CN107744418B

CN107744418B - Catheter with hydraulic actuator and locking system

Info

Publication number: CN107744418B
Application number: CN201711155958.8A
Authority: CN
Inventors: D.H.舒默; M.L.格林; P.C.萨克斯顿
Original assignee: Abbott Cardiovascular Systems Inc
Current assignee: Abbott Cardiovascular Systems Inc
Priority date: 2013-03-12
Filing date: 2013-03-12
Publication date: 2020-07-10
Anticipated expiration: 2033-03-12
Also published as: WO2014142808A1; CN107744418A; CN105228562A; JP6172779B2; CN105228562B; JP2016514003A; EP2967949A1; CR20150528A

Abstract

A catheter includes a pressure lumen defined by proximal and distal seals and inner and outer tubular members. An actuator member movable between a first position and a second position is disposed within the pressure chamber. Fluid introduced into the pressure chamber exerts a force on the actuator member to move the actuator member toward the second position. A locking mechanism disposed between the inner and outer tubular members includes a latch including an engaged state preventing movement of the outer tubular member relative to the inner member and a disengaged state allowing movement of the outer member. The latch is displaced to the disengaged state when the actuator member is moved to the second position. When the actuator member is in the second position and the latch is in the disengaged condition, fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal to urge the outer tubular member proximally.

Description

Catheter with hydraulic actuator and locking system

Technical Field

The disclosed subject matter relates to catheters for delivering medical devices, such as self-expanding stents, for treating the luminal system of a patient. In particular, the disclosed subject matter relates to a delivery catheter having a retractable sheath that is moved by a hydraulic actuator.

Background

Various systems are known for intraluminal delivery of medical devices, such as stents or screens, using retractable sheaths. However, there is still a need for continued improvements of such known delivery systems.

One example of such a system is described in Wilson et al, U.S. patent No. 6,425,898, which is incorporated herein by reference, wherein a delivery system is provided having an inner member with a stop attached thereto. During deployment, the stop prevents the stent from moving proximally during sheath retraction to deploy the stent.

Conventional self-expanding stent delivery systems generally include a handle portion and an elongate shaft, wherein a stent is disposed within a delivery portion at a distal end of the shaft. To deploy the stent, an outer sheath is provided that can be retracted relative to the stent to release the stent from its delivery configuration. The sheath in such systems typically spans the entire length of the catheter, resulting in increased profile and stiffness throughout the length of the catheter. Such stiffness and increased profile at the distal end of the catheter may restrict certain applications, such as certain size-limited nerves and other indications. Furthermore, because the sheath spans the entire length of the catheter, the risk of the sheath sticking to other components of the catheter during passage through the circuitous lumen system of the patient is increased, thereby inhibiting deployment of the stent.

Another problem with such delivery systems is that the sheath typically pulls back at a 1:1 ratio to the user input (force). Because stents may embed into the outer sheath during storage and transport due to high static friction, a large initial input is typically required to release the stent, which may cause erroneous placement. When initially releasing the stent, it may be desirable to slowly pull back the sheath to achieve proper placement and then more easily retract the sheath to prevent inadvertent movement of the stent.

Furthermore, the amount of force required to retract the sheath (particularly a stent having a length longer than that required for a peripheral indication) can be significant. To overcome this problem, a lubricious liner may be used to reduce the amount of force required to retract the sheath. However, there remains a need for improved delivery systems for self-expanding stents that have reduced force requirements for delivering self-expanding stents and the like.

Thus, there remains a continuing need for efficient and economical systems for delivering medical devices that are easy to use and provide accurate placement. The presently disclosed subject matter meets these and other needs.

Disclosure of Invention

Objects and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Other advantages of the disclosed subject matter will be realized and attained by the apparatus particularly pointed out in the written description and claims hereof as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter includes a catheter comprising: an inner tubular member having a proximal end, a distal end, and an outer surface, the inner tubular member further having a fluid lumen defined therein, the fluid lumen having a fluid flow port defined by the outer surface along the distal end of the inner tubular member, among other things. The catheter also includes an outer tubular member movable relative to the inner tubular member, the outer tubular member having a proximal end, a distal end, and an inner surface facing the outer surface of the inner tubular member. A proximal seal extends from the inner surface of the outer tubular member toward the outer surface of the inner tubular member. The proximal seal is located proximal to the fluid flow port. A distal seal extends from the outer surface of the inner tubular member toward the inner surface of the outer tubular member. The distal seal is located distal to the fluid flow port. A pressure lumen is defined by the proximal seal, the distal seal, the outer surface of the inner tubular member, and the inner surface of the outer tubular member.

An actuator member is disposed within the pressure chamber, the actuator member having a sealing section and a cam section. The actuator member is movable between a first position and a second position. Fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the seal section to move the actuator member from the first position to the second position. Additionally, a locking mechanism is disposed between the outer surface of the inner tubular member and the inner surface of the outer tubular member. The locking mechanism includes a latch having an engaged state preventing movement of the outer tubular member relative to the inner tubular member and a disengaged state allowing movement of the outer tubular member relative to the inner tubular member. Displacing the latch to the disengaged state by the cam segment when moving the actuator member to the second position. When the actuator member is in the second position and the latch is in the disengaged condition, fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal to urge the outer tubular member in a proximal direction.

In accordance with another aspect of the disclosed subject matter, there is provided a method of deploying a catheter, comprising: the above-described catheter is provided, among other things. In particular, the catheter includes an inner tubular member having a proximal end, a distal end, and an outer surface. The inner tubular member also has a fluid lumen defined therein having a fluid flow port defined by the outer surface along the distal end portion of the inner tubular member. An outer tubular member is movable relative to the inner tubular member, the outer tubular member having a proximal end, a distal end, and an inner surface facing the outer surface of the inner tubular member. The catheter also includes a proximal seal extending from the inner surface of the outer tubular member toward the outer surface of the inner tubular member, the proximal seal being proximal to the fluid flow port. A distal seal is provided extending from the outer surface of the inner tubular member toward the inner surface of the outer tubular member, the distal seal being distal to the fluid flow port. Thereby providing a pressure lumen defined by the proximal seal, the distal seal, the outer surface of the inner tubular member, and the inner surface of the outer tubular member.

