Catheter having monolithic multilayer distal outer member

A catheter having an integral multi-layer distal member

[0001] Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62/163, 822, filed on May 19, 2015, the contents of which are incorporated herein by reference in its entirety.

Technical field

[0003] The presently disclosed subject matter relates to devices for use in percutaneous transluminal coronary angioplasty (PTCA) or stent delivery systems or the like. In particular, the presently disclosed subject matter relates to a catheter having an integral multi-layered distal member.

Background technique

[0004] In percutaneous transluminal coronary angioplasty (PTCA) surgery, the guiding catheter is advanced in the patient & apos; s vasculature until the distal tip of the guiding catheter is seated in the desired coronary artery. The guidewire is advanced from the distal end of the guide catheter to the coronary artery until the distal end of the guidewire traverses the area to be expanded. A dilatation catheter having an expandable bladder on its distal portion is advanced into the coronary anatomy via the previously introduced guidewire until the capsule of the dilatation catheter is positioned across the ward. Once positioned, one or more expansions of the expanded bladder to a predetermined size at an appropriate pressure using the inflation fluid to compress the stenosis against the artery wall are performed one or more times to open the vessel passage. Typically, the expanded diameter of the capsule approximates the same diameter as the original diameter of the body lumen, which dilates to complete the dilation but not excessively enlarge the arterial wall. After the capsular dilation, the blood recovers through the dilated artery and can remove the dilatation catheter and the guidewire therefrom.

[0005] In such intracavitary procedures, restenosis of the arteries, i.e., re-formation of arterial occlusion may be present, which may necessitate another intracavitary surgery or some other means of repairing or reinforcing the expanded region . In order to reduce the rate of restenosis and to reinforce the dilated area, the physician may additionally or alternatively implant the intravascular prosthesis into the interior of the artery at the site of the lesion. Such stents or brackets may be bare metal, polymeric or coated with a medicament or other therapeutic agent. The stent or brackets may also be used to repair blood vessels having endomembrane or anatomical portions, or for weakening segments that substantially reinforce blood vessels. The stent or stent is typically in a contracted state at the desired location within the coronary artery to which the catheter, which in many ways resembles the capsule-shaped catheter in the capsule cavity, is delivered and is expanded by expansion of the capsule Large diameter. The capsule is contracted to remove the catheter, and the stent is implanted into the artery at the location of the dilatation ward. Covers on the inner or outer surface of the stent have been used, for example, to treat pseudoaneurysms and perforated arteries as well as to prevent plaque prolapse. Similarly, vascular grafts, including cylindrical tubes made of tissue or synthetic materials such as polyesters, expanded polytetrafluoroethylene, and DACRON®, can be implanted into the blood vessel to reinforce or repair blood vessels, or Anastomosis is used to connect blood vessel segments together. For details of the example stent, see, for example, U.S. Patent No. 5,507,768 to Lau et al. And U.S. Patent No. 5,458,615 to Klemm et al., The contents of each of which are incorporated herein by reference in their entirety In the text.

[0006] In addition to percutaneous transluminal angioplasty (PTA), PTCA and plaque resection surgery, cystic catheters are also used to treat peripheral systems (e.g., in venous systems or the like). For example, the capsule catheter is initially advanced by a guidewire to position the capsule proximal to the stenosis. Once in place, the capsule then expands and the blood vessel & apos; s restriction is opened and the stent or stent can be delivered as needed. Likewise, the capsule catheters are also used to treat other luminal systems throughout the body.

[0007] In general, the capsule catheter includes a hollow catheter shaft, wherein the capsule is fastened at the distal end. The interior of the capsule is in fluid flow relationship with the expansion lumen extending along the length of the shaft. Whereby the fluid under pressure can be supplied to the interior of the capsule via the expansion lumen. In order to position the capsule in a narrow area, the catheter shaft is designed in multiple parts to have suitable pushability (i.e., ability to transmit force along the length of the catheter), tracking and flexibility to enable easy The tortuous anatomy of the duct system progresses within. The catheter is also designed such that it can be retrieved from the patient after delivery. Conventional capsule catheters for intravascular surgery (e.g., endoluminal shaping and stent delivery) often have a relatively hard proximal shaft section to facilitate catheter advancement in the body lumen, with moderate (or transitional) flexibility And a relatively flexible distal shaft section to facilitate passage through tortuous anatomical structures (e.g., distal coronary arteries and nerve arteries) that do not damage the vessel wall or damage the stent in the case of stent delivery.

