 332, 334. As shown in FIG. 20A , the cage 330 is attached to the outer surface 224 of the inner catheter 34 by either adhesive or thermally fused Pebax encapsulation 338 . Each wire 336 has an arcuate extension 340 left free of the encapsulation 338 as shown in FIGS. 20A and 20B .

As shown in FIG. 20B , in the locking configuration, the cage structure 330 snaps onto the coupler 130 of the external catheter. The unencapsulated arcuate portion 340 of each wire 336 extends out of the encapsulation 338 and away from the wire 336 of the cage 330 . When cage 330 is received between ring 342 and split ring 344 of snap fit mechanism 346, locking mechanism 346 is actuated, and inner and outer catheters 34, 36 are engaged.

Referring further to FIG. 21 , proximal coupler 130 of external catheter 36 may include two locking slots 350 , 352 formed by rings 354 , 356 connected by connecting elements 358 . have.

17a to 17c, 18a and 18b, 19a and 19b, 20a to 20c, as well as 10a to 10g, 11a to 11c, 12a and 12b, 13a and 13b, 14A and 14B, 15A-15D and 21 , when the surgeon linearly displaces the inner member 34 within the inner channel 122 of the proximal coupler 130, the snap fit annular ring ( Channel 122 between the arms of proximal rings 240, 312 where 252, 320 or cage 330 is flexibly bent outward to allow forward motion of inner catheter 34 (towards distal tip 162). ) enter When the snap fit annular rings 252, 320 or cage 330 further pass through the intermediate split rings 244, 262, 268, 310, 328 of the snap-fit fasteners, the arm of the bevel proximal ring returns to its original position. Upon return, the arms of the middle split ring flexibly bend outward to allow rings 252 and 320 of cage 330 to be positioned between the distal solid ring and the middle split ring. After the rings/cages 252, 320, 330 snap fit between the rings of the snap fit locking mechanism, the arms of the middle split ring return to their original positions.

To disengage the inner member 34 from the outer member 36, the surgeon pulls the inner member 34 out of the inner channel of the proximal coupler 130. During removal of the snap fit annular rings/cages 252, 320, 330 from the channel, the pulling action causes the arms of the middle split ring to bend outwardly, thereby locking the snap fit annular rings/cages 252, 320, 330 therebetween. Allow passage, freeing the inner catheter 34 from the proximal coupler 130 of the outer catheter 36.

Returning to FIG. 3D , the inflation lumen distal shaft 66 in the middle section 42 of the subject guide catheter/pre-inflation dilation system 10 may be made of a braid reinforcement structure 260 . Braid reinforcement member 260 creates a somewhat flexible tubing connected to cooperating mechanism 222 of interconnection unit 220 of inner member 34 . An RX (Rapid Exchange) port 94 for passing the guide wire 12 may be formed through the wall of the braid reinforced expansion lumen distal shaft 66 .

Braided reinforcement structure 260 may be constructed from metal patterns or wires within braided reinforced expansion lumen distal shaft 66 to prevent kinking imparting longitudinal rigidity to shaft 66 . A metal braid 260 may be embedded in the braid reinforcement shaft 66 to add to it the increased flexibility required for retraction of the inner member 34 relative to the outer delivery sheath 120 during a procedure.

A flat wire helical coil (eg, made of a shape memory alloy such as Nitinol) having a wire thickness of approximately 1 mil to 3 mils may be embedded in the braid 260 . Such a coil may be formed of a very thin plastic coating disposed on its inner and outer surfaces, which facilitates reducing the wall thickness of the inflation lumen distal shaft 66 to less than 7 mils, preferably to approximately 5 mils. do.

The principle of strengthening the tubular member by the catheter shaft coil reinforcement 170 in the form of the flat wire helical coil 262 or forming the tubular member from the flat wire helical coil is in the subject guide catheter expansion/pre-expansion system 10. External delivery sheath 120 (FIGS. 7, 8B, 9A-9D, 10A, 11C, 12B-12C, 13A-13B, 14B, 15A-15C, 16A-12C) 16b, 17a and 17b, 18a and 18b, 19b, 20b and 21) as well as microcatheter 46 (Figs. 2a and 2b, 5a, 22 and 24a and 24b) can be applied In external delivery sheath 120 and/or microcatheter 46, these flat wire helical coils may be embedded at predetermined locations along the length of the wall, for example at the proximal end and/or distal end.