Further, in accordance with the method herein, the catheter includes an actuator member disposed within the pressure lumen, the actuator member having a sealing segment and a cam segment. The actuator member is movable between a first position and a second position. Fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the seal section to move the actuator member from the first position to the second position. A locking mechanism is disposed between the outer surface of the inner tubular member and the inner surface of the outer tubular member. The locking mechanism includes a latch having an engaged state preventing movement of the outer tubular member relative to the inner tubular member and a disengaged state allowing movement of the outer tubular member relative to the inner tubular member. Displacing the latch to the disengaged state by the cam segment when moving the actuator member to the second position.

Using the catheter described above, the method further comprises disposing a device between the outer surface of the inner tubular member and the inner surface of the outer tubular member at a location distal to the distal seal. The method further includes introducing fluid into the pressure chamber through the fluid flow port to move the actuator member toward the second position and displace the latch of the locking mechanism to the disengaged condition, wherein fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal to urge the outer tubular member in a proximal direction when the actuator member is in the second position and the latch is in the disengaged condition.

It is to be understood that both the foregoing general description and the following detailed description and drawings are examples and are intended to illustrate and not limit the scope of the disclosed subject matter in any way.

The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to illustrate and provide a further understanding of the apparatus of the disclosed subject matter. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate the principles of the disclosed subject matter.

Drawings

The subject matter of the present application will be more readily understood from the following detailed description when read in conjunction with the accompanying drawings, in which:

fig. 1 is a side schematic view of a representative catheter in accordance with the disclosed subject matter.

Fig. 2 is a perspective view of the distal section of the catheter of fig. 1.

Fig. 3A is a cross-sectional perspective view of the catheter of fig. 2 taken along line 3-3.

Fig. 3B is a cross-sectional perspective view of another embodiment of the catheter of fig. 2 taken along line 3-3.

Fig. 4 is a cross-sectional perspective view of a distal section of a catheter in accordance with the disclosed subject matter with a sheath in a closed position.

Fig. 5 is a cross-sectional side view of the distal end of the catheter of fig. 4, with the catheter in a fully retracted position.

Fig. 6 is a cross-sectional perspective view of a distal segment of an alternative embodiment of a catheter in accordance with the disclosed subject matter, with the sheath in a fully retracted position.

Fig. 6A is a cross-sectional view of the catheter of fig. 6 taken along line 6A-6A.

Fig. 7 is a detailed perspective view of the catheter of fig. 4 taken along line 7-7.

Fig. 8 is a cross-sectional perspective view of the catheter of fig. 7.

Fig. 9 is a cross-sectional side view of a distal end of another embodiment of a catheter with an actuator and locking mechanism in an engaged state according to the disclosed subject matter.

Fig. 10A is a perspective view of an actuator member, fig. 10B is a side view of the actuator member of fig. 10A, and fig. 10C is a cross-section of the actuator member of fig. 10B, in accordance with the disclosed subject matter.

FIG. 11A is a perspective view of a locking mechanism according to the disclosed subject matter, FIG. 11B is a side view of the locking mechanism of FIG. 11A, FIG. 11C is a front view of the locking mechanism of FIG. 11A, FIG. 11D is a cross-section of the locking mechanism of FIG. 11B taken across lines 11D-11D, and FIG. 11E is a detailed view of the locking mechanism of FIG. 11D around line 11E.

Figure 12 is a cross-sectional side view of the catheter with the locking mechanism in a disengaged state.

Detailed Description

Reference will now be made in detail to embodiments of the disclosed subject matter, one example of which is illustrated in the accompanying drawings. The disclosed subject matter will be described in conjunction with a detailed description of the system.

As disclosed herein, the devices presented herein may be used to treat the luminal system of a patient. In particular, the disclosed subject matter is particularly useful for treating the cardiovascular and peripheral systems of a patient.

In accordance with the disclosed subject matter, there is provided a catheter comprising: an inner tubular member having a proximal end, a distal end, and an outer surface, the inner tubular member further having a fluid lumen defined therein, the fluid lumen having a fluid flow port defined by the outer surface along the distal end of the inner tubular member, among other things. The catheter also includes an outer tubular member movable relative to the inner tubular member, the outer tubular member having a proximal end, a distal end, and an inner surface facing the outer surface of the inner tubular member. The proximal seal extends from an inner surface of the outer tubular member toward an outer surface of the inner tubular member. The proximal seal is located proximal to the fluid flow port. The distal seal extends from the outer surface of the inner tubular member toward the inner surface of the outer tubular member. The distal seal is located distal to the fluid flow port. The pressure lumen is defined by a proximal seal, a distal seal, an outer surface of the inner tubular member, and an inner surface of the outer tubular member.

An actuator member is disposed within the pressure chamber, the actuator member having a sealing section and a cam section. The actuator member is movable between a first position and a second position. Fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the seal section to move the actuator member from the first position to the second position. In addition, a locking mechanism is disposed between the outer surface of the inner tubular member and the inner surface of the outer tubular member. The locking mechanism includes a latch having an engaged state preventing movement of the outer tubular member relative to the inner tubular member and a disengaged state allowing movement of the outer tubular member relative to the inner tubular member. The latch is displaced to the disengaged state by the cam segment when the actuator member is moved to the second position. When the actuator member is in the second position and the latch is in the disengaged state, fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal to urge the outer tubular member in the proximal direction.

A method for deploying the above catheter is also disclosed. The details of the method at deployment will be described in detail in connection with the features of the catheter.

For purposes of illustration only, an exemplary embodiment of a hydraulic delivery system for a self-expanding stent or the like, at least a portion of which is delivered within the vasculature, is schematically illustrated in fig. 1 and 2. The examples herein are not intended to limit the scope of the disclosed subject matter in any way. Specifically, as shown, the hydraulic delivery system contained herein is a catheter 100 for cardiovascular intervention or the like. Catheters for other uses and indications, such as peripheral and below-knee interventions, are contemplated herein. The catheter 100 includes an inner tubular member 110 having a proximal end, a distal end, and an outer surface. The catheter 100 also includes an outer tubular member or sheath 120 that is movable relative to the inner tubular member 110 and has a proximal end, a distal end, and an inner surface facing the outer surface of the inner tubular member 110. As shown in fig. 2, in the present embodiment, the outer tubular member 120 is provided only at the distal end portion of the catheter. For other embodiments, the outer tubular member 120 may be disposed at the proximal and/or distal end of the catheter. As further described herein, the catheter of the disclosed subject matter can be configured to deliver any suitable length of medical device, such as a stent. That is, the catheter may be configured to generate a force sufficient to retract the outer tubular member, wherein the generated force is greater than a resistance force caused by the medical device acting on the outer tubular member.

