# Patent

## Title
Apparatus for deploying occluding structures in body lumens

## Abstract

Occluding structures may be created within a body lumen by advancing a length of material distally through the body lumen. By drawing a distal location on the advanced length of material in a proximal direction, the material may be compacted into a structure which at least partially occludes the lumen. The occluding structure may be used for a variety of purposes, including removing obstructions from the body lumen, such as kidney stones from the ureter; providing hemostasis in a blood vessel; providing occlusion of a fallopian tube; temporary constraint of stone fragments in the urinary tract; capture or restraint of clot in blood vessels; and the like. Apparatus for performing the method may comprise a length of material attached at its distal end to tubular guide or other advancement member. Tensioning members may also be provided for collapsing and compacting the length of material within the body lumen.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser. No. 10/886,886, filed on Jul. 7, 2004, the full disclosure of which is incorporated herein by reference.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical apparatus and methods. More particularly, the present invention relates to methods and apparatus for deploying conformable structures in the ureter and other body lumens.
It is common for kidney stones to pass from the kidney through the ureter to the urinary bladder. While muscular peristalsis of the ureter will often pass the stones into the bladder without complication, in some instances large and/or irregularly shaped stones may become lodged within the ureter causing discomfort and potential damage to the ureter and upper collective system.
A number of ways have been proposed for dislodging such kidney stones. For example, extracorporeal shock wave lithotripsy (ESWL) can be used to break up the kidney stones but is often ineffective when the stones are present in the ureter. Moreover, ESWL can produce irregularly-shaped fragments which, while smaller than the original stone, may have sharp edges that will prevent spontaneous passage of the particles through the ureter. In the case of a stone or fragment, impacted in the ureter, it is common practice to attempt capture, using a wire stone basket. The basket is introduced through a ureteroscope which itself is typically introduced retrograde through the urinary tract.
In many cases, further lithotripsy through the scope is performed (ISWL). It is often difficult to advance such stone baskets past the obstructing material. Attempts to pass wire baskets or other grasping apparatus past a stone lodged in the ureter also presents risk of damage to the ureter. Abrasion, stretching, or perforation of the ureter at the impaction site can cause local urine leakage or edema even if the stone or resulting debris is successfully captured; and removal of the basket with the stone may be quite difficult. In some instances, baskets containing captured stones or fragments cannot themselves be removed, and it is difficult if not impossible to release the captured stone material back into the lumen of the ureter. In those cases, the basket must often be retrieved surgically. Finally, if and/or when ISWL is performed, it would be useful to have some means of stabilizing stone fragments at the treatment site, rather than letting them escape up the ureter in a retrograde direction.
For these reasons, it would be desirable to provide improved methods and apparatus for capturing and removing kidney stones from the ureter. It would be further desirable if the methods and apparatus were useful for containing and/or retrieving other materials from other body lumens, such as for extracting clot, thrombus, and/or other obstructing materials from blood vessels in embolectomy procedures. It would still further be desirable if the methods and apparatus were useful for still other procedures, including luminal occlusion, for example vascular occlusion for hemostasis, restricting blood flow to target tissue regions, and the like. The methods and apparatus of the present invention should be generally atraumatic in use, require significantly less skill than basket manipulation, optionally allow the release of captured material, should be simple and economical in construction and use, and should provide minimum risk and trauma to the patient. At least some of these objectives will be met by the inventions described hereinbelow.
2. Description of the Background Art
The use of an everting sleeve composed of thin, tensilized polytetrafluoroethylene for introducing catheters to body lumens is described in U.S. Pat. Nos. 5,531,717; 5,676,688; 5,711,841; 5,897,535; 6,007,488; 6,240,968; and EP605427B 1. A wire basket for advancing stone through a body lumen during lithotripsy procedure is available under the Stone Cone tradename from Boston Scientific Corporation. See Published U.S. Application No. 2003/0120281. Copending application Ser. No. 10/794,337, filed on Mar. 5, 2004, the full disclosure of which is incorporated herein by reference, describes a sheath delivery system that could be used in performing some of the methods described herein.
BRIEF SUMMARY OF THE INVENTION
The present invention provides methods and apparatus for deploying an occluding structure in a body lumen. The occluding structure will usually be intended for temporary placement and will often be used for removing kidney stones and other urinary calculi, blood clots, thrombus, and other materials which obstruct body lumens. In other instances, however, the occluding structures could be deployed permanently for occluding blood vessels, fallopian tubes, and the like for a variety of purposes, particularly when the occluding structure is lodged in a lumen having a diameter which decreases in the direction of blood or other fluid flow.
