US20040093056A1 - Medical appliance delivery apparatus and method of use - Google Patents

Abstract

The present invention, in an exemplary embodiment, provides a stent deployment apparatus comprising excellent safety and stent placement and deployment features. An exemplary stent deployment apparatus in accordance with the present invention can facilitate the precise delivery of stents in a safe and repeatable fashion. In particular, a preferred deployment apparatus allows the physician to concentrate on correct placement without having to estimate extent of deployment by providing a physical safety mechanism that limits deployment to the critical deployment point. Moreover, to exceed this threshold, an audible and/or tactile indicator informs the physician that she can no longer retract the stent beyond this point. The stent deployment apparatus guidewire may also be extended rather than retracting the outer catheter to deliver the stent. Moreover, the distal tip is designed to comfortably guide the deployment apparatus through a diseased or occluded lumen so that the stent can be delivered in the most beneficial location. Additionally, the distal tip facilitates the removal of the deployment apparatus even if a defective stent is only partially radially expanded. In alternative embodiments, the stent deployment apparatus allows for the insertion of an optical scope to facilitate stent delivery.

Description

FIELD OF THE INVENTION
• The present invention relates generally to medical devices directed to the prevention of nonvascular vessel or passageway occlusion, and more particularly to stent deployment apparatuses and methods for utilizing these devices in the treatment of both benign and malignant conditions.[0001]
BACKGROUND OF THE INVENTION
• Stents are devices that are inserted into a vessel or passage to keep the lumen open and prevent closure due to a stricture, external compression, or internal obstruction. In particular, stents are commonly used to keep blood vessels open in the coronary arteries and they are frequently inserted into the ureters to maintain drainage from the kidneys, the bile duct for pancreatic cancer or cholangiocarcinoma or the esophagus for strictures or cancer. Nonvascular stenting involves a range of anatomical lumens and various therapeutic approaches, however, accuracy of installation is universally important.[0002]
• In order to serve its desired function, the stent must be delivered precisely and oriented correctly. In order to facilitate the delivery of stents, medical device companies began to design deployment apparatuses that allow physicians to deploy stents more precisely. Unfortunately, guidance of the stent has substantially remained a function of physician skill resulting from substantial practice. This fact has become particularly evident with the advent of radially expanding stents. If after full deployment of the stent, the physician discovers the stent has been implanted incorrectly, there is no conventional way of correcting the error short of removing the stent. In particular, as a rule of thumb, once the exterior catheter, of conventional delivery devices, has been retracted beyond 60%, it generally cannot be realigned with respect to the stent. As a result, physicians must be sure of their stent placement prior to deploying the stent beyond the 60% point. We will refer to this 60% point throughout the application as the critical deployment point.[0003]
• Conventional stent delivery devices, however, do not have any safety mechanism to prevent excessive deployment of a misaligned stent. In fact, conventional delivery devices require the physician to estimate extent of deployment, which results in either overly conservative or excessive deployment—both of which leads to stent misplacement.[0004]
• An additional limitation of conventional stent delivery devices is the distal tip of conventional stent delivery devices are not adequately designed to (1) facilitate the clearance of obstructed lumen, or (2) facilitate the removal of the delivery device once the stent is radially expanded. In particular, most distal tips are not configured to comfortably guide the delivery device through a diseased or occluded lumen so that the stent can be delivered in the most beneficial location. Moreover, once the stent is radially expanded conventional designs rely exclusively on dimensional mismatching to ensure proper removal of the delivery device. In the event the stent does not adequately expand to preset dimensions, a conventional delivery device would be stuck in the patient until some invasive procedure is performed to remove it and the defective stent.[0005]
• Therefore, there remains an existing need for a stent deployment apparatuses that has a safety mechanism to prevent excessive deployment of a misaligned stent. Preferably it would be desirable if the safety mechanism had a physical and/or audible indication means to inform the physician when she has reached maximum reversible deployment. As an additional safety feature, there is an existing need for a distal tip designed to allow for the removal of the deployment apparatus even if the stent does not radially expand to its preset expansion diameter. An existing need also exists for a stent deployment apparatus that has a distal tip adequately configured to navigate through diseased and/or occluded lumens so that the stent can be delivered to this target area.[0006]
• There also remains an existing need for a stent deployment apparatus that increases physician control during stent deployment. Moreover, there exists a need for a stent deployment apparatus that allows for the insertion of an optical scope to facilitate stent delivery.[0007]
SUMMARY OF EXEMPLARY EMBODIMENTS
