Expandable guide sheath and apparatus and method using the same

The present invention relates generally to devices and methods of carrying the device and / or drug during a medical procedure, and in particular to a guide sheath that accesses the body lumen and / or delivers the device to the patient's body lumen.

(Background technology) Minimal invasive procedures are available in a variety of medical settings, for example, for vascular interventions (eg, angiogenesis, stenting, embolization prevention, cardiac electrical stimulation, cardiac mapping and visualization). Has been carried out for. These procedures generally depend on accurately guiding and placing the device within the patient's vascular structure.

(Background technology) During such procedures, the target tube is accessed via an intervening vascular structure with a guide wire traveling to the target tube, thereby providing a "line" to the tube. Can be given. One or more instruments (eg, catheters, sheaths, etc.) travel over guide wires or "rails" and into the tube. Therefore, diagnostic and / or therapeutic procedures can be performed by advancing one or more instruments over these tracks.

There are many dangers associated with advancing the instrument on the guide wire. For example, catheters or other instruments can cause sharp bends and scrape or damage the walls of the tube, especially as the instrument progresses through narrow passages or winding anatomy (or anatomical structures). is there. Such instruments also pose the risk of moving the embolic material or puncturing the wall of the tube.

In addition, access to very small tubes deep in the body (eg, placing pacing leads in the patient's heart, eg, in the ventricle, in the coronary vein) is often desired. However, instruments (eg, guide sheaths, leads, etc.) may have a relatively large cross-sectional area and / or may have a relatively blunt distal end, which is such an instrument. Makes it difficult to go deep into the small tube as desired.

Therefore, devices and methods for carrying the device into a blood vessel or into another body lumen (or body lumen) and / or accessing the tube or other body lumen may be useful.

(Outline of the invention) The present invention generally covers devices and methods for accessing the body lumen and / or carrying instruments and / or agents into the body lumen during a medical procedure. More specifically, the present invention uses a guide sheath, and the patient's body lumen (eg, within the patient's coronary, neural and / or peripheral vascular structure, the patient's gastrointestinal tract, urinary reproductive) using the guide sheath. It is intended for methods that facilitate the delivery of instruments and / or drugs into tubes, respiratory vessels, lymphatic vessels, and / or within surgically formed channels.

In one gist of the invention, for example, from a contracted state that minimizes the contour of the sheath to allow insertion into the body lumen, the sheath extends at least partially to define the lumen within it ( A sheathing device comprising a long inflatable sheath that can be inflated into an expanded or inflated state is provided. The sheath is a smooth material, polymer, and / or elastic material, preferably made of a material with relatively thin walls, thereby being substantially flexible and / or weak. Give a tubular sheath to get. For example, the sheath may include a wall thickness between about 0.001 and 1.25 mm, preferably between about 0.005 and 0.6 mm.

If desired, the sheath may include one or more reinforcing elements that extend along the sheath, eg, coaxially, spirally, and / or around the sheath. Such reinforcing elements may support the sheath during transport and / or reinforce the sheath in the desired shape and / or size in the extended state. In addition or in place of this, a reinforcing or reinforcing member may be provided to support or support the sheath to facilitate introduction of it in a contracted state. If desired, the sheath and / or reinforcement may be coated with an antithrombotic and / or hydrophilic coating.

Preferably, the inflatable sheath includes the proximal and distal ends and is long enough to extend between the entrance site to the patient's body and the target body lumen. And, for example, it has a length of about 2 cm to 300 cm, more preferably about 20 cm to 150 cm. In one form, the sheath may be a tubular member, and in another form, the sheath is a sheet material, the edges of which both the sheet and the reinforcing member define a lumen (or lumen). It may include a sheet material attached to the reinforcing member.

The distal end of the sheath may include an opening that communicates with the lumen so that instruments inserted through the lumen can be advanced from the opening into the body lumen. Alternatively, the distal end of the sheath may be substantially closed, and / or the opening so that the instrument inserted through the lumen can progress from the opening to the body lumen. It may include a separation portion to be formed. If desired, the sheath substantially anchors the device in a position within the body lumen to prevent movement of the treatment device through the sheath during transport (eg, an inflatable cuff or). A balloon) may be included at the distal end.

In another gist of the present invention, there is provided a device comprising a flexible reinforcing member having a proximal end and a distal end, as well as an inflatable sheath. The sheath may extend between the proximal and distal ends of the stiffener and can inflate from a contracted state that minimizes the contour (or profile) of the sheath and is close to the stiffener. It can be an dilated state that at least partially defines the lumen that extends at least partially between the distal end and the distal end. As in the previous embodiment, the sheath is a smooth material, polymer, and / or elastic material, preferably relatively thin, flexible and / or weak (or flimsy). It may be made of a material with certain walls.

Reinforcing members may include one or more strands extending along the sheath, eg, coaxially, spirally and / or circumferentially in the sheath. In a preferred embodiment, the stiffener carries the sheath so that the distal end of the stiffener pushes the body lumen against the proximal end of the stiffener so that there is virtually no risk of twisting or bending. , A long member with sufficient column strength that can travel through the body lumen. For example, the stiffener may be a guide wire, catheter, or other cylindrical member, around which a sheath can be coated, or around which the sheath can be kept contracted. In another embodiment, the stiffener may have a bow-shaped cross section, whereby a groove extending between the proximal and distal ends, at least with the sheath contracted within it. Grooves that can be partially placed may be defined.

The sheath is provided at one or more locations on the stiffener, eg, at the distal end of the stiffener, or at both the proximal and distal ends of the stiffener, at the proximal and distal ends. It may be mounted continuously in an intermediate position between the portions and / or along the stiffeners. In addition or instead, the sheath may be detachably attached to the reinforcing member. If desired, a constraint (or constraint) may be provided to selectively hold the sheath in the contracted state. For example, the stiffener and sheath may be placed on a catheter or other tubular member, and / or one or more filaments may be placed around the sheath to keep the sheath contracted.

Yet another gist of the invention provides a method of accessing a patient's body lumen. The body lumen may be, for example, the patient's urogenital tract, respiratory tract, gastrointestinal tract, lymphatic system, or tract or other channel within the vascular system. In addition or instead, the body lumen may be a channel surgically formed by the patient (eg, an interstitial cavity accessed via a surgically formed portal site).

In general, the inflatable sheath travels from the entrance site towards the body lumen with the sheath contracted. The sheath may travel on the guide wire or along with (or along the rail) other rails. Preferably, the sheath is advanced from the inlet site until the distal end of the sheath is placed within the body lumen, while the proximal end of the sheath remains outside the entrance site.

When the sheath reaches the target body lumen, the sheath may be inflated into an expanded state, thereby defining the lumen inside the sheath. The lumen extends, for example, from the entrance site to the target body lumen. The sheath introduces, for example, a fluid (eg, saline, contrast agent, carbon dioxide, oxygen and / or air) into the lumen defined by the sheath, and / or an instrument in the lumen defined by the sheath. May be expanded to an expanded state by introducing.

Diagnostic and / or therapeutic procedures may be performed within the body lumen through the lumen defined by the sheath. In one form, the entrance site may be a percutaneous site communicating with the patient's vascular structure, and the body lumen is, for example, within the patient's coronary, peripheral or neurovascular structure. It may be a blood vessel. Treatment may include introducing one or more instruments or agents into the target vessel via the lumen defined by the sheath. Instruments or agents include, for example, catheters, guidewires, balloons, stents, filters, pacing reeds, atherectomy devices, thrombectomy devices and / or agents (eg, anti-inflammatory agents, antithrombotic agents, suppressors). Agents, etc.). In a preferred embodiment, the target vessel may be a narrowed or occluded area within the artery. In another preferred embodiment, the target vessel may be a coronary vein and one or more instruments may include electrical reeds.

At the end of the procedure, the sheath may be removed from the body lumen. If necessary, the sheath was expanded prior to removal from the body lumen, for example by creating a vacuum within the sheath and / or by pulling the sheath into a catheter or other tubular member. It may be crushed at least partially from the state. Alternatively, the sheath splits into two or more pieces along a single longitudinal seam, or two or more seams, to facilitate removal from the body lumen. You can stay.

Thus, the sheaths of the present invention may provide a primary access device that is substantially flexible, can be crushed (or folded), and / or has elasticity. This primary device has a relatively flat (or thin, or low profile) contour (or posture or height) and is difficult to access, for example, through narrow passages and / or winding anatomy. Facilitates the progression to deeper positions in the patient's body. Upon reaching the desired position, the primary device may be opened and / or inflated to allow one or more secondary devices to travel through the primary device. The primary device may provide a smooth path to prevent incision of the tube wall and / or to facilitate sending the secondary device to a location that is difficult to access. The primary device may expand freely to accommodate the secondary device and / or substantially convert the axial force generated by pushing, for example, the secondary device into a radial force, thereby secondary. The risk of damaging the passage through which the next device travels may be minimized.

