# Patent

## Title
Rapid-exchange retractable sheath self-expanding delivery system with incompressible inner member and flexible distal assembly

## Abstract

Delivery system for delivery of a medical device includes an inner member having a proximal section, a distal section and a longitudinal axis therebetween. The inner member has a first layer and a second layer wherein the first layer and the second layer are attached together at a first segment and a second segment. The second segment is spaced from the first segment along a length of the inner member and the first layer and the second layer are free of attachment between the first segment and the second segment. The inner member further includes at least two wires disposed along the length of the inner member between the first layer and the second layer. As disclosed, the at least two wires can include a first coil and a second coil moveable relative to each other between the first and second segments.

## Background
CROSS REFERENCE TO RELATED APPLICATION
The present application claims priority to U.S. Provisional application Ser. No. 60/980,686, filed Oct. 17, 2007. The aforementioned patent application is expressly incorporated herein by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates to a delivery system for delivery of one or more medical devices, such as a stent, stent-graft or filter. Particularly, the present invention is directed to a delivery system having improved torque response. The delivery system includes an inner member having a tip, a bumper freely disposed on the inner member, a sheath disposed about the inner member, and a handle attached to the inner member. The inner member includes two layers and a coil member disposed therebetween.
DESCRIPTION OF RELATED ART
A variety of systems are known for intraluminal delivery of a medical device within a patient. However, there remains a need for continued improvement of such known delivery systems. For example, while delivery systems for delivering medical devices such as stents have existed for a long time, to date, no systems have been developed that allow the user to adjust or tighten the components of the system after shipment of the device to the physician. During commercialization of a delivery system, it is necessary to sterilize the device prior to packaging and shipment. In the process of sterilization and/or shipment, it is typical for portions of the device to expand longitudinally with respect to one another. As a result, portions of the device (e.g., stent, sheath, core, etc. that were assembled together in close alignment may become more loosely spaced.
An example of such a system is described in U.S. Pat. No. 6,425,898 to Wilson et al., wherein a delivery system is provided having an inner member with a stop attached preventing the stent from migrating proximally within the sheath during retraction of the sheath for stent deployment. As with other systems known in the art, the system described by Wilson does not permit re-adjustment of the different to the inner member. During deployment, the stop helps to “push” the stent out of the sheath during deployment, by components of the mechanism after sterilization and shipment.
Further, a variety of catheter shafts are known to be used with delivery systems. One example of such a system is the Maserati myocardial injection device which includes an elongated shaft that can be steered through the patient anatomy toward the heart chamber wall. This steering requires effective axial and torque control. Since the curved catheter tip must be finely rotated to direct it toward the target site prior to needle penetration, any amount of whipping or poor torque response in the catheter shaft can prolong the intervention or result in inaccurate delivery of biologics and ineffective treatment.
There thus remains a continued need for an efficient and economic system for delivering a medical device that is easy to use that can be adjusted to provide for an acceptable tolerance between various components of the system. There is also a need for catheter shaft designs that exhibit beneficial torque response without significant whipping, allowing the physician to aim the catheter tip better for improved delivery accuracy and treatment outcome. The present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the methods and systems 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 invention, as embodied and broadly described, the invention is directed to a sheath retractable delivery system for a medical device. This system is made of four main components: an inner member, an outer member, distal assembly, a stabilizer, and a proximal control handle. The inner member runs inside of the outer member and are movable relative to each other. The inner member has a proximal end and a distal end and defines a longitudinal axis between the proximal end and the distal end. A tip is formed at the distal end of the inner member. A bumper can be freely disposed on the inner member. The bumper has a proximal end and a distal end. A seat is defined between the tip and the distal end of the bumper. Additionally, a sheath is disposed about the inner member, the sheath having a proximal end and a distal end. The sheath is movable from a first sheath position substantially covering the seat, and a second sheath position axially offset with respect to the first sheath position to expose the seat. The distal assembly consists of the stent, the catheter tip, and the distal segment of the inner member and the outer member. The stabilizer is a tubular component sits over the proximal segment of the outer member. The inner member, the outer member, and the stabilizer are all connected to each other by the proximal control handle.
In accordance with a further aspect of the invention, the bumper can include a sleeve member having a length. The sleeve member can include a tubular wall having a plurality of perforations defined therein. At least one perforation can be an elongate slot and oriented generally perpendicularly to the longitudinal axis. Additionally or alternatively, at least one perforation can be substantially I-shaped. The perforations can be configured to provide varying stiffness along the length of the sleeve member. In accordance with this aspect of the invention, the perforations can be spaced along the longitudinal axis of the sleeve, wherein the spacing is varied between longitudinally adjacent perforations. Optionally, the perforations are varied in size. In further accordance with the invention, the tubular wall can define a longitudinal channel therein. In accordance with a further aspect of the invention, the bumper can be provided with a covering disposed about the sleeve member. The bumper can further include a radiopaque portion. Additionally or alternatively, the perforations can be filled in with a filling material.
In accordance with another aspect of the invention, a delivery system as described above is provided further including a flush port and a non-return valve operably coupled to the flush port.
In further accordance with the invention, a hypotube can be provided disposed about the inner member. The hypotube has a distal end and a proximal end, with the distal end of the hypotube being proximal to the proximal end of the bumper.
In accordance with another aspect of the invention, the delivery system can further include a stabilizer disposed about the inner member and extending from the handle. The stabilizer preferably includes a flexible member capable of at least one degree of movement. Optionally, the stabilizer can have an adjustable length.
In accordance with a further aspect of the invention, the delivery system can also be provided with an actuator configured to move the sheath with respect to the inner member along the longitudinal axis from the first sheath position to the second sheath position. The actuator can include a push-pull configuration. Additionally or alternatively, the actuator can include a rotatable member, and shuttle assembly to translate rotational movement of the rotatable member into linear movement of the sheath. The actuator can also include a rack and pinion mechanism with a manual override device. In accordance with another aspect of the invention, the delivery system can also include a lock having an unlocked position permitting movement of the sheath and/or actuator, and a locked position prohibiting movement of the sheath and/or actuator.
In still further accordance with the invention, the sheath can include a first material at its proximal end and a second, different material at its distal end. The sheath can define a first diameter at its proximal end, and a second, different diameter at its distal end. The sheath can include an outer layer and an inner layer and a reinforcing layer disposed between the outer layer and the inner layer. In still further accordance with the invention, the tip can include a radiopaque portion.
In further accordance with the invention, the delivery system can further include an adjustment member configured to move the inner member with respect to the sheath. The adjustment member can include an adjustment lock. The adjustment lock preferably has a locked position to prevent the inner member from being displaced longitudinally with respect to the sheath and an unlocked position to allow the inner member to be displaced longitudinally with respect to the sheath. The adjustment member preferably includes an adjustment hypotube disposed about the proximal end of the inner member. Preferably, the adjustment hypotube is attached to the inner member. The adjustment member can further include a hub fixedly attached to the adjustment hypotube.
In further accordance with the invention, a delivery system can be provided as describe above including a second bumper disposed on the inner member proximal to the first bumper, the second bumper having a proximal end and a distal end. In further accordance with this aspect of the invention, a second seat is defined between the proximal end of the first bumper and the distal end of the second bumper.
In accordance with another aspect of the invention, a delivery system as described above may be provided further including a guide sheath disposed about the sheath.
In further accordance with the invention, a method for delivering two or more medical devices is provided. The method includes the steps of providing a delivery system for delivery of a medical device as described above, introducing the delivery system into a patient; delivering a first medical device; moving the inner member with respect to the sheath; and delivering a second medical device.
In accordance with a further aspect of the invention, a method can be provided wherein the first medical device and second medical device are delivered without removing the delivery system from the patient. Additionally or alternatively, the tip can be brought into contact with the distal end of the sheath during the inner member moving step. The method can further comprise the step of deploying a third medical device.
In further accordance with the invention a method for assembling a delivery system for delivery of a medical device is provided. The method includes the steps of providing a sheath and a bumper. The method includes the step of positioning the bumper into the sheath. The method further includes the steps of providing a medical device having a proximal end and a distal end and disposing the medical device in the sheath distal to the bumper, providing an inner member, and placing the inner member through the distal end of the sheath, and attaching a handle to the inner member.
In further accordance with the invention, the bumper positioning step can include positioning the bumper into the distal end of the sheath. The inner member placing step can also include positioning the proximal end of the inner member through the medical device and the bumper.
In further accordance with the invention, the method can entail the step of applying a lubricious material to the distal end of the sheath. In accordance with this aspect of the invention, the lubricious material application step can include the step of applying a pressurized fluid to the proximal end of the sheath to cause the lubricious material to coat the medical device.
In accordance with another aspect of the invention, the method can further include the steps of providing a tip and positioning the tip on the distal end of the inner member. The inventive method can also include the step of applying tension to the proximal end of the inner member to cause the distal end of the sheath to come into physical contact with the tip.
In accordance with still another aspect of the invention, the bumper providing step can include the steps of providing a sleeve member, providing a radiopaque portion, and placing the radiopaque portion on the sleeve member. The bumper providing step can also include the steps of providing a covering member and disposing the covering member on the sleeve member and radiopaque portion.
In still further accordance with the invention, the method can further comprise the steps of providing an actuator and an adjustment member, and adjusting the position of the inner member relative to the sheath using the adjustment member.
In one aspect of the invention, the delivery system includes an inner member having a proximal section, a distal section and a longitudinal axis therebetween. An outer member is disposed about the inner member and the distal section of the inner member includes at least two wires wound about the inner member. The inner member includes a first layer and a second layer to define a multilayered tubular member. The first layer is rotationally moveable relative to the second layer. If desired, a trilayered tubular member could be formed with an inner layer, and outer layer, and a middle layer therebetween. Preferably, the inner member is lubricious. The distal section can be incompressible and/or configured to exhibit minimal elongation.
In one embodiment, the sixteen wires are wound about the inner member in substantially the same direction. In another embodiment, first and second wires are between first and second layers are capable of movement relative to each other.
The inner member can include radiopaque markers. Additionally, the radiopaque markers may act as a stop as the sheath moves from the first sheath position to the second sheath position. In some embodiments, the delivery system includes the radiopaque markers bands which have polymer bumps. In some embodiments, the outer member of the delivery system is a retractable sheath and the delivery system is a self-expandable stent delivery system.
In accordance with a further aspect of the invention, in some embodiments, the delivery system includes a catheter shaft which includes a multilayered tubular member having an axis and a first layer and a second layer along a length thereof and at least first and second coils disposed between the first and second layers, wherein the first layer is rotationally free from the second tubular layer and the first and second coils are capable of movement relative to one another.
In some embodiments, the catheter shaft includes the multilayered tubular member which has a proximal end and a distal end, and further wherein the first layer of the catheter shaft is bonded to the second layer at least one of the proximal or distal ends of the catheter. In some embodiments, the catheter shaft includes the multilayered tubular member which has a proximal end and a distal end, and further wherein the first layer of the catheter shaft is bonded to the second layer at least one of the proximal or distal ends of the catheter. In some embodiments, the catheter shaft includes the first and second layers and the first and second coils are bonded together only at the proximal and distal ends of the shaft.