The occluding structure typically comprises a length of material which is initially positioned in the body lumen in a generally elongate or unfurled configuration. The length of material is subsequently pulled, furled, or drawn back on itself so that the material compresses or compacts into the desired occluding structure. The material typically comprises a polymer film, a woven fabric, a non-woven fabric, and composites and laminates thereof. Exemplary polymer materials include polytetrafluoroethylene (PTFE), polyethylene (PE), perfluoroalkoxy (PFA), polyurethane (PU), perfluoromethylvinylether (MFA), and perfluoropropylvinylether (PPVE). Other exemplary materials include films, fabrics woven of any supple material such as nylon, polyester, silk, etc., lamination of these materials, and the like. The materials will generally be chosen so that they compress or compact into a relatively soft, non-traumatic mass of material. The compaction may be by folding, twisting, spiraling, or otherwise collapsing so that the length of the material becomes shorter and the width becomes greater, where length is a dimension generally aligned with the axis of the body lumen and width is the dimension generally transverse to the axis when the material is in the body lumen. In the exemplary embodiments, the length of material prior to compaction is in the range from 1 cm to 10 cm, usually from 2 cm to 6 cm, and most typically from 3 cm to 5 cm. The original length will be foreshortened so that the resulting compacted mass has a width that approximates the internal diameter of the lumen in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm, and preferably from 3 mm to 5 mm.
By deploying the length of material in its elongated configuration, the material will have a very low profile which permits it to be advanced through narrow body lumens, and more particularly, past obstruction(s) which may be present within the lumen, along the way bypassing structures, valves, sphincters, etc. For example, the length of material may be deployed past stones and other urinary calculi, past blood clots, past regions of thrombosis in blood vessels, and the like. By then compacting the length of material on a distal side of the obstruction, the compacted material may then be drawn in a proximal direction to form a relatively stiff plug or occlusion which is drawn proximally in order to move or more usually remove the obstruction from the body lumen. Deployment of the occluding member, however, may be used for other purposes, including containment of materials, e.g., stone debris during lithotripsy and distal protection against the release of emboli in performing vascular procedures; hemostasis when deployed in blood vessels; contraception when deployed in the fallopian tubes; and the like.
In a first specific aspect, a method for compacting a structure in a body lumen comprises advancing a length of material distally in the body lumen and drawing a distal location on the advanced length of material proximally to compact the material into a structure which at least partially occludes the body lumen. Typically, the length of material is advanced distally past an obstruction in the body lumen and thereafter drawn proximally against the obstruction. The obstruction may then be moved by pulling or drawing the compacted material against the obstruction to reposition the obstruction within or outside of the body lumen. Additionally or alternatively, the compacted structure may prevent the obstruction from moving in a distal direction without movement or removal of the material. In a specific embodiment, the body lumen is a ureter, cystic duct, or common bile duct, and the obstruction comprises one or more stones or other calculi. In a more specific embodiment, the body lumen is a ureter and the length of material is advanced from the urinary bladder into the ureter and past the kidney stone(s) lodged within. Optionally, energy may be directed to disrupt the kidney stones while engaged by the compacted material.
The length of material may be advanced in a variety of ways. For example, the length of material may be advanced or otherwise introduced through a tubular guide. In one instance, the tubular guide is first positioned through the body lumen and the length of material is advanced therethrough, typically using a separate advancement member. In a second instance, the tubular guide and the length of material are introduced simultaneously. Note that the tubular guide may subsequently be drawn proximally in order to expose an unsupported portion of the material. In a third instance, the length of material is advanced using an advancement member. The length of material is attached at or near a distal end of the advancement member, such as a guidewire, and the advancement member and length of material are simultaneously introduced through the body lumen and optionally past an obstruction. In a fourth and presently preferred instance, the tubular guide is introduced through the body lumen where a length of material is originally carried within the interior of the tubular guide. The length of material is everted over a distal end of the tube as the tube is introduced and acts as a barrier to protect the wall of the body lumen since the everted material will remain generally stationary relative to the wall. In the latter instance, the length of material is typically in the form of a sleeve which emerges from an interior lumen, passage, or receptacle of the tubular guide to cover an exterior of the tubular guide as the tubular guide is advanced and the sleeve everts.