For purposes of illustration only, reference is made to fig. 3A, which depicts a representative cross-sectional view of an exemplary inner tubular member 110 taken along line 3-3 of fig. 2 in accordance with the disclosed subject matter. The inner tubular member 110 also includes a fluid lumen 310 defined therein. In one embodiment, the inner tubular member may also have a guidewire lumen 320 defined at least along the length therein. For example, the guidewire lumen 320 (if provided) may extend the entire length of the inner tubular member 110 (such as for an "over the wire" configuration), or only along the distal length (such as for a "quick-swap" embodiment). Alternatively, the catheter 100 may have a single lumen design, and the guidewire and pressurized fluid may share the same lumen (not shown), wherein seals or valves may be provided at the distal and proximal ends.

FIG. 3B depicts another embodiment of a representative cross-sectional view of the example inner tubular member 110 taken along line 3-3 of FIG. 2. In this embodiment, as shown in FIG. 3B, the guidewire lumen 320 may be at least partially defined by a separate guidewire tube 321 disposed within the fluid lumen 310 and sealed on one side, such as, for example, by a marker (not shown), for illustration purposes only. This coaxial configuration enables a reduction in the diameter, and thus profile, of the inner tubular member 110. In fact, the guidewire tube 321 defining the guidewire lumen 320 can be formed from a film of suitable strength to prevent penetration of the guidewire therethrough. The hydraulic fluid can thus flow within the fluid lumen 310, but not out of the guidewire lumen 320.

For purposes of illustration only, reference is now made to the rapid exchange configuration of the catheter disclosed herein, as shown in fig. 4. In general, the catheter includes an inner tubular member 110 having a proximal end, a distal end, and an outer surface. The inner tubular member 110 also includes a fluid lumen 310, the fluid lumen 310 having a fluid flow port 420 defined by the outer surface 111 along a distal end of the inner tubular member 110. The catheter further comprises an outer tubular member 120, the outer tubular member 120 being movable relative to the inner tubular member 110 and having a proximal end, a distal end and an inner surface 121 facing the outer surface 111 of the inner tubular member 110. As described in more detail below, the fluid flow port 420 allows fluid to flow from within the fluid lumen 310 into the space defined by the inner and outer

tubular members

110, 120 for manipulation and retraction of the outer tubular member 120. The markings 422 may define the distal end of the fluid flow port 420. As embodied herein, the rapid exchange catheter further includes a guidewire lumen 320, the guidewire lumen 320 extending along the distal end of the catheter and including a proximal guidewire port 410 and a distal guidewire port 430.

As shown, the outer tubular member 120 may be moved from an extended position, as shown in fig. 4, to a retracted position, as shown in fig. 5. When the outer tubular member 120 is extended, the outer tubular member 120 holds a medical device, such as the stent 440 depicted herein, in a compressed or delivered state. A distal tip 460 may also be provided to further surround the medical device at the delivery device. When the outer tubular member 120 is retracted (as shown in fig. 5 and 6), the medical device is withdrawn and expanded to the deployed state.

The outer tubular member 120 may further include at least one movable tubular structure 130 coupled to the proximal end of the outer tubular member and/or the distal end of the outer tubular member. Additional details regarding the Movable Tubular Structure are set forth in the currently pending application entitled "the same lifting Movable Tubular Structure" filed on even date herewith and assigned to Abbott Cardiovascular Systems Inc., the contents of which are incorporated herein by reference in their entirety.

The fluid cavity 310 has a fluid flow port 420. The fluid flow ports 420 define the outer surface of the inner tubular member 110 along the inner tubular member 110. As described in more detail below, the fluid flow port 420 allows fluid to flow from within the fluid lumen 310 into the space defined by the inner and outer

tubular members

110, 120 and between the proximal and

distal seals

720, 730. The markings 422 may define the distal end of the fluid flow port 420.

For purposes of illustration only, fig. 7 and 8 depict a pressure lumen 450, a proximal seal 720, and a distal seal 730. For purposes of discussion and illustration, other components within the pressure chamber are not illustrated herein, but may be understood from the more detailed description in U.S. application No. 13/467,679 entitled "the having Dual Balloon Hydraulic Actuator" by Abbott Cardiovascular Systems Inc. in Michael Green and Michael Bialas and U.S. application No. 3/467,715 entitled "the having the device hydro the having the device within the Tandem Chambers" in Michael Green and Michael Bialas, both of which are hereby incorporated by reference in their entireties. The proximal seal 720 extends from the inner surface of the outer tubular member 120 toward the outer surface of the inner tubular member 110 and is located proximal to the fluid flow port 420. The proximal seal 720 is fixed to the inner surface of the outer tubular member 120 and is free to move relative to the inner tubular member 110.

With continued reference to fig. 7 and 8, the catheter 100 further includes a distal seal 730 spaced apart from the proximal seal 720. The distal seal 730 extends from the outer surface of the inner tubular member 110 toward the inner surface of the outer tubular member 120 and is located distal to the fluid port 420. The distal seal 730 is fixed to the outer surface of the inner tubular member 110 and is free to move relative to the inner surface of the outer tubular member 120. In this manner, the outer tubular member 120 is free to move relative to the distal seal 730. As embodied herein, and as shown in fig. 7, one or both of the proximal and distal seals may form a dust seal 740 across the corresponding surface.

As shown in fig. 7 and 8, for illustrative purposes only, the catheter 100 includes a pressure lumen 450 defined by a proximal seal 720, a distal seal 730, the outer surface 111 of the inner tubular member 110, and the inner surface 121 of the outer tubular member 120. The pressure chamber 450 is in fluid communication with the fluid flow port 420.