In some embodiments, the first coil of the catheter shaft is wound in a first direction and the second coil is wound in a second direction opposite the first direction. In some embodiments, the first and second coils of the catheter shaft are wound at substantially equal pitches.
In some embodiments, the catheter shaft includes at least a third coil disposed between the first and second layers. In some embodiments, the first and second coils of the catheter shaft are wound in opposite directions. In some embodiments, the third coil of the catheter shaft is wound in the same direction as the second coil.
In some embodiments, the first coil of the catheter shaft is disposed at an innermost location relative to the axis of the multilayered tubular member and the third coil of the catheter shaft is disposed at an outermost location relative to the axis of the multilayered tubular member. In some embodiments, the second coil of the catheter shaft is disposed between the first and third coils of the catheter shaft. In some embodiments, the third coil of the catheter shaft has a pitch greater than a pitch of the first coil of the catheter shaft. In some embodiments, the first and second coils of the catheter shaft have substantially the same pitches.
In some embodiments, the catheter is a sensor and the at least one coil of the catheter shaft is an electrode or lead. In some embodiments, the catheter includes at least one insulating wire. In some embodiments, the catheter shaft exhibits minimal whipping. In some embodiments, the catheter shaft exhibits improved torque response.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the delivery system, and method of the invention. Together with the description, the drawing serves to explain the principles of the invention.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is a cross sectional view of a first representative embodiment of the delivery system for delivering a medical device in accordance with the present invention.
FIGS. 1b-1d are enlarged views of selected details of FIG. 1a. 
FIG. 2 is an alternative partial cross sectional view of a proximal portion of the device of FIG. 1.
FIG. 3 is an enlarged partial cross sectional view of a distal portion of an alternative embodiment of a delivery system in accordance with the present invention.
FIG. 4 is a partial cross sectional view of a distal tip portion of the device of FIG. 1.
FIG. 5 is a partial cross sectional view of a radiopaque marker band of the device of FIG. 1.
FIG. 6a is a fragmented perspective view of a bumper of the device of FIG. 1.
FIG. 6b is a perspective view of an alternative embodiment of a bumper of the device of FIG. 1.
FIG. 7a is a plan view of a bumper of the device of FIG. 1.
FIG. 7b is a plan view of an alternative embodiment of a bumper of the device in accordance with the present invention.
FIG. 7c is a cross-sectional view of the alternative embodiment of the bumper taken about line 7c of FIG. 7b. 
FIGS. 8a-8d are a cross-sectional view, plan view and cutaway views of a sheath of the device of FIG. 1.
FIG. 9 is an enlarged cross sectional view of a distal portion of the device of FIG. 1.
FIG. 10 is a cross sectional view of an alternative embodiment of a delivery system in accordance with the present invention.
FIG. 11 is a partial cross sectional view of a proximal portion of an alternative delivery system in accordance with the invention.
FIG. 12 is a cross sectional view of a proximal portion of an alternative embodiment of a delivery system in accordance with the present invention.
FIG. 13 is a perspective view of an actuator lock of the device of FIG. 1.
FIGS. 14a-14c are partial views of a stabilizer of the device of FIG. 1 and two alternative embodiments, respectively.
FIG. 15 is a partial cross-sectional view of an alternative embodiment of a delivery system in accordance with the present invention.
FIG. 16 is a cross sectional view of an alternative nose design of the delivery device in accordance with the present invention.
FIGS. 17A and 17B show a medical device delivery system in accordance with the present invention.
FIG. 18 shows a flexible but primarily incompresible cable tube material suitable l for use in the accordance with the present invention.
FIGS. 19 A-D show a distal assembly according to an alternative embodiment of a delivery system in accordance with the present invention.
FIGS. 20A-20D show cross-sections of the delivery system using the cable tube material.
FIG. 21 shows a distal outer sheath with a flexible radiopaque marker band in accordance to with the present invention.
FIGS. 22 A-B show the distal outer sheath in a retracted position.
FIG. 23 shows a prior art catheter shaft with coil member.
FIG. 24 shows the cross section of the catheter of FIG. 23.
FIG. 25 shows the prior art catheter shaft that includes a simple, two-strand braid design.
FIG. 26 shows the cross section of the catheter of FIG. 25.
FIG. 27 shows a representative embodiment of a delivery system in accordance with the present invention
FIG. 28 shows the cross section of the catheter of FIG. 27.
FIG. 29 shows a characteristic of a catheter of the present invention.
FIG. 30 shows effect of placing a catheter shaft that includes a simple braid under torque.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the invention will be described in conjunction with the detailed description of the apparatus. The methods and apparatus presented herein are used for delivering a medical device, such as a stent, stent graft or filter, to a desired location in a patient. In accordance with the invention, it is possible and desired to provide a system for delivering such devices that is relatively inexpensive to manufacture and easy to use.
For purpose of explanation and illustration, and not limitation, an exemplary embodiment of the delivery system for a medical device in accordance with the invention is shown in FIGS. 1a-1d and is designated generally by reference character 1. This exemplary embodiment or portions thereof is also depicted in FIGS. 2, 4-6a, 7-9, and 13-14a. Additional embodiments are shown in FIGS. 3, 6b, 10-12 14b-14c and 15 for purpose of illustration and not limitation.
A variety of types of medical devices are suitable for delivery by the delivery system of the present invention. For purpose of illustration and not limitation, medical device 400 is depicted herein as a self-expanding stent. Such devices are generally well known in the art. However, the delivery system 300 of the present invention is not limited to the delivery of self-expanding stents. Other devices may also be used. For example, stent-grafts, coils, filters, balloon expandable stents, stent grafts, and embolic protection devices may be delivered within a patient's vasculature using the delivery system 300 of the present invention. Other devices such as a prosthesis retrieval mechanism may also be delivered with the delivery system 300 to a predetermined location in a patient's luminal system. Moreover, combinations of medical devices and/or beneficial agents can also be delivered using the device of the present invention. For example, multiple stents and/or a combination of stents and embolic protection devices and/or beneficial agents can be delivered using delivery system 300 of the present invention, as described in detail below.
The delivery system in accordance with the present invention includes an inner member having a proximal end and a distal end, generally defining a longitudinal axis therebetween.
For purposes of illustration and not limitation, the inner member 10 is schematically depicted in FIGS. 1, 9 and 10. Inner member 10 is generally a longitudinal elongate member having a proximal end 12 and a distal end 14. Preferably, inner member is a tubular member having a cylindrical wall 16 that defines a lumen 18 therethrough and having an inner surface 20 (See FIG. 1b). Lumen 18 preferably traverses the entirety of the length of inner member 10, and is configured to permit passage of a guidewire (not shown) therethrough. Alternatively, the lumen may be defined only in the distal portion of the inner member to facilitate rapid exchange of a guidewire as described further below.
Inner member 10 is preferably made from a polymeric material such as PEEK and preferably traverses substantially the entire length of delivery system 300. However, any of a variety of materials can be used for inner member 10. For example, inner member could be made from other polymers such as PTFE, PVDF, Kynar, or polyethylene of various suitable densities. Alternatively, inner member could be made from a metallic material, such as Nitinol or stainless steel. As a further alternative, inner member 10 can be a composite member comprising a fabrication of several different materials, such as a co-extrusion of different polymers, or fiber-reinforced composite material such as fiber-reinforced resin material.
In accordance with an exemplary embodiment of the invention, suitable dimensions for inner member 10 include a length of about 60 inches, an external diameter of about 0.045 inches and an internal diameter of about 0.038 inches. It is recognized, however, that the dimensions will depend on the intended or desired applications for the delivery system and the above dimensions should not be considered limiting in any manner.
Surface 20 of lumen 18 is preferably provided with a lubricious coating 22 thereon, such as silicone or a suitable hydrophilic material to facilitate passage of a guidewire therein. However, a variety of coatings and/or surface treatments can be used.
A variety of different configurations may be used for inner member 10. With specific reference to FIG. 3, in accordance with another exemplary embodiment of the invention, a guidewire proximal port is provided a relatively short distance along the length of inner member 10. In accordance with this aspect of the invention, inner member 10 defines a guidewire exit port 11 near the distal end of delivery system 300 to permit entry and exit of a guidewire (not shown). A delivery system made in accordance with this aspect of the invention would be suitable for use as a rapid exchange catheter, which offers the advantage of not having to use an elongated guidewire or guidewire extension, so as to further simplify the delivery procedure.
Further in accordance with the invention, a tip is located at or proximate the distal end 14 of inner member 10. FIG. 9 shows an exemplary embodiment of a tip in accordance with the invention. Preferably, the tip provides an enlarged cross dimension at or proximate the distal end of the inner member, as will be described.
Tip 30 is preferably, although not necessarily, formed as a separate piece from inner member 10. For purposes of illustration and not limitation and as depicted in FIG. 4, tip 30 has a proximal end 32, a distal end 34, and has a generally cylindrical shape with a substantially constant diameter section 36 and a distal tapered section 38. Tip 30 is molded from a relatively soft material, which may be softer than inner member 10 so as to reduce trauma to the vasculature of a patient. In accordance with a preferred embodiment of the invention, the tip is molded from a polyether block amide, sold under the trade name of PEBAX by Atofina Chemicals Inc. of Philadelphia, Pa. However, various other materials can be used for the tip as is known in the art. A preferred material is sold under the trade name of PEBAX 4033. It is further contemplated that the tip 30 may be made of a material that is harder and/or has greater stiffness than the inner member 10.
Preferably, distal end 34 of tip 30 is in longitudinal alignment with distal end 14 of inner member 10. Having inner member 10 traverse the entire length of tip 30 provides for a smooth surface for a guidewire (not shown) to move against inside lumen 18. Alternatively, if a discontinuity (not depicted) were present in lumen 18, such as if tip 30 extended beyond distal end 14 of inner member 10, a guidewire could collide with the discontinuity.
Suitable dimensions of tip 30 can include a length of about 0.5 inches, a distal external diameter of about 0.06 inches and a proximal outside diameter of about 0.08 inches, although actual dimensions will depend upon the intended application and the above dimensions should not be considered limiting in any manner and have been provided for exemplary purposes.
Tip 30 can be formed as a single piece with inner member 10 or made separately and then attached using any suitable technique, such as fusion bonding, laser welding/curing, UV bonding, adhesive or the like. Tip 30 is preferably mounted on the distal end 14 of the inner member 10 using an adhesive. In accordance with a preferred embodiment of the invention, the tip 30 is mounted on the distal end 14 of inner member. Next, an adhesive primer is applied to the joint created between proximal end 32 of tip 30 and inner member 10 and is permitted to dry. Preferably, the primer is selected so as to wick into the joint between the two components simply upon application. Next, an adhesive accelerator is applied to the joint and permitted to wick in and dry. An adhesive is then applied in a similar manner. Optionally, at this point, the inner member can be placed in a heated environment for a period of time sufficient to cure the adhesive. For example, the assembly can be placed into an oven for about 1-10 minutes at a temperature between about 50 and about 70 degrees centigrade. Preferably, the assembly is cured at about 57 degrees C. for about two minutes.
Preferred primer, accelerator and adhesive components include 7451 Loctite® accelerator, 7701 Loctite® primer and 4014 Loctite® adhesive from Loctite Corporation, although others can be used. For example, a UV cured adhesive may be utilized for assembly.
For purposes of illustration and not limitation, as depicted in FIG. 5 herein, the tip 30 may further define a distal radiopaque portion 40. Distal radiopaque portion 40 may be a sleeve member that is formed separately from tip 30 and attached to the proximal reduced diameter portion 42, or may be formed integrally therewith. For example, radiopaque portion 40 can be formed by impregnating the polymeric material of tip 30 with radiopaque particulate such that the particulate become lodged in the polymeric structure. In this manner, it is possible for tip 30 to comprise a single integral piece. Alternatively, the radiopaque material can be applied as a coating or by other techniques as described below. Suitable materials that may be utilized to form the radiopaque portion 40 may include: gold, silver, nickel, stainless steel, tantalum, platinum, iridium, cobalt or similar materials or composites thereof which have desirable radiopaque features.
In accordance with an exemplary embodiment of the invention, distal radiopaque portion 40 is provided as a composite sleeve comprising platinum and iridium. Suitable dimensions of such a markerband include an outside diameter of about 0.065 inches, an internal diameter of about 0.062 inches, and a length of about 0.024 inches although the actual dimensions will depend on the intended application, wherein the dimensions above have been provided for exemplary purposes and should not be considered limiting in any manner. Such a markerband can be attached to tip 30 in a variety of ways. For example, Masterbond EP3HTMED Epoxy available from Masterbond, Inc. or Loctite 4014 adhesive can be used, although many other adhesives are appropriate and within the scope of the invention.
The delivery system in accordance with the invention further includes a bumper. The bumper is freely disposed on the inner member.