• It is a principal objective of an exemplary stent deployment apparatus in accordance with the present invention to provide a device that can facilitate the precise delivery of stents in a safe and repeatable fashion. In the furtherance of this and other objectives, a preferred deployment apparatus allows the physician to concentrate on correct placement without having to estimate extent of deployment. In particular, in a preferred embodiment, the present deployment apparatus has a physical safety mechanism that limits deployment to the critical deployment point (i.e., −60%). The critical deployment point may range form 5% to 95% but is preferably about 60%. At this point, if the physician is satisfied with placement, she can engage the safety means to what we refer to as the Proceed Orientation (PO) and fully deploy the stent. It is preferred that when the safety mechanism is engaged to the PO, a physical twist and a possible audible indicator sounds to inform the physician that if she deploys the stent any further, she can no longer retract the stent beyond this point. Though the present stent and delivery system eliminates the need for repositioning, such safety features are still preferable. In a preferred embodiment, the slight audible indication is the sound of a tab or stop snapping to allow free deployment of the stent.[0008]
• An additional objective of a preferred embodiment of the present invention is to provide a stent deployment apparatus where the handle portion is held and the outer tubular member of the device is retracted.[0009]
• Yet another objective in accordance with the present invention is to provide a deployment apparatus having a distal tip designed to facilitate the clearance of obstructed lumen. In the furtherance of this and other objectives, the exemplary distal tips are configured to comfortably guide the deployment apparatus through a diseased or occluded lumen so that the stent can be delivered in the most beneficial location.[0010]
• Still another objective of a preferred deployment apparatus in accordance with the present invention is to provide a distal tip that facilitates the removal of the deployment apparatus once the stent is radially expanded. In the furtherance of this and other objectives, the distal tip is designed to clear the stent during removal, in the event the stent does not adequately expand to preset dimensions. In a preferred embodiment, removal is facilitated by providing a distal tip that has a substantially bidirectional conic shape. This allows for the removal of the present deployment apparatus, while conventional deployment apparatuses would be stuck in the patient until some invasive procedure was performed to remove it and the defective stent. This results from the fact that conventional deployment apparatus designs rely exclusively on dimensional mismatching between the distal tip and the radially expanded stent to ensure proper removal of the deployment apparatus. As a function of the design of the present invention, the compressed stent is adequately retained in place and does not prematurely creep up the proximally facing conic end of the distal tip and prematurely deploy.[0011]
• An additional objective in accordance with an exemplary embodiment of the present invention is to provide a stent deployment apparatus that allows for the insertion of an optical scope to facilitate stent delivery. In the furtherance of this and other objectives, the device is capable of letting a flexible optical scope of about 5-6 mm diameter be coupled along the exterior of the outer tubular member thereof. Alternatively, it is envisioned that an ultra thin optical scope may pass along side the guidewire through the internal diameter of the internal tubular member of the device.[0012]
• In addition to the above objectives, an exemplary stent deployment apparatus preferably has one or more of the following characteristics: (1) applicable for various interventional applications such as addressing stenosis; (2) biocompatible; (3) compliant with radially expanding stents; (4) capable of distal or proximal stent release; (5) smooth and clean outer surface; (6) length of the device variable according to the insertion procedure to be employed; (7) outer dimension as small as possible (depends on the diameter of crimped stent); (8) dimensions of the device must offer enough space for the crimped stent; (9) radiopaque markers, preferably on the inner tubular member, to indicate proximal and distal ends of the stent; (10) sufficient flexibility to adopt to luminal curvatures without loss of ability to push or pull; (11) low friction between the inner tubular member and outer tubular member; (12) sufficient resistance to kinking; (13) good deployment, ability to reposition partially deployed stent; (14) added with a scale to observe the stent position during the insertion procedure; (15) insertion procedure should require low force; or (16) sufficiently economical to manufacture so as to make the deployment apparatus disposable.[0013]
• Further objectives, features and advantages of the invention will be apparent from the following detailed description taken in conjunction with the accompanying drawings.[0014]
BRIEF DESCRIPTION OF THE FIGURES
• FIG. 1 is a perspective view of a device for delivering and deploying a radially self-expanding stent in accordance with the present invention;[0015]
• FIG. 2 is a side view of the device for delivering and deploying a radially self-expanding stent in accordance with the present invention.[0016]
• FIG. 3A depicts enlarged views of portions of the deployment safety mechanism along[0017]lines3A-3A of the device of FIG. 2
• FIG. 3B shows a cross section view of the deployment safety mechanism along[0018]lines3B-3B of FIG. 3A;
• FIG. 3C is a perspective view of a portion of the complementary portion of the deployment safety mechanism region of the handle as shown along[0019]lines3C-3C of FIG. 3A;
• FIG. 3D is a perspective view of the stop of the deployment safety mechanism as shown along[0020]lines3C-3C of the device of FIG. 3A.