As recognized in the art, the outer tubular member 120 contains a medical device to be delivered. A medical device, such as a self-expanding stent, is deployed by retracting the outer tubular member 120 (catheter sheath). Retraction is achieved by directing fluid under pressure through fluid chamber 310 using conventional means such as a pressure generator or syringe. The pressure generator may include a threaded engagement mechanism or other locking mechanism to control the pressurization and depressurization of a pressure chamber (not shown). Additionally, a pressure gauge may be provided with the pressure generator to monitor the pressure system of the conduit. The pressure generator may be configured to allow a quick release of hydraulic pressure to stop or inhibit deployment of the stent. The pressure generator may also be configured to create and/or maintain a negative pressure in the conduit. The pressure generator may further create a vacuum that reduces the profile of the conduit. For example, by creating a vacuum, the outer tubular member 120 disclosed herein may be configured to reduce profile and/or lock into position. An example of a suitable pressure generator is the atom pressure generator atom Medical-55 ATM.

An adaptor may be provided at the proximal end of the catheter for accessing the fluid lumen, and may be configured to connect to a fluid source (not shown). Referring to fig. 7, fluid is introduced into the fluid chamber and exits the fluid chamber at flow port 420 and fills the pressure chamber 450. Once sufficient fluid is introduced into the pressure chamber 450, a force is exerted on the distal seal and the proximal seal. Because the distal seal 730 is fixed relative to the inner member, only the proximal seal 720 and the outer tubular member 120 attached to the proximal seal 720 can move relative to the inner member in the proximal direction P. Movement of the proximal seal 720 upon application of a force in the pressure lumen 450 moves the outer tubular member 120 along the inner tubular member in the proximal direction P, thereby enabling deployment of the medical device. As embodied herein, the distal seal 730 is configured as a dust seal with the inner surface of the outer tubular member 120. The outer tubular member 120 thereby moves relative to the distal seal 730. The proximal seal 720 mounted to the inner surface of the outer tubular member 120 is configured as a dust seal with the outer surface 111 of the inner tubular member 110. The proximal seal 720 is free to move relative to the inner tubular member 110.

Although shown in fig. 7 and 8 as a single piece seal configuration, each seal of the disclosed subject matter can be a multi-piece seal assembly if desired, for example, the seal assembly can include a seal member and a sleeve that provides a backing to the seal member, as is known in the art, seals 720 and 730 can further be supported by a proximal sleeve and a distal sleeve (not shown), respectively.

Since a higher fluid pressure is required to retract the outer tubular member 120, the pressure chamber is formed to withstand such pressure, achieving minimal to no leakage. A variety of suitable seal configurations and materials may be used, such as, but not limited to, sliding seals, rings, cup seals, lip seals, and compression sleeves. For example, each seal may be formed as a separate member and attached to a corresponding tubular member, or may be formed as part of a tubular member. For purposes of illustration only, with respect to the seal, it is possible to haveWith hydrophilic materials, such as, but not limited to, HydroMed^TM、Hydrothane^TM、Hydak^(R). Seals made from such materials may be configured to wet out when exposed to an aqueous environment, thereby sealing more tightly while maintaining smoothness. The seal may thus comprise an expandable material or composite of materials to increase accordingly to match the size of the outer tubular member. That is, the seal may include expanding with the outer tubular member to maintain an adequate seal.

As the pressure chamber expands, the exposed surface area of the seal may also increase, resulting in a proportional increase in the retraction force at a given fluid pressure. Thus, the inflatable pressure chamber provides a greater retractive force at a given pressure. Seals made from such materials may be configured to wet out when exposed to an aqueous environment, thereby sealing more tightly while maintaining smoothness. Alternatively, the proximal and distal seals may be coated with a hydrophobic layer, such as oil or wax, or made of a hydrophobic material, such as a fluorocarbon or olefin, such as polypropylene used with a suitable pressurized fluid to prevent seal wetting. By way of example only, a silicone seal with a Hydromer 2314-172 coating may be provided. In another embodiment, an O-ring may be used for a seal configuration composed of silicone, buna rubber, or other suitable elastomer. Also, for purposes of example only, the seal may comprise a soft syringe, such as a low durometer Pebax. Additionally or alternatively, high viscosity hydraulic fluid may be used to inhibit leakage.

Embodiments of the disclosed subject matter allow the pressure chamber to operate with a variety of different suitable pressures. For exemplary purposes only, in one embodiment, the pressure chamber may handle positive pressures up to 750 psi and negative pressures approaching 14 psi. Exemplary operating parameters for cardiovascular catheters include operating pressures in the approximate range of 40 ATM to 50 ATM (or about 588-.

According to another aspect, the catheter may further include an elbow or balloon component (not shown) within the lumen to prevent leakage. An elbow or balloon component is attached to the outer surface of the inner tubular member and is in fluid communication with the fluid flow port, wherein fluid introduced through the fluid flow port inflates the balloon component to further retract the outer tubular member.

In yet another aspect of the disclosed subject matter, a spacer element (not shown) may be provided within the pressure chamber. The pressure lumen may prevent collapse of the outer tubular member, the proximal seal, and the distal seal at the delivery and containment catheter device. The spacer element may also reduce the amount of fluid required to retract the outer tubular member. The spacer element may be made of any of a variety of suitable shapes and materials, such as a ring member having a diameter corresponding to the inner and outer diameters of the inner and outer tubular members, respectively.

If desired, the distal seal may form a stop or stop member for the medical device. Alternatively, in accordance with another aspect of the disclosed subject matter, the catheter can include a stop 710 secured to the inner tubular member 110, as depicted in fig. 7 and 8. The stopper is disposed distal of the pressure lumen and proximal of a medical device (e.g., stent) to be delivered. In this manner, the stopper 710 seals the hydraulic fluid lumen 310, but allows passage of the guidewire tube 321 and/or guidewire (not shown). The stop 710 may be made of or include a radiopaque material to provide visibility to the physician performing the procedure for catheter placement so that the medical device may be accurately positioned at the treatment site. The stop 710 is thus a radiopaque marker. For example, the marker may be a radiopaque metal ring, or made of tungsten-loaded polymer to increase softness and flexibility. Other known suitable markers may be used. In other embodiments, the pressure lumen 450 is spaced apart from the medical device being delivered, as discussed further herein.

In accordance with another aspect of the disclosed subject matter, other features, such as a spring, may be provided to bias the outer tubular member 120 in the proximal direction P. Examples of springs and other features that may be implemented with embodiments of the present subject matter may be found in U.S. application No. 13/467,660 entitled "cable lifting hydratic activator", owned by Abbott cardio pulmonary Systems inc. by Michael Bialas and Michael Green, U.S. application No. 13/467,679 entitled "cable lifting Dual Balloon hydratic activators", owned by Abbott cardio Systems inc. by Michael Green and Michael Bialas, and U.S. application No. 3/467,715 entitled "cable lifting hydratic activator with tape changer", owned by Michael Green and Michael Bialas, the contents of which are incorporated herein by reference in their entireties.