Alternatively, the entire length of external delivery sheath 120 and/or microcatheter 46 may be formed from a flat wire helical coil. The pitch between the coils can be adjusted to provide a flexible gradient along the length of the tubular member (sheath 120 and/or microcatheter 46) increasing towards its distal end to facilitate atraumatic surgery. have.

Referring to FIGS. 22A and 22B and FIGS. 23A to 23C , the monorail rapid exchange (RX ) design can be implemented to allow the use of short guide wires. In the embodiment shown in FIGS. 22A and 22B , which show an isometric view of the subject coil reinforced inner member shaft 400 and a side view taken along line A-A thereof, the distal section 40' of the inner member 34' is the inner member. and a tapered element 402 attached to the outer surface 224 of (34). The outer shaft 400 of the inner member 34' is reinforced with a coil reinforcement structure 404 extending from the distal tip 406 to the RX entry port 94 shown in FIGS. 2A-2C and 3C and 3D. is a coil The distal tip 406 has a tapering interface with an inner surface of the outer catheter 36 with a tapered element 402 when the inner catheter 34' is filled in the outer catheter 36 as required by the surgical procedure. It is a soft tip.

The distal section 40' includes a concentric guide wire lumen 408 communicating with the RX entry port at the proximal end of the inner catheter 34 (shown in FIGS. 2A-2C and 3C and 3D).

As shown in FIGS. 23A-23C , the proximal end 412 of the monorail microcatheter embodiment shown in FIGS. 22A and 22B utilizes a skived hypo-tube pusher 414 . The proximal end 412 of the coil reinforced inner member shaft 416 and the hypo-tube pusher 414 serve as the coil reinforced inner member shaft 416 (guide wire lumen 408) shown in FIGS. 22A and 22B ) and a proximal outer jacket 418 extending as a tube along the proximal end 412 of the monorail microcatheter embodiment of the inner member 34' from (and including) the hypo-tube pusher 414.

The embodiment shown in FIGS. 23A and 23B features an RX guide wire “notched” end/entry 420 fabricated by piercing the proximal outer jacket 418 . Subsequently, the coil reinforced inner member shaft 416 is inserted into the proximal outer jacket tube 418 through the RX entry “notch” 420 . The skived hypo-tube 415 is further inserted through its lumen 422 into the proximal outer jacket tube 418 and the coil reinforced inner member shaft 416 and the polymer of the proximal outer jacket tube 418 are internally The member shaft 416 and pusher 414 are fused to connect together to form the proximal end 412 of the monorail microcatheter inner member 34'.

For the convenience of the surgeon, the pushing/pulling element 134 of the outer catheter 36 may be colored (color coated) as shown in FIG. It may have a distinct color to distinguish it from the usual gray or silver color of coronary guide wires used to deliver devices or stent delivery systems as well as other elements. Alternatively, the proximal outer jacket 418 of the push-pull element 414 may be color coated to distinguish its color from the color of other elements of the subject system.

Referring further to FIGS. 24A and 24B showing an additional coil-reinforced balloon catheter embodiment 500 of the internal catheter, the structure has the properties of an inflatable balloon 44 and a reinforced shaft of a microcatheter 46 having the following properties: Combine traits:

a. coil-reinforced shaft 502 provides additional kink resistance and pushing capability while still maintaining flexibility for navigating tortuous vascular structures;

b. The longer distal tip 504 of the construct includes a low profile tapered soft tip to facilitate crossing stenosis and hard lesions.

As shown in FIGS. 24A and 24B , the distal section 504 of the subject structure 500 includes an inner member shaft 500 reinforced with a coil reinforcement structure 506 extending the length of the inner member shaft 500 . includes A distal tapered element 508 is positioned on the inner member shaft 500 and extends between ends 510 and 512 in enclosing relationship with the inner member shaft 500 . The distal tapered soft tip 514 may be in the form of a microcatheter 46 positioned at the end of the coil strengthening shaft 500 .

Similar to the embodiment shown in FIGS. 22A and 22B , the balloon member 44 is provided with radio opaque markers 264, 266 positioned on the inner member shaft 500 within the balloon member 44 along with the inner member shaft ( 500) is located on. At its proximal end 516, the balloon member 44 interferes with the outer tip 164 of the proximal tapered element 178 of the outer member sheath 120. At the distal end 518 , the balloon member 44 snugly encloses the shaft 500 .