For purposes of illustration and not limitation, bumper 50 is schematically depicted in FIGS. 6-7b. Bumper 50 is generally a longitudinal sleeve member 51 including a proximal end 52 and a distal end 54, with a tubular wall 56 having inner surface 58 and outer surface 60 defining a lumen 62 therethrough. As embodied herein, lumen 62 is configured to permit passage of inner member 10 therethrough. Sleeve member 51 is preferably made from a metallic material such as stainless steel or nickel-titanium alloy, but can be made from any suitable material of sufficient compressive strength and flexibility, such as selected polymeric materials. Preferably, sleeve member 51 is made from 304V stainless steel tubing. Further still, the bumper may be constructed of multiple pieces that are assembled to form a longitudinal sleeve member as shown and described herein.
Bumper 50 may be further provided with a channel 53 as depicted in FIG. 6b, such that bumper 50 is provided with a “Cn-shaped cross-section. Channel 53 can be used to facilitate the flushing of a liquid such as saline solution and/or a beneficial agent to the patient. By providing channel 53, a larger flow channel is provided between inner member 10 and sheath 90, thereby permitting more fluid to be delivered to the patient with greater ease.
In further accordance with the present invention, the delivery system further includes at least one seat that is defined between the tip and the distal end of the bumper.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 1b, a seat 116 is defined between proximal end 32 of tip 30 and the distal end 54 of bumper 50. Seat also occupies an annular space defined between inner member 10 and sheath 90. Seat 116 is sized and shaped to receive a medical device 400 thereon, discussed in detail below. Seat 116, and hence medical device 400 will be exposed when a sheath, as will be described, is moved with respect to inner member 10 from a first sheath position substantially covering seat 116 as depicted in FIG. 1b, to a second sheath position axially offset to expose seat 116.
For purposes of illustration and not limitation, as depicted in FIG. 15, in further accordance with the invention, delivery system 300 can be provided with more than one seat 116 to permit delivery of more than one medical device 400. In accordance with this aspect of the invention, more than one bumper 50a-50n can be provided defining more than one seat 116a-116n, permitting delivery of more than one medical device 400a-400n. The multiple medical devices can be delivered in close proximity to one another, or further apart. If it is desired to deliver each of a plurality of medical devices to substantially displaced locations, it is possible to deliver a first medical device 400, and realign the distal end 98 of sheath 90 with tip 30, if desired, using the adjustment member 270 before moving delivery system 300 to a different location within the patient's vasculature system, as discussed in detail below. When more than one bumper 50 is provided, an intermediate bumper, such as 50a or 50b, can be provided with a radiopaque marker 76a-n at each end to help aid in visualization and delivery of the medical device 400 and/or placement of the delivery system 300 within a patient's vasculature system.
An additional restraining device (not shown) can also be provided to prevent axial movement and/or radial expansion of medical device 400. Such a device can include a membrane or resilient clip. It would also be possible to provide seat 116 with a number of radial protrusions affixed thereto to prevent axial displacement of medical device 400 during delivery thereof. Further still, it is contemplated that after disposing the medical device 400 within seat 116, a retaining agent may then be disposed thereupon to aid in retaining the medical device 400 within the seat 116. The retaining agent may be configured to be dissolvable upon contact with a fluid such as saline, blood or other biocompatible fluid.
In further accordance with the invention, bumper 50 is configured to move freely on inner member 10 with no points of fixation therebetween. Distal end 54 of bumper 50 abuts medical device 400. The proximal end 52 of bumper may optionally abut a hypotube 250 (See FIG. 2). By permitting bumper 50 to move freely, it is possible to permit the longitudinal positions of the various components (e.g., tip 30, medical device 400, bumper 50, hypotube 250) of delivery system 3300 to be adjusted relative to one another after receipt by the physician. Thus, when the delivery system is assembled with a medical device 400 thereon, it is possible to build up a desired longitudinal tolerance between tip 30, medical device 400, bumper 50, and any other components that are disposed on inner member 10.
For purposes of illustration and not limitation, as embodied herein, tubular wall 56 of bumper 50 preferably has one or more perforations 64 defined therein. As shown in FIG. 6a, perforations 64 generally are oriented circumferentially about tubular wall 56. Preferably, in accordance with this exemplary embodiment of the invention, the perforations 64 are disposed circumferentially about wall 56 in pairs so as to define hinge points 70 therebetween (See FIG. 7). As depicted, each perforation 64 subtends an angle of less than 180 degrees of the circumference of cylindrical wall 56. However, a single perforation subtending an angle greater than 180 degrees is also within the scope of the invention. Perforations 64 can be formed by laser discharge, milling, etching or any other suitable techniques.
Collectively, perforations 64 are preferably sized and shaped, and spaced from one another to modify the flexural characteristics of bumper 50 in a predetermined manner without altering the compressibility of bumper 50. For example, alternating pairs of perforations 64 can be rotated with respect to each other by a predetermined angle, such as 90 degrees as depicted in FIG. 6a. In this manner, it is possible to provide for enhanced flexure of bumper 50 in two directions that are substantially perpendicular to one another. Similarly, the longitudinal spacing between perforations can be varied to provide for varying rigidity along the length of bumper 50. Likewise, the circumferential placement of perforations 64 about sleeve 51 can be varied to impart desired bending characteristics to bumper 50.
In accordance with an exemplary embodiment, for purpose of illustration and not limitation, sleeve member 51 has a total length of about 30 inches and pairs of perforations are spaced from each other longitudinally by about 0.1 inches on center in a more distal portion of sleeve member 51, and by about 0.2 inches on center in a more proximal portion of sleeve member 51. Additional spacings between perforations along the length of the sleeve member 51 may be implemented, if desired, to vary flexural characteristics gradually, or in a step like fashion.
There are many ways in which the perforations 64 can be shaped and arranged in accordance with the invention. For example, the perforations can be varied in size and/or in longitudinal spacing to create regions of greater or lesser axial flexibility. Furthermore, alternating pairs of perforations 64 need not be alternated merely by rotating them 90 degrees. Any pattern of rotation to create a desired bending characteristic can be achieved.
Moreover, the perforations do not need to be circumferentially aligned slit shapes. For example, and in accordance with an alternate embodiment of the invention as depicted in FIGS. 6-7a, perforations 64 may include longitudinal components, such as an I-shape. In accordance with this aspect of the invention, perforations 64 include a circumferential component 66 and a longitudinal component 68. When arranged as shown in FIG. 7a, perforations 64 define hinge points 70 therebetween.
A variety of other shapes and arrangements are possible for perforations 64. For example, as depicted in FIG. 6, curved perforations can also be used. In accordance with this aspect of the invention, the perforations can be ellipsoidal in shape (64a) or could take the form of a curved slot (64b).
Referring now to FIGS. 7b and 7c, there is shown an alternative embodiment of a bumper 50 in accordance with the present invention wherein the bumper 50 includes a plurality of articulating joints 64b instead of slots 64 as shown and described above with reference to FIGS. 6-7a. The articulating joints 64b as shown in FIGS. 7b and 7c, are configured to have male 164 and female 264 components, wherein the male component 164 is configured to be received by the female component 264. The male and female components 164, 264 are retained by one another by an overlap of the wall thickness at the rounded portion of the joint between the male and female components as shown in FIG. 7c, and referenced by callout 65. The overlap can be described as being the relation of the tube circumference to the diameter of the circular diameter of the male component. A preferred relation between the diameter of the male component and the circumference of the tube is about 0.25. The connection between the male and female components may gain further support by overcoating or covering the plurality of articulating joints with a covering such as heat shrink tubing or the like.
There are many ways in which the articulating joints 64b can be shaped and arranged in accordance with the invention. For example, the articulating joints can be varied in size and/or in longitudinal spacing to create regions of greater or lesser axial flexibility. Furthermore, alternating pairs of articulating joints 64b need not be alternated merely by rotating them 90 degrees. Any pattern of rotation to create a desired bending characteristic can be achieved.
In yet another alternative embodiment, the bumper 50 may be formed of one or more coil assemblies. It is contemplated that two coil assemblies can be utilized to form the bumper 50, wherein an inner coil is wound having a specific pitch and the outer coil is wound having a specific 19 pitch, wherein the coils' pitches define flexible properties of the bumper 50. The flexibility of the bumper 50 may be further tuned or adjusted by varying the thickness of the material from which the coil assemblies are constructed of.
Ordinarily, if perforations 64 are provided, a physician must be careful to ensure that all air is purged from delivery system 300 before it is introduced into a patient, since introducing air into a patient's blood stream can have dire consequences. Thus, in accordance with an additional aspect of the invention, perforations 64 are filled in with a filling material that is flexible relative to the material that sleeve 51 is made from. Examples of suitable materials include, but are not limited to polymeric materials. Even more preferably, an elastomeric material can be used. By using a material that is flexible, the flexibility characteristics imparted to sleeve member 51 by perforations 64 are not lost. The filling material can be molded over sleeve 51, for example, in an overmolding process.
The filling material thus fills in the voids created by perforations 64 that would otherwise be filled by air. By filling in perforations 64, the air is displaced, so air cannot become trapped in perforations 64 when a physician flushes device 300 in preparation for a procedure.
Moreover, using a filling material can provide additional advantages. The filling material can include a beneficial agent. Such a beneficial agent can be delivered to a location inside of a patient, for example, by exposing perforations 64 containing the beneficial agent. If so configured, the filling material 64 will dissolve, thereby releasing the beneficial agent into the patient's bloodstream. Optionally, a release agent can be flushed through device 300 such that, upon contacting the filling material, cures the beneficial agent to be released into the patient's bloodstream. Such a release agent can, for example, be directed through flush port 240 (described in detail below) and subsequently through channel 53 defined in bumper 50.
In accordance with another aspect of the invention, as embodied herein and as depicted in FIGS. 5-6, a proximal radiopaque portion 76 can be provided. As embodied herein, proximal radiopaque portion 76 is provided in the form of a markerband, similar to distal radiopaque portion 40. Proximal radiopaque portion 76 is disposed about, and preferably attached to, distal end 54 of bumper 50. Attachment is preferably provided via adhesive bond. Suitable adhesives include, for example Loctite ̃4014 adhesive obtainable from Loctite Corp. Attachment may be accomplished in other manners as well. For example, where proximal radiopaque portion 76 is provided as a metallic member, it can be attached to tubular wall 56 of bumper 50 by way of swaging, soldering, press fitting or brazing. If proximal radiopaque portion 76 is provided as a polymeric member containing radiopaque particulate material, it can be molded over sleeve 56. Alternatively, a radiopaque dye can be applied directly to the sleeve member surface.
As with distal radiopaque portion 40, proximal radiopaque portion 76 can take anyone of a number of forms as described in detail above. In accordance with an alternative embodiment of the invention, proximal radiopaque portion 76 can be provided as a coating applied to bumper 50. For example, distal end 54 of bumper 50 can be coated with a radiopaque material such as silver, tantalum, gold, tungsten, platinum, iridium and the like or any composites thereof. Similarly, distal end 54 can be dipped into a suitable radiopaque coating such as a polymer coating, having a radiopaque material entrained therein, or such a coating could be applied to bumper 50 by other methods including extrusion, spraying or any other suitable method.
In accordance with an additional aspect of the invention, as depicted in FIG. 6a, a covering member 80 may be provided for bumper 50. As depicted herein, covering member 80 has a proximal end 82, a distal end 84, an exterior surface 86 and an interior surface 88. Preferably, covering member 80 is heat shrinkable tubing or the like, although alternative films of membranes can be used.
Covering member 80 is preferably applied to sleeve 51 after affixing proximal radiopaque portion 76 thereto. With reference to the heat shrink embodiment of FIG. 6a, covering member 80 is preferably applied to sleeve 51 in the following manner. First, a suitable length of heat shrinkable tubing, preferably exceeding bumper 50 in length, is cut and fit over sleeve 51, including proximal radiopaque portion 76 (if provided). Next, the covering member 80 is stretched from either end into tension. The assembly including sleeve 51, proximal radiopaque portion 76 and covering member 80 is subsequently brought in communication with a heat source sufficient to cause covering member 80 to shrink around sleeve 51. Once the heating step is completed, excess covering material is trimmed from bumper 50.
Covering member 80 can take on a variety of forms. Although heat shrinkable tubing is depicted herein, using heat shrinkable tubing is not necessary. In accordance with an alternative embodiment of the invention, covering member 80 can be extruded over bumper 50. Alternatively, covering member 80 can take the form of a tape material wrapped around bumper 50, and, if necessary, melted together to form a covering. In lieu of providing a separate radiopaque marker, distal end 84 of covering member 80 can be impregnated with radiopaque material to form proximal radiopaque portion 76, described in detail above. Suitable materials that can be used to form covering member 80 include, but are not limited to heat shrinkable polymeric materials. It is further contemplated that the covering member 80 may be disposed upon the bumper 50 through a dip coating, spray coating, extrusion, or other similar manufacturing processes. The covering member 80 may impart mechanical properties, which are desirable to the functionality of the device; for example, the covering member may include a friction reducing coating, a beneficial agent or other similar biocompatible coatings. Further still, the covering member may be constructed of more than one material along the length of the bumper.