According to another gist of the present invention, there is provided a device that feeds an instrument (eg, a guide wire) into the body lumen of a patient, eg, beyond (or across) a complete occlusion in a blood vessel. The device generally includes a catheter or other elongated and / or tubular member with proximal and distal ends, and an inflatable sheath attached to the outer surface of the catheter. The sheath (eg, flexible and / or weak tubular members, and / or sheet) can inflate from a contracted state that minimizes the contour of the sheath, and the sheath is proximal and distal to the sheath. It can be an dilated state that at least partially defines the accompanying lumen extending between the ends.

In yet another gist of the present invention, a catheter or other elongated member having an inflatable sheath extending along the outer surface of the elongated member is used to provide a body lumen. A method of transporting the device via an obstruction is provided. The distal end of the catheter may be introduced into the body lumen proximal to the occlusion with the sheath contracted. The distal end of the catheter may be advanced to pass through the occlusion until the distal end of the sheath is located distal to the occlusion. The distal end of the catheter may include one or more elements (eg, imaging element, incision element, and / or steering element) that facilitate passage through the occlusion to advance the distal end.

An instrument, such as a guide wire or other elongated member, may be advanced through the sheath until the distal end of the instrument is located distal to the occlusion. The sheath may be inflated prior to insertion of the instrument, for example by introducing a fluid into the lumen of the sheath, or may be inflated when the instrument is inserted into the sheath.

The catheter and sheath may then be removed from the body lumen so that the guidewire or other elongated member remains beyond (or across) the occlusion. One or more instruments may be advanced on the guidewire to observe and / or treat the occlusion, eg, after the catheter has been withdrawn.

Other objects and features of the present invention will become apparent by considering the following description made in connection with the accompanying drawings.

<figref num="1A">FIG. 1A is a partial cross-sectional side view of a first preferred embodiment of a sheathing device including an inflatable sheath and a reinforcing member, showing a state in which the sheath is contracted.</figref><figref num="1B">FIG. 1B is a partial cross-sectional side view of a first preferred embodiment of a sheathing device including an inflatable sheath and a reinforcing member, showing an expanded state of the sheath.</figref><figref num="2A">FIG. 2A is a cross-sectional view of the device of FIG. 1A cut along line 2A.</figref><figref num="2B">FIG. 2B is a cross-sectional view of the device of FIG. 1B cut along line 2B.</figref><figref num="3A">FIG. 3A is a cross-sectional view of another reinforcing member that may be incorporated into the sheath device.</figref><figref num="3B">FIG. 3B is a cross-sectional view of another reinforcing member that may be incorporated into the sheath device.</figref><figref num="3C">FIG. 3C is a cross-sectional view of another reinforcing member that may be incorporated into the sheath device.</figref><figref num="4A">FIG. 4A is a cross-sectional view of another form of the sheathing device comprising an inflatable sheath attached to the reinforcing member shown in FIG. 3A, showing a state in which the sheath is contracted.</figref><figref num="4B">FIG. 4B is a cross-sectional view of another form of the sheathing device comprising an inflatable sheath attached to the reinforcing member shown in FIG. 3A, showing the expanded state of the sheath.</figref><figref num="5">FIG. 5 is a detailed perspective view of the distal end of the sheathing device, including an inflatable sheath having a weakened area to form an opening in its wall.</figref><figref num="6">FIG. 6 is a perspective detail view of another distal end of a sheathing device that includes an inflatable sheath that includes an obliquely cut distal end with an opening.</figref><figref num="7">FIG. 7 is a side view of another form of sheathing device comprising an inflatable sheath having an inflatable cuff at one end.</figref><figref num="8">FIG. 8 is a partial cross-sectional side view of a sheathing device including a wire loop that wraps around an inflatable sheath and constrains the sheath in a contracted state.</figref><figref num="9A">FIG. 9A is a detailed perspective view of the sheath device, showing a state in which the inflatable sheath is contracted.</figref><figref num="9B">FIG. 9B is a detailed perspective view of the sheath device, showing an inflatable sheath.</figref><figref num="10A">FIG. 10A is a detailed perspective view of another form of the sheath device, showing a state in which the inflatable sheath is contracted.</figref><figref num="10B">FIG. 10B is a detailed perspective view of another form of the sheath device, showing an inflatable sheath.</figref><figref num="11A">FIG. 11A is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="11B">FIG. 11B is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="11C">FIG. 11C is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="11D">FIG. 11D is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="11E">FIG. 11E is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="11F">FIG. 11F is a partial cross-sectional view of the patient's vascular structure showing a method of delivering a stent over a stenosis using a sheathing device in accordance with the present invention.</figref><figref num="12A">FIG. 12A is a partial cross-sectional view of the patient's heart showing a method of delivering electrical reeds into the coronary vein using a sheathing device in accordance with the present invention.</figref><figref num="12B">FIG. 12B is a partial cross-sectional view of the patient's heart showing a method of delivering electrical reeds into the coronary vein using a sheathing device in accordance with the present invention.</figref><figref num="12C">FIG. 12C is a partial cross-sectional view of the patient's heart showing a method of delivering electrical reeds into the coronary vein using a sheathing device in accordance with the present invention.</figref><figref num="12D">FIG. 12D is a partial cross-sectional view of the patient's heart showing a method of delivering electrical reeds into the coronary vein using a sheathing device in accordance with the present invention.</figref><figref num="13A">FIG. 13A is a side view of another form of a sheath device comprising a tubular restraint from which the sheath device is deployed.</figref><figref num="13B">FIG. 13B is a side view of another form of the sheath device comprising a tubular restraint from which the sheath device is deployed.</figref><figref num="14A">FIG. 14A is a partial cross-sectional view of the patient's colon, showing a method of feeding a colon scope using a sheathing device in accordance with the present invention.</figref><figref num="14B">FIG. 14B is a partial cross-sectional view of the patient's colon, showing a method of feeding a colon scope using a sheathing device in accordance with the present invention.</figref><figref num="14C">FIG. 14C is a partial cross-sectional view of the patient's colon, showing a method of feeding a colon scope using a sheathing device in accordance with the present invention.</figref><figref num="15A">FIG. 15A is a partial cross-sectional view of a vein showing how a stent is delivered via a venous valve.</figref><figref num="15B">FIG. 15B is a partial cross-sectional view of the vein showing how the stent is delivered via the venous valve.</figref><figref num="15C">FIG. 15C is a partial cross-sectional view of the vein showing how the stent is delivered via the venous valve.</figref><figref num="15D">FIG. 15D is a partial cross-sectional view of the vein showing how the stent is delivered via the venous valve.</figref><figref num="16">FIG. 16 is a perspective detail view of another form of sheathing device, including an outer sheath that can be separated as the inflatable sheath inside it expands.</figref><figref num="16B">FIG. 16B is a perspective detail view of another form of sheathing device, including an outer sheath that can be separated as the inflatable sheath inside it expands.</figref><figref num="16C">FIG. 16C is a perspective detail view of another form of sheathing device, including an outer sheath that can be separated as the inflatable sheath inside it expands.</figref><figref num="17A">FIG. 17A is a cross-sectional view of the device shown in FIG.</figref><figref num="17B">FIG. 17B is a cross-sectional view of the device shown in FIG. 16B.</figref><figref num="17C">FIG. 17C is a cross-sectional view of the device shown in FIG. 16C.</figref><figref num="18">FIG. 18 is a side view of another embodiment of the device of the invention, including a catheter and an inflatable sheath.</figref><figref num="19A">FIG. 19A is a cross-sectional view of the device of FIG. 18 showing a state in which the sheath is contracted.</figref><figref num="19B">FIG. 19B is a cross-sectional view of the device of FIG. 18 showing the expanded state of the sheath.</figref><figref num="19C">FIG. 19C is a cross-sectional view of the device of FIG. 18 showing the sheath in which the guide wire is located.</figref><figref num="20A">FIG. 20A is a cross-sectional view of a blood vessel showing a method of feeding a guide wire over an occlusion in the blood vessel.</figref><figref num="20B">FIG. 20B is a cross-sectional view of a blood vessel showing a method of feeding a guide wire over an occlusion in the blood vessel.</figref><figref num="20C">FIG. 20C is a cross-sectional view of a blood vessel showing a method of feeding a guide wire over an occlusion in the blood vessel.</figref><figref num="20D">FIG. 20D is a cross-sectional view of a blood vessel showing a method of feeding a guide wire over an occlusion in the blood vessel.</figref>

(Detailed description of preferred form) With reference to the drawings here, FIGS. 1A-2B show the body lumen (not shown) and / or one or more instruments (not shown) into the body lumen. A first preferred embodiment of the device 10 for feeding is shown. The body lumen is, for example, a tube in the patient's vascular structure, a genitourinary system, a respiratory tube, the lymphatic system, and a passage in the patient's gastrointestinal tract.