• FIG. 4A is a side perspective view of the distal region of the device of FIG. 2, along[0021]lines4A-4A;
• FIG. 4B depict an enlarged sectional view of the distal region of the device of FIG. 2, along[0022]lines4B-4B.
DETAILED DESCRIPTION OF AN EMBODIMENT
• A general problem in the diagnosis and therapy of both vascular and nonvascular anomalies is the fact that the instruments must be inserted into or pass the area of maximum diameter of about 15 mm. As a result, the inserted instruments take away a very large portion of the free lumen and may increase the danger of injury to the patient.[0023]
• Therefore, it is the primary objective of the present invention to provide an instrument, which can be inserted gently, ensures a good utilization of the available space and makes it possible to carry out active therapeutic measures, wherein the instrument is to be particularly suitable for the introduction and placement of stents.[0024]
• A preferred embodiment of the present deployment apparatus comprises inner and outer tubular members interactively coupled with each other in a manner that one can move rotationally and proximally or distally with respect to the other. The tubular members are preferably nonpyrogenic. In order to deliver the stent, the deployment apparatus comprises a distal tip and a stent retaining hub, between which the stent is placed. The distal tip and the stent-retaining hub are both functionally coupled with the inner tubular member. The inner tubular member terminates with a luer or in a preferred embodiment, a proximal handle similar to the outer handle hub. The luer is preferably a female threaded luer, but alternative termini are within the skill of the stent deployment device engineer. In fact, a suitable alternative would be a handle having similar internal diameter characteristics as the luer while providing greater surface area for manipulating the deployment apparatus. As stated above, a preferred alternative would be a proximal handle that is similar in geometrical shape but preferably smaller than the outer handle hub, to facilitate movement, however the proximal handle may be of any size functionally acceptable by the user. The deployment apparatus is preferably sterilized by a validated sterilization cycle EtO. Moreover, the device is capable of resterilization (validated cycle) with no degradation of performance. However, it is preferable to provide a disposable device.[0025]
• The deployment apparatus is preferably about 100 cm±2 cm total. The inner diameter of the inner tubular member is approximately about 1 mm and the outer diameter of the outer tubular member is preferably about 5 to 6 mm in diameter. For purposes of this discussion, the usable length of the inner tubular member shall be from the inner tubular member distal hub/handle end to the distal tip. The usable length of the outer tubular member shall be from the distal hub/handle end of the outer tubular member to the distal tip. The overall length of the device shall be from the distal hub/handle end of the outer tubular member to the distal tip of the inner tubular member when assembled and not deployed. There will also be preferably three radiopaque (platinum iridium) markers for marking the stent, the stent deployment distance, and depth. The outer tubular member is preferably manufactured of stiffer synthetic material. In a preferred embodiment, the length of the outer tubular member is preferably shorter than that of the inner tubular member.[0026]
• However, these dimensions may differ as a function of the stent diameter and/or if an optical scope is employed to facilitate stent delivery. The outer tubular member may be configured to allow for the coupling of an optical stent along the outer diameter thereof. Alternatively, the inner diameter of the inner tubular member may be enlarged sufficiently to accommodate the optical scope and additionally the increased crimped stent diameter. However, it is expected, though not required, that the smallest diameter that allows for example a bronchoscope to pass will be employed in this alternative embodiment. It should be understood that through hindsight, after exposure to the present specification, one of ordinary skill would be able to adapt the current device to receive an ultra thin optical scope to the internal diameter of the device without undo experimentation and without departing from the spirit of the present objectives.[0027]
• An exemplary deployment apparatus in accordance with the present invention is durable while affording adequate flexibility to navigate through anatomical lumens without kinking. To this end, it is preferable that the deployment apparatus is formed of biocompatible synthetics and in a preferred embodiment reinforced with metal structure. This should allow for deployment within an accuracy of about ±3 mm. Moreover, the stent is preferably released with a force lower than 30 Newtons at 37° C. though the force and deployment temperatures may be modified to suit the needs of specific anatomical conditions.[0028]
• The inner tubular member is composed of a thin elastic synthetic material, such as polyurethane or Teflon®. At its proximal end, the inner tubular member has a standard adaptor or connector. At its distal end, the inner tubular member is equipped with a tip specific for various anatomical lumens.[0029]