The delivery system in accordance with the present invention further includes a sheath disposed about the inner member, wherein the sheath has a proximal end and a distal end. The sheath is movable between a first sheath position substantially covering the seat, and a second sheath position axially offset with respect to the first sheath position to expose the seat.
For purposes of illustration and not limitation, as embodied herein, FIGS. 8a-8b, show a representative sheath 90 having a proximal portion 92 terminating in proximal end 94, a distal portion 96 terminating in distal end 98, an outer surface 100 and an inner surface 102. Sheath 90 can extend over the entire length of inner member 10 or only a portion thereof. Sheath 90 must be of a sufficient length to capture medical device in seat 116. Sheath 90 can be a single piece construction, or can be made from multiple pieces of material.
In accordance with the invention, it is possible to provide sheath 90 with varied stiffness (i.e., durometer) along its length. This may be accomplished in a variety of ways. For example, proximal portion 92 of sheath 90 embodied herein can include a first material and distal portion 96 of sheath 90 includes a second, different material at its distal end 98. In accordance with the invention, the sheath may also define an intermediate region 104 wherein the first material is blended with the second material. For example, the first material can be a first polymer material and the second material can be a second, different polymer material. In accordance with an exemplary embodiment of the invention, distal portion 96 of the sheath has a length of about 4 inches, and sheath 90 has a total length of about 50 inches. It is understood that the dimensions of sheath 90 will depend on the intended application.
The second polymer material incorporated into distal portion 96 of sheath 90 can be less stiff than the first polymer material 94 in proximal portion 92 of sheath 90. For example, the first polymer material can include NYLON 12 and the second polymer material can include NYLON 680. Other polymer materials however, may be used in lieu of or in combination with the above-described materials. For example, a block copolymer material such as Pebax 7233 can be used. Alternatively, other materials such as polyvinylchloride (PVC) or polyurethanes can be used.
Variation in stiffness can be predetermined by blending the materials in varying proportions along the length of sheath 90 such that the majority of material at the proximal end 94 of sheath 90 is NYLON 12 and the majority of material at distal end 98 of sheath 90 is NYLON 68. It is also be within the scope of the invention to vary the rigidity of sheath 90 by varying the diameter along the sheath.
Additionally or alternatively, the sheath 90 can define a first external diameter 01 at its proximal end 94, and a second, different external diameter 02 at its distal end 98. Preferably, the first diameter is smaller than the second diameter. For example, and in accordance with a representative embodiment of the invention, the sheath 90 can have a 01 of about 5.5 French and a 02 of about 6.0 French, although these dimensions can vary depending on the intended application. In accordance with this aspect of the invention and as depicted in FIG. 8a, a step 106 is provided to allow for the change in diameter between the proximal end 94 and distal end 98 of sheath 90. Step 106 allows for the change in diameter to occur over a longer or shorter distance along sheath 90, depending on the application. Alternatively, a more gradual taper can be provided if desired.
In accordance with another aspect of the invention, the sheath can include an outer layer and an inner layer.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 8c, sheath 90 can be provided with an inner layer 110 attached to or formed with an outer layer 112. Preferably, inner layer 110 includes a lubricious material to facilitate the sliding of sheath 90 in a proximal direction when the medical device 400 is deployed. For example, different types of polymers such as PTFE or high-density polyethylene (HOPE) can be used for the inner layer 110. Additionally, other lubricious polymers can be used. The outer layer 112 preferably provides sufficient strength to capture a medical device 400 therein, as well as allow movement between the first position and the second position. The multiple layers can be formed separately and adhered or bonded together or co-extruded as a single member.
In further accordance with the invention and as depicted in FIGS. 8c and 8d, sheath 90 can include a reinforcing layer 114 disposed between the outer layer 112 and the inner layer 110. Preferably, the reinforcing layer 114 includes braided material. For example, the reinforcing layer 114 can be provided in the form of a braided stainless steel tube or sheet (See FIG. 8c. Preferably, the braid includes flattened filaments, as opposed to having filaments with a round cross-section. Although a metallic braided material such as that depicted in FIG. 8d is preferred, it is not necessary. It is also possible to provide a tube including woven fabric or appropriately oriented filaments, such as carbon fibers encased in a polymeric matrix. Likewise, such reinforcing fibers could additionally or alternatively be incorporated into inner layer 110 and/or outer layer 112 during the manufacturing process. The reinforcing layer 114 need not be present through the entire length of the sheath. For example, it is possible for reinforcing layer to be provided along the proximal portion 92 of sheath 90 only, or some greater or lesser portion.
In accordance with an exemplary embodiment of the invention, sheath 90 has a wall thickness of about 6.0 mil, wherein inner layer 110 and reinforcing layer 114 have a thickness of about 2.0 mil, and outer layer 112 has a thickness of about 4.0 mil. Wherein the dimensions above are provided as examples and should not be considered limiting in any manner.
When sheath 90 is provided with an inner layer 110, outer layer 112 and a reinforcing layer 114 sheath 90 is preferably formed in the following manner. First, inner layer 110 is formed through a tubular extrusion process, and disposed about a forming mandrel (not shown). The forming mandrel preferably has a shape that corresponds to the desired shape of the inside of the sheath 90. Next, reinforcing layer 114, preferably provided in the form of a stainless steel braid material, is positioned over a predetermined length of inner layer, preferably leaving a distal portion of the inner layer 110 uncovered by reinforcing material. Next, the outer layer 112 is extruded and positioned over the reinforcing layer 114. Preferably, outer layer 112 is provided in the form of two separate tubular members that are overlapped slightly at their ends over reinforcing layer 114. Each portion of outer layer 112 can be a different material selected to provide a different durometer as described above. The two portions of outer layer 112 can overlap by an amount such as about 0.1 inches. Next, a sleeve of heat shrinkable material is positioned over the entire sheath assembly. Finally, heat is applied to the assembly. When heat is applied, the heat shrinkable tubing shrinks, and causes inner layer 110 to fuse with outer layer 112, trapping reinforcing layer 114 therebetween. The heating process also causes inner layer 110 to conform to the shape of the forming mandrel. Thus, if it is desired to have a sheath 90 with a varied and/or stepped diameter, the mandrel can be formed accordingly. After the assembly cools, the heat shrinkable tubing is cut away, leaving behind sheath 90.
In further accordance with the invention, the delivery system includes a handle connected to the proximal end of the inner member. The handle is used to manipulate the delivery system through a patient's lumen and to deploy the delivery system to deliver the medical device.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIGS. 1 and 2, handle 120 is connected directly to inner member 110 if desired or necessary. However, an indirect connection through an intermediate coupling can be provided, as described in detail below. Handle 120 has a proximal end 122, a distal end 124 and an external gripping surface 126. Preferably, handle 120 is also provided with an actuator 130 to move sheath 90 from the first sheath position to the second sheath position, as discussed in detail below. When the delivery system 300 includes an internal actuator mechanism 130 as depicted in FIGS. 1-2, handle 120 can further include a nose piece 210, as discussed below.
Handle 120 is preferably formed of a plastic material, although other suitable materials can be used. For example, handle 120 can be made from ABS plastic and/or polycarbonate and may include fiberglass fiber reinforcement. Optionally, gripping surface 126 may be enhanced by applying a softer material thereto to enhance gripping. For example, a coating of rubber (not shown) or other similar elastic material can be used to enhance gripping and thereby make it easier for a physician to traverse the patient's vasculature using the delivery system.
In further accordance with the invention, an actuator can also be provided. The actuator is configured to move the sheath with respect to the inner member along its longitudinal axis 15 (See FIG. 1a) from the first sheath position to the second sheath position, thus uncovering the seat to permit a medical device captured or contained therein to be deployed.
As embodied herein, and in accordance with one aspect of the invention, actuator 130 can include a push-pull configuration as depicted in FIG. 10. In accordance with this aspect of the invention, proximal end 94 of sheath 90 is attached to actuator 130, and the proximal end 12 of inner member 10 is attached to handle 120. In accordance with this embodiment of the invention, Sheath 90 can be moved from the first sheath position to the second sheath position by moving actuator 130 proximally, toward handle 120. As actuator 130 is moved with respect to handle 120 seat 116 is uncovered, thereby permitting medical device 400 to be deployed.
This embodiment of the invention presents the advantage that the position of inner member 10 and hence, the position of medical device 400, remains stationary in the patient's vasculature as sheath 90 is moved proximally. This permits precise placement of the medical device 400. Moreover, actuator 130 can take on a variety of different forms. For purposes of illustration and not limitation, in accordance with another embodiment of the invention and as depicted in FIG. 1a, the actuator 130 can include a rotatable member and shuttle assembly to translate rotational movement of the rotatable member into linear movement of the sheath.
In accordance with this aspect of the invention, sheath 90 can be advanced proximally with respect to inner member 10 to uncover seat 116.
The proximal end 94 of sheath 90 is preferably attached, either directly or indirectly, to a shuttle 140, wherein shuttle 140 is configured to travel in a shuttle guide 160. As embodied herein, shuttle 140 has a proximal end 142, a distal end 144, an external surface 146 and a lumen 148 defined therethrough, as depicted in FIG. 1D. Lumen 148 has a proximal section 150 and an enlarged distal section 152. Distal section 152 of lumen 148 is sized to receive proximal end 94 of sheath 90. Sheath 90 is preferably attached to shuttle 140 by way of adhesive bonding, although alternative attachment techniques can be used such as fusion bond or force fit. When an adhesive bond is used, glue ports 151 are preferably provided for injecting an adhesive material, such as Loctite 4014, into section 152. Shuttle 140 is further provided with a proximal groove 154 and a distal groove 156 (See FIG. 2), each of which are configured to receive an o-ring 158. a-rings 158 are configured to prevent flushing liquid from flowing into handle 120 as discussed below in the discussion of flush port 240. An additional inner seal 153 (see FIG. 1d) is provided in proximal section 150 of lumen 148 proximal to flush port 149 to seal between shuttle 140 and hypotube 250.
Shuttle 140 is preferably made of a moldable polymeric material with reinforcement fibers. For example, shuttle 140 can be made from a mixture of nylon 66 and fiberglass, although other suitable materials can be used.
Preferably, shuttle 140 is provided with rails formed thereon (not shown) that are configured to ride in longitudinal slots 162 in a shuttle guide 160 to permit axial movement but not rotational movement of the shuttle 140. Shuttle 140 is further provided with a protuberance 147 thereon. Protuberance 147 is configured to mate with a helical guide groove 176 in thumbscrew 170 (See FIG. 2), Thumbscrew 170 has a proximal end 172, a distal end 174, and an exterior surface 178. Thumbscrew 170 is attached at its distal end 174 to proximal end 182 of knob 180. Attachment is preferably achieved by adhesive connection, but may also be achieved by way of bonding, welding, snap-fit, force-fit or threaded connection. Knob 180 and thumbscrew 170 thus cooperate to form a thumbscrew assembly 188 (See FIG. 1a, and are configured to rotate about shuttle guide 160. Thumbscrew 170 and knob 180 are preferably made from a polymeric material such as ABS plastic via injection molding.
In operation, when a user rotates knob 180 and thumbscrew 170 about the longitudinal axis of the delivery system 300, protuberance 147, and hence, shuttle 140 with 15 sheath 90 attached thereto is advanced in a proximal direction, withdrawing the distal end 98 of the sheath and exposing seat 116. It is further contemplated that the helical groove 176 may be formed having more than one thread pitch. For example, when the sheath is initially being retracted, it may be desirable to move the sheath a greater amount for each rotation of the thumbscrew, this prevents the medical device from “jumping” during deployment and enables more precise placement of the medical device within the patient's vasculature. After initial movement of the sheath, the thread pitch may be changed to slow the movement of the sheath.
In accordance with another aspect of the invention, a rack-and-pinion assembly as shown in FIG. 11 can be used. Rack-and-pinion assembly 190 includes a rotatable actuator 192, a first shaft 194 connected to a drive gear 196. In accordance with this embodiment of the invention, shuttle 140 is attached to a rack 198. Rack 198 can be formed into the outer surface 256 of hypotube 250. Thus, rotational movement of actuator 192 is translated into longitudinal movement of shuttle 140 and sheath 90. Additionally, manual override 198a attached to rack 198 and/or sheath 90 can be provided, wherein the user can push on override 198 to move the sheath. Other methods and mechanisms are also within the scope of the invention. For example, retraction device such as a handle or spool could be connected to sheath by way of a pull wire (not shown).
Similarly, sheath 90 could be retracted by using a system of hydraulically or pneumatically controlled pistons. 10 In further accordance with the invention and as depicted in FIG. 12, a hydraulic system is depicted for retracting sheath 90. In accordance with this aspect of the invention, sheath 90 is affixed to a piston 191 having a seal 193 about its periphery. A supply of pressurized fluid 195, such as air or liquid saline solution, can be brought into fluid communication with a distal face 197 of piston 191 by opening valve 199. When valve 199 is in an open condition, the pressurized gas acts on distal face 197 of piston 191, causing it to be displaced in a proximal direction. Additionally, sheath 90 could also be retracted by using electromagnetic solenoids and/or drive motors.