Generally, the device 10 includes a flexible elongated reinforcing member 12 that provides the "spine" of the device 10 and an inflatable membrane or sheath 20. The stiffener 12 includes a proximal end 14 and a distal end 16 that define a longitudinal axis 18 between them. In addition, the stiffener 12 is long enough to be advanced from a position outside the patient's body (not shown) to the site to be accessed and / or treated via intervening internal passages. Can have The distal end 16 may have dimensions and / or shape for insertion into the body lumen, eg, a round or other substantially non-traumatic distal tip 17, "J" Includes tip (not shown), etc.

In one form, the reinforcing member 12 is a solid or hollow guide wire, catheter, thread, or the like. Preferably, the stiffener 12 is sufficiently flexible to facilitate progress in the winding anatomy without incision or perforation, but twisting and / or by pushing the proximal end 14. Has sufficient column strength and / or torque-ability to allow the distal end 16 to travel through the body lumen without substantial risk of bending. Reinforcing member 12 is one or more lumens 19 (as shown in FIGS. 2A and 2B), extending between the proximal end 14 and the distal end 16, eg, fluid. It may have a lumen that allows it to be sent via it and / or accept a guidewire or other device (not shown) via it.

The reinforcing member 12 may have a substantially symmetrical cross section, eg, a cylindrical cross section as shown in FIGS. 2A and 2B, or an asymmetric cross section, eg, an arch as shown in FIGS. 3A-4B. May have a cross section of. In the embodiments shown in FIGS. 3A-4B, the stiffener 112 may define a groove 113 extending at least partially between its proximal and distal ends (not shown in FIGS. 3A-4B).

The reinforcing member 12 or 112 can be formed from various materials using various methods known to those skilled in the art. For example, the stiffener may be formed from plastic, glass, composite (or composite), and / or metal using known methods (eg, extrusion), thereby flexibility and column strength. Give the desired combination of. The terms "spine," "spine member," or "reinforcing member" used herein facilitate the introduction of the sheath into the patient's body lumen by supporting or reinforcing an inflatable membrane or other sheath. And / or may include long, flexible structures (or structures) that may facilitate the secondary device to follow along the axis of the sheath and / or over the entire device. The stiffener 12 may have a diameter of about 0.05 to 5 mm, preferably about 0.2 to 2 mm or other maximum cross section.

With reference to FIGS. 1A and 1B, the inflatable membrane or sheath 20 extends between the proximal end 20, the distal end 24, and the proximal end 22 and the distal end 24. Includes side walls, thereby at least partially defining the lumen 26. The term "sheath" or "guide sheath" as used herein means that the structure is substantially tubular or only partially defined if it is a structure that at least partially defines the lumen. Any structure may be included, regardless of whether it specifies.

The sheath 20 can be expanded from the contracted state as shown in FIGS. 1A and 2A to the expanded state as shown in FIGS. 1B and 2B. When the sheath 20 is in the contracted state, the device 10 may have a low contour (or posture or height) to facilitate insertion into the body lumen (not shown). For example, as is most commonly seen in FIG. 2A, the sheath 20 is placed around or adjacent to the stiffener (eg, using internal vacuum and / or external force against the lumen 26 of the sheath 20). Can be folded, twisted, wrapped, or compressed. In the expanded state, the sheath 20 is unfolded, untwisted, unwound or inflated, eg, fluid (eg, drug, antithrombotic, etc.) and / or one or more instruments. The lumen 26 may be defined, at least in part, to be accepted via it.

Because the sheath 20 is relatively thin, the device 10 has a relatively low contour (or posture or posture) of, for example, about 0.1 to about 10 mm, preferably about 0.2 to about 3 mm, when the sheath 20 is in a contracted state. Height) can be. Conversely, when the sheath 20 is inflated and expanded, a relatively large lumen 26 with a diameter or other maximum cross section between about 0.3 and about 100 mm, preferably about 0.3 to about 20 mm. Can be provided.

The sheath 20 can be made of a material that is relatively thin and flexible as compared to the reinforcing member 12. Thus, the sheath 20 may be flimsy (or flimsy), i.e., it has little or no rigidity so that the sheath 20 provides little resistance to expansion and / or contraction. It does not have to be, and / or may be substantially consistent with the anatomy in which it is deployed. The term "flimsy" as used herein means that the material of the sheath 20 is not biased to take any particular shape configuration, thus the sheath 20 is eg, for example. Any shape and / or structure imposed on it, by folding or compressing, and by receiving internal pressure or force, can be adopted. To achieve this, the sheath 20 may have a relatively thin wall thickness of, for example, about 0.001 to 1.25 mm, preferably about 0.005 to 0.06 mm.

The sheath 20 is made of a material capable of forming a relatively thin and flexible structure, for example, polytetrafluoroethylene (PTFE), foamed polytetrafluoroethylene (EPTFE), fluorinated ethylene propylene (FEP), polyethylene terephthalate. It may be composed of (PET), urethane, olefin, polyethylene (PE), silicone, latex, isoprene, chronoprene and the like. The sheath 20 may be made of a smooth material to facilitate insertion of one or more instruments (not shown) via the lumen 26, and / or liquid silicone or other. It may be coated to be hydrophilic with a coating. Preferably, the sheath 20 is made of a material that is substantially inelastic so that unfolding or folding of the material of the sheath 20 mainly contributes to the expansion and contraction of the sheath 20. Therefore, the total circumference of the sheath 20 does not have to change substantially between the contracted state and the expanded state. Alternatively, the sheath 20 is provided so that the elasticity of the material of the sheath 20 contributes secondarily to the expansion and contraction of the sheath 20, that is, the circumference of the sheath 20 increases as the sheath 20 expands in an expanded state. As such, it may be formed of an elastic material.

The sheath 20 may be substantially non-porous. In another embodiment, the sheath 20 is porous, eg, substantially continuously or at one or more positions along its length, and the fluid delivered into the lumen 26 is the wall of the sheath 20. It may be allowed to be fed as desired via, for example, the fluid may be fed to the wall of the tube (not shown) where the sheath 20 extends. In another embodiment, the sheath 20 may have one or more discontinuous openings (not shown) at one or more locations along its length.

In addition or instead, the sheath 20 may include a thin metal leaf. Alternatively, the sheath 20 may include a thin mesh (eg, perforated urethane film, etc.). In yet another embodiment, the inner surface of the sheath 20 is smoothed by applying a smooth coating, lining, ridges, etc. (not shown) and / or by applying a lubricant. Can be improved. The sheath 20 may have a single layer or multiple layers of such material so that the desired flexibility and smoothness is obtained. Thus, as described below, the sheath 20 accommodates an instrument that easily inflates and / or linings the body lumen to reduce friction and / or travel through the body lumen.

If desired, the sheath 20 may include one or more reinforcing elements (not shown). For example, wires, threads, filaments, etc. made of plastic, glass, composites and / or metals may be attached to the outer and / or inner surfaces of the wall of sheath 20 and / or the wall of sheath 20. It may be embedded in. In addition and / or otherwise, the sheath 20 may include a relatively thickened area that can be formed directly from the wall material. One or more reinforcing elements may extend circumferentially and / or spirally around the sheath 20 and / or axially along the sheath 20, depending on the desired reinforcement. One or more reinforcing elements may be biased to take the desired shape or configuration when the sheath 20 expands into an expanded state.

In another form, the sheath is a tubular structure of braided (or woven) material or a partially tubular structure (not shown) that can be attached to a reinforcing member to provide a sheathing device. It's okay. For example, the sheath is braided, woven, and / so to be a sheet in which the tubular body or its tip can be attached to a reinforcing member, similar to the forms described elsewhere herein. Alternatively, it may consist of braided, one or more plastic and / or metal wires, threads or other strands. The braided (or braided) strands are twisted, folded, crimped (or crimped), and / or wound and / or axially moved (eg, sheathed) as described above. The braided yarn (or braid) may be compressed into a contracted state by pulling both ends away from each other and compressing the braided (or braided) strands radially under axial tension.

The proximal end 22 of the sheath 20 may include an annular collar or handle that may facilitate the operation of the sheath 20 and / or insertion of one or more instruments into the lumen 26. In addition or as an alternative, the proximal end 22 may substantially seal the lumen 26 from the proximal flow of fluid, but may allow the instrument to be introduced into the lumen 26. Hemostatic valves known in the art (also not shown) may be included. For example, as shown in FIGS. 1A and 1B, a toughly borst valve 23 may be provided at the proximal end 22 of the sheath 20, for example, to limit passage into the lumen 26. Alternatively, other structures, such as slit valve adapters, can selectively seal the lumen 26, operate the sheath 20, and / or facilitate the introduction of instruments into the sheath 20. , Removal clamps, o-rings, side ports, adjustable fixed devices, etc. (not shown) may be provided.

The distal end 24 of the sheath 20 includes those of various shape configurations. For example, as shown in FIGS. 1A and 2A, the distal end 24 of the sheath 20 may be offset proximally from the distal tip 17 of the stiffener 12. In addition, the distal end 24 may have a rounded shape (eg, as shown in FIG. 2), an obliquely cut shape (eg, as shown in FIG. 6), or the non-traumatic shape of the device 10. It may include other tapered shapes that can facilitate the intrusion of.