[0008] Conventional catheter shafts are often constructed with an inner member tube and an outer member tube with an annular space therebetween for expansion of the capsule. In the design of catheter shafts, it is desirable to prescribe or control the characteristics (e.g., strength, stiffness, and flexibility) of the sections of the catheter shaft to provide the desired catheter performance. This is conventionally practiced by combining separate lengths of tubular members of different materials and / or sizes and then assembling these separate members into uniaxial lengths. However, transitions between segments of different hardness or material can be the cause of undesirable kinking of the length along the length of the catheter. Such kinked catheters are particularly prominent in fast exchange (RX) catheters where the proximal shaft segment does not include additional construction of the guidewire lumen tube. For example, conventional RX catheters typically include a proximal hypotube with a single inflation lumen therethrough, a medial transitional section, and a dual lumen or coaxial configuration at the distal segment , Having both a guidewire lumen and an expansion lumen therein. Known techniques for minimizing kinks at transitional portions between more rigid proximal segments and more flexible distal segments include minimizing kinks at the transition portion between the more rigid proximal segments and the more flexible distal segments including two or two of materials having different flexibility More than one segment are joined together to form an axis. Such transitional bonding needs to be strong enough to withstand the tension and thrust on the shaft during use.

[0009] [0009] To address the problem, catheters with varying degrees of flexibility and / or hardness have been developed where each segment of the catheter shaft is specifically tailored to provide the desired catheter performance. For example, each of U.S. Patent Nos. 4,782,834 to Maguire and US 5,375,655 to Burns discloses a catheter having a plurality of sections along the length of a catheter made of a material having a different hardness U.S. Patent No. 4,976,690 to Solar discloses a catheter having a medial midline portion that provides increased flexibility along the catheter shaft; U.S. Patent No. 5,423,754 to Cornelius discloses the use of a catheter in a catheter The distal portion of the catheter has a greater flexibility due to both material transitions and dimensional transitions in the shaft; the proximal portion of the catheter disclosed by Cornelius U.S. Patent No. 5,649, 909 is useful as a result of the application of the polymeric coating to U.S. Patent No. 8,444,608 to Haslinger discloses a multilayered catheter shaft using a combination of a high Shore D durometer material and a lower Shore D hardness gauge material to reduce the stiffness of the shaft, Kink, the content of each of which is incorporated herein by reference in its entirety.

[0010] However, one difficulty is balancing the generally conflicting properties of the strength and flexibility of the catheter shaft. Another difficulty is providing a flexible transition that improves the operability of the catheter but has a sufficiently strong transitional bond. In addition, the use of multiple shaft segments can cause undesired kinking along the length of the conduit, and if any imperfections occur in the bond between the segments, the bonds may cause failure (e.g., cracking) position.

[0011] Thus, there remains a need for a catheter with an axis that has a combination of improved properties (e.g., strength, flexibility, ease of manufacture, and lower cost). There is also a need for a catheter that has improved tracking capability to further penetrate a tortuous anatomy (e.g., a distal coronary artery) while maintaining the ability to retract from the meandering anatomy without failure. There is also a need for a catheter with an outer member that can be coupled to both the proximal metal hypotube and the inflatable bladder.

Summary of the Invention

The objects and advantages of the presently disclosed subject matter are set forth in the description which follows, and will become apparent from the following description, and will be learned by practice of the subject matter of the disclosure. Additional advantages of the disclosed subject matter will be realized and attained by the method and system particularly pointed out in the written description and claims hereof as well as from the accompanying drawings.

In order to achieve these and other advantages and in accordance with the purpose of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter provides a capsule catheter comprising: an outer shaft comprising a hypotube and an entirety A multi-layered distal external member and having an inflation lumen defined therethrough; a bladder in fluid communication with the expansion lumen; and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multi-layered distal member has a proximal portion and a distal portion. An integral multilayer distal outer member having: an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi; and an outer layer comprising an outer layer having a tensile strength at room temperature of less than about 130 & lt; RTI ID = 0.0 & gt; Lt; / RTI & gt; per square inch of flexural modulus of the second polymer. The proximal end of the monolithic multi-layered distal member is coupled to the hypotube. The monolithic multi-layered distal member is necked down to a reduced diameter along at least a portion of its length. The capsule has a proximal capsule axis coupled to a distal end of the monolithic multi-layered distal member. The inner tubular member extends distally through at least a portion of the capsule from a proximal port in a proximal portion of the monolithic multi-layered distal member.