Referring now to FIG. 6, which depicts an "on-the-wire" variation of the disclosed subject matter for purposes of illustration only. In this embodiment, the catheter 100 includes an inner tubular member 110, an outer tubular member 120 (shown in a retracted position), a guidewire lumen 320, and a fluid lumen 310 having a fluid flow port 420. The catheter 100 also includes a medical device (such as stent 400), shown in an expanded state, a stent holder 510, and a distal guidewire port 430.

As shown in fig. 6A, for illustrative purposes only, the inner tubular member 110 or elongate catheter shaft of the catheter may include first and second

tubular members

110 and 610, respectively, the first and second

tubular members

110 and 610 being in coaxial relationship with one another to define a central guidewire lumen 320 within the first tubular member 110 and an annular fluid lumen 310 located between the first and second tubular members 610 of the inner tubular member or shaft. Fluid chamber 310 may be supplied with hydraulic medium under positive pressure and, if desired, may be caused to withdraw hydraulic medium from pressure chamber 450 (i.e., provide negative pressure). The catheter is sized and configured for delivery within a corresponding body lumen for a given indication, such as vasculature for vascular intervention. The catheter includes a guidewire lumen for delivery over a guidewire 620, as shown in fig. 6A. For example, in one embodiment, such as for neurological indications, the catheter may be compatible with a 0.012 or 0.010 guidewire. The portion of the inner tubular member extending distally of the lumen may be defined by an extension of the first tubular member 110, or by an extension of the second tubular member 610, or by a separate tubular member, if desired. Although a coaxial shaft and over-the-wire (OTW) catheter configuration is depicted in fig. 6, those skilled in the art will recognize that other configurations and known materials of construction may be used without departing from the scope of the disclosed subject matter, for example, a rapid exchange and/or dual lumen configuration as previously described.

Further, in accordance with the disclosed subject matter, an actuator member and a locking member may also be provided to prevent the outer tubular member of the catheter from moving in the proximal direction in advance. For purposes of illustration and not limitation, reference is made to a conduit having one or more pressure chambers as described above. An actuator member is disposed within the pressure chamber for movement between a first position and a second position. Additionally, a locking mechanism is disposed within the pressure chamber. The locking mechanism has an engaged state for preventing movement of the outer tubular member relative to the inner tubular member and a disengaged state for allowing movement of the outer tubular member. When the actuator is moved to the second position, the locking mechanism is displaced to the disengaged position.

Reference is now made to the representative catheter embodiment of fig. 9, which depicts a locking system in accordance with an embodiment of the disclosed subject matter. The locking system includes an actuator member 801 disposed within a pressure chamber 450, as depicted. The actuator member 801 is movable between a first position and a second position. The actuator member 801 includes a sealing section 801A and a cam section 801B.

Referring now to fig. 10A-10C, an exemplary embodiment of an actuator member 801 of the disclosed subject matter is depicted. Generally, as depicted in the perspective view of fig. 10A, the actuator member 801 is cylindrical in form and is movable along the outer surface of the inner tubular member. As shown in fig. 10B, the seal segment 801A depicted therein is formed as a radially outwardly extending flange, although other configurations may be used. The cam section 801B is formed as an angled surface disposed at the proximal end of the actuator member. The cam surface may form an angle with respect to the longitudinal axis, such as between about 10 ° and about 45 °. Alternatively, the cam may be a continuous surface or the like. In addition, the actuator member may be provided with a dust seal or similar arrangement where the inner diameter decreases along one or both ends to form a seal with the outer surface of the inner tubular member. The actuator member may be made of any suitable material capable of functioning as desired. For example, for cardiovascular indications, grade 6 medical materials having a durometer in the range of approximately 50 to about 90 may be used.

Referring back to fig. 9, a stop member 810 may be disposed between the outer tubular member 120 and the inner tubular member 110. For example, as embodied herein, the stop member 810 may comprise a self-floating member, such as a sleeve, that is movable relative to the outer tubular member 120. The stop member 810 may be disposed distally of the actuator member 801 to define a first position of the actuator member 801 relative to the fluid flow port 420. As depicted in fig. 9, the stop member 810 separates the actuator member 801 from the distal seal 730, and the initially disposed actuator member 801 is proximal to the fluid flow port 420 when in the first position. The stop member 810 defines one or more flanges or steps that increase the inner diameter in the proximal direction, as shown in fig. 9. Any suitable member may be used for the stop member 810, such as a sleeve. When the actuator member 801 is in the first position, the seal section 801A of the actuator member interfaces with the flange or stop member 810 to form a seal with the outer and inner

tubular members

120, 110. The seal created by the seal section 801A of the actuator member 801 defines a distal chamber portion 450A and a proximal chamber portion 450B within the pressure chamber 450. When the actuator is in the first position, the stop member 810 is disposed in the distal lumen 450A.

As fluid is introduced into the distal lumen portion 450A of the pressure lumen 450 through the fluid flow port 420, a force is exerted on the sealing section 801A to move the actuator member 801 in the proximal direction P from the first position toward the second position. When the actuator member 801 moves toward the second position, the actuator member 801 becomes spaced apart from the stop member 810 and the seal created by the seal segment 801A is interrupted. Thus, proximal movement of the actuator member 801 causes the distal and

proximal lumen portions

450A and 450B to be in fluid communication with one another, and fluid introduced into the distal lumen portion 450B moves into the proximal lumen portion 450B. When the actuator member 801 is in the second position, fluid introduced into the pressure chamber 450 through the fluid flow port 420 may now exert a force on the proximal seal 720.

As noted previously, and as further depicted in fig. 9, the locking system embodied herein also includes a locking mechanism 850 disposed between the outer surface of the inner tubular member 110 and the inner surface of the outer tubular member 120. The locking mechanism 850 is positioned proximally of the actuator member 801 in this embodiment. In general, the locking mechanism 850 may include a body member 851 coupled with the outer tubular member 120 or secured to the outer tubular member 120, as described in detail below. The locking mechanism also includes a latch 862, the latch 862 having an engaged state as depicted in fig. 9 and a disengaged state substantially as depicted in fig. 12, and described further below.