In some instances, the tubular guide or other advancement member will also be used to draw back the advanced length of material proximally to compact the material into the occluding structure. In such instances, the systems used to perform the methods of the present invention may consist only of the length of material and the tubular guide or other advancement member. More usually, however, the systems of the present invention will include at least a third component which comprises a tension member for drawing proximally on the length of material after it has been advanced by the tubular guide or other advancement member. The tension member may have a wide variety of forms and may comprise suture, filament, a thread, a wire, a tube, or other elongate element that can be permanently or releasably attached to a distal location on the length of material. Frequently, the tension member will be woven, threaded, or otherwise incorporated into the length of material to facilitate the compaction of the material as the tension member is pulled backward. In an illustrated embodiment, the tension member is a filament which is woven in and out of axially spaced-apart locations on the length of material to permit folding of the length of material as the tension member is drawn proximally. The tension member could alternatively pass through loops or other attachment points on the length of material or could be woven in as part of the fabric of the length of material. Alternately, the tension member could pass through the lumen of a tubular sleeve of the material.
When using a separate tension member, the methods of the present invention will frequently comprise detaching the tension guide or other advancement member from the length of material prior to compacting the material. Alternatively, when using a tubular guide disposed within a sleeve-like length of material, the tubular guide may be partially withdrawn in a proximal direction leaving a distal portion of the length of material unsupported and ready for compaction. In many cases, it will be possible to reverse compaction of the length of material by distally advancing the tension member prior to detachment. For example, it may be desirable under certain circumstances to reverse compaction to release entrapped materials that cannot be removed. By releasing and recapturing, removal could be completed.
In certain embodiments, the length of material will comprise fold structures such as lines or other scored notched, or weakened regions or variations in thickness or geometry which impart a preferential folding pattern upon drawing the length of material in the proximal direction. Exemplary lengths of material may comprise strips, sleeves, ribbons, tubes, and the like, and preferred materials have been set forth above.
In a preferred method for introduction, a sleeve-like length of material is introduced using a tubular guide. The sleeve material is initially stowed within a central lumen or other passage or receptacle in the tubular guide. A first end of the sleeve is immobilized relative to an entry point into the body lumen being treated. The tubular guide is then advanced in a distal direction, and the length of material emerges from a distal end of the tube and everts so that the sleeve material covers the inner wall of the body lumen. Thus, as the apparatus is introduced, the length of material acts as a protective barrier to reduce trauma to the wall of the body lumen. It may farther act to facilitate passage of the device past any stones or other obstructions which are present in the body lumen. Pulling back on the tubular guide and/or the tension member with tubular guide in distal position will reverse advancement of the tubular guide. Finally, after the apparatus has been introduced a sufficient distance beyond any obstruction or other target location, the tubular guide may be withdrawn proximally from the sleeve until it is proximal to the obstruction. The sleeve can then be pulled back to provide the compacted material which is useful for removal of the obstruction, temporary or permanent occlusion of the body lumen, hemostasis, or other purposes. Pulling back the sleeve could be accomplished using the tubular guide, itself, but will more usually be accomplished using a separate tension member as described above.
The present invention farther provides apparatus useful for performing the methods just described. The apparatus may comprise a length of material and a tension member attached to a distal location on the length of material. The tension member will be adapted to compact the material into an occluding structure when the member is pulled proximally relative to the length of material when present in the body lumen. Frequently, the apparatus will further comprise a tubular guide or other advancement member for facilitating introduction of the apparatus into the target body lumen. Other aspects of the apparatus have been described above in connection with the methods of the present invention.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a ureter having a kidney stone lodged between the kidney and bladder.
FIGS. 2A and 2B illustrate a first apparatus in accordance with the present invention which comprises a sleeve-like length of material, a tubular guide, and a tension member.
FIGS. 3A-3H illustrate use of the apparatus of FIGS. 2A and 2B for removing a kidney stone from a ureter.
FIGS. 4A and 4B illustrate a variation in the protocol of the method of FIGS. 3A-3H.
FIG. 5A illustrates a second apparatus constructed in accordance with the principles of the present invention consisting of a length of material and a separate advancement member.
FIG. 5B illustrates a third apparatus similar to the second apparatus of FIG. 5A, except that the advancement member is threaded through a portion of the ribbon-like length of material.
FIGS. 6A-6C illustrate use of the apparatus of FIG. 5A in accordance with the principles of the present invention.
FIGS. 7A and 7B illustrate a modified protocol according to the principles of the present invention.