[0014] As embodied herein, the second polymer can be a polyether block amide (e.g., commercially available from Pebax®). The polyether block amide can have a Shore D hardness between 63D and 72D. In some embodiments, the first polymer can be nylon. The nylon can be selected from the group consisting of nylon 12, nylon 11 and copolymers thereof.

[0015] Additionally and as embodied herein, the monolithic multi-layered distal member can have at least one intermediate layer disposed between the inner layer and the outer layer. The capsule catheter can include an inner tubular member coupled to the monolithic multi-layered distal member at the proximal port. The inner tubular member can include a plurality of inner tubular members. The multilayer inner tubular member can include an outer layer of an inner lubricating layer and a polyether block amide (e.g., Pebax®).

[0016] In some embodiments, the monolithic multi-layered distal member is necked down to a reduced diameter along a portion of its length such that the proximal portion has a proximal outer diameter and the distal portion has a distal outer diameter, The proximal outer diameter is greater than the distal outer diameter. Alternatively, the monolithic multi-layered distal member is necked down to its reduced diameter along its entire length such that the monolithic multi-layered distal member has a constant diameter along its entire length.

[0017] In some embodiments, the monolithic multi-layered distal member is necked down to a reduced diameter along a first portion of its length and necked down to a second reduced diameter along a second portion of its length, Such that the proximal portion has a proximal outer diameter and the distal portion has a distal outer diameter that is greater than the distal outer diameter. Additionally, the monolithic multi-layered distal member can be necked down to a third reduced diameter along a third portion of its length, which can be proximal to the proximal capsule axis.

As embodied herein, the hypotube can further include a distal end, and the outer surface of the hypotube can be roughened at the closest distal end.

[0019] The subject matter of the present disclosure also provides a capsule catheter having an outer shaft comprising a hypotube and an integral multi-layer distal member. The outer shaft has an expansion lumen defined therethrough. The monolithic multi-layered distal member has a proximal portion and a distal portion. An integral multi-layer distal outer member having an inner layer comprising a first polymer having a tensile strength greater than about 8,000 pounds per square inch; and an outer layer comprising an outer layer having a tensile strength of less than about 130,000 Pounds per square inch of flexural modulus of the second polymer. The proximal end of the monolithic multi-layered distal member is coupled to the hypotube. The monolithic multi-layered distal member is necked down to a reduced diameter along at least a portion of its length such that the proximal portion has a proximal outer diameter and the distal portion has a distal outer diameter. The proximal outer diameter is greater than the distal outer diameter. The capsule catheter also includes a capsule in fluid communication with the inflation lumen. The capsule has a proximal capsule axis coupled to a distal end of the monolithic multi-layered distal member. The capsule catheter also includes an inner tubular member having a guide wire lumen defined therethrough. The inner tubular member extends distally through at least a portion of the capsule from a proximal port in a proximal portion of the monolithic multi-layered distal member. This capsule catheter can include any or all of the features described herein above with respect to the capsule catheter.

[0020] The subject matter of the present disclosure also provides a method of manufacturing a capsule catheter. The method includes neck-fastening a tubular member to form an integral multi-layered distal member that is at least partially constricted along its length. An integral multi-layer distal outer member having an inner layer comprising a first polymer having a tensile strength greater than about 8,000 pounds per square inch; and an outer layer comprising an outer layer having a tensile strength at less than about 130,000 Pounds per square inch of flexural modulus of the second polymer. The method also includes providing a hypotube; coupling a proximal end of the monolithic multi-layered distal member to a hypotube to form an outer shaft having an expansion lumen defined therethrough; A proximal bladder axis; coupling a proximal bladder axis to a distal end of the monolithic multi-layered distal external member; and providing a distal end having a guidewire lumen defined through An inner tubular member thereof. The inner tubular member extends distally through at least a portion of the capsule from a proximal port in the monolithic multi-layered distal member. Such a method can include any or all of the features described herein above with respect to the capsule catheter.