For example, as shown in FIG. 6, the taper 28 "of the distal end 24" of the sheath 20 "may facilitate the device 10" to follow on the guide wire (not shown). And / or it may facilitate the passage of the device 10 "through the body lumen (also not shown). The taper 28" minimizes the risk of the sheath 20 "being caught. And / or the device 10 "can be deflated into a contracted state when the device 10" is advanced through the body lumen without external restraints. Alternatively, the sheath is far away. The edges may be substantially blunt (or round) (not shown).

The distal end 24 of the sheath 20 may be substantially closed or may have one or more openings. For example, as shown in FIG. 2A, the distal end 24 of the sheath 20 may be attached to the distal end 16 of the stiffener 12 and the lumen 26 may be substantially closed at the distal end 24. The distal end 24 of the sheath 20 may be removable from the reinforcing member 12 so as to release the sheath 20 from the reinforcing member.

For example, the distal end 24 of the sheath 20 may be attached to the stiffener 12 with an adhesive, solder or other binding material, but nevertheless, for example, pulling the sheath 20 proximally to the stiffener 12. It can be torn freely or separated from the distal end 16 of the reinforcing member 12 by or by pushing the reinforcing member 12 distal to the sheath 20. Alternatively, the instrument (not shown) advances through the inflatable member 20 and presses against the closed distal end 24 to separate the distal end 24 from the reinforcing member 12. You can. This allows an opening (not shown) to be formed at the distal end 24 of the sheath 20 through which the fluid and / or one or more instruments (also not shown) can travel. Can be done.

Alternatively, a mechanical connector that can hold the distal ends 16 and 24 together and can act to release the distal end 24 of the sheath 20 from the distal end 16 of the stiffener 12. (Not shown) may be provided. In yet another embodiment, a cinch loop (not shown) that can be selectively opened or closed may be provided at the distal end 24, or a removable clip (also not shown). It may be provided. In addition or in lieu of this, the distal end 24 of the sheath 20 is, for example, a bioabsorbable adhesive or other material of fluid that decomposes to provide an opening when exposed to body fluids (not shown). May be joined to the distal end 16 of the reinforcing member 12 using.

In yet another embodiment, as shown in FIG. 5, the distal end 24'of the sheath 20'is a region that can be cut or penetrated, eg, a relatively thin or weakened region 30'of the side wall of the sheath 20'. May include. The weakened area 30'tears along the weakened seam (or seam) when an instrument (not shown) within the lumen 26' is pressed against the weakened area 30' to form an opening. It may be (not shown) or punctured (not shown), which allows the instrument to travel through the opening into the body lumen.

In yet another embodiment, as shown in FIG. 6, the sheath 20 "so allows an instrument (not shown) inserted through the lumen 26" to proceed through the opening 28 "into the body lumen. The distal end 24 "of" may include an axial opening defined by one or more openings 28 "communicating with lumen 26", eg, a tapered distal end 24 ". ..

Alternatively, as shown in FIG. 7, the distal end 424 of the sheath 420 may include an inflatable cuff 430. The cuff 430 may be an inflatable annular balloon attached to the periphery of the sheath 420. In order to inflate and / or wither the cuff 430, one or more lumens (not shown) may be provided within the stiffener 412 communicating with the inside of the cuff 430. The inflated cuff 430 may be used to secure the sheath 420 within the body lumen (not shown) and / or the distal segment of the body lumen is a segment proximal to the inflated cuff 430. May act to separate from.

For example, the sheath 420 may be fed into the blood vessel and the cuff 430 may be inflated to seal the blood vessel. Manipulation or treatment within one or more vessels may be performed within the vessel proximal to the inflated cuff 430. Thus, if embolic debris (or debris) is released within the proximal portion of the blood vessel, the cuff 430 can prevent the debris from being delivered to the distal portion of the blood vessel.

In another embodiment, the proximal opening 426 of the sheath 420 may be located within a blood vessel (not shown), thereby starting from the proximal opening 426 and via the lumen 426 of the sheath 420. It forms a bypass or shunt channel that can be located within the body lumen extending to the distal cuff 430. In yet another embodiment, one or more lumens (not shown) may be formed in or along the wall of the sheath 420 itself. If desired, one or more cuffs or pockets (not shown) may be formed along the sheath 420 at one or more locations to secure the sheath 420, eg, of a contrast agent. The flow may be restricted for retrograde injection purposes and / or the sheath 420 may be biased to inflate into a particular shape or structure.

As shown in FIGS. 1A-2B, in one embodiment, the sheath 20 is substantially attached to the reinforcing member 12 at one or more locations between the proximal and distal ends of the reinforcing member 12. It may be a closed tubular body. For example, the sheath 20 may be attached to the stiffener only at the distal ends 24, 16. Alternatively, for example, when the stiffener 12 is placed along the wall of the sheath 20, the sheath 20 is located at the proximal end 22, the distal end 24, or near, or both of the sheath 20. It may be attached to the reinforcing member 12.

If desired, the sheath 20 may be attached to the stiffener 12 at one or more additional points, eg, between the proximal end 22 and the distal end 24, at intervals. Alternatively, the stiffener 12 may be attached substantially continuously to the sheath 20 between the proximal end 22 and the distal end 24 of the sheath 20. The reinforcing member 12 may be attached inside the sheath 20, that is, inside the lumen 26, or outside the sheath 20. The sheath 20 and the reinforcing member 12 are attached to each other using known methods (eg, bonding by adhesive, ultrasonic waves, welding, sewing thread or other strands (not shown)).

Alternatively, the stiffener 12 may be housed in a separate pocket or lumen (not shown) of the sheath 20 extending between the proximal end 22 and the distal end 24 of the sheath 20. As described above, the reinforcing member 12 may not be fixed in the pocket or the lumen (may be loose), or may be attached to the sheath 20 in the lumen.

In another embodiment shown in FIGS. 4A and 4B, the sheath 120 may be a sheet material whose tip 121 is attached to the reinforcing member 112. Therefore, the reinforcing member 112 partially defines the lumen 126 together with the sheet of the sheath 120. As described above, the sheath 120 may be attached substantially along the length of the reinforcing member 112, but as an alternative, the sheath 120 may be attached intermittently to the reinforcing member 112.

If desired, any of the sheaths described above (eg, sheath 20 shown in FIGS. 1A-2B) may have at least one or more seams extending from proximal end 22 to distal end 24 at least partially. It may be configured to tear along (not shown) and / or to separate from the reinforcing member 12. For example, the sheath 20 is a relatively thin seam (shown) that extends between two or more pairs of spaced openings and / or proximal end 22 and distal end 24. ) May be included. In addition or instead, the material of the sheath 20 preferentially tears along the longitudinal axis 18 so that the sheath 20 separates into two or more longitudinal strips (not shown). May be biased. These features are characterized when the device (not shown) is placed in lumen 26, for example, when the device is planned to be implanted in the body lumen so that it is virtually non-removable. It may be easy to remove the sheath 20 and / or the entire device 10 from the body lumen.

The device 10 may also include a restraint (or constraint) to cover and / or protect the sheath as it travels through the patient's vascular structure or other body passages. For example, as shown in FIG. 8, one or more wires, threads, monofilaments, or other strands 50 may be placed around the sheath 20 to keep the sheath 20 in its contracted state. Strand 50 may include a plurality of loops extending around the sheath 20 and may be secured with one or more removable filaments (not shown) supplied through the loops. To open the sheath 20, one or more removable filaments may be removed from the loop, for example by pulling the removable filament from the proximal end of device 10. The loop is then broken and one or more of those strands are removed.

Alternatively, other restraints (eg, jacket (or wrap), binder (or tie), adhesive, bioabsorbable capsule material (eg, sucrose), etc. may be used (not shown). In yet another embodiment, a catheter, sheath, or other tubular member (also not shown) may be provided, eg, when the sheath 20 is in a contracted state, as shown in FIGS. 13A and 13B. A catheter 80 may be used that may include a lumen 82 into which device 10 (or any of the other sheath devices described herein) may be located. Device 10 may be a pushing (or succulent) element 84. (For example, other elongated members extending from the wire or reinforcing member 12 (see FIGS. 1A-2B, not shown in FIGS. 13A and 13B)) may be included. The pushing element 84 is far from the catheter 80. The device 10 may be deployed toward the position side as shown in FIG. 13B, or may be advanced toward the proximal side as shown in FIG. 13A to pull the device 10 into the catheter 80.

In another embodiment shown in FIGS. 16A-17C, the outer sheath 180 may be provided. The outer sheath 180 is at least partially coupled to the sheath device 110 to keep the inflatable sheath 120 in a contracted state. The outer sheath 180 may be made of, for example, a material similar to the inflatable sheath 120, having a wall thickness of about 0.005 to 0.06 mm. Thus, the outer sheath 180 may be substantially flexible and / or one that facilitates the progression of the device 110 within the patient's body cavity.