DETAILED DESCRIPTION OF THE INVENTION
The methods and apparatus of the present invention are useful for intervening in any body lumen of a patient where it is desired to temporarily or permanently occlude at least a portion of the lumen. Most commonly, the methods will be used to move or remove an obstruction from the body lumen, but the methods will also find use in stabilizing such obstructions, particularly while the obstructions are undergoing other treatments such as lithotripsy; preventing distal embolization in vascular procedures; providing temporary or permanent hemostasis in the vasculature; treating aneurysms, particularly in the cerebral vasculature; providing contraception by occlusion of the fallopian tubes; and the like. Thus, potential target body lumens include the urinary tract, particularly the ureter; the vasculature, including the cerebral, peripheral, and coronary vasculature; the fallopian tubes, and the like. The following description is directed particularly at the removal of kidney stones from the ureter, but it will be appreciated that the principles of the present invention described will apply more broadly as discussed above.
Referring now to FIG. 1, the present invention may be used for engaging and retrieving a kidney stone KS or fragments from a ureter U between a kidney K and a bladder B. Access to the bladder will be through the urethra UA using conventional access devices which will not be described herein. Access to the ureter U will be through the os O in a wall of the bladder leading into the lumen of the ureter.
A first exemplary system 10 for performing the methods of the present invention comprises a sleeve-like length of material 12 and a tubular guide 14, as shown in FIGS. 2A and 2B. The sleeve-like length of material 12 has a trailing end 16 and an anchor end 18. The length of the sleeve-like length of material will typically be in the range from 1 cm to 10 cm, usually from 2 cm to 6 cm, although much longer lengths may find use in different circumstances. The sleeve will usually have a continuous sidewall with no openings (other than at the trailing end 16 and anchor end 18), but could also have open regions, have a loose weave in the case of woven materials, or otherwise have openings or discontinuities in the sidewall without departing from the principles of the present invention.
Referring now in particular to FIG. 2B, the sleeve-like length of material 12 may be arranged so that it is initially within a central passage 20 of the tubular guide 14. The material 12 can be arranged so that the anchor and 18 of the sleeve-like length of material 12 will initially be on the exterior of the tubular guide 14 and generally held stationary as the tubular guide is advanced. As the tubular guide 14 is advanced through the body lumen, the trailing end 16 is everted over the distal end 22 of the guide member, generally as shown in FIG. 2B. The trailing end 16 will usually include a tension member 24 which may be a suture, filament, thin wire, or other element which is attached at or near the terminus of the trailing end 16 and which preferably is woven and out of the material 12 over at least a portion of the length of material 12. Such woven or pleated structures will be described in more detail hereinbelow. Pulling on the tension member 24 will collapse and compact the length of material 12 in order to provide the desired luminal occlusion.
Referring now to FIGS. 3A-3H, use of the system 10 for removing a kidney stone KS from a lumen L of a ureter U will be described. Initially, access is gained to the os O of the bladder B (FIG. 1) in a conventional manner. The tubular guide 14 will then be passed through the os O and into the lumen L of the ureter with the anchor end 18 of the sleeve-like member 12 being held stationary relative to the os. Specific systems for doing this are described in copending application Ser. No. 10/794,337, the full disclosure of which is incorporated herein by reference.
Referring now to FIG. 3B, the tubular guide 14 is advanced so that the sleeve-like length of material 12 everts from the distal end 22 of the guide. As the everting end 23 of the tubular guide 14 approaches the kidney stone KS, the sleeve-like length of material 12 will continue to be everted, but will have an exposed surface 13 which remains generally stationary relative to the inner wall of the ureter U and the exterior of the kidney stone KS. Such eversion of the sleeve-like length of material 12 acts like a “tractor tread” in allowing the tubular guide 12 to bypass the kidney stone, as illustrated in FIG. 3C. In addition to facilitating bypass of the kidney stone KS, the eversion of the length of material 12 also reduces the risk of perforation or other trauma to the ureter.
Referring now to FIG. 3D, once past the kidney stone KS, the tubular guide 14 will continue to be advanced through the lumen L in the distal direction (toward the kidney K) until the trailing end 16 has been partly or fully exposed so that the region including the tension member 24 lies distal to the kidney stone KS.
At this point, the tubular guide 14 will be at least partly withdrawn in a proximal direction so that its distal end 22 is located proximal of the kidney stone KS, as shown in FIG. 3E. The portion of the sleeve-like member 12 which lies distal to the kidney stone will radially collapse (since its internal support has been withdrawn) leaving a slack “shell” having the tension member 24 laced therethrough in place. By drawing in a proximal direction (arrow 30) on tension member 24, the trailing end 16 of the sleeve-like member 12 will be caused to axially collapse, generally in the manner of an accordion, as shown in FIG. 3F. By continuing to draw on the tension member 24 the trailing end 16 of the sleeve-like member 12 will be fully compacted against a distal surface of the kidney stone KS, as shown in FIG. 3G. By then pulling on any or all of the sleeve-like member 12, tubular guide 14, and tension member 24 in a proximal direction, the compacted trailing end 12 of the sleeve-like length of material will draw the kidney stone in a proximal direction toward the bladder, as shown in FIG. 3H. Note that at any time after the trailing end 16 had been compacted, it would have been possible to apply laser or other energy in order to fragment the kidney stone and further facilitate its withdrawal. The presence of the compacted trailing end 16 would help prevent loss of the resulting stone fragments into the kidney.