Returning to FIGS. 1-24B , to perform a cardiac procedure and specifically a pre-inflation routine, the proximal end of the coronary guide wire 12 enters the RX port 94 formed in the inflation lumen distal shaft 66 and , extends through the inner channel (GW lumen 96) of the inner member 34 towards and beyond the outermost distal end 52 of the micro-catheter 46.

Subsequently, the outer delivery sheath 120 of the inner member 34 and the locked outer member 36 are first placed into the microcatheter 46 of the inner channel 48 of the guide catheter 14 and, as a single unit, the inner and outer delivery sheath 120. Both external members 34 and 36 are integrated and advanced within the guide catheter 14 toward the treatment site 22 . The sheath 120 of the outer member and the inner member 34 may be displaced by pushing the outer member pusher 134 together. This action extends beyond the distal end 50 of the guide catheter 14 and extends the microcatheter 46 of the inner member 34 to the GW 12 with the outer member 36 until it reaches the lesion site 92. ) to slide along. At this stage of the procedure, the balloon member 44 is in a deflated configuration.

The guide wire 12 extending beyond the distal end 50 of the guide catheter 14 allows the microcatheter 46 (with deflated balloon 44 attached to the distal tip 162) to the treatment site 26. serves as a guide to slide towards

Subsequently, the balloon member 44 (located at the treatment site 22) is coupled with an inflation lumen distal shaft 66 and an inflation lumen hypotube ( It is inflated by a balloon inflation system 62 coupled to an inflation hub 56 through an inflation lumen defined by 64 .

Subsequently, once the lesion is inflated, the balloon 44 can be deflated and the outer delivery sheath 120 can be advanced as an integral unit with the inner member 34 (in a combined mode of operation) across the lesion 22 and , the inner member can subsequently be disengaged (unlocked) from the outer delivery sheath 120 and removed from the sheath 120 .

Alternatively, the inner member 34 can be disengaged and withdrawn from the sheath 120 immediately after lesion expansion, and the outer member 36 is advanced across the lesion 22 .

The sheath 120 may be left in position proximal to the treatment site (immediately after expansion of the lesion).

After pulling on the inner member 34 , the stent may be delivered to the site 22 . A stent in a closed configuration may be introduced into the blood vessel 16 inside the sheath 120 . When in place, the stent supporting the balloon (not shown) may be inflated to open the stent. Subsequently, the outer delivery sheath 120 is removed leaving the stent open to the blood vessel 16 .

Although the present invention has been described in terms of specific forms and embodiments thereof, it will be understood that various modifications other than those discussed above may be made without departing from the spirit or scope of the invention as defined in the appended claims. For example, functionally equivalent elements may be substituted for elements specifically shown and described, and certain functions may be used independently of other features, all without departing from the spirit or scope of the invention as defined in the appended claims. and, in certain instances, certain positions of elements, steps or processes may be reversed or intervened.

Claims (23)