The device 110 may include a reinforcing member 112 similar to that described with reference to FIGS. 3A-4B. Similar to the other embodiments, the reinforcing member 112 may be fitted with an inflatable sheath 120. The stiffener 112 may include one or more lumens 119 (three exemplary lumens are shown), and the outer sheath 180 is continuous with the stiffener 112, eg, along the length of the stiffener 12. Alternatively, they may be joined or attached intermittently. One or more lumens within the stiffener 112 may provide injection, aspiration, agitation and / or perfusion through the device 110, eg, from the proximal end to the distal end of the device 110. Alternatively, the outer sheath 180 may be attached directly to the inflatable sheath 120, eg, at a position on the outer circumference of the inflatable sheath 120 and / or along its length (not shown).

As is most commonly seen in FIGS. 16A and 17A, the outer sheath 180 may define the lumen 182 at least partially (alone or with the stiffener 112). An inflatable sheath 120 may be housed in the lumen 182 in a contracted state. In addition, the outer sheath 180 may include, for example, one or more weakened regions 186 extending between the proximal and distal ends (not shown) of the outer sheath 180. The weakened area 186 may have spaced openings and / or have continuous or discontinuous thin areas that may extend substantially axially along the outer sheath 180. You can do it.

The weakened region 186 can be separated when an internal pressure is applied to inflate the inflatable sheath 120 towards the expanded state. For example, fluid may be introduced into the lumen 182 of the outer sheath 180 until sufficient pressure is created to tear or separate the weakened region 186. Alternatively, a fluid or instrument (shown) so that the inflatable sheath 120 inflates until the inflatable sheath 120 pushes the outer sheath 180 radially outwards until the weakened region 186 separates. May be introduced into the inflatable sheath 120.

For example, during use, the device 110 and the outer sheath 180, as shown in FIGS. 16A and 17A, leave the outer sheath 180 intact and the inflatable sheath 120 in a contracted state, leaving the body lumen (eg, blood vessels). Etc. (not shown)). When the desired position is reached, internal pressure is applied to separate the weakened region 186 of the outer sheath 180, as shown in FIGS. 16B and 17B. The inflatable sheath 120 may then be inflated to its expanded state, as shown in FIGS. 16C and 17C. The separate portions 188 of the outer sheath 180 may be flexible enough so that they do not substantially impede the expansion of the inflatable sheath 120, and / or the inflatable sheath 120 When inflated, it may substantially match its shape.

In yet another embodiment, with reference to FIGS. 1A-2B, if the restraint is provided around the sheath 20, it is not necessary to attach the sheath 20 to the reinforcing member 12. The sheath 20 (eg, a tubular body) is simply placed around the reinforcing member 12 and is located around or close to the reinforcing member 12 before being inserted into or constrained by the restraint. , Folded, twisted, crimped, or compressed to a contracted state. In addition or in place of this, vacuum pressure may be used to compress the sheath 20 alone or with folding, and / or inject fluid into the lumen 26, as described below. , The sheath 20 may be inflated.

Although only one reinforcing member is shown in FIGS. 1A-2B, it will be understood that the sheathing device of the present invention may include more than one reinforcing member. For example, as shown in FIGS. 9A and 9B, an embodiment of a sheath device 210 including two reinforcing members 212 is shown, to which an inflatable membrane or other sheath 220 is attached. The sheath 220 may be compressed, for example, by twisting the reinforcing member 212 around a longitudinal axis 218 and wrapping the sheath 220 around the reinforcing member 212 to compress it into the contracted state shown in FIG. 9A. By untwisting the reinforcing member 212, the sheath 220 is unwound and expanded in an expanded state as shown in FIG. 9B, thereby providing a cavity 226 within the sheath 220.

In addition, the reinforcing members 12 and 212 shown in FIGS. 1A-2B, 9A and 9B generally extend parallel to the longitudinal axes 18 and 218, but other reinforcing members are also added to the reinforcing members 12 and 212. Or instead. For example, as shown in FIGS. 10A and 10B, one or more reinforcing members 312 may be provided that spirally extend around the tubular sheath 320. Reinforcing member 312 is a wire or other strand attached to the outer or inner surface of the sheath 320 or embedded within the wall of the sheath 320. One or more spiral reinforcements also facilitate the expansion and / or deflation of the sheath 320. For example, the end of the reinforcing member 312 may be axially pulled out from one end to compress the sheath 320. In addition or in lieu of this, the stiffener 312 is biased to have the configuration shown in FIG. 10B, facilitating expansion of the sheath 320 into an expanded state.

In addition or otherwise, circumferential or peripheral rings or strands (not shown) may be provided around the sheath 320. Such reinforcing rings or strands may support and / or bias the sheath 320 towards an expanded state, similar to the spiral reinforcing members described above.

Further, the device described above includes an inflatable sheath having a single lumen, but it may be possible to provide one or more sheaths, each having one or more lumens. Will be understood. For example, the sheath may be manufactured to have a plurality of lumens, for example by extrusion molding. As another example, multiple inflatable sheaths similar to those described above are attached to each other and / or to one or more common reinforcing members to provide a device having multiple inflatable lumens. (Not shown). The sheaths may be concentric with each other and may be loosely arranged within each other, or attached to each other along one or more edges. Alternatively, the sheaths may be placed adjacent to each other and, for example, may be attached together or to one or more common reinforcing members. Therefore, a plurality of instruments can be interlocked with each other and advanced via each lumen of the sheath.

If desired, one or more components of the sheathing device described above (eg, reinforcements, sheaths, and / or constraints) may be one or more radiation opaque markers (eg, radiation opaque materials, radiation). Bands or other elements (not shown) formed of impermeable ink or other deposits or the like may be included. Such markers and / or radiation opaque materials may facilitate imaging and / or monitoring of the device while using the device, for example, using X-ray fluorescence perspective. In addition, markers that are spaced apart from each other may be provided, for example, at a known distance from each other, in a predetermined manner to indicate the distance and / or mapping of the patient's vascular structure and / or. Access may be facilitated. Alternatively, other external or internal imaging systems and methods well known in the art (eg, magnetic resonance imaging, ultrasound, etc.) may be used.

The sheathing device of the present invention may be used to provide access to various body cavities and, for example, to perform diagnostic and / or therapeutic procedures. In general, a device with an inflatable sheath in a contracted state may be introduced into a natural or artificially formed entrance site in the patient's body and one or more internal passages (formation) within the patient's body. It may proceed to (including, for example, the incised surface) the passageway. Preferably, the device is advanced from the inlet site until the distal end of the sheath is located within the target body lumen, with the proximal end of the sheath remaining outside the entrance site. Due to its low contour, the device can easily travel through the winding anatomy until the distal end is located in a relatively small and inaccessible body lumen.

The sheath is then inflated into an expanded state, thereby defining the lumen within the sheath. Thus, the lumen defined by the sheath extends from the entrance site through an intervening internal passage to the target body lumen or site and from the entrance site to the target body lumen or site (or path). Can give a passage). If desired, as described above, if the sheath is kept contracted and / or covered by the restraint, the restraint is at least partially before it is inflated to the expanded state. It may be removed from the sheath.

Diagnostic and / or therapeutic procedures as illustrated below may be performed within the body lumen through the lumen defined by the sheath. At the end of the procedure, the sheath is removed from the body lumen, preferably from the patient's body.

For example, as shown in FIGS. 11A-11F, the sheathing device 10 may be used to facilitate delivery of the stent 60 into the constriction or occlusion 92 within the vessel 90. Vessel 90 may be a coronary, peripheral, or coronary vessel within the vascular structure of a patient, a carotid network, an artery or vein within the cerebrum or other vessel.

As shown in FIG. 11A, the device 10 with the sheath 20 in a contracted state is a percutaneous entrance site (not shown) until the distal end 16 is placed within the target vessel 90. ) And are introduced into the patient's vascular structure. For example, a guide wire (not shown) is pre-positioned into blood vessel 90 from the percutaneous entrance site across the stenosis 92 using conventional methods. The device 10 may travel on the guide wire until the distal end 24 of the sheath 20 is located within or beyond the stenosis 92, as shown in FIG. 11A. If the device 10 includes a reinforcing member 12, the reinforcing member 12 includes a guide wire cavity (not shown), and the guide wire is inserted through the guide wire cavity to insert the device 10 on the guide wire. You may be able to proceed. Alternatively, the sheath 20 may be advanced in its contracted state without prior placement of guide wires. The distal tip of the seat 20 or reinforcement 12 is flexible or flexible enough to avoid trauma to the vascular structure during progression, or can be steered during progression. By being molded, moldable, or deformable, the navigation of the vascular structure can be facilitated.