• The inner tubular member and the outer tubular member can be displaced relative to each other in longitudinal direction as well as in a radial direction. The deployment apparatus in accordance with the present invention can be used most advantageously for the placement of stents. Such stents are available in various embodiments of metal and/or synthetic material. They usually are composed of a fabric of metal wires, which expand by themselves as a result of their natural tension. Stents of a so-called shape memory alloy are also known. These stents have a small radial diameter at a low temperature, while they expand radially when exceeding an upper threshold temperature, so that they can keep a stenosis open in this manner. It is particularly advantageous to use stents of an alloy of nickel and titanium, the so-called nitinol.[0030]
• An exemplary deployment apparatus according to the present invention can be used for the placement of various stents, whether they are self-expanding stents or stents, which require an activation. For this purpose, the stent is placed in the free space between the outer tubular member and the inner tubular member. Positioning of the stent in the deployment apparatus can be carried out in the area between the tip and the stent retaining hub at the distal end of the inner tubular member. Alternatively, in its insertion position, fasteners or other suitable retaining elements may hold the stent.[0031]
• In relevant embodiments, when the stent is inserted and after the stenosis has been passed, the outer tubular member is retracted, so that the stent is released. Alternatively, the distal end of the outer tubular member may be placed about the stenosis so that the inner tubular member may be extended so that the stent is placed in direct contact with the desired location prior to expansion. A self-expanding stent then by itself assumes the expanded position. This eliminates the need for post expansion positioning techniques. With an alternative embodiment of the device, the device has fasteners that retain contact with a portion of the stent in the event that the stent needs to be retracted or repositioned. A stent suitable for such procedures would be one in accordance with the disclosure in copending U.S. patent application Ser. No. 10/190,770, which is incorporated herein in its entirety by this reference.[0032]
• The following reference numbers and corresponding stent placement and deployment device components are used when describing the device in relation to the figures:[0033]
• [0034]10 Stent Delivery & Deployment Device
• [0035]12 Guidewire
• [0036]14 Proximal Handle/Female Threaded Luer
• [0037]16 Hypotube
• [0038]18 Safety Mechanism
• [0039]20 Stop
• [0040]22 Female Locking Member on the Stop
• [0041]24 Tab of the Stop
• [0042]30 Inner Tubular Member
• [0043]32 Inner Diameter of Inner Tube
• [0044]40 Handle
• [0045]42 Cavity in Proximal Portion of Handle
• [0046]44 Base of Handle Cavity
• [0047]46 Male Locking Member
• [0048]48 Inner Handle Hub
• [0049]49 Outer Handle Hub
• [0050]50 Outer Tubular Member
• [0051]52 Outer Diameter of Outer Tubular Member
• [0052]54 Distal Region of Outer Tubular Member
• [0053]56 Inner Diameter of Outer Tubular Member
• [0054]60 Distal Tip
• [0055]62 First End of the Tip
• [0056]64 Medial Region of the Tip
• [0057]66 Second End of the Tip
• [0058]68 Axial Passage
• [0059]70 Retaining Hub
• [0060]72 Distal Region of Retaining Hub
• [0061]74 Proximal Hub of Retaining Hub
• [0062]76 Pusher
• [0063]80 Proximal Marker
• [0064]82 Medial Marker
• [0065]84 Distal Marker
• The figures show an exemplary placement and[0066]deployment device10 in accordance with the present invention. Referring in particular to FIGS.1-2, the present invention provides astent deployment apparatus10 that includes anouter tubular member50 and aninner tubular member30, wherein the outertubular member50 and theinner tubular member30 can be displaced relative to each other. At the proximal end of anexemplary device10 is a threadedfemale luer14, coupled with a portion of theinner tubular member30 and preferably a portion of ahypotube16. As stated earlier, a suitable alternative terminus may be employed as long as it provides the minimum benefits provided by a luer. Thehypotube16 is disposed about theinner tube30 and extends from a location adjacent to theluer14 through a portion of thehandle40 of thedeployment apparatus10. In an alternative embodiment, thehypotube16 terminates within theluer14. A safety mechanism18 is provided that is formed in part by the complementary fitting of a portion of thehandle40 and astop20 coupled with thehypotube16 between theluer14 and thehandle40. Thestop20 is preferably molded onto thehypotube16, the molding process resulting in atab24 formed on thestop20 that is subsequently broken when the physician desires to place thedeployment apparatus10 in the proceed orientation. In an exemplary embodiment, when thetab24 is broken and thedeployment apparatus10 is placed in the proceed orientation; thestop20 may potentially rotate freely about thehypotube16. It should be kept in mind that thestop20 may take a variety of shapes, including but not limited to, rectangular, round, conical etc. In a preferred embodiment, thestop20 is conical with a tapered effect to facilitate entrance and removal from thebase handle cavity44.