For purposes of illustration and not limitation, reference is now made to fig. 11A-11E, which depict exemplary embodiments of the locking mechanism of the disclosed subject matter, hi general, as depicted in the perspective view of fig. 11A, locking mechanism 850 includes a cylindrical body member 801 having a recess 852 and at least one latch 863 extending from body member 801 fig. 11B depicts a side view of locking mechanism 850 of fig. 11A, and fig. 11C is a front view of the locking mechanism of fig. 11A, for example, and as best shown in fig. 11A and 11C, locking mechanism 850 here includes three latches 863 spaced apart around body member 851 and extending distally from body member 851 fig. 11B, 11D is a cross-section of the locking mechanism of fig. 11B spanning lines 11D-11D, and fig. 11E is a detail view of the locking mechanism of fig. 11D around line 11E, as depicted in fig. 11B and 11D, each latch 863 may be at least partially formed by a projection 863 having a protrusion 863A projection, such as a cantilevered end, a cantilevered surface, such as angled portion 860, a hook actuator may be engaged by a cantilevered end, such as angled portion, a hook, and a hook, may be formed by a hook, and a hook, such as at any suitable angle, such as angle, a hook.

Referring again to fig. 9, the body member 851 includes a recess 852 defined in an outer surface of the body member 851 to assist in securing the locking mechanism 850 to the outer tubular member 120. During assembly, the locking mechanism may be coupled with the outer tubular member 120 or secured to the outer tubular member 120. For example, the outer tubular member 120 may be received within the recess 852 to form a groove 854 along a portion of an outer surface of the outer tubular member 120. A filler 855 may be disposed in the groove 854 of the outer tubular member 120 within the recess 852 to couple the outer tubular member 120 to the body member 851 of the locking mechanism 850. Moreover, the filler material may be provided with additional hoop strength to secure this portion of the outer Tubular member within the recess of the locking mechanism, as disclosed in the currently pending application entitled "cable HavingMovable Tubular Structure", assigned to Abbott Cardiovasular Systems Inc. and filed on even date with the present application, the contents of which are incorporated herein by reference in their entirety. The packing may interface the locking mechanism with the outer tubular member sandwiched therebetween to create a grip and lock.

The filler material may be any suitable material capable of providing sufficient hoop strength to couple the outer tubular member with the locking mechanism. For example, the filler may include at least one of nylon, fluoropolymer (such as Kynar), PEEK, resin, platiniridium, ceramic, and metal (such as metal tape, etc.). In accordance with certain aspects of the disclosed subject matter, the filler material may include a material that doubles as a bond with the material of the outer tubular member. For example, the material of the filler may include the same material as the outer tubular member. The compatibility of the filler and the outer tubular member thereby achieves a more secure lock between the outer tubular member and the locking mechanism even if the outer tubular member is not thermally compatible with the locking mechanism. In addition, the increase in thickness of the outer tubular member and the filler bonded to the recess provides strength that is not included in the single-layer material itself. In addition, by thermal bonding, a substantially continuous surface of the adjacent outer tubular member and the filler material is provided to eliminate areas or edges that may become stuck as the system is advanced or withdrawn from the vasculature. In addition, the lock created by the filler material provides strength for maintaining the integrity of the catheter components. The filler may thus be bonded to the outer tubular member by heat bonding, thermal bonding, adhesive bonding, or the like, and by crimping or swaging of a suitable material adhesive.

Referring again to fig. 9, the locking system may further include a sleeve 865 coupled to the inner tubular member 110. The sleeve 865 is disposed between the inner tubular member 110 and the locking mechanism 850 and defines a flange or engagement edge at its distal end. As depicted in fig. 9, the hook projection 863A of the latch 863 is configured to engage an edge of the sleeve 865 when in an engaged state. Alternative arrangements may be provided to form an engagement edge on the inner tubular member for engagement by the latch. For example, the inner tubular member may be provided within a ring or projection, or a slot may be defined in an outer surface of the inner tubular member. For the sleeve, any suitable material may be used.

Fig. 12 illustrates an embodiment of the subject matter with latch 863 in a disengaged state. When the actuator member 801 is moved to the second position as previously described, the cam section 801B of the actuator member 801 engages the latch 863. With the force of the cam 801B moving in the proximal direction P, the latch 863 is displaced by the cam section 801B to the disengaged state due to the influence of hydraulic pressure acting on the sealing section of the actuator member 801, and thereby releases the sleeve or other engagement edge for subsequent movement of the outer tubular member in the proximal direction.

In the embodiment of fig. 12, the sleeve is replaced by a slot 117 defined in the outer surface of the inner tubular member 110 for illustration purposes. In this embodiment, the latch 863 engages the slot 117 when in the engaged state. As depicted in the embodiment of fig. 12, when the actuator member 801 is moved to the second position, the cam section 801B of the actuator member 801 disengages the latch 863 to release the outer tubular member for subsequent movement in the proximal direction by fluid pressure acting on the proximal seal.

The locking mechanism may be made of or comprise any suitable biocompatible material, such as PEEK. Because it is not necessary to bond the outer tubular member directly to the locking mechanism, the locking mechanism (and, more specifically, the body member of the locking mechanism) may include a material that is not used in thermal bonding with the material of the outer tubular member. As such, it is advantageous for the locking mechanism to be made of a suitable material having a higher melting temperature than the melting temperature of the outer tubular member and/or the filler. Thus, the locking mechanism maintains its structural integrity even when heat energy or heat is applied to the area in which the locking mechanism is located. If desired, the locking mechanism may further include a PTFE liner or other low friction or lubricious layer.

In accordance with another aspect of the disclosed subject matter, there is provided a method of deploying a catheter, the method comprising: a catheter as described previously above is provided, among others. The method also includes disposing a device (such as a stent) between the outer surface of the inner tubular member and the inner surface of the outer tubular member at a location distal to the distal seal. The position of a device, such as a stent, along a catheter depends on the desired indication, such as cardiovascular intervention or peripheral intervention. Fluid is introduced into the pressure chamber through the fluid flow port to move the actuator member toward the second position and displace the latch of the locking mechanism to the disengaged state. When the actuator member is in the second position and the latch is in the disengaged state, fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal of the pressure chamber to urge the outer tubular member in the proximal direction. As the outer tubular member is actuated in the proximal direction, the stent is exposed and deployed in the luminal system of the patient. Upon deployment of the stent, the catheter is withdrawn from the luminal system. Additional details and features relating to the method will be described and/or understood from the above description, or are incorporated by reference.