When the device 10 is placed in the blood vessel 90, a restraint (not shown) that holds the sheath 20 in a contracted state or covers the sheath 20 is provided, for example, mechanically or chemically (eg, bioabsorbable suture). It may be removed (suture) and / or physiologically (eg, heat-activated nitinol tie). For example, as mentioned above, this may involve retreating the covering catheter or sheath (not shown), or removing the loop or other strands surrounding the sheath 20 (also not shown). ..

The sheath 20 may then be inflated from its contracted state to its expanded state. For example, a fluid (not shown) may be introduced into the lumen 26 to inflate the sheath 20, so that the sheath 20 inflates and, for example, between the entrance site and the vessel 90, the patient's pulse. Aligns (or linings) or contacts the walls of one or more vessels in the vascular structure. Alternatively, as shown in FIG. 11B, the sheath 20 is free to inflate when one or more instruments (eg, catheter 62 and stent) are advanced through the lumen 26. It may simply be released.

Explained with reference to FIG. 11B, one or more instruments may be introduced into the vessel 90 via the lumen 26 defined by the sheath 20. For example, a catheter 62 carrying a stent 60 is introduced into the proximal end 22 of the sheath 20 (not shown in FIGS. 1A-11F) until the stent 60 is placed in the vessel 90 and the lumen 26 It may proceed via. Stent 60 may include any known prosthesis (eg, a stent that is inflatable or self-expanding by a balloon), and catheter 62 may include, for example, a balloon, sheath, nose cone and / or others. Any known sending device may be included, including the element of. If necessary, other instruments (eg, thrombectomy devices, agitation devices, balloon catheters, filters, closure devices, etc.) (not shown) are introduced via the sheath 20 before or after the catheter 62. For example, the stenosis 92 may be widened and / or provided distal protection (ie, trapping embolic material released during the procedure).

The guidewire or other rail on which the device 10 can be advanced may be removed before one or more instruments are advanced through the sheath 20, or the guidewire is in place beyond the constriction 92. You can stay. In addition, if the device 10 includes a concentric reinforcing member 12 within the sheath 20, the catheter 62 is placed on the reinforcing member 12 (ie, between the reinforcing member 12 and the sheath 20), as shown in FIG. 11B. ) You may proceed. Alternatively, if the sheath is removable from the reinforcing member, the reinforcing member 12 may be removed from the sheath 20 (not shown). In yet another embodiment, as shown in FIGS. 4A and 4B, the instrument (not shown in FIGS. 4A and 4B) may be advanced via the lumen 126 adjacent to the reinforcing member 12. Therefore, one advantage of carrying the catheter or other device within the sheath 20 is that the need for guidewire lumens within the device may be eliminated, thereby contouring (or posture or height) of the device. Can be made smaller than the equipment sent on the guide wire.

Continuing with reference to FIG. 11B, the smooth nature of the sheath 20 facilitates the catheter 62 to travel through the lumen 26, thus allowing the patient's vascular structure to be narrow and tortuous. Facilitates passage through lesioned and / or fragile areas. For example, the sheath 20 can convert the axial force generated when pushing an instrument (eg, catheter 62) into or pushing into a narrow area into a radial force. Radial forces widen a narrow area, making it easier for the instrument to pass through it. This operation can be further enhanced by pressurizing the sheath 20 internally (or from the inside), for example by introducing a fluid into the lumen 26. Thus, the sheath 20 may facilitate the stent 60 to travel beyond (or across the stenosis 92) the stenosis 92, as shown in FIG. 11C.

In addition, the sheath 20 can guide an instrument traveling through the sheath 20 along the smooth passage of the lumen 26, so that the sheath 20 punctures or punctures the wall of the tube within the vascular structure. The risk of injuring and / or interfering with the device can be substantially reduced. In addition, the sheath 20 expands and covers the wall, thereby restraining plaque and thrombi between the sheath 20 and the wall of the tubing, so that the sheath 20 carries the risk of embolic material etc. moving from the patient's vascular structure. Can be minimized.

If the distal end 24 of the sheath 20 is closed, an opening 28 may be formed to allow one or more instruments to advance through the lumen 26 and out of the sheath 20. For example, as described above, when a first instrument (eg, a catheter 62 carrying a stent 60) travels through the lumen 26 and is pressed against the distal end 24 as shown in FIG. 11D. The distal end 24 may be separated from the reinforcing member 12. Alternatively, if the distal end 24 of the sheath 20 is attached to the stiffener 12, for example, by advancing the stiffener 12 distally and / or pulling the sheath 20 proximally. The end 24 may be separated from the stiffener 12 and the opening 28 may be formed before or after introducing, for example, a catheter 62 or other instrument (not shown) into the lumen 26.

In yet another embodiment, as shown in FIG. 5 and as described above, the sheath 20'has a weakened region 30' that can be used to form an opening (not shown in FIG. 5). It may be included in the distal end 24'. For example, fluid (eg, saline and / or contrast) may be introduced into the lumen 26'of the sheath 20' until sufficient internal pressure is generated and the weakened area 30'is destroyed or torn. .. Alternatively, an instrument (eg, catheter 62, guide wire, etc. (not shown) shown in FIGS. 11B-11F) was advanced within the lumen 26'and pressed against the weakened area 30'to be weakened. Region 30'may be broken to form an opening. In yet another embodiment, a device 10 "including a sheath 20" with an opening 28 "already provided at the distal end 24", as shown in FIG. 6, for example, may be used.

Returning to FIG. 11E, when the stent 60 is placed beyond the stenosis 92, the sheath 20 is at least partially retracted and the stent 60 and / or the catheter 62 is placed in the tube 90 and / or the stenosis. Expose within 92. As shown in FIG. 11F, the stent 60 may be expanded, for example, by expanding the stenosis 92 or providing a scaffold on the stenosis 92. Once the stent 60 has been delivered (and additional procedures have been completed), the catheter 62 and device 60 may be removed from the tubing 90 and the patient's vascular structure via the inlet site.

In one form, the catheter 62 or other device (not shown) may first be removed into the sheath 20 via the sheath 20 and then immediately removed. If desired, the sheath 20 may be aspirated by drawing fluid from within the lumen 26 of the sheath 20, eg, by connecting a vacuum source to the proximal end of the sheath 20, prior to removing the sheath 20 from the tube 90. It may be crushed at least partially from the expanded state. Alternatively, a catheter or other tubular member (not shown) may be advanced over the sheath 20 to facilitate its removal. In another embodiment, the sheath 20 may be removed simultaneously with the catheter 62 or other device, for example by regressing the device into the sheath 20. In yet another embodiment, the sheath 20 may be removed from the patient before removing the catheter 62 or other device. The procedure may be monitored using an external imaging device, such as fluoroscopy, MRI and / or ultrasound, parts (eg, device 10, stent 60 and / or catheter 62), which it progresses and It will be appreciated that / or elements for facilitating imaging during removal (eg, radiation opaque markers (not shown)) may be included.

Reference is made to FIGS. 12A-12D to illustrate another method of using sheathing device 10 (or any of the sheathing devices described above) to provide access to a target tube within the patient's vascular structure. .. Specifically, device 10 may be used, for example, to deliver an electrical lead 70 for a pacemaker into a coronary vein 96 adjacent to, for example, the left ventricle of the heart. As shown in FIG. 12A, the device 10 in which the inflatable sheath 20 supported by the reinforcing member (not shown) is in a contracted state may first be advanced into the coronary vein 96.

For example, with the sheath 20 folded, device 10 is introduced from a percutaneous entrance site (not shown) (eg, deep vein or subclavian vein) and via the patient's venous system. It may be advanced into the right atrium of the heart and into the coronary sinus (not shown) to reach the target coronary vein 96. The device 10 may travel on the guide wire (not shown) in the same manner as described above. Due to its relatively low contour (or height), device 10 may have access to a smaller coronary vein, or may be advanced further into the targeted coronary vein than conventional devices. It's okay.

Once the device 10 is located in or near the target vein 96, fluoroscopy and / or other imaging methods may be used to facilitate positioning of the device 10. Device 10 (eg, distal end 24 of sheath 20, covering restraint, etc.) may include one or more radiopaque markers (not shown) to facilitate imaging. .. In addition or in place of this, the contrast agent is intravenously passed, for example, via the fluid lumen in the reinforcing member (not shown) of the device 10 and / or via the lumen 26 of the sheath 20. It may be introduced in the above to facilitate imaging. Such imaging can be used to identify the position of the sheath 20 with respect to nearby structures and ensure that the device 10 travels as close as possible to the target location. Preferably, the device 10 is advanced such that the distal end 24 of the sheath 20 is located in the coronary vein 96 adjacent to the left ventricle (not shown) of the patient's heart.

As shown in FIG. 12B, the sheath 20 may be inflated between the entrance site and the target vein 96. If a restraint (not shown) is provided, it may be removed before the sheath 20 is inflated. For example, a fluid containing saline and / or a contrast agent may be introduced into the sheath 20 to inflate the sheath 20 in an expanded state. The contrast medium delivered into the sheath 20 also facilitates imaging of vein 96. For example, if the hyperopic end 24 of the sheath 20 is initially closed, the contrast medium delivered into the lumen 26 may inflate the sheath 20 to fit the shape of the surrounding tube, thereby the sheath. Makes it easy to image the tube in which 20 is deployed.