BRIEF DESCRIPTION OF THE DRAWINGS Fig

[0021] Figure 1 schematically depicts a representative embodiment of a catheter in accordance with some aspects of the presently disclosed subject matter.

[0022] FIG. 2 is a cross-sectional view of a catheter shaft embodiment along line 7-7.

[0023] FIG. 3 is a cross-sectional view of an alternative embodiment of a catheter shaft along line 7-7.

4 schematically depicts a partial representative embodiment of a catheter in accordance with some aspects of the presently disclosed subject matter.

detailed description

[0025] Reference will now be made in detail to the various exemplary embodiments of the presently disclosed subject matter, exemplary embodiments of which are illustrated in the accompanying drawings. The structure of the disclosed subject matter and corresponding manufacturing methods will be described in connection with a detailed description of the catheter.

[0026] In accordance with the presently disclosed subject matter herein, a capsule catheter is provided that includes an outer shaft comprising a hypotube and a monolithic multi-layered distal member and having an expansion tube A cavity in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multi-layered distal member has a proximal portion and a distal portion. An integral multi-layer distal outer member having an inner layer comprising a first polymer having a tensile strength greater than about 8,000 pounds per square inch; and an outer layer comprising an outer layer having a tensile strength of less than about 130,000 Pounds per square inch of flexural modulus of the second polymer. The proximal end of the monolithic multi-layered distal member is coupled to the hypotube. The monolithic multi-layered distal member is necked down to a reduced diameter along at least a portion of its length. The capsule has a proximal capsule axis coupled to a distal end of the monolithic multi-layered distal member. The inner tubular member extends distally through at least a portion of the capsule from a proximal port in a proximal portion of the monolithic multi-layered distal member.

[0027] drawings ( wherein like reference numerals throughout the various views always refer to the same or functionally similar elements) is used to further illustrate various embodiments and to explain various principles and advantages all in accordance with the disclosed subject matter . For illustrative and illustrative purposes and not limitation, exemplary embodiments of a capsule catheter having an integral multi-layered distal member are shown in FIGS. 1-3. Catheters with integral multi-layer distal members described herein and methods of making and using the catheters are not limited to the illustrative embodiments described or depicted herein.

1-3 illustrate an embodiment of the presently disclosed subject matter, i.e., a capsule catheter 100, which is a fast exchange type catheter. As shown in FIG. As illustrated in FIG. 1, the catheter 100 includes an elongate catheter shaft 10 having a proximal end, a distal end, an outer shaft 13, a proximal shaft segment 12, and a distal shaft segment 14. As shown in FIG. The outer shaft has an expansion lumen 11 defined therethrough. The proximal shaft section 12 can be a hypotube 30 having a distal end 31 and an outer surface 32. [ The hypotube 30 can be made of any suitable material, such as a metal (e.g., stainless steel). In some embodiments, the hypotube 30 can be roughened at the proximal distal end 31 to allow for improved integration to the monolithic multi-layered distal member 40. In some embodiments, The elongate catheter shaft 10 also includes an inner tubular member 50. The monolithic multi-layered distal member 40 has a tubular wall 48 with an inner layer 41 and an outer layer 42. [ The monolithic multi-layered distal member 40 also includes a distal portion 43 and a proximal portion 44. As shown in FIG. The expansion lumen 11 is defined by a plurality of tubular members 40. The inner tubular member 50 has a guidewire lumen 51 defined therein, which can be adapted to slidably receive the guidewire 52. [ The catheter 100 can also include an inflatable capsule 20 disposed on the distal portion 43 of the monolithic multi-layered distal member 40. [ The capsule 20 can have a proximal end 21 and a distal end 22.

The inner layer 41 of the monolithic multi-layered distal member 40 can include a first polymer having a tensile strength greater than about 8,000 pounds per square inch. For example and without limitation, the inner layer 41 can include nylon (e.g., nylon 12, nylon 11, or copolymers thereof). The outer layer 42 of the monolithic multi-layer distal member 40 can include a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. For example and without limitation, outer layer 42 can include polyether block amides (e.g., commercially available from Pebax®). The polyether block amide can have a Shore D hardness between 63D and 72D and can be, for example, Pebax® 63D, Pebax® 70D or Pebax® 72D. As is known to those of ordinary skill in the art, a tubular product formed from two polymer components is coextruded using a coextrusion machine to produce an outer layer 41 and an inner layer 41 with the two polymeric materials , The integral multi-layer distal member 40 can be formed.