In accordance with embodiments of the previously described subject matter, the components of the catheter may be made of a variety of suitable materials. For example, the proximal and distal seals of the expandable chamber arrangement may be formed of any suitable material. The seal may be rubber or silicon, for example only. In embodiments having an expandable pressure chamber, the seal may be formed from a low durometer rubber having a compressed state and an expanded state. The seal may compress and deform significantly in the initial delivery configuration, transitioning to an expanded state when the pressure chamber is pressurized. Alternatively, the seal may be made of a hydrophilic polymer that absorbs fluid in the pressure chamber and expands along the outer tubular member. Alternatively, the proximal and distal seals may be made of a hydrophobic material.

For example, suitable materials include, but are not limited to, polymeric materials such as nylon, urethane, polyurethane, PEEK, PTFE, PVDF, fluoropolymers (such as Kynar), PE, HDPE, tri-layer materials (including L25), Plexar, PEBAX, or polyethylene of suitable density. in one example, the outer tubular member comprises a nylon braided tube with a PTFE inner side.

As another alternative, the inner and/or outer members may each be constructed from a plurality of outer tubular members. The stop may further form a joint for two adjacent tubular members. The outer tubular member may further be constructed of a composite or fiber-reinforced composite material (such as a fiber-reinforced resin material or a braided material) including a plurality of different materials prepared (such as co-extrusion of different polymers). By way of example only, an exemplary embodiment may include a braided tube with a PTFE liner, a polyamide middle layer with a braid, and a Pebax 72D outer layer. In addition, to improve flexibility, a spiral or spiral member configuration may be used in constructing the inner and outer tubular members.

Exemplary constructions for the outer tubular member include a single layer of polyimide or PEEK, a three layer material of L25, Plexar, HDPE, or a braided tube with a PTFE inner liner, a polyimide middle layer with braid, and a Pebax 72D outer layer.

It is further contemplated that the inner and outer tubular members may be made of other biocompatible materials. As such, the inner and outer tubular members of the catheter may be constructed of the above-described polymers, combinations or blends of these polymers, either alone or in combination with other materials or other bioabsorbable materials.

The inner and outer tubular members may be manufactured by using a variety of known techniques such as, but not limited to, extrusion, injection molding, air blowing, drawing, deep drawing, polymerization, cross-linking, impregnation with solutions, powder deposition, sintering, electrospinning, melt spinning, temperature deformation, stretch blowing, chemical grafting of any combination of the above with reinforcing elements (e.g., metal fabrics, coils, glass fibers, carbon fibers and other types of organic or inorganic fibers, liquid catalysts), and classical mechanical processing techniques (e.g., milling, drilling, grinding, etc.). Where a metallic element (such as a hypotube) is to be incorporated, a variety of metal fabrication techniques may be used, such as, but not limited to, machining, tube drawing processes, drilling, milling, EDM, other deformation methods, electroplating, sputtering, electro-grafting, sintering and deposition, and the like. In one embodiment of the disclosed subject matter, the inner tubular member comprises a stainless steel hypotube at least at its proximal end.

Additionally, the inner and outer tubular members may be constructed of PE, polypropylene, Kynar, or urethane by extrusion work using an extruder such as those available from a number of known suppliers. These materials can be post-processed in a number of ways including: by way of example only and not limitation, extrusion, molding (such as injection molding or dip molding), textile processing (such as weaving or knitting), and forming. Suitable forming processes are rolling and welding of sheet material or vacuum forming into tubular form, to name a few.

If desired, the inner and outer tubular members may be further coated with any of a variety of materials to enhance their performance using coating techniques, including numerous suitable coatings and coating techniques under the subject matter of patents owned by Abbott L organisms (such as, U.S. Pat. No. 6,541,116, U.S. Pat. No. 6,287,285, U.S. Pat. No. 6,541,116), the entire contents of which are incorporated herein by reference.

The inner and outer tubular members may have any suitable cross-sectional shape, including oval, polygonal, or prismatic, although a circular cross-section is generally preferred. The inner and outer tubular members may also have any suitable size and diameter depending on the desired application. The catheter is suitably sized and configured for delivery within a corresponding body lumen for a given indication, such as the vasculature for vascular intervention.

As embodied herein, the outer tubular member may include an outer layer and an inner layer. The outer tubular member may be provided with an inner layer attached to or formed with an outer layer. The inner layer or liner may comprise a lubricious material to facilitate sliding of the outer tubular member in the proximal direction when retracting the outer tubular member. For example, different types of polymers such as PTFE or any fluoropolymer and High Density Polyethylene (HDPE) may be used for the inner layer or coated on top of each other. In addition, other lubricious polymers may be used. As embodied herein, the outer layer provides sufficient strength to capture the medical device therein and enable movement between the first and second positions. The multiple layers may be formed separately and bonded or bonded together or co-extruded as a single member.

Further, in accordance with the disclosed subject matter, the outer tubular member may include a reinforcing layer, such as a braided material, disposed between the outer layer and the inner layer. For example, the reinforcement layer may be provided in the form of a braided stainless steel tube or the like. The braid may comprise flattened filaments rather than filaments having a circular cross-section. Alternatively, the reinforcing layer may be in the form of a tube comprising plant or suitably oriented filaments, such as carbon fibres encased in a polymeric matrix. Also, such reinforcing fibers are additionally or alternatively included in the inner and/or outer layers during the manufacturing process.

When the outer tubular member is provided with the inner layer, the outer layer, and the reinforcing layer, the outer tubular member may be formed in the following manner. First, the inner layer is formed by a tubular extrusion process and disposed around a forming mandrel (not shown). As embodied herein, the forming mandrel has a shape that corresponds to the desired shape of the interior of the outer tubular member. Next, a reinforcing layer, which may be provided in the form of a stainless steel braided material, is positioned over a predetermined length of the inner layer. Next, the outer layer is extruded and positioned over the reinforcement layer, which may be provided in the form of two separate tubular members that slightly overlap over the reinforcement layer at their ends. Each portion of the outer layer may be a different material selected to provide a different durometer as described above. The two portions of the outer layer may overlap by an amount, such as approximately 0.1 inches. Next, a sleeve of heat shrink material is positioned over the entire outer tubular member assembly. Finally, heat is applied to the assembly. When heat is applied, the heat shrink syringe shrinks and fuses the inner layer with the outer layer, trapping the reinforcing layer therebetween. The heating process also conforms the inner layer to the shape of the forming mandrel. After the assembly cools, the heat shrink syringe is cut away, leaving the outer tubular member.