Referring now to FIGS. 4A and 4B, it will also be possible to additionally compact a portion of the sleeve-like length of material 12 against the proximal or bladder-side of the stone S prior to fragmentation and/or removal. Initially, the trailing end 16 of the sleeve-like member 12 is compacted, as generally described above and shown in FIG. 4A. By then further withdrawing the guide member in a proximal direction toward the bladder, an additional length 36 of the sleeve-like length of material 12 will be allowed to collapse. That additional collapsed section may then be compacted against the proximal side of the kidney stone by either further drawing on the tension member 24 (moving the stone proximally) or by simply advancing the tubular guide 14 and collapsed sleeve in a distal direction. Either way, a proximal portion 36 of the sleeve-like length of material 12 will be compacted, as shown in FIG. 4B. Lithotripsy or other energy-based disruption of the kidney stone KS may then be performed with loss of the fragments in either direction being inhibited. The kidney stone and/or resulting fragments may then be withdrawn from the ureter U as generally described above, except that the stone/fragments will be substantially encapsulated by the sleeve-like material.
Referring now to FIG. 5A, an alternative construction of the apparatus of the present invention will be described. System 40 comprises an advancement member 42 and a ribbon-like length of material 44. The advancement member may be a solid-core wire, a tube, or other small diameter or flat/thin member having sufficient column strength to permit its advancement through body lumen and preferably past an obstruction, such as a kidney stone in a ureter. For example, the advancement member may be in the form of a guidewire of the type commonly used in urological procedures. The ribbon-like length of material 44 may be composed of any of the materials listed previously and may have a length in the ranges set forth above. The length of material 44 will typically consist of only a single layer with a width in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm, and a thickness of 1 mm or less. Optionally, the ribbon-like length of material 44 will comprise a flattened tube or other multiple-layer or laminated structure instead of a single layer as illustrated. The ribbon-like length of material 44 may also have a plurality of axially spaced-apart fold structures 46 disposed over at least a distal length thereof. A distal end 48 of the length of material 44 will be attached at or near a distal end of the advancement member 42 so that the advancement member can pull or otherwise carry the ribbon-like length of material through the target body lumen as it is advanced. Optionally, as shown in FIG. 5B, the advancement member 42 can be penetrated or “laced” through axially spaced-apart locations on the ribbon-like length of material 44. As illustrated, the lacing occurs through consecutive sections defined by the fold structures 46. In both cases, the advancement member 42 will be used to advance at least a portion of the ribbon 44 past a stone KS or other object to be retrieved or stabilized.
In use, the deployment system 40 of FIG. 5A is introduced by advancing advancement member 42 through the os O (FIG. 1) and into the lumen of the ureter U, as shown in FIG. 6A. The advancement member 42 carries the ribbon-like length of material 44 distally within the lumen and past the kidney stone KS as shown in FIG. 6B. After the desired distal positioning has been achieved, the advancement member 42 may be drawn in the proximal direction, as shown in FIG. 6C, while the proximal portion of the ribbon-like length of material 44 is left in place. In this way, a region 50 of the ribbon-like length of material 44 which is distal to the kidney stone KS, as shown in FIG. 6B, may be simultaneously or sequentially compacted into the foreshortened occluding structure 52, as shown in FIG. 6C. The compacted structure 52 may then be used in any of the ways described previously, including for moving and/or removing the kidney stone into the bladder, stabilizing the kidney stone during lithotripsy, optionally combined with the removing the fragments of the kidney stone into the bladder, or the like.
As described thus far, the material compaction systems 10 and 40 have been shown to be directly introduced, i.e. introduced without an external sheath or other introducing member. As shown in FIGS. 7A and 7B, however, any of the material compaction systems may be introduced through a sheath 70 which is first introduced into the lumen of the ureter U in a conventional manner. The sheath 70 may be a simple tubular sheath or could be an everting-sleeve sheath of the type described in copending application Ser. No. 10/794,337, the full disclosure of which has previously been incorporated herein by reference. In any event, once the sheath 70 is in place past the kidney stone KS, the sheath may be withdrawn leaving the material compaction system in place. System 10 is illustrated, but system 40 or any other systems according to the present invention could be introduced through the sheath. Once the system 10 is in place, it may be foreshortened by drawing on tension member 24 using the resulting compacted component in any of the ways described previously.
While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