1, proximal port 46 can be provided in tubular wall 48 of proximal portion 44 of monolithic multi-layered distal member 40 for illustrative and non-limiting purposes and is capable of The lumen 51 of the inner tubular member 50 is in fluid communication. The inner tubular member 50 can be coupled to the monolithic multi-layered distal member 40 at the proximal port 46. [ The guidewire 52 is capable of exiting the proximal port 46 proximally and extending to the proximal end of the catheter 100 adjacent and outside of the proximal segment 12. [

[0031] The monolithic multi-layered distal member 30 can be necked down to a reduced diameter along at least a portion of its length. For example, as illustrated in FIG. 4, for the purpose of illustration, a monolithic multi-layered distal member can be necked down to a reduced diameter along a portion of its length so that the integral multi-layer distal member 40 The end portion 44 can have a proximal outer diameter DP. , And the distal portion 43 of the monolithic multi-layered distal member 40 can have a distal outer diameter Dd. . As further illustrated in FIG. 4, the distal outer diameter Dm can be smaller than the proximal outer diameter DP. . In some embodiments, the monolithic multi-layered distal member is necked down to a reduced diameter DP along a first portion of its length. , And is necked down to a second reduced diameter Dd along a second portion of its length. Such that the proximal portion has a proximal outer diameter and the distal portion has a distal outer diameter, the proximal outer diameter being greater than the distal outer diameter. Additionally, the monolithic multi-layered distal member can be necked down to a third reduced diameter D3 along a third portion (not shown) of its length. The third reduced diameter can be smaller than the rest of the distal outer member 40 and can be closest to the proximal bladder axis 23 to allow the proximal bladder shaft 23 to more easily fit over the distal outer member 40 to effect thermal bonding to the reduced profile.

Alternatively, the monolithic multi-layered distal member may be necked down to its reduced diameter along its entire length such that the monolithic multi-layered distal member has a constant diameter along its entire length.

[0033] In accordance with the presently disclosed subject matter, necking of the distal outer member 40 can provide a more accurate size and reduced tolerance, enable shearing forces to be imparted to the material, and enable the partial orientation to be introduced into the polymeric material, It is possible to increase the strength of the distal outer member 40 and to provide an increased stent or support pusher without significantly affecting the flexibility. Furthermore, introducing a partial (e.g., linear) orientation into the polymeric material of the distal outer member 40 can provide more fracture strength than an axis made from a fully oriented polymer material (e.g., blown) More pushing force, and can still take some action (e.g., stretching or elongation) into consideration while recovering from the tortuous anatomy and reduce the likelihood of rupture or detachment.

[0034] At the junction between the hypotube 30 and the monolithic multi-layered distal member 40, the proximal portion 44 of the monolithic multi-layered distal member 40 can be configured to receive the distal end 31 of the hypotube 30 . The inner layer 41 of the multilayered tubular member 40 can be coupled to the outer surface 32 of the hypotube 30. [ The multi-layer distal outer member 40 allows selection of the material of the inner layer 41 to be compatible with the hypotube 30 in combination. For example, in some embodiments, the metal hypotube 30 will be coupled to the nylon inner layer 41 of the monolithic multi-layered distal member 40. [ The hypotube 30 and the monolithic multi-layered distal member 40 can be coupled by any known means (e.g., by applying heat to an overlapping region). For example and without limitation, electromagnetic energy (e.g., thermal energy, laser energy, or acoustic energy) can be applied to the distal outer member 40 for incorporation into the hypotube 30.

At the junction between the capsule 20 and the monolithic multi-layered distal member 40, the proximal end 21 of the capsule 20 and the proximal bladder axis 23 can be secured in a sealed manner to the monolithic multi- The outer layer 42 of the outer member 40 so as to be closest to the distal portion 43 of the monolithic multi-layered distal member 40. [ The multi-layer distal outer member 40 allows selection of the material of the outer layer 42 to be compatible with the material of the bladder 20 (which can be a different material from the inner layer 41 that is compatible with the hypotube 30).