• As illustrated in FIGS.[0067]3A-3D, apreferred stop20 includesfemale locking members22 comprising channels formed along the exterior thereof that are complementary to themale locking members46 formed on theinterior cavity42 along the proximal region of thehandle40. Thecavity42 of thehandle40 is designed to receive thestop20 and prevent further deployment. As a result, thestop20 is molded at a distance along thehypotube16 such that the distance between the distal end of the stop and thebase44 of thecomplementary cavity42 of thehandle40 roughly corresponds to the critical deployment point. It should be noted that thefemale locking members22 andmale locking members46 of the safety mechanism18 might be reversed so that thefemale locking members22 andmale locking members46 are on thehandle40 and thestop20, respectively. Additionally, alternative safety mechanisms may be employed to ensure accurate deployment beyond the critical deployment point.
• The[0068]handle40 is preferably molded to a portion of the outertubular member50, which extends from thehandle40 to thedistal tip60 of thedevice10. The outertubular member50 is disposed about theinner tubular member30. In an exemplary embodiment, the outertubular member50 is clear so that theinner tubular member50 is visible there through. Moreover, markers80-84 preferably formed on portions of theinner tubular member30 are also visible through the outertubular member50.
• Referring now to FIGS.[0069]4A-4B, in thedistal region54 of thedevice10, there is astent placement hub70, which holds the stent (not shown) during the placement procedure. In a preferred embodiment, thestent placement hub70 comprises two double conical shaped elements, one disposed at each end of the stent and coupled with theinner tubular member30. In an exemplary form, the distal most double conical shaped element is the distal tip of thedevice60. In alternative embodiments, the stent placement hub may also comprise proximal72 and distal74 stops between which the stent rests in its crimped state. Moreover, the proximal end of the stent may also be restrained by conventional coupling methods (not shown) to facilitate retrieval if necessary. By way of example, which is in no way to be construed as limiting, a stent having suture disposed about its proximal end may be retained by thestent retaining hub70 that has releasable finger-like members engaging the suture.
• The device is configured such that an[0070]optional guidewire12 may be passed through theinternal diameter32 of the device through theluer14 at the proximal end, thedistal tip60 at the distal end and theinner tubular member30 there between. In an alternative embodiment, theinternal diameter32 of thedevice10 is sufficient to receive an optical scope (not shown) there through.
• Referring to the functional aspects of the[0071]device10, there is shown in FIG. 1 adeployment apparatus10 that includes an elongate and flexible outertubular member50 constructed of at least one biocompatible thermoplastic elastomer, e.g. such as polyurethane and nylon, typically with anoutside diameter52 in the range of about between 6-9 mm. Acentral lumen56 runs the length of the outertubular member50. Adistal region54 of the outertubular member50 surrounds the stent to be placed (not shown), and maintains the stent in a crimped delivery configuration, against an elastic restoring force of the stent. The stent, when in a normal unrestrained configuration, generally has a diameter (for example, 10-20 mm) substantially larger than theinterior diameter32 of theinner tubular member30. Typically the expanded stent is larger in diameter than the body lumen in which the stent is fixed, and the restoring force tends to maintain the stent against the tissue wall.
• [0072]Outer tubular member50 is mounted at its proximal end to ahandle40. Outertubular member50 can be pushed and pulled relative to innertubular member30 by hand manipulation of thehandle40 at the proximal end of the outertubular member30 and holding the proximal end of thehandle40.