In further accordance with another aspect of the invention, the delivery system includes a lock having an —unlocked position permitting movement of the sheath, and a 25 locked position prohibiting movement of the sheath.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 13, a lock 200 is provided. The lock 200 prevents accidental deployment of the medical device 400 by preventing movement of the sheath 90 with respect to inner member 10. As depicted in FIGS. 1a and 13 lock 200 is provided in the form of an elongate member having a proximal end 202, a distal end 204, a longitudinal groove 206 and a knob 208 located at distal end 204. Lock 200 is installed and slidably disposed in a linear protrusion 182 in knob 180. Lock 200 has a locked position wherein the lock is engaged with a recess 214 in handle 120. In this position, lock 200 prevents rotational movement of knob 180 with respect to handle 120, and hence prevents longitudinal movement of sheath 90 with respect to inner member 10. Lock 200 can be moved from its locked position in a distal direction with respect to handle 120 so that lock 200 disengages from recess 214 and is fully within the longitudinal length of knob 180. In this position, lock 200 no longer prevents rotational movement of knob 180 and thus sheath 90 can be moved by actuating actuator thereby permitting movement of sheath 90. A user presses on knob 208 to disengage or engage lock 200.
As embodied herein, lock 200 is attached to knob 180. When moved from a locked position to an unlocked position, lock 200 also serves as a bearing surface for a user's thumb to facilitate rotational movement of knob 180 with respect to handle 120.
In accordance with an exemplary embodiment of the invention, lock 200 is formed of a polymeric or epoxy material containing approximately 20% fiberglass. However, other materials can be used. For example, a metallic material or other plastic or composite material may be used to form lock 200.
A variety of configurations can be used as a lock 200. For example, a sliding plate configuration need not be used for lock 200. A pushbutton locking device or rotatable member could be used. Similarly, a frangible member could be used whereby the frangible member is ruptured when a certain threshold torque is exceeded. Lock 200 could also include a key member (not shown) that would need to be inserted or removed in order to permit movement of the sheath 90.
In accordance with another aspect of the invention, a delivery system in accordance with the invention can be provided further including a stabilizer disposed about the inner member and extending from the handle.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIGS. 1a and 14a, a stabilizer 220 is provided having a proximal end 222, a distal end 224, an exterior surface 226, and an interior surface 228 with a lumen 230 defined therethrough. Stabilizer 220 is preferably a tubular member disposed about sheath 90 and attached at its proximal end 222 to nose 210. Specifically, proximal end 222 of stabilizer can be fitted into an enlarged diameter portion 214 of lumen 212 in nose 210. The two parts may be joined by adhesive bond, may be melted together, or connected in other various ways as are known in the art including threaded connections, press fit connections and the like.
Stabilizer 220 is preferably a flexible member capable of at least one degree of movement. For example, stabilizer 220 can be provided in the form of a coil spring or other flexible tubular member capable of bending along its longitudinal axis upon the application of a transverse force. Lumen 230 of stabilizer 220 is configured to permit sheath 90 to pass freely therethrough. With reference to FIG. 14c, the external surface 226 of stabilizer 200 can be configured to fit into a guide sheath 234 with an introducer valve 236 that has already been introduced into a patient's lumen. The guide sheath 234 defines a lumen 238 that permits passage of delivery system 300. Introducer valve 236 provides for a liquid tight seal. Optionally, an a-ring 239 or other seal can be provided. Introducer valve 236 can also be provided in the form of a pierced membrane that surrounds sheath 90 or stabilizer 220. The liquid tight fit between stabilizer 220 and guide sheath 234 thus does not impede retraction of sheath 90 when actuator 130 is actuated. Thus, it is possible to introduce delivery system 300 into a patient, deliver a medical device 400 and withdraw delivery system 300 with minimal blood loss to the patient. The stabilizer 220 may be constructed having a length proportional to the overall length of the delivery system 300. In a preferred embodiment, the ratio between the stabilizer and the overall length of the delivery system 300 is about 2:1.
In an alternative embodiment depicted in FIG. 14b, stabilizer 220 can have an adjustable length. In accordance with this aspect of the invention, stabilizer has a distal reduced diameter portion 221 that is slidably received in a proximal, increased diameter portion 223. A fixation member 225 can also be provided to fix the position of the two portions 221, 223 of stabilizer 220 with respect to each other. Optionally, distal portion 221 can be threadably received in proximal portion 223. In accordance with this aspect of the invention, portions 221, 223 can be provided in the form of concentric coil springs where the pitches are chosen such that one is threadably received inside of the other. It is further contemplated that the distal reduced diameter portion 221 may be utilized independently of the increased diameter portion 223.
Stabilizer 220 may be made from a metallic material such as stainless steel, but other materials can be used. For example, stabilizer can be of a braided shaft design, a multi-layer design, or other polymeric extrusion.
Additionally or alternatively, a strain relief (not shown) disposed about the stabilizer 220 can be provided. The strain relief is configured to reduce the stress concentration at the juncture between the stabilizer 220 and the nose 210. Such a strain relief is made, for example, from HS 101 irradiated polyolefin that can be obtained from Insultab, Inc., although any suitable material of construction can be used.
In accordance with an additional aspect of the invention, the delivery system can be configured such that the sheath and inner member define an annular space therebetween, wherein the annular space is arranged in fluid communication with a flush port to permit a fluid to pass therethrough.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 2, flush port 240 is arranged to be in fluid communication with an annular space 244 defined between the outer surface 60 of bumper 50 and the inner surface 102 of sheath 90. Shuttle 140 is sized and shaped to be received by recess 134 in nosepiece 132. a-rings 158 are configured to provide a liquid-tight seal between shuttle 140 and wall portion 136 of recess 134 when a liquid is flushed through flush port 240. In addition, a shuttle flush lumen 149 (See FIGS. 1d and 2) is provided to permit fluid to pass through outer space 243 shuttle to access annular space. When a fluid agent, such as saline, is flushed through flush port 240 and annular space 244, o-rings 158 prevent the saline fluid from moving past shuttle 140 into handle 120. A hose 246 can also be attached to flush port 240, preferably by way of adhesive connection, although other joining techniques are appropriate.
In accordance with another embodiment of the invention, a flush port 240 can also be fitted onto proximal end 12 of inner member 10 (See FIG. 12). Such a flush port can be used for flushing lumen 18. Such a flush port can further include an adaptor (not shown) in fluid communication with the lumen. Flush port 240 can take on a variety of forms. In accordance with an alternative embodiment of the invention, Flush port 240 can be provided with a non-return valve. In accordance with this aspect of the invention, a non-return valve (not shown) can be attached to flush port 240 to permit a positively pressurized stream of flushing fluid (e.g., saline solution) to pass through flush port 240, but prevent air from passing into flush port 240 after the stream of flushing fluid is disconnected. The non-return valve can be, for example, a check valve that includes an elastic member biased to keep the valve in a closed condition. The elastic member can be provided in the form of a spring. Alternatively, a membrane of elastic material containing an orifice could be used, whereby a positively pressurized fluid can pass through the orifice but air at atmospheric pressure cannot. Such a non-return valve is preferably used to direct a beneficial agent though channel 53 of device 300 to a predetermined location in a patient.
An alternative embodiment of the nose 210 can be seen in FIG. 16, wherein the nose 1210 as illustrated in FIG. 16 includes a flush port 1240. Nose 1210 further includes a valve 1211 wherein the valve 1211 eliminates the O-rings 158 of the shuttle assembly, thereby reducing friction within the system. As shown in FIG. 16, the flush port 1240 is configured to directly receive the distal end of a syringe, for example, the flush port 1240 may be constructed having geometry similar to that of a luer fitting, thereby allowing the delivery system to be flushed with the use of a conventional syringe.
In further accordance with the invention, the delivery system can further include a hypotube disposed about the inner member. The hypotube has a distal end and a proximal end, where the distal end of the hypotube is proximal to the proximal end of the bumper.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIGS. 1d and 2, hypotube 250 has a proximal end 252, a distal end 254, an outer surface, and a lumen 258 defined therethrough. As embodied herein, hypotube 250 is disposed about inner member 10. Distal end 254 of hypotube 250 is proximal to the proximal end 52 of the bumper 50. Proximal end 252 of hypotube 250 is adjacent to distal end 276 of adjustment hypotube 272, discussed in detail below. Hypotube 250 may be made of a metallic material, but may also be made from a polymeric material or may be a resin-impregnated fiber reinforced member.
Hypotube 250 is preferably connected near its proximal end 252 to a connector 260. Connection may be achieved, for example, by way of adhesive bond, threaded or keyed connection, force fit, or the like. Connector 260, in turn, is in abutting relationship with proximal end 172 of thumbscrew 170, such that thumbscrew 170 can rotate with respect to connector 260.
Connector 260 is preferably made from a plastic 15 material such as ABS plastic, but may also be made from other polymeric or metallic materials.
In accordance with a representative embodiment of the invention, hypotube 250 has a length of about 1.6 inches, an external diameter of about 0.065 inches and an inside diameter of about 0.05 inches. Hypotube 250 may be made from stainless steel, although other materials can be used. For example, plastic materials and/or composite materials such as single or multilayer extrusions can be used. It will be understood that dimensions can vary depending on the intended use of delivery system 300.
In further accordance with the invention, a medial portion 121 of handle 120 including gripping surface 126 can be attached onto connector 260, preferably by way of adhesive bond. As depicted in FIG. 2, an external threading 262 is provided on connector 260 to provide an attachment point for complementary threading 123 on medial portion 121 of handle 120, although other joining techniques can be used, such as adhesive bonding, solvent welding and the like.
The delivery system in accordance with the invention also can include an adjustment member configured to move the inner member with respect to the sheath.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 2, adjustment member 270 includes an adjustment hypotube 272 disposed about the proximal end 12 of inner member 10. Adjustment hypotube 272 is preferably attached to inner member 10 and has a proximal end 274 and a distal end 276. Adjustment member 270 can further include a hub 278 fixedly attached to the proximal end 274 of the adjustment hypotube 272. Distal end 276 of adjustment hypotube 272 is disposed adjacent hypotube 250. Adjustment hypotube may be made of metal, but also may be made from a polymeric of fiber-reinforced resin material.
In further accordance with the invention, the adjustment member can include an adjustment lock where the adjustment lock has a locked position to prevent the inner member from being displaced longitudinally with respect to the sheath and an unlocked position to allow the inner member to be displaced longitudinally with respect to the sheath.
For purposes of illustration and not limitation, as embodied herein and as depicted in FIG. 2, adjustment lock 280 is provided. Adjustment lock 280 can be provided at proximal end 122 of handle 120. As embodied herein, adjustment lock is provided in the form of a body having a collet (not shown) that is threaded into threads 125 located at proximal end 122 of handle 120. In operation, when adjustment lock 280 is in a locked position, collet clamps down on adjustment hypotube 272, and adjustment member 260 and inner member 10 cannot move longitudinally with respect to sheath 90 without actuating actuator 130. However, when adjustment lock 280 is in an unlocked position, relative movement between inner member 10 and sheath 90 can be achieved without actuating actuator 130. In this manner, small adjustments can be made by a physician to align sheath 90 with tip 30 before use of delivery system 300. Such adjustments can be necessary if inner lumen 10 elongates in the process of sterilization.
For purposes of illustration and not limitation, as depicted in FIG. 15, in further accordance with the invention, when delivery system 300 is provided with more than one seat 116 to permit delivery of more than one medical device 400, adjustment member 270 (see FIG. 2) can be used to realign the distal end 98 of sheath 90 with tip 30 after a medical device has been delivered. For example, after a fist medical device, such as a stent 400ais delivered, seat 116a is exposed, and sheath 90 is still covering medical device 400b. By unlocking adjustment lock 280, inner member 10 and tip 30 can move longitudinally with respect to sheath 90, bumper 50a, and medical device 400b. Inner member 10 is then moved in a proximal direction with respect to sheath 90. In the process, bumper 50a, which is preferably freely disposed over inner member 10, is urged against medical device 400b, and the distal end 98 of sheath 90 is brought into contact with tip 30, and the adjustment lock 280 is locked to prevent bumpers 50a-50n and medical devices 400b-400nfrom moving with respect to sheath 90 or inner member 10. Delivery system 300 can then be displaced to a different location within the patient to deliver subsequent medical devices 400b-40011. The ability to deliver multiple medical devices without removing delivery system 300 from the patient can decrease the total amount of time necessary for the medical procedure This arises from eliminating the need for preparing and introducing multiple delivery systems to the patient. In addition, introducing a single delivery system into a patient instead of multiple devices also reduces trauma to the patient.
Moreover, in the embodiment of the invention in FIG. 15, it would also be possible to equip each bumper 50a-50n with channels 53a-53n(not shown) as described in detail above to direct a beneficial agent to a predetermined location in a patient. Thus, each time a medical device 400a-400n is delivered, it is possible to direct a beneficial agent through channels 53a-53n and/or via material deposited in perforations 64 in each bumper segment 50a-50n. An agent to release beneficial agent in perforations 64 can additionally or alternatively be introduced through flush port 240 and directed through channels 53a-53n to a predetermined location in a patient.