## Claims

1. Apparatus for deploying a conformal structure in a body lumen, said apparatus comprising,
a length of material consisting essentially of a flat polymeric film; and
a tension member attached to a distal location on the length of material, said tension member adapted to advance said length of material in a non-compacted configuration into the body lumen and to compact the material into an occluding structure in response to the member being pulled proximally relative to the length of material when present in body lumen.

2. Apparatus as in claim 1, wherein the length of material compacts by folding, twisting or spiraling.

3. Apparatus as in claim 1, wherein the tension member is embedded within the length of flat polymeric film.

4. Apparatus as in claim 1, wherein the tension member penetrates the length of flat polymeric film at multiple spaced-apart locations along the length.

5. Apparatus as in claim 4, wherein the length of material has fold structures between at least some of the spaced-apart locations.

6. Apparatus as in claim 1, wherein the tension member is positioned in a plurality of connecting loops disposed at multiple spaced-apart locations along the length of material.

7. Apparatus as in claim 1, wherein the tension member is positioned in substantially continuous passage formed in or on the length of material.

8. Apparatus as in claim 1, wherein the tension member comprises a filament woven into the length of material.

9. Apparatus as in claim 1, wherein the tension member is attached only at a distal end of the length of material.

10. Apparatus as in claim 1, wherein the tension member has sufficient column strength to advance the length of material distally in the body lumen.

11. Apparatus as in claim 10, wherein the tension member comprises a guide wire structure.