• A[0073]guidewire12 is preferably disposed within theinterior lumen32 of an elongate and flexible innertubular member30, which can be constructed of materials similar to those employed to form the outertubular member50. However, it is preferable that innertubular member30 is formed from a more durable material. Adistal tip60 is coupled with innertubular member30 about the distal end thereof. Also attached to theinner tubular member30 are aproximal marker80, at least onemedial marker82 and adistal marker84. The markers are constructed of a radiopaque material, e.g. platinum iridium, and surround theinner tubular member30.Markers80,82 and84 are axially spaced apart to mark the length of the stent and to mark the critical deployment distance for that stent length. The markers identify a stent-retaining hub0.70 of theinner tubular member30, more particularly the distal region of theinner tubular member30 is surrounded bystent12. The markers may also be of varying sizes and shapes to distinguish distance between distal and proximal regions.Markers80 and84 may have outer diameters slightly smaller than the interior diameter of outertubular member50. The outertubular member50 thus functions as a carrier for the stent, with innertubular member30 providing a retaining means for radially compressing the stent and maintaining the stent along thestent retaining hub50, so long as the outertubular member50 surrounds the stent.
• In an alternative embodiment,[0074]items72 and74 are marker bands (not retaining hubs) formed on the outertubular member50. These marker bands visually mark the ends of the stent and thus will be over the step area of the tip and thepusher76. All the marker bands including80,82 and84 are preferably either Platinum Iridium or Stainless Steel. Moreover, the marker bands of80,82, and84 will be depth marks and will be spaced in preferably 1 cm intervals. These depth marks are preferably formed on theinner tubular member30 and are a visual aid for the physician to assist with determining the depth at which the stent has been advanced.
• [0075]Inner tubular member30, along its entire length, has aninterior lumen56 open to both the proximal and distal ends of theinner tubular member30. Anaxial passage68 throughdistal tip60 continueslumen32 to allow theguidewire12 to pass from theluer14 through thedistal tip60.
• [0076]Handle40 and outertubular member50 are movable relative to innertubular member30. More particularly, thehandle40 is moved proximally relative to the stent-retaininghub70, facilitating the movement of outertubular member50 relative to innertubular member30 so as to provide a means for controllably withdrawing the outertubular member50, relative to theinner tubular member30, resulting in the release of the stent for radial self-expansion.
• When the[0077]device10 is used to position the stent, the initial step is to positionguidewire12 within the anatomy of a patient. This can be accomplished with a guide cannula (not illustrated), leavingguidewire12 in place, with the exchange portion of the guidewire extended proximally beyond the point of entry into the anatomy of the patient.Deployment apparatus10 is then advanced over theguidewire12 at the exchange portion, with theguidewire12 being received intopassage68 ofdistal tip60. Asdevice10 is inserted into the body, the proximal portion ofguidewire12 travels proximally (relative to the device) to the proximal end ofguidewire lumen32.
• Once[0078]device10 is positioned, the physician maintainsguidewire12 and innertubular member30 substantially fixed with one hand, while movinghandle40 in the proximal direction with the other hand, thus to move outertubular member50 proximally relative to innertubular member30. As the outertubular member50 is retracted, the stent remains substantially fixed relative to innertubular member30, and thus radially self-expands. As thehandle40 and correspondingly the outertubular member50 is retracted, thehandle40 encounters the safety mechanism18 for the critical deployment point. Theinner tubular member30, via thehandle40, may have to be rotated to align and insert thestop20 into thehandle40. When fully inserted, further deployment cannot occur without twisting and snapping the stop thetab24 portion of thestop20. Continued retraction of the outertubular member50 results in complete deployment of the stent.
• After deployment, the stent ideally radially self-expands to a diameter greater than the diameter of outer[0079]tubular member50. Accordingly,device10 can be withdrawn proximally through the stent. However, in the event that the stent does not radially expand fully,distal tip60 is configured to facilitate removal ofdeployment apparatus10 through the lumen of the stent.
• Guidewire[0080]12 can be withdrawn as well. Theguidewire12 emerges from the proximal end of theluer14. However, should the medical procedure involve further treatment, e.g., placement of a further stent, thedeployment apparatus10 can be removed without removing theguidewire12.Device10 is removed by progressively pulling the device away from the guidewire12 (which removes the guidewire from within the inner tubular member30), all while maintainingguidewire12 in place.