Although the disclosed subject matter has been described herein with respect to certain preferred embodiments, those skilled in the art will recognize that numerous modifications and improvements may be made to the disclosed subject matter without departing from the scope of the subject matter. Additional features known in the art, such as disclosed in U.S. patent No. 7,799,065 to Pappas, which is incorporated herein by reference in its entirety, may also be included. Furthermore, while individual features of one embodiment of the disclosed subject matter may be discussed herein or illustrated in the drawings of that one embodiment but not other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from multiple embodiments.

In addition to the various embodiments depicted and claimed, the disclosed subject matter is also directed to other embodiments having any other possible combination of the features disclosed and claimed herein. As such, the particular features presented herein can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter includes any suitable combination of the features disclosed herein. Moreover, although reference is made to stents throughout the present disclosure, other suitable devices and implants may also be delivered by using the catheters and systems disclosed herein. Thus, the foregoing descriptions of specific embodiments of the disclosed subject matter have been presented for purposes of illustration and description. Is exhaustive or limits the disclosed subject matter to the disclosed embodiments.

It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations as come within the scope of the appended claims and their equivalents.

Claims

1. A catheter, comprising:

an inner tubular member having a proximal end portion, a distal end portion, and an outer surface, the inner tubular member further having a fluid lumen defined therein, the fluid lumen having a fluid flow port defined through the outer surface along the distal end portion of the inner tubular member;

an outer tubular member movable relative to the inner tubular member, the outer tubular member having a proximal end, a distal end, and an inner surface facing the outer surface of the inner tubular member;

a proximal seal extending from an inner surface of the outer tubular member toward an outer surface of the inner tubular member, the proximal seal being proximal to the fluid flow port;

a distal seal extending from an outer surface of the inner tubular member toward an inner surface of the outer tubular member, the distal seal being distal to the fluid flow port;

a pressure lumen defined by the proximal seal, the distal seal, an outer surface of the inner tubular member, and an inner surface of the outer tubular member;

an actuator member disposed within the pressure chamber, the actuator member having a sealing section and a cam section, the actuator member being movable between a first position and a second position, wherein fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the sealing section to move the actuator member from the first position to the second position; and

a locking mechanism disposed between an outer surface of the inner tubular member and an inner surface of the outer tubular member,

wherein fluid introduced through the fluid flow port and into the pressure chamber exerts a force on the proximal seal to urge the outer tubular member in a proximal direction.

2. The catheter of claim 1, wherein the locking mechanism includes a latch having an engaged state that prevents movement of the outer tubular member relative to the inner tubular member and a disengaged state that allows movement of the outer tubular member relative to the inner tubular member.

3. The catheter of claim 2, wherein the locking mechanism includes a body member and the latch is defined at least in part by an arm extending from the body member.

4. The catheter of claim 2, wherein the locking mechanism comprises a sleeve coupled to the inner tubular member, wherein the latch engages the sleeve when in the engaged state.

5. The catheter of claim 2, wherein a slot is defined in an outer surface of the inner tubular member, the latch engaging the slot when in the engaged state.

6. The catheter of claim 1, further comprising a stop member disposed between the outer and inner tubular members to define the first position of the actuator member relative to the fluid flow port.

7. The catheter of claim 6, wherein the stop member comprises a sleeve movable relative to the outer tubular member.

8. A catheter as recited in claim 1, wherein said actuator member moves in said proximal direction from said first position to said second position.

9. The catheter of claim 6 or 7, wherein the sealing section of the actuator member forms a seal with the stop member when the actuator member is in the first position to define a distal lumen portion and a proximal lumen portion within the pressure lumen.

10. The catheter of claim 9, wherein the distal lumen portion and the proximal lumen portion are in fluid communication with each other when the actuator member is moved in the proximal direction from the stop member to break the seal therebetween.

11. The catheter of any one of claims 1, 2, and 4-8, wherein the locking mechanism comprises a body member secured to the outer tubular member.

12. The catheter of claim 3, wherein the body member has a recess defined in an outer surface thereof, the outer tubular member being received within the recess to form a channel along a portion of the outer surface of the outer tubular member, the channel having a filler disposed therein to couple the outer tubular member to the body member of the locking mechanism.

13. The catheter of claim 12, wherein the filler comprises at least one of nylon, fluoropolymer, peek, epoxy, ceramic, and metal.

14. A catheter according to any of claims 12-13, wherein the filler comprises a material compatible for thermal bonding with the material of the outer tubular member.

15. The catheter of any one of claims 12-13, wherein the filler comprises a suitable hoop strength to couple the outer tubular member within the recess of the body member.

16. The catheter of any one of claims 12-13, wherein the body member comprises a material that is incompatible for thermal bonding with the material of the outer tubular member.

17. The catheter of any one of claims 12-13, wherein the locking mechanism comprises a biocompatible material having a higher melting temperature than the filler.

18. The catheter of any of claims 1-8 and 12-13, wherein the outer tubular member comprises a nylon braided tube with a PTFE liner or a fluoropolymer braided tube with a lubricious liner such as PTFE.

19. The catheter of any of claims 1-8 and 12-13, wherein the inner tubular member further comprises a guidewire lumen defined therein.

20. The catheter of any of claims 1-8 and 12-13, further comprising a stent holder disposed distally of the pressure lumen along the inner tubular member and a stent positioned at the stent holder.

21. The catheter of claim 20, wherein the distal end of the inner tubular member further comprises a distal tip disposed distal of the stent holder.

22. The catheter of any of claims 1-8 and 12-13, further comprising at least one movable tubular structure coupled to the outer tubular member and disposed at least one of a proximal end of the outer tubular member or a distal end of the outer tubular member.

23. The catheter of claim 13, wherein the metal comprises platinum iridium.

24. The catheter of any of claims 1-8 and 12-13, wherein with the actuator member in the second position, the fluid is introduced through the fluid flow port and into the pressure chamber.