In further accordance with the invention, the delivery system also includes a method of assembling a delivery system for delivering a medical device. The method includes providing a sheath, providing a bumper, positioning the bumper into the sheath, providing a medical device, disposing the medical device in the sheath, providing an inner member having a tip formed at a distal end thereof, placing the inner member through the medical device and the bumper, and positioning a handle over the inner member. For purposes of illustration and not limitation, reference will be made to a method of assembling the delivery device of FIG. 1 described in detail above.
As embodied herein, the method includes providing a sheath such as sheath 90 depicted herein. However, other types of sheaths may be used. For example, although a bendable sleeve type member has been depicted herein, other forms of sheaths, including sheaths that peel away from a medical device and sheaths that fold over onto themselves when a distal end thereof is pulled proximally may be used.
The method also includes, providing a medical device and disposing the medical device in the sheath. As previously mentioned, different types of medical devices 2 can be provided in accordance with the method of the invention.
When the medical device 400 is provided in the form of a self-expanding stent, the stent is compressed from an 40 expanded state to a compressed state for loading by crimping the stent in a stent-crimping machine. This may be accomplished, for example, by stretching out the distal end 98 of sheath 90 with tweezers, and positioning distal end 98 into the stent crimping machine so that the machine grips the distal end 98 of sheath 90. The stent crimping machine then crimps the stent and advances it proximally into the distal end 98 of sheath 90. After the stent has been loaded, the stretched out portion of the distal end 98 is then trimmed off. The distal end 98 of sheath 90 is provided without a reinforcing layer 114. This is particularly advantageous where the distal end 98 is stretched out to load the stent as described above. Moreover, the medical device disposing step includes placing the medical device 400 into the distal end of 15 the sheath. The medical device disposing step preferably occurs after the bumper positioning step, as described below. It is further contemplated that the medical device 400 may be coated with a lubricious coating such as silicone oil or the like prior to crimping, thereby reducing frictional forces between the medical device and the crimping device as well as frictional forces between the medical device and the sheath. Additionally, the lubricious coating may reduce frictional forces during deployment of the medical device.
The method further includes the steps of providing a nose and placing the sheath through the nose, if desired.
In accordance with this aspect of the invention, sheath 90 is placed through a nose 210 of a handle 120 that is provided, as described above. Preferably, the sheath 90 is placed through the nose 210 prior to positioning the bumper 50 in the sheath 90, as described below. In accordance with another aspect of the invention, the nose providing step additionally includes the steps of providing a stabilizer such as stabilizer 220 and disposing stabilizer 220 on nose 210, if desired.
Even more preferably, if a rotatable actuator is to be provided, shuttle 140 is positioned on the sheath 90 prior to placing the sheath 90 through the nose 210. In this manner, the method further includes the step of positioning the shuttle 140 into a guide member such as shuttle guide 160 as depicted herein.
In further accordance with the invention, the method includes providing a bumper and positioning the bumper into the sheath. For purposes of illustration and not limitation, a bumper such as bumper 50 described herein may be provided. The bumper positioning step further includes the step of positioning bumper 50 into the distal end 98 of the sheath 90. Other variations of bumper 50 described herein are also appropriate for the bumper positioning step.
Additionally, the bumper providing step includes the steps of providing a sleeve member 51 having a cylindrical wall 56, providing a proximal radiopaque portion 76, and placing the proximal radiopaque portion 76 on the sleeve member 51. Proximal radiopaque portion 76 can take various forms, as described in detail above. The bumper providing step also includes the steps of providing a covering member 80 as described in detail above, and disposing covering member 80 on sleeve member 51 and proximal radiopaque portion 76 of bumper 50, if desired.
In still further accordance with the invention the method further includes providing an inner member and placing the inner member through the medical device and the bumper.
For purposes of illustration and not limitation, the inner member placing step generally provides for placing inner member 10 through medical device 400 and bumper 50. Preferably, the inner member placing step occurs after disposing bumper 50 in sheath 90. Even more preferably, the proximal end of the inner member 10 is inserted in the distal end of the sheath.
The inner member placing step also includes positioning the proximal end 12 of the inner member 10 through the medical device 400 and the bumper 50. This is particularly appropriate in the situation where the method also includes the steps of providing a tip 30 and positioning the tip 30 on the distal end 14 of the inner member 10. In this situation, the proximal end 12 of inner member 10 is the only end of inner member 10 that is placed through medical device 400 and bumper 50 since tip 30 has already been attached. The tip providing step can further include the steps of providing a distal radiopaque portion 40 and placing the radiopaque portion on the tip 30. The method can also include the step of annealing the inner member, as described in detail above.
In further accordance with the invention, the method further includes the step of positioning a handle over the inner member.
For purposes of illustration and not limitation, a handle 120 as described in detail above may be provided. In accordance with this aspect of the invention, the handle positioning step includes the steps of providing a thumb screw assembly. The thumb screw assembly 188 of this embodiment includes, for example, a knob 180 and a thumb screw 170. The thumb screw assembly 188 is further positioned on nose 210. The handle positioning step also includes disposing a lock 200 on the thumb screw assembly 188 as described in detail above. The lock 200 preferably snaps into place.
In accordance with another aspect of the invention, the method also includes the step of positioning a hypotube 30 over the proximal end of the inner member.
For purposes of illustration and not limitation, as embodied herein, hypotube 250 is positioned over the proximal end 12 of inner member 10. In accordance with this aspect of the invention, a connector 260 as described above is also provided, disposed coaxially over hypotube 250. The method further includes the step of attaching connector 260 to hypotube 250 by way of an adhesive or other connection.
In accordance with another aspect of the invention, the method further includes the step of applying a lubricious material to the distal end 98 of sheath 90. In accordance with this aspect of the invention, the lubricious material application step preferably occurs when inserting the inner member placing step. For example, when inserting proximal end 12 of inner member 10 through medical device 400 and bumper 50 (where medical device 400 and bumper 50 already having been disposed in sheath 90), a small gap (such as two inches in length) is maintained between proximal end 32 of tip 30 and distal end 98 of sheath. A small amount of lubricant (e.g., two drops of liquid silicone oil) is then applied to distal end 98 of sheath 90. Other suitable liquid lubricants can also be used. A pressurized fluid is then applied to the distal end of the sheath to cause the lubricious material to coat the medical device 400. This step is achieved, for example, by installing a force air fixture over distal end 98 of sheath 90. The force air is activated, and the silicone oil or other lubricant can be seen to migrate along medical device 400, provided that distal end 98 of sheath 90 is made from a transparent material.
In a preferred embodiment, the method further includes the steps of providing an adjustment member 270 configured to move the inner member 10 with respect to the sheath 90 and disposing the adjustment member 270 on the inner member 10. The adjustment member disposing step preferably includes positioning the adjustment member 270 on the proximal end 12 of the inner member 10.
In further accordance with the invention, the method includes the step of applying tension to the inner member.
For purposes of illustration and not limitation, as embodied herein, tension is applied to the proximal end 12 of the inner member 10 to cause the distal end 98 of the sheath 90 to come into physical contact with proximal end of tip 30. The tension applying step is performed after disposing adjustment member 270 over inner member 10, but before attachment of adjustment member 270 to inner member 10. Before attachment of adjustment member 270 to inner member 10, it should be verified that proximal end 32 tip 30 is properly aligned with distal end 98 of sheath 90 and that distal radiopaque portion 40 is flush and aligned with medical device 400. Preferably, thumb screw assembly 188 is positioned over inner member prior to attaching adjusting member to inner core 10, although handle 120 is assembled and attached to delivery system 300 at a later stage if properly configured. Tension may be applied again by the physician upon receipt of the delivery system if inner member 10 lengthens during sterilization or shipping by unlocking adjustment lock 280, and moving adjustment hypotube 272 proximally to bring proximal end 32 of tip 30 into contact with distal end 98 of sheath 90. The method steps need not be practiced in any particular order. The method of the invention can be modified as needed to suit a particular purpose, depending at least in part on the final configuration of the delivery system. For example, handle 120 could be configured so that it is installed last, or thumb screw assembly 188 could be configured such that it is installed after connector 260 is installed.
In further accordance with the invention, the delivery system can further include an incompressible inner member. The inner member which this embodiment pertains has two main sections; a distal section and a proximal section. The distal section is designed to be flexible, and during stent deployment, it is critical for the inner member design not to move, give or bow proximal from the compressible load. The proximal section is designed to have a relatively high longitudinal stiffness to provide good push-ability. At the joint area of these two sections, it is desired that there is a smooth transition so that the inner member acts as one delivery system. Refer to FIGS. 17A and 17B. The inner member is made up of material that is flexible as well as material that will not buckle under compression. The inner member is broken up into two separate sections as noted above. In a preferred embodiment, the proximal section of this design is a Parylene coated mandrel. The Parylene coating provides a lubricious surface to lower the frictional forces between the inner and outer member, In further embodiments of the invention, any material known or convenient can be used. The mandrel enables the proximal portion of the system to be small in profile, but still provide the good push-ability and resistance to buckle under compression.
In further accordance with this embodiment of the invention, the distal section of the delivery system comprises a cable tube material. The cable tube design enables the distal section of this system to be incompressible and have minimal elongation all while not needing a supportive jacket. Current self-expanding delivery systems achieve these required attributes by using multiple layers of material meaning more manufacturing steps and larger overall profile, e.g., the polymer version shown in FIG. 20A suffers from bowing or compression during deployment. The stacked coil version shown in FIG. 20B suffers from a large profile and added manufacturing steps. In a preferred embodiment, the cable tube design used is a 16-fillar (wire O-0.12-mm) wound cable that is then grinded on the OD to achieve a lower profile. The cable tube ends can then laser welded or bond around the perimeter with any method known or convenient to ensure that the cable doesn't open up. If the cable was to open up, the system would elongate and/or compress. Specifications on a preferred embodiment on this piece can be found in FIG. 18. The cable 1100 shown in FIG. 18 is right-hand wound and includes 16 wires each having a diameter approximately 0.12 mm, formed from stainless steel SS304 (C=0.08 max, Si=1.00 max, Mn=2.00 max, P=0.045 max, S=0.030 max, Ni=8.00-10.50, Cr=18.00-20.00, Fe=REF). The cable 1100 of FIG. 18 has a minimum inner diameter of approximately 0.0240 inches, outer diameter of approximately 0.031.+-.0.0012 inches, pitch length of 3.18.+-0.100 mm, and droop of 130.+-.30 mm. The ends of the cable of FIG. 18 are preferably laser welded to prevent unwinding. A cross section of the delivery system 700 of FIG. 20D utilizing the cable tube material is shown in FIG. 20C including cable tube 730 and guidewire lumen 732.
In a further preferred embodiment, it is desired that the distal section have a lubricious ID, so to achieve that this design has a tri-layer material that runs through the ID of the cable tube. In a preferred embodiment, the tri-layer material is made up of HDPE on the ID, Primacor in the middle, and Pebax 72D on the outside. HDPE layer provides the lubricious surface of the guide wire to ride in and the Pebax on the outside allow the material to be manufactured. The primacor in-between holds the two materials together.
In accordance with a further aspect of the invention, it is desired that the inner member has a smooth transition from the stiffness of the proximal section to the flexibility of the distal section. It is also desired that this joint be strong enough to not come apart if the inner member is being pulled in tension (e.g., if the system gets caught on removal) and strong enough to not buckle under the maximum compression seen during deployment. In a preferred embodiment, the distal section can be thermally bonded or soldered to a shaved portion of the proximal section and a polymer sleeve can cover this section and adhesive bonded to both sections. (See FIGS. 17A and 17B.)
In accordance with another aspect of the invention, the delivery system has a flexible distal assembly 600 where a medical device such as a stent 630 or self-expanding implant is crimped and positioned in between the inner and outer members, 600a and 600b, respectively (See FIG. 19). In a preferred embodiment, the outer member 600b sits over the medical device keeping it collapsed. The inner member 600a can provide radiopaque markers 620, 622 that keep the stent 630 in place and give the physician the ability to align the stent under a fluoroscope when the system is in the body. The inner member proximal radiopaque markers 620 can also act as a stop as the outer member 600b is retracted back, so the medical device can be deployed into the body. The inner member can further include a distal radiopaque marker 622. It is desired that the distal assembly profile be as small as possible, have a low deployment force (<4 lbs), and be flexible enough to track through tortuous human anatomy.