• Returning to[0081]distal tip60, as illustrated in FIGS.4A-4B,distal tip60 can have a variety of confirmations, but by way of non-limiting example,distal tip60 comprises first62 and second66 ends having a smaller diameter than themedial region64 thereof. In a preferred embodiment, each end is conical in shape so as to allow thetip60 to wedge through an incompletely expanded stent when pulled proximally with respect to the stent. Moreover, the dual conical end design facilitates removal but sufficiently prevents the crimped stent from releasing from thestent retaining hub70 and prematurely expanding.Distal tip60 may alternatively have a flaredmedial region64 so as to facilitate retrieval and retraction of amisaligned stent12.
• With respect to additional safety features incorporated in the[0082]present device10, in a preferred embodiment, thedevice10 has a deployment safety mechanism18 that comprises male46 and female22 locking members that are brought into functional engagement as the stent is being deployed. Once the stent has reached the critical deployment point, the distal end of thestop20 is substantially flush with thebase44 of thehandle cavity42 and thefemale locking members22 of thestop20 are in operative communication with the correspondingmale locking members46 formed on the interior surface of thecavity42 of the handle. When the safety mechanism18 is engaged as described above, the stent cannot be deployed further without physician intervention. In order to deploy the stent beyond this point, the physician has to rotate thestop20 to cause thetab24 to break. Once thetab24 is broken, thedevice10 is in the proceed orientation and deployment may proceed.
• In a preferred embodiment, the physician will feel a tactile indication that the[0083]device10 can be deployed further. Alternatively, the breaking of the tab may also, or as a substitute to tactile indication, results in an audible indication that further deployment is possible. Additionally, the physician is apprised of the fact that deployment beyond this point is irreversible except for interventional retrieval methods. As discussed earlier, the critical deployment point is preferably about 60% deployment, beyond which retraction is not recommended. As a result, the safety mechanism18 removes the need to estimate extent of deployment and provides a reliable means of accurately deploying stents. Alternative locking mechanisms may be provided as long as they retain the important characteristic of giving the physician a sensory indication of extent of stent deployment and removes the need to estimate extent of deployment. By way of non-limiting example only, the locking mechanism could comprise a breakable seal, tab/stop lock, diverted channel locking mechanism, etc.
• Referring particularly to FIG. 5, an[0084]alternative safety mechanism118 is presented that is a principally a diverted channel mechanism. In practice, adetent90 formed preferably on the hypotube has free proximal/distal travel to the critical deployment point at which time physician intervention is required to continue deployment. In a preferred embodiment, theInner Tubular Member30 is rotated until the travel of the detent is no longer obstructed. The channel in which the detent travels may be of a variety of geometrical shapes such as M, W, L, S Z, etc; the preferred geometry being substantially Z shaped, as shown in FIG. 5.
• In an additional embodiment (not shown) of[0085]deployment safety mechanism118, thedevice10 has a deployment safety mechanism that comprises male and female locking members that are brought into functional engagement as thestent12 is being deployed. Once thestent12 has reached the critical deployment point, the male locking member cannot be advanced further because of a detent formed on the inner diameter of the outer tubular member catches the cavity formed on the corresponding portion of the male locking member. As a result, in order to further advance thedevice10 to fully deploystent12, the inner tubular member must be rotated so as to break the detent. Once the detent is broken, the physician will feel a tactile indication that thedevice10 can be deployed further.
• Alternatively, the breaking of the detent may also, or as a substitute to tactile indication, results in an audible indication that further deployment is possible. Additionally, the physician is apprised of the fact that deployment beyond this point is irreversible except for interventional retrieval methods. As discussed earlier, the critical deployment point is preferably about 60% deployment, beyond which retraction is not recommended. As a result, the[0086]safety locking system60 removes the need to estimate extent of deployment and provides a reliable means of accurately deploying stents. Alternative locking mechanisms may be provided as long as they retain the important characteristic of giving the physician a sensory indication of extent of stent deployment.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes, which come within the meaning and range of equivalency of the claims, are to be embraced within their scope.[0087]

Claims (21)

What is claimed is:

1. A device for allowing a user to deploy a stent in an anatomical lumen of a patient, the device comprising:

a longitudinally extending inner tubular member having distal and proximal ends, the distal end comprising a tip;

a longitudinally extending outer tubular member having an outer and inner diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle, coupled with a portion of the outer tubular member, the handle having first and second ends and the second end defining a cavity having at least one stop compatible locking member formed therein;

a hypotube having a first end, a second end, an outer surface, an inner surface and a stop formed on the hypotube between the first and second ends, the outer surface of the stop comprising at least one locking member complementary to the handle cavity to form a safety mechanism;

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited by the safety mechanism to