[0036] The interior of the capsule 20 can be in fluid communication with the expansion lumen 11. For example, in some embodiments, the inflatable bladder 20 can be coupled to the outer surface 42 of the monolithic multi-layered distal member 40. As shown in FIG. The expandable bladder 20 can have a proximal bladder axis 23 at the junction between the capsule 20 and the tubular member 40. As shown in FIG. The capsule 20 can further include a distal capsule axis 24 that is secured to the distal end of the inner tubular member 50 in a sealing manner. The capsule may also include an operative length 25 between the proximal vertebral body segment 26 and the distal vertebral body segment 27. [ The joint 15 at the proximal end of the shaft can be configured to direct expansion fluid into the inflation lumen 11 and thereby into the capsule.

[0037] The proximal bladder axis 23 of the capsule 20 can be fusion bonded to the outer layer 42 of the monolithic multi-layered distal member 40 (e.g., by applying heat to the overlapping regions). For example and without limitation, electromagnetic energy (e.g., thermal energy, laser energy, or acoustic energy) can be applied to the proximal bladder axis 23 of the capsule 20 to bond at least a portion of the proximal bladder axis 23 to the outer layer 42. [ The proximal thylak axis of the heated capsule causes the polymeric material of the capsule 20 to soften or contract and flow. In some embodiments, the thermal tube (not shown) can be positioned about the outside of the proximal thymus shaft 23 of the capsule 20. [ Heat shrink tubing (also referred to as & quot; heat shrink tubing & quot;) can consist of a polymeric material configured to shrink upon heating. U.S. Patent No. 7,951,259, which is incorporated herein by reference in its entirety, discloses the use of heat shrink tubing in the manufacture of a catheter having a flexible distal end. The heat-shrinkable tubing shrinks upon heating and applies a radially inward force to the proximal bladder axis 23. The heat- In the event that the polymer of the proximal capsule axis 23 is in a molten or softened state, the diameter of the proximal cannula will be reduced by the force exerted by the thermal tube. After cooling of the capsule, the heat-shrinkable tube can be removed. Heating can be effected, for example, by laser heating (e.g., using C02 laser), contact heating (e.g., using aluminum nitride, resistive, RF), hot air, resistive heating, induction heating or the like. As embodied herein, a solid state laser can be used to heat the constrictor tube and soften the proximal capsule axis 23 for illustrative and non-limiting purposes. As a result, the outer surface of proximal capsule axis 23 can be bonded to the outer surface of distal portion 43 of monolithic multi-layered distal member 40 in its softened or molten state. The distal capsule axis 24 of the capsule 20 can be combined with the distal segment of the inner tubular member 50 in the same manner so as to provide a tapered, anti-invasive distal region (or tip) of the catheter.

[0038] The support mandrel 16 can be placed in the expansion lumen 11, with the distal end being located distally of the proximal port 46. [ The mandrel is typically a metal member (e.g., a stainless steel or NiTi member), thereby enhancing the pushability of the catheter 100. [ Alternatively, the distal end 31 of the hypotube 30 can include a cutting portion, as is known to those of ordinary skill in the art and as described in U.S. Patent Publication No. 2012/0303054, the contents of which are hereby incorporated by reference in their entirety In the text.

2 illustrates an enlarged cross-sectional view of the catheter 100 taken along line 2-2 in FIG. 1 for illustrative and non-limiting purposes. Starting from the center and moving outward, there is a guide wire 52 disposed within the guide wire lumen 51 defined by the inner tubular member 50. As shown in FIG. The inner tubular member 50 is disposed within an expansion lumen 11 defined by a unitary multi-layered distal member 40. As shown in FIG. The monolithic multi-layered distal member 40 includes an inner layer 41 and an outer layer 42. The multi- In some embodiments, a coating (e.g., a lubricating coating conventionally used on the catheter shaft) can optionally be provided on at least one segment of the outer surface of the monolithic multi-layered distal member 40. In one embodiment,

[0040] As embodied herein, the multi-layered distal member 40 is a unitary configuration extending distally from the hypotube 30 to the capsule 20. As shown in FIG. In contrast, a typical capsule catheter includes at one end a separate central shaft portion that is coupled to the hypotube and a separate distal outer shaft at the other end that is included in the midlap seal. According to the presently disclosed subject matter, the unitary configuration of the distal outer member 40 thus provides a seamless outer member that extends straight from the hypotube 30 to the proximal bladder axis 23 and eliminates the need for a catheter in a known capsule catheter An intermediate lap seal (located between the typical axial section and the distal shaft section) at a potential fault location. According to the presently disclosed subject matter, the monolithic configuration of the distal outer member 40 can provide a simpler design, easier and less expensive manufacturing, and fewer parts.