As shown in FIGS. 12B and 12C, the electrical pacing lead 70 may be advanced through the lumen 26 of the sheath 20 until the tip 72 of the lead 70 is within the target vein 96. Similar to the method described above, the sheath 20 may already include an opening 28 in its distal end 24 that is in contact with the lumen 26, or the opening may be the closed distal end 24 of the sheath ( (Not shown) may be formed. The tip 72 may be deployed from the sheath 20, for example by retracting the sheath 20 or by advancing the tip 72 through the opening 28 and beyond the distal end 24 of the sheath 20. The tip 72 is substantially fixed in vein 96.

As shown in FIG. 12D, the sheath 20 may then be removed from vein 96 and the patient's vascular structure. Preferably, the sheath 20 may be split into one, two or more pieces so that the sheath 20 is easily removed from around the reed 70. Embedding of the lead 70 can then be completed using conventional methods.

Referring to FIGS. 14A-14C, a method of delivering a colonoscope 76 into a patient's colon 98 using any of the forms of sheathing apparatus 10 described above is shown. As shown in FIG. 14A, device 10 is advanced into colon 98 with the sheath 20 contracted. As shown in FIG. 14B, as the sheath 20 progresses to the desired position, it is inflated into an expanded state, defining the lumen 26. The colonoscope 76 can be advanced via the lumen 26 of the sheath 20 as in the form described above. If desired, the sheath 20 may be shaped such that the colonoscope 76 can image the surrounding tissue within the colon 76 as the colonoscope 76 advances through the sheath 20. For example, the material of the sheath 20 may be substantially transparent to the visible light (or other parts of the spectrum) used by the colonoscope 76. Alternatively, in other applications, the sheath 20 allows other imaging sources (eg, ultrasound energy) to pass through the sheath 20 substantially freely to allow imaging of surrounding tissue. You can do it. The sheath 20 may be removed from around the colonoscope 76, as shown in FIG. 14C, or at least partially around the colonoscope 76 to facilitate removal after treatment, for example. You can let it stay. In addition, the sheath 20 may be adapted to introduce fluid (eg, air, carbon dioxide, etc.) into the gastrointestinal lumen.

Described with reference to FIGS. 15A-15C, the sheathing device of the present invention may facilitate retrograde progression of one or more instruments within a patient's venous system. For example, as shown in FIG. 15A, an exemplary vein 102 containing a plurality of valves 104 is shown. As shown in FIG. 15B, the sheath device 10 (which may be in any of the embodiments described herein) can be advanced into vein 102 with the inflatable sheath 20 contracted. .. Once in the desired position, as shown in FIG. 15C, the sheath 20 may be inflated to its expanded state, thereby opening the valve 104 and the sheath 20 having a relatively large diameter through the vein 102. A lumen 26 may be provided. Similar to the embodiments described above, one or more instruments (eg, stent 60 and catheter 60 as shown in FIG. 14D) may be advanced through the lumen 26 to complete the procedure.

The sheathing device of the present invention may also be used to perform other diagnostic and / or therapeutic procedures within the vascular structure. For example, the device is for sending imaging elements (eg, endovascular ultrasound (IVUS) devices, endoscopes and fiber optic elements, etc.) and / or therapeutic instruments (eg, angioplasty catheters, stent delivery, etc.). Devices and devices for atherosctomy or thrombectomy, etc.) may be provided with an inflatable lumen for delivery.

In another method, the sheathing device of the present invention can be used to access and / or carry instruments to other body lumens within the patient's body. For example, the device may be used within a patient's urogenital tract, respiratory tract, gastrointestinal tract, lymphatic system, or vascular (or vascular) system. In addition, the device is introduced into a surgically formed opening and advanced into a surgically formed passage (eg, a passage formed in the interstitial cavity to obtain biopsy). Good.

Another embodiment of the sheath device 510 of the present invention will be described with reference to FIGS. 18 and 19A-19C. Generally, the device 510 includes a catheter or other elongated member 512 and an inflatable sheath 520. The catheter 512 may be a long tube made of a material with uniform or variable flexibility, eg, having a distal end 514 that is sufficiently flexible. Catheter 512 may include one or more lumens (not shown) extending from the proximal end (not shown) to the distal end 514.

In a preferred embodiment, the catheter 512 may include one or more diagnostic or therapeutic elements at the distal end 514. For example, the catheter 512 may be an imaging element (eg, an endovascular ultrasound (IVUS) device, etc.) and / or to observe, cross, and / or treat an obstruction in a blood vessel (not shown), for example. Incision elements (eg, cutting elements, elements for blunt incisions, excision (or ablation) elements) may be included. In addition or in lieu of this, the catheter 512 may include a steering element (not shown) for manipulating the distal end 514 inside the patient's body.

The sheath 520 may be a membrane or other structure that is sufficiently flexible and preferably weak. For example, the sheath 520 may include any of the materials and / or structures contained in the forms described above. The sheath 520 may be attached to the outer surface of the catheter 512 so that it is substantially non-removable. For example, the sheath 520 may include a sheet whose longitudinal edges are attached at one or more positions along the length of the catheter 512. Alternatively, the sheath 520 may be a tubular member with an outer surface attached at one or more positions along the length of the catheter 512. Therefore, at least a portion of the sheath 520 may extend between the proximal and distal ends of the catheter 512.

The sheath 520 can expand from a contracted state (shown in FIG. 19A) to minimize the contour (or attitude or profile) of the sheath 520, for example, to an expanded state (shown in FIGS. 19B and 19C). .. In the expanded state, the sheath 520 defines an auxiliary lumen 522, at least in part. The auxiliary lumen 522 may extend between the proximal end (not shown) of the sheath 520 and the distal end 524, the end of which is preferably adjacent to the distal end 514 of the catheter 512. ..

The distal end 524 of the sheath 520 may include an opening (not shown) that communicates with the ancillary lumen 522. In another embodiment, the distal end 524 may be closed and, similar to the configuration described above, is inserted into the lumen 522, including a separation that forms an opening (not shown). The instrument (eg, the guide wire 580 shown in FIG. 19C) may be adapted to travel into the body lumen through the opening.

If desired, a restraint (not shown) may be provided to keep the sheath 520 in a contracted state, for example, as the device 510 is advanced through the patient's body. For example, an outer sheath (not shown) may be provided to accommodate the catheter 512 and sheath 520. The outer sheath can be removed before the sheath 520 is inflated. In addition or instead, an adhesive may be used to temporarily secure the sheath 520 along the outer surface 518 of the catheter 512. Thus, the adhesive may hold the sheath 520 substantially flat along the outer surface 518 of the catheter 512, as shown in FIG. 19A. The adhesive may shift when internal pressure is applied into the lumen 522 of the sheath 520, or may dissolve in the body lumen to release the sheath 520 and inflate the sheath 520.

With reference to FIGS. 20A-20D, for example, using the device 510 shown in FIG. 18, the instrument (eg, the guide wire 580) is passed through, for example, a complete occlusion 592 within a blood vessel or other body lumen 590. Explain how to send. First, as shown in FIG. 20A, with the sheath 520 contracted, the device 510 is occluded at the distal end 514 of the catheter 512, eg, via a percutaneous portal site (not shown). It may be introduced into the tube 590 until it is located proximal to (eg, upstream).

Explaining with reference to FIG. 20B, the distal end 514 of the catheter 512 holds the occlusion 592 until the distal end 524 of the sheath 520 is located distal (eg, downstream) to the occlusion 592. It may be penetrated and advanced. The catheter 512 may include one or more elements 516 at the distal end 514 to facilitate the catheter 512 traveling through the occlusion 592. For example, the catheter 512 may carry an imaging element (eg, an IVUS device (not shown)) for imaging the obstruction 592 at the distal end 514. In addition or instead, an incision element (eg, cutting, core, blunt incision and / or ablation (or ablation) element (not shown)) is distal to form a passage 594 through the occlusion. It may be provided at the end 514. If desired, the catheter 512 includes a steering element (not shown) to facilitate operation of the distal end 514 of the catheter 512 as the catheter 512 travels through the occlusion 592. It's fine.

When the sheath 520 extends through the obstruction 592, a long member (eg, a guidewire 580 or other instrument (not shown)) is placed so that the distal end 582 of the guidewire 580 is distal to the obstruction 592. It may be inserted into the sheath 520 until it is positioned. The sheath 520 can inflate as the guide wire 580 or other instrument travels within the sheath 520. Alternatively, the sheath 520 may be deployed, for example, by introducing a fluid into the lumen 522 of the sheath 520 (see FIG. 29B), similar to the form described above.