It is further desired that the flexible distal assembly 600 have a radial strong outer member 600b that can withstand the radial outward force of self-expanding medical devices such as stents, but also be flexible without kinking. If the outer member kinks, the medical device will not deploy or will partially deploy causing injury to the patient. In a preferred embodiment according to this embodiment, a thin walled polyimide outer member which gives the needed radial strength and filling the ID of the outer member 600b around the stent with soft polymer material on the inner member leaving less than 0.5-mm gap axially and ≦0.0015′′ gap radially anywhere underneath the distal outer member can achieve the flexibility needed and to prevent the outer member from kinking. Further, to prevent kinking the marker bands 622, 624 can have polymer “bumps” that they are glued to and then glued to the inner member 600a. These bumps can have tapered side walls and/or steps that transition between marker band profile to inner member profile to reduce kink points. The tip 640 of the distal assembly 600 is attached to the inner member 600a and fills the ID of distal edge of the outer member 600b and then rises in profile to cover the distal end of the outer member 600b. The tip 640 then tapers to the tri-layer material creating a nose for the complete system. In a preferred embodiment, the tip 640 is made of radiopaque filled low durometer Pebax (Pebax 25D). In accordance with a further aspect according to this embodiment, the tip 640 has a non-uniform taper 610 that the outer member end pushes up against. This feature can ensure that there is always room for liquid to exit between the outer member and inner member. Liquid exiting between these two members can show the system has been appropriately flushed. See FIG. 19: Non-uniformed taper.
In accordance to a further embodiment of the medical device delivery system, the system includes a radiopaque visual aid of the sheath retracting for physicians during a procedure. This visual will provide proof with confidence that the device being deployed is fully deployed. In an embodiment according to this aspect of the invention, the visual aid is a radiopaque filled polymer tube that is cut into small sections and bonded to the distal end of the outer member sheath on the retractable sheath delivery system. This ring could be laser or heat bonded, mechanically bonded, bonded by glue or otherwise attached to the sheath by any process known or convenient. In a preferred embodiment, the radiopaque filled polymer is a low durameter Pebax. The radio-opaque filler used is Tungsten. The fill percentage is between 45-93 wt %. The marker band will be flexible, which is important for trackability of the delivery system. The marker band is useful when a medical device such as a self-expanding implant is deployed into the human anatomy. The distal marker will move as the distal sheath is retracted. As the sheath retracts, the physician will see the distal marker move closer to proximal marker under fluoroscope. As the distal marker 810 gets closer to the proximal marker 812 the, the physician will be able to know how much of the implant is deployed and how much is left. Once the distal marker 810 is on top of the proximal 812, the physician will know with confidence that the delivery system has fully retracted. FIG. 21 illustrates a distal outer sheath 800 with distal marker 810 and proximal marker 812. FIG. 22 illustrates the invention in its crimped state and its retracted state respectively including outer sheath 800′, distal marker 810′ and proximal marker 812′. A variety of radiopaque fillers and thermoplastic and thermosetting polymers can be formulated together and formed into a flexible marker. Suitable radio-opaque fillers can include tungsten powder, Bismuth and Barium family compounds, lead, gold and platinum powders. Tungsten is preferred because of its high nuclear-density and cost/performance balance. Thus, lower concentrations of Tungsten can be mixed in various base polymers to yields greater radiopacity, all while preserving the polymers desirable flexible properties; compared to the more conventional Bismuth and Barium types, which tend to embrittle the base polymer at higher concentrations.
In another aspect of the invention, a delivery system is provided including a catheter shaft design that has multiple strands wound opposite to each other and capable of changing major diameters when a torque is applied. The change in major diameter can cause the strands to cinch and lock upon each other. This configuration results in improved torque response when the catheter is rotated in a given direction. In addition to improving the torque response, the catheter shaft also allows for improved manufacturability because the coils of the shaft can replace the electrode and lead components of the prior art shaft designs if desired, such as for example, a Maserati shaft known in the prior art.
As depicted in FIGS. 23 to 26, a catheter shaft having a coil generally is known in the art. For example, FIGS. 23 and 24 depict a shaft 910 having a single coiled wire 920 rotating about the shaft 910 in one direction, e.g., right-hand direction. As shown in FIG. 24, the coiled wire 920 is embedded within the wall of the catheter shaft 910. In this regard, it will be appreciated that the coil 920 may be bonded along the inner or outer surface of the shaft wall with similar effect. The coiled wire supplies increased axial and bending stiffness to the catheter shaft. Although such catheter shafts exhibit improved torque, they have drawbacks from whipping, which results in inaccurate delivery of biologics and ineffective treatment.
Another prior art catheter shaft having a coil member is depicted in FIGS. 25 and 26. This prior art catheter shaft includes a two-strand braid design. The two strands are oppositely clocked (i.e., one counter-clockwise, and one clockwise), and woven to form a stronger overall structure that is more resistant to twist. As depicted in the cross-section (FIG. 26) the strands may be disposed between an inner and outer layer 1022 and 1024, respectively, of the catheter wall. However, the strands 1020 are embedded and secured within the layers. It is also possible to co-extrude the braiding 1010 within a single-layered catheter shaft, similar to that shown for the coiled wire example above. The braid design may have improved torque response compared to the single direction coil due mainly to an increase in the torsion modulus to flexural modulus ratio in the catheter confined in the curved conduit. The lower the flexural modulus of the shaft portion in the curved conduit, the lower the unintended changes in flexural modulus with rotational orientation of the bending, thus there are lower changes in shaft stored energy. In the shaft portion proximal (and distal) to the confining curved conduit, the higher the shaft torsion modulus, the less rotation change is required to store or release a given amount of shaft stored energy.
The prior art catheters described above are each susceptible to catheter whipping, which occurs when the catheter shaft stores energy as a first end is rotated, and at some input angle, the catheter releases that energy, causing the output angle to quickly rotate through a relatively large angle until it again matches with the input angle. This phenomenon is well known and continues to be a vexation of catheter design. As such, there is a continued need for improved catheter design. Hence, and in another aspect of the present invention, a catheter shaft is provided that not only improves torque but also does not suffer from the whipping drawbacks of the prior art. For purpose of explanation and illustration, and not limitation, an exemplary embodiment of the of the catheter shaft with improved torque response in accordance with the invention is shown in FIGS. 27 and 28. As shown in FIG. 27, a shaft member 500 has a multilayered construction. For example, the shaft includes a first layer 510 and a second layer 512. A coil 520 is disposed between the first and second layers (510 and 512). The inner and outer layers of the catheter shaft 500 are not bonded along the entire length of the catheter shaft, such that the inner and outer layers can be generally rotationally free relative to one another. Instead, the proximal and distal layers are bonded over a short segment of the catheter. In one embodiment, the coil wire size may be equal or larger than 0.004′′×0.010′′. In an alternative embodiment, the coil and wire dimensions may be as follow: 0.095′′ MAX OD and 0.066′′ MIN ID using 0.003′′×0.010′′ wire. In an alternative embodiment, the coil and wire dimensions may be as follow: ID: 0.066′′; Wire: 0.003′′ thick×0.008′′ wide; No. of Filars: 4; No. of layers: 3; tight wound on both inside and mid layer, open pitch with pitch length=0.080′′; Length: 108.2 to 108.7 cm; Distal weld length (max): 0.080′′; Proximal weld length (max): 1′′; Rounded ends, no sharp edges; Minimal band radius: 0.5′′.
As shown in FIG. 28, a plurality of coil members (open outer coil RH 520, middle coil LH 522, and inner coil RH 524) can be disposed between the first and second layers (510 and 512). In this regard, the proximal end and distal end of the shaft include the layers and coils bonded together as described above.
For purpose of illustration and not limitation, the embodiment of FIG. 28 has three coil members disposed relative to the longitudinal axis of the catheter shaft such that a first coil is an inner coil, a second coil is a middle coil and a third coil is an outer coil. In one embodiment, the inner and middle coils are wound in opposite directions, while the outer coil is wound in a direction opposite the middle coil. For example, FIG. 28 shows a catheter having an outer coil 520 wound in a right-hand direction, and a middle coil 522 would in a left-hand direction, and an inner coil 524 wound in a right-hand direction. Preferably, the inner and middle coils are coiled such that the pitches defined by the helix of the coil are tightly packed. The outer coil preferably is configured to have a greater pitch than the inner or middle coils. Additionally, the outer coil can include an opening for better adhesion with a polymer jacket heat fused to the outer surface of the shaft, if such polymer jacket is desired. Although this embodiment has been described as having three coil members, the shaft may include at least two coils, for example, four or more coils.
The individual coils disposed between the inner and outer layers of the shaft are capable of moving relative to each other when torqued and are also capable of moving relative to the inner and outer layers. Therefore, when the catheter is torqued, the coils can or will tend to deflect as energy is added to them. For example, and with reference to the embodiment of FIG. 28, a clockwise torque will cause the inner coil which is coiled in a right-hand direction to increase in diameter. In contrast, the same torque will cause the middle coil to decrease in diameter since the middle coil is left-handed. As a result, the inner and outer coils will cinch each other and form a locked structure. Since the coils will be unable to deflect further under additional torque, the torque will be efficiently transferred through the catheter without significant whipping. Accordingly, the torque response of the catheter shaft is thus improved. The same effect applies if more than two coils are provided. When the shaft is torqued such that the mid coil embodied herein will tend to open, the inner and outer coils will tend to close. Since the mid coil is sandwiched by the inner and outer coils, which are wound in opposite direction to the mid coil, the same cinch effect applies to lock the three coil layers together preventing loss of the torsional energy. Thus the torque transmission is improved.
In accordance with the invention, the shaft exhibits minimal or no whipping and improved torque. The improvements of the shaft are depicted in FIG. 29, which illustrate torque results by displaying the input and output angle of the catheter shaft in accordance with the present invention. As demonstrated, the input and output angles match each other quite closely, exhibiting minimal or no whipping and therefore improved torque response of the catheter shaft. As shown in FIG. 29, rotation in the clockwise direction results in close correlations between input and output motion.
By contrast, as illustrated in FIG. 30, a prior art catheter shaft having a braid exhibits an input angle advancing in a gradual manner, while the output angle acts in a step fashion, indicating significant catheter whipping. As shown in FIG. 30, poor correlation between input and output shaft motion manifests as whipping.
In an alternative embodiment of the invention, the improved catheter construction is configured and disposed in a portion of the catheter that will be located within the aortic arch during the interventional procedure. This represents the section where the energy storage fluctuations that cause whipping mainly occur. As a result, a braided shaft or other design may be used for the long proximal portion of the shaft where the torsion modulus is high and there is little fluctuation in shaft stored energy. This may reduce cost of manufacturing and increase benefit-to-cost ratio or facilitate other custom designs and applications. Similarly, if an additional section of curvature exists, such as within the heart chamber or within a complementary guide catheter, this section of the catheter may also include the improved catheter construction in accordance with this invention.
In one embodiment, a method for manufacturing a shaft of the invention is provided. During manufacturing of the shaft, three coils are wound over each other by conventional coiling machine known in the art without releasing of tension. The ends of the three coils are securely welded together locking up the tension within the shaft. In this regard, when the coil is released from the coiling machine, each coil tries to release its tension but the outer diameter (OD) is constrained by the neighboring layer. Therefore, the three layers “lock up” to each other. In contrast, the known coiling process of the prior art allows the coil to release from the mandrel (of the coiling machine) post process and the coil diameter grows to the final diameter while the tension from winding releases.
In accordance with another aspect of the invention, the shaft may provide improved shaft having electrodes and/or leads. For example, the prior art Maserati catheter includes electrodes positioned near the distal end of the catheter to receive signals that are delivered through leads along the catheter shaft to a proximal processor. The electrodes and leads can be difficult to place accurately, making it a very tedious and costly manufacturing step. In one embodiment of the invention, the coils can be used as the electrode and lead. For example, the middle and inner coils can be tightly wound and protected along the length of the catheter by the inner and outer shaft layers, the outer layer can be exposed near the distal end of the catheter to expose the coils as an effective electrode. In this regard, electrical signals can be received by the coils and passed along the length of the catheter to the proximal end, where the coils are routed to, and connected with, leads that interface with the processor. In this way, the electrode, leads, and placement thereof, are all combined into the shaft manufacturing using the design of the present invention. Additionally, one or more insulated wire can be fabricated into the coil strands and be used as lead wires for an electrode that is away from the coil, such as the tip electrode and the electrode located a short distance proximal to the tip electrode. This eliminates the need to route a long skinny and fragile wire through the proximal shaft.
It will be apparent to those skilled in the art that various modifications and variations can be made in the device, method and system of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.