[0041] In some embodiments, the monolithic multi-layered distal member 40 can include an intermediate layer 45, as best shown in FIG. Depending on the material used, the intermediate layer 45 can provide an improved moisture barrier lining thereby improving the connection of materials to the outer layer 42 and the inner layer 41 and / or further processing of the catheter shaft (e.g., thermal bonding to other conduit components ) Provides a reduced stratification. In an alternative embodiment (not shown), a plurality of intermediate layers can be present.

[0042] For example, the intermediate layer 45 can be a tie layer and can improve the attachment of incompatible or less compatible first polymers to the second polymer, and further treatment of the catheter shaft, including but not limited to heat To other catheter components, for example, capsules and / or other shaft segments). The intermediate layer can comprise any suitable tie material known to those of ordinary skill in the art, such as ethylenepropylene acid copolymer (available from Dow Chemical, Primacor EAA), ethylene methyl acrylic acid copolymer Commercially available from DuPont, Nucrel) and / or Plexar tie layer resins available from Lyondel IBasell.

[0043] According to one aspect, the inner tubular member 50 can comprise an integral construction of a single material or multi-layer tube. For example, the inner tubular member can be a multi-layered tubular member and include at least an inner layer and an outer layer, including any of the construction materials, features and / or layers as described herein. Additionally or alternatively, the inner tubular member 50 can include a lubricious liner and an outer layer that can be bonded, such as nylon or polyether block amides (e.g., commercially available from Pebax®) or any other suitable for the intended purpose material. In one embodiment, the inner tubular member 50 can include a first inner layer that includes high density polyethylene (HDPE), a second intermediate layer that includes an adhesive layer (e.g., Primacor), and a third outer layer, It includes Pebax®. Other examples of suitable materials for the inner tubular member 50 are indicated in U.S. Patent Nos. 6,277,093 and 6,217,547, each of which is incorporated herein by reference in its entirety. The inner tubular member 50 can be formed by conventional methods, including but not limited to extrusion or coextrusion.

According to one embodiment of the presently disclosed subject matter, the capsule 20 can be composed of a wide variety of suitable materials such as nylon, copolyamides (e.g., polyether block amides (e.g., commercially available from Pebax®), polyesters , Copolyesters, polyurethanes, polyethylenes or the like. Additional suitable materials are provided in U.S. Patent Nos. 7,074, 206,7,828,766 and 8,052,638, each of which is incorporated by reference in its entirety Alternatively or in addition, in some embodiments, the capsule 20 can be a multi-layer capsule (not shown), such as described in U.S. Patent Application Serial No. 14/212, 966, Incorporated herein by reference in its entirety.A capsule 20 can have a first layer made of a first polymeric material having a first durometer hardness, and a second layer made of a first polymeric material having a hardness of a second durometer The second durometer can be greater than the first durometer hardness and the second layer can be an outer layer relative to the first layer, as embodied herein, For example and without limitation, the capsule Can have a first layer composed of Pebax® having a durometer hardness between 5f5D and about 63 D. The second layer can be formed from Pebax® having a durometer hardness between about 70D and about 72D constitute.

The capsule 20 can have an unexpanded configuration with wings to encase the capsule to form a small facet configuration for introduction and advancement in the patient & apos; s internal lumen. As a result, the capsule expands to the nominal working diameter by unfolding and filling the molded volume of the capsule. As described above, the capsule 20 can have a working length 25, a distal vertebral body section 27, and a distal capsule axis 23. [ The distal capsule axis 23 can have a first segment, the first segment having a first diameter and a first wall thickness. The distal capsule axis 23 can have a second segment with a second diameter and a second thickness. The second diameter can be greater than the first diameter and the second wall thickness can be thinner than the first wall thickness as described in U.S. Application Serial No. 13/609, 968, the contents of which are incorporated herein by reference in its entirety.