The device 510 may then be retracted through the closure 592 and / or out of the tube 590. Then, as is well known to those skilled in the art, for example, one or more instruments (not shown) to treat the obstruction 592 and / or to send the drug or fluid over the obstruction 592, travel on the guidewire 592. You may let me. Thus, unlike the previous form, the sheath 520 may provide a lumen for a secondary device (eg, a guidewire) that can be delivered in conjunction with the catheter 512.

The present invention includes those of the following aspects. (Aspect 1) A device that accesses the patient's body lumen Flexible reinforcement with distal and proximal ends sized and shaped for insertion into the body lumen; and An inflatable sheath that extends between the proximal and distal ends of the stiffener, from a contracted state that minimizes the contour of the sheath and allows insertion into the lumen with the stiffener. A sheath that can be inflated, leaving the sheath in an expanded state that at least partially defines the lumen between the proximal and distal ends of the stiffener. Equipment including. (Aspect 2) The device of aspect 1 comprising a material with a smooth sheath. (Aspect 3) The device of aspect 1 in which the sheath contains a polymer. (Aspect 4) The apparatus of aspect 3, wherein the polymer comprises at least one of PTFE, EPTFE, FEP, PET, urethane, olefin and PE. (Aspect 5) The device of aspect 1, wherein the sheath comprises an elastic material. (Aspect 6) The apparatus of embodiment 5, wherein the elastic material comprises at least one of silicone, latex, isoprene and chronoprene. (Aspect 7) The device of embodiment 1, wherein the sheath comprises a tubular member attached to the reinforcing member at one or more locations between the proximal and distal ends of the reinforcing member. (Aspect 8) The device of aspect 7, wherein the stiffener comprises one or more strands extending along the sheath. (Aspect 9) The device of aspect 8, wherein the one or more strands extend along the sheath in at least one of axial, spiral, and circumferential directions. (Aspect 10) The device of aspect 1, wherein the sheath comprises a sheet material whose tip is attached to the reinforcing member such that both the sheet and the reinforcing member define a lumen. (Aspect 11) Aspect 1 in which the sheath comprises a distal end having an opening communicating with the lumen so that an instrument inserted through the lumen can proceed from the opening into the body lumen. Equipment. (Aspect 12) The sheath contains a substantially closed distal end, the distal end contains a separation for forming an opening, and an instrument inserted through the lumen enters the body lumen from the opening. A device of aspect 1 that is capable of progressing. (Aspect 13) The device of aspect 12, wherein the separation portion comprises a region where the material constituting the sheath is weakened. (Aspect 14) The sheath contains a substantially closed distal end attached to the distal end of the stiffener and is separable from the stiffener so that the distal end of the sheath forms an opening, providing a lumen. The device of aspect 1 in which an instrument that is passed through and inserted is allowed to travel through an opening into a body lumen. (Aspect 15) The device of embodiment 1, wherein the sheath is configured to tear so that the sheath can be removed from around an instrument placed in the lumen. (Aspect 16) The device of aspect 15, wherein the sheath comprises a weakened area extending between the proximal and distal ends of the sheath. (Aspect 17) The device of aspect 1 in which the sheath has a wall thickness of about 0.01 inches (0.25 mm) or less. (Aspect 18) The device of embodiment 1, wherein the stiffener has sufficient column strength to allow the distal end to travel through the body luminal cavity without the risk of twisting or distorting by pushing the proximal end. (Aspect 19) The device of aspect 1, wherein the stiffener comprises a guide wire. (Aspect 20) The stiffener has a bow-shaped cross section, which is a groove extending between the proximal and distal ends, within which at least a portion of the sheath minimizes the cross-sectional contour of the device. A device of aspect 1 that defines a groove that is placed in a contracted state. (Aspect 21) The device of embodiment 1, wherein the reinforcing member comprises an elongated member extending substantially parallel to the longitudinal axis of the sheath. (Aspect 22) The device of embodiment 1 in which the sheath is attached to the reinforcing member at one or more points. (Aspect 23) The device of aspect 21, wherein the sheath is attached to the proximal and distal ends of the stiffener. (Aspect 24) The device of aspect 21, wherein the sheath is attached to the reinforcing member substantially continuously between the distal and proximal ends of the reinforcing member. (Aspect 25) The device of aspect 21, wherein the sheath is fixed to a reinforcing member so that it can be removed. (Aspect 26) The device of embodiment 1, wherein the reinforcing member comprises a plurality of elongated members extending substantially parallel to the longitudinal axis of the sheath. (Aspect 27) The device of aspect 1, further comprising a restraint that selectively holds the sheath in a contracted state. (Aspect 28) The device of aspect 27, wherein the restraint comprises a tubular member having a lumen in which a reinforcing member and a sheath can be placed. (Aspect 29) The restraint comprises an outer sheath that surrounds the contracted sheath, and the outer sheath contains one or more weakened regions that are separable to allow the sheath to expand into an expanded state. The device of aspect 27. (Aspect 30) The device of aspect 29, wherein the outer sheath is attached to the reinforcement at one or more points between the proximal and distal ends of the reinforcement. (Aspect 31) The outer sheath has a lumen in which the sheath can be placed in a contracted state, the lumen is configured to receive fluid within it, and the fluid pressure is one or more of the weakened regions. A device of aspect 29 that is designed to be separated. (Aspect 32) The device of aspect 27, wherein the restraint comprises one or more strands that are placed around an inflatable member. (Aspect 33) The device of aspect 27, wherein the restraint comprises at least one of an adhesive and a bioabsorbable encapsulant. (Aspect 34) The device of embodiment 1 having a plurality of lumens extending between the proximal and distal ends with the sheath expanded. (Aspect 35) The device of aspect 34, wherein each of the plurality of lumens is configured for at least one of injection, aspiration, perfusion and agitation. (Aspect 36) A device that accesses the patient's body lumen, a weak, inflatable sheath that is sufficient for the sheath to extend between the entrance site into the patient's body and the target body lumen. Includes sheath, including length, proximal end, and distal end, The sheath is inflatable from a contracted state that minimizes the contour of the sheath and allows insertion into the body lumen, and at least partially extends the lumen extending between the proximal and distal ends. A device that is in the specified extended state. (Aspect 37) A device of aspect 36, comprising a material with a smooth sheath. (Aspect 38) A device of aspect 36, wherein the sheath comprises a polymer. (Aspect 39) A device of embodiment 36, wherein the sheath comprises an elastic material. (Aspect 40) A device of aspect 36, wherein the sheath comprises a tubular member. (Aspect 41) The device of aspect 36, further comprising one or more reinforcing members extending along the sheath. (Aspect 42) The device of aspect 41, wherein one or more reinforcing members extend along the sheath in at least one axial, spiral, and circumferential direction. (Aspect 43) A device of embodiment 36, further comprising a long reinforcing member, the sheath comprising a sheet material whose tip is attached to the reinforcing member, and both the sheet and the reinforcing member defining a lumen. (Aspect 44) Aspect in which the sheath comprises a distal end having an opening in contact with the lumen so that an instrument inserted through the lumen can travel through the opening into the body lumen. 36 devices. (Aspect 45) The sheath contains a substantially closed distal end, the distal end contains a separation for forming an opening, and an instrument inserted through the lumen is inserted through the opening into the body lumen. A device of aspect 36, which is capable of progressing to. (Aspect 46) A device of embodiment 36, wherein the sheath is configured to tear so that the sheath can be removed from around an instrument placed in the lumen. (Aspect 47) A device of embodiment 36, wherein the sheath has a wall thickness of about 0.01 inches (0.25 mm) or less. (Aspect 48) The device of aspect 36, further comprising a restraint that selectively keeps the sheath in a contracted state. (Aspect 49) A device of embodiment 36, further comprising one or more instruments that can be inserted through the lumen of the sheath. (Aspect 50) A device that transports the patient into the lumen of the body. Flexible catheters including proximal and distal ends; An inflatable sheath attached to the outer surface of the catheter that includes a lumen extending between the proximal and distal ends of the sheath and is inflatable from a contracted state that minimizes the contour of the sheath. A device comprising a sheath that is in an dilated state in which the sheath at least partially defines an auxiliary lumen extending between the proximal and distal ends of the sheath. (Aspect 51) A device of aspect 50, comprising a material with a smooth sheath. (Aspect 52) A device of aspect 50, wherein the sheath contains a weak substance. (Aspect 53) The sheath contains a substantially closed distal end, the distal end contains a separation for forming an opening, and an instrument inserted through the lumen is inserted through the opening into the body lumen. A device of aspect 50, which is capable of progressing to. (Aspect 54) A device of aspect 50, wherein the sheath has a wall thickness of about 0.01 inches (0.25 mm) or less. (Aspect 55) The device of aspect 50, further comprising a restraint that selectively keeps the sheath in a contracted state.

The present invention may take various modifications and alternative forms, but specific examples are shown in the drawings and described in detail herein. However, the invention should not be limited to the particular form or method disclosed, and the invention should extend to all variants, equivalents, and alternatives within the spirit and scope of the appended claims. It should be understood that.