## Claims

1. A delivery system for delivery of a medical device, the delivery system comprising:
an inner member having a proximal section, a distal section and a longitudinal axis therebetween, the inner member including a first layer and a second layer, the first layer and the second layer being attached together at a first segment and a second segment, the second segment being spaced from the first segment along a length of the inner member, the first layer and the second layer being free of attachment between the first segment and the second segment; the inner member further comprising at least two wires disposed along the length of the inner member between the first layer and the second layer, wherein the at least two wires include a first coil wound about the longitudinal axis in a first direction and a second coil wound about the longitudinal axis in an opposite direction, the first coil having a first diameter and the second coil having a second diameter, wherein at least one of the first diameter and the second diameter changes when a torque is applied; and
an outer member disposed about the inner member.

2. The delivery system of claim 1, wherein the length of the inner member is incompressible and exhibits minimal elongation.

3. The delivery system of claim 1, wherein the first layer is rotationally moveable relative to the second layer.

4. The delivery system of claim 1, wherein the at least two wires are capable of movement relative to each other between the first segment and the second segment.

5. The delivery system of claim 1, wherein the inner member further includes a middle layer disposed between the first layer and the second layer.

6. The delivery system of claim 1, wherein the first layer is lubricious.

7. The delivery system of claim 1, wherein the inner member includes at least two radiopaque markers.

8. The delivery system of claim 7, wherein the outer member is a sheath moveable relative to the inner member and the two radiopaque markers are configured to inhibit movement of the sheath from a first position to a second position.

9. The delivery system of claim 8, wherein the radiopaque markers have polymer bumps.

10. The delivery system of claim 1, further comprising a stent mounted on the inner member.

11. A catheter shaft comprising:
a multilayered tubular member having an axis and a first layer and a second layer, the first layer and the second layer being attached together at a first segment and a second segment, the second segment being spaced from the first segment along a length of the tubular member, the first layer and the second layer being free of attachment between the first segment and the second segment;
the tubular member further comprising at least a first coil and a second coil disposed along the length of the tubular member between the first layer and the second layer, the first coil having a first diameter and the second coil having a second diameter, wherein at least one of the first diameter and the second diameter changes when a torque is applied.

12. The catheter shaft of claim 11, wherein the multilayered tubular member is bonded to the second layer at at least the first segment or the second segment with the first and second coils therebetween.

13. The catheter shaft of claim 12, wherein the first and second layers and the first and second coils are bonded together at the first segment and the second segment of the tubular member.

14. The catheter shaft of claim 11, wherein the first coil is wound in a first direction about the axis and the second coil is wound in a second direction about the axis opposite the first direction.

15. The catheter shaft of claim 14, wherein the first and second coils are wound at substantially equal pitches.

16. The catheter shaft of claim 11, further including at least a third coil disposed between the first and second layers.

17. The catheter shaft of claim 16, wherein the first and second coils are wound in opposite directions.

18. The catheter shaft of claim 17, wherein the third coil is wound in opposite direction as the second coil.

19. The catheter shaft of claim 16, wherein the first coil is disposed radially-inward relative to the second coil and the third coil is disposed radially-outward relative to the second coil.

20. The catheter shaft of claim 19, wherein the third coil has a pitch greater than a pitch of the first coil.

21. The catheter shaft of claim 19, wherein the first and second coils have substantially the same pitches.

22. The catheter shaft of claim 11, wherein the catheter is a sensor and at least one of the first and second coils is an electrode or lead.

23. The catheter shaft of claim 22, wherein the catheter further includes at least one insulating wire coupled with the at least one of the first and second coils.

24. The catheter shaft of claim 11, wherein the change of the at least one of the first diameter and the second diameter cause the first coil and the second coil to cinch together.

25. The catheter of claim 1, wherein the change of the at least one of the first diameter and the second diameter cause the first coil and the second coil to cinch together.