An intravascular delivery system having a proximal section, a distal section, and an intermediate section portion positioned between the proximal and intermediate sections, configured for controllable displacement of a vessel of interest, comprising:
An outer member formed by an elongated outer delivery sheath of a flexible, substantially cylindrical contour defining a sheath lumen having a proximal end and a distal end, the outer delivery sheath being formed between the intermediate section and the distal section. an outer member extending over and consisting of an outer tip tapered at the distal end of the sheath lumen;
The tapered outer tip of the outer member at the distal end of the outer delivery sheath is comprised of a wall extending in a cylindrical fashion between the proximal and distal edges of the tapered outer tip, the wall having an inner diameter and an outer diameter wherein the inner diameter and the outer diameter of the wall progressively decrease in a direction from the proximal edge to the distal edge of the tapered outer tip;
An inner member having an elongated body defining an inner channel extending along a longitudinal axis, the inner member extending inwardly along the sheath lumen of the outer member in controllable relationship with the outer delivery sheath, the inner member comprising: wherein the elongated body has a tapered distal portion comprised of a tapered delivery catheter having an external diameter and having an elongated body of a predetermined length, the tapered delivery catheter being displaceable beyond the distal end of the sheath; The wall of the tapered outer tip of the outer member at least temporarily interfaces with the distal portion of the inner member, and the inner diameter of the wall of the tapered outer tip of the outer member is the tapered outer tip of the outer member. an inner member smaller than the outer diameter of the distal portion of the inner member at the interface between the wall of the outer tip and the distal portion of the inner member; and
an interconnection mechanism disposed in operative coupling with the inner member and the outer member and controllably actuated to operate the guide catheter expansion/pre-expansion sub-system in an engaged or disengaged mode of operation; ;
In the combined mode of operation, the inner member and the outer member of the guide catheter expansion sub-system are coupled for a common controllable displacement along the guide wire, and the inner member when engaged is independent of the outer member. displacement is prevented;
and in the disengaged mode of operation, the inner member and the outer member are disengaged for retraction of the inner member from the outer member. According to claim 1,
the tapered distal portion of the inner member interfaces at an outer surface with an inner surface of the tapered outer tip of the sheath lumen;
the tapered outer tip of the outer member is an elastomer tapered outer tip;
in the disengaged mode of operation, the inner diameter of the wall of the tapered outer tip of the outer member is smaller than the outer diameter of the inner member;
In the combined mode of operation, the inner member and the tapered outer tip of the outer member interact to create a gap between the outer diameter of the tapered outer tip of the sheath lumen and the outer diameter of the distal portion of the inner member. wherein the dimensional transitions of form substantially equal-height interface transitions therebetween. According to claim 1,
The sheath is reinforced along its length, the outer member further comprising a distal soft tip encapsulating material surrounding the reinforced sheath of the outer member at the distal end, the distal soft tip encapsulating material forming the distal soft tip encapsulating material of the sheath. A flexible, low durometer elastomeric material having a sloping durometer value that increases from an end toward the proximal end. According to claim 3,
The system of claim 1 , wherein the outer member further comprises a distal lubrication liner sandwiched between an outer surface of the sheath and an inner surface of the distal soft tip encapsulating material. According to claim 1,
The delivery catheter is a microcatheter,
a balloon member attached to the tapered distal portion of the inner member proximate to the tapered delivery microcatheter; and
and an inflation lumen extending into the inner member between the proximal section and the balloon member at the distal section to provide a fluid passageway between the external balloon inflation system and the balloon member. According to claim 5,
wherein the balloon member has a proximal portion having a proximal diameter greater than a distal diameter at the distal portion. According to claim 5,
The balloon member assumes an inflated configuration and a deflated configuration wherein, in the deflated configuration, the balloon member is displaced from the blood vessel and subsequently pre-transformed when the balloon member is controllably deformed into the inflated configuration. An endovascular system positioned at least in alignment with a treatment site for a dilatation procedure. According to claim 5,
wherein the elongate body of the inner member and the microcatheter are coil-reinforced along their length, and wherein the distal tapered portion of the inner member is mounted with a distal tapered element positioned on the coil-reinforced elongate body. According to claim 2,
The outer delivery sheath of the outer member has a tubular body having a first predetermined circumference, the tubular body of the outer member extending between the proximal end and the tapered outer tip at the distal end of the outer delivery sheath. and, at the proximal end, the outer delivery sheath is configured with an entry opening having a second predetermined circumference, the second predetermined circumference of the entry opening extending to the first circumference of the tubular body of the outer delivery sheath. Excess, system. According to claim 9,
wherein the tapered outer tip of the outer member has a resiliently expandable configuration, and wherein the entry aperture at the proximal end of the outer sheath has the contours of a funnel. According to claim 2,
a channel extending along its length in fluid communication with the sheath lumen; Consisting of, intravascular system. According to claim 11,
The outer sheath of the outer member is a flexible sheath having a first flexibility along its length and the outer member pusher is a flexible member having a second flexibility along its length, the second flexibility being the first flexible An intravascular system that substantially equals or exceeds performance. According to claim 1,