[0046] For the purposes of example and as embodied herein, techniques disclosed in U.S. Patent Nos. 6,206,127, 7,828,766, 7,906,066 and 8,052,638 can be used Similar techniques to form the capsule 20, each of which is incorporated herein by reference in its entirety. In some embodiments, the capsule 20 can be formed by melt extruding a thermoplastic polymer material to form a tube, and then extruding it at a pressure (e.g., between about 150 and about 500 pounds per square inch) Lt; 0 & gt; C, or at elevated temperatures of the extrudate in a mold. Blow molding can include placing the extruded tube within a mold or capture member. By introducing pressurized fluid into the lumen, the extruded tube can be radially expanded under suitable conditions until the outer surface of the extruded tube engages and conforms to the inner surface of the capture member. In addition, by expanding the tube axially with a load applied to at least one end of the extruded tube, while extruding the tube radially in a pressurized medium in the lumen, the polymeric material of the extruded tube can be bi- Stretching.

[0047] According to another aspect, the capsule 20 can be formed using a two-stage blow molding process, such as disclosed in U.S. Patent Application No. 2012/0065718, which is incorporated herein by reference in its entirety.

For the purposes of illustration and not limitation, and with reference to a coronary cystic catheter, the length of the capsule catheter as disclosed herein can be generally about 100 to about 200 centimeters, preferably about 135 to about 150 centimeters for PTCA Cm and typically about 145 cm, and can be of other suitable sizes for other various applications. For purposes of example and not limitation, the monolithic multi-layer distal outer member can have an outer diameter (OD) of about .042 inches (1. 07 mm) to about 0.10 inches (2. 54 mm), and (ID) of about 0.033 inches (0.84 mm) to about 0.08 inches (2.23 mm). For exemplary and non-limiting purposes, the inner tubular member can have a diameter of from about 0.022 inch (0.56 mm) to about 0.050 inch (1.27 mm) depending on the diameter of the guidewire to be used with the catheter OD, and an ID of about 0.015 inches (0.38 mm) to about 0. 040 inches (1.00 mm). For exemplary and non-limiting purposes, the capsule can have a length of about 6 millimeters to about 100 millimeters and an expanded working diameter of about 1.2 millimeters to about 10 millimeters.

[0049] When a catheter according to the presently disclosed subject matter is used in an angioplasty procedure, the capsule catheter is advanced through the guidewire until the capsule is properly positioned across the stenosis. By introducing the inflation fluid through the expansion lumen, the capsule can expand in a conventional manner. After one or more expansions, the capsule is contracted and the catheter is removed from the patient. When the capsule has a stent or a support frame (not shown) mounted thereon, a similar procedure is used for implanting the stent into the body lumen. For example, a radially expandable stent can be releasably mounted on the capsule 20 for delivery and deployment within a body lumen. It is possible to advance the capsule catheter in the body lumen with the capsule 20 in the non-inflated configuration and to expand the capsule by introducing the inflation fluid into the interior of the capsule such that the capsule 20 and the capsule The stent thereof is enlarged. The capsule 20 can then be narrowed to allow repositioning of the catheter or removal of the catheter from the body lumen so that the stent remains implanted into the body lumen.

[0050] In a sense not previously discussed herein, various catheter components can be formed and joined by conventional materials and methods. For example, one or more sections of the tubular member can be biaxially oriented tubular members and can include tapered regions, as described in detail in U.S. Patent Application No. 2013/0178795, which is incorporated herein by reference in its entirety. Likewise, the inner tubular member can be formed by conventional techniques, such as those disclosed in U.S. Patent Nos. 6,277,093 and 6,177,547, each of which is incorporated herein by reference in its entirety. In addition, although not illustrated, a coiled or braided reinforcement can be included in the shaft at various locations, as is conventionally known and disclosed in U.S. Patent No. 7,001,420 Which is incorporated herein by reference in its entirety.

While the presently disclosed subject matter has been described herein with respect to certain preferred embodiments, those skilled in the art will recognize that modifications and improvements can be made without departing from the scope of the presently disclosed subject matter. For example, although the catheter described herein includes a capsule catheter, a catheter having an integral multi-layered distal component in accordance with the presently disclosed subject matter can be a variety of suitable catheters including a catheter having a catheter positioned above a working device (e.g., a stent) A retractable sheath or cannula. In these embodiments, the sheath or cannula can be a monolithic multi-layered distal member having any of the layers, construction materials, features and benefits described herein. While individual features of one embodiment of the disclosed subject matter may be discussed or illustrated in one embodiment and not in the accompanying drawings of other embodiments, it should be apparent that individual features of one embodiment can be combined with another embodiment of the present invention One or more features or in combination with features from multiple embodiments.