The interconnection mechanism includes a snap-fit mechanism comprising a proximal coupler disposed at the proximal end of the sheath of the outer member and the outer portion of the elongated body of the inner member. Consists of a cooperating element disposed on a surface, the proximal coupler comprising a distal solid ring and an intermediate split ring located at a predetermined distance from the solid ring, the cooperating member comprising an intermediate-shaft locking ring, a square annular shape a member selected from a group comprising a ring and a snap-fit cage, wherein the cooperating member is attached to the outer surface of the elongated body of the inner member, and for engaging the outer member and the inner member. and releasably locked in a snap-fit manner between the distal solid ring and the middle split ring. According to claim 13,
wherein the cooperating member is secured to the outer surface of the inner member in enclosing relationship therewith, and wherein the proximal coupler further comprises a proximal inclined split ring at a proximal end. According to claim 14,
and a fenestration system formed in the sheath at the proximal end. According to claim 5,
wherein the microcatheter is formed of a flexible material having differential flexibility along its length, and wherein the flexibility of the microcatheter increases toward the distal end. According to claim 16,
The microcatheter includes a helical coil of flat wire extending along the predetermined length of the microcatheter, and a pitch of the helical coil of flat wire varies along the length of the microcatheter toward the distal end. An intravascular system that increases the flexibility of the microcatheter. According to claim 1,
a helical coil member of flat wire forming at least a portion of a wall of each of the members selected from the group comprising the outer delivery sheath of the outer member, the delivery catheter, the elongate body of the inner member, and combinations thereof. and wherein the helical coil of the flat wire is formed of a shape memory alloy containing Nitinol or a radiopaque material. According to claim 1,
The tapered delivery catheter structure is a microcatheter formed with a longitudinally extending lumen for sliding along a guide wire,
an inner member pusher coupled at the distal end to the proximal end of the inner member; and
an outer member pusher coupled at a distal end to the proximal end of the outer member;
wherein the outer member pusher is color coated, the color coating having a color distinct from a color of the guide wire and a color of the inner member and the inner member pusher. An intravascular system equipped with a guide catheter dilation sub-system cooperating with a guide wire, the intravascular system comprising:
A guide catheter expansion sub-system having a proximal portion, a distal portion, and an intermediate junction portion interconnected between the proximal portion and the distal portion, the guide catheter expansion sub-system comprising:
an outer member formed by a flexible substantially cylindrically contoured elongated sheath with reinforcing structures along the sheath, the sheath defining a sheath lumen having a proximal end and a distal end, the sheath comprising: the guide catheter expansion sub-system; a cylinder extending between a distal portion of and the intermediate junction portion, the outer member having a distal soft elastic tip positioned at the distal end of the sheath lumen and having a thickness decreasing from the proximal edge to the distal edge of the distal soft elastic tip; an outer member consisting of a shaped wall, the wall having an inner diameter at the distal edge;
An inner member having a coil-reinforced elongated body defining an inner channel extending along a longitudinal axis, the inner member extending inwardly along the sheath lumen in controllably displaceable relationship with the sheath, the inner member comprising: having a tapered distal portion comprised of a delivery catheter structure tapered at the distal end, the tapered distal portion of the inner member having a coil-reinforced elongated body of a predetermined length, the elongated body of the inner member comprising the outer having an outer diameter greater than the inner diameter of the wall of the distal soft elastic tip of the member, wherein the tapered distal portion of the inner member resiliently contacts the inner surface of the distal soft elastic tip of the sheath at an outer surface. an interfacing inner member wherein the tapered delivery catheter structure is displaceable beyond the distal end of the sheath; and
arranged to operatively couple with the inner and outer members of the guide catheter expansion sub-system and controllably operated to operate the guide catheter expansion sub-system in an intermittently engaged or disengaged mode of operation. An interconnecting mechanism wherein the outer surface of the tapered distal tip of the inner member and the outer surface of the wall of the distal soft elastic tip of the outer member have a substantially smooth transition therebetween in the coupled operating mode. It consists of an interconnection mechanism that forms;
in the combined mode of operation, the inner member and the outer member of the guide catheter expansion sub-system are coupled for a common controllable displacement along the guide wire;
In the disengaged mode of operation, the inner member and the outer member are disengaged for controllable discrete linear or rotational displacements relative to each other. According to claim 20,
wherein the sheath at the proximal end is configured with an entry aperture having a circumference that exceeds the circumference of the tubular body of the sheath, the entry aperture being reinforced by a bevel split ring element attached proximate the entry aperture. . According to claim 20,
further comprising a guide wire capable of being advanced from a vessel of interest to at least a treatment site, the guide catheter dilation sub-system for controllable displacement along the guide wire;
an inner member pusher coupled at the distal end to the proximal end of the inner member;
an outer member pusher coupled at a distal end to the proximal end of the outer member; and
an elastic jacket surrounding the inner member at least at the proximal end and the inner member pusher along at least the distal end, the tapered delivery catheter structure having a longitudinally extending lumen for sliding along the guide wire; An intravascular system consisting of an elastic jacket, which is a microcatheter formed of The method of claim 22,
wherein the outer member pusher is color coated, the color coating having a color distinct from a color of the guide wire and a color of the inner member and the elastic jacket surrounding the inner member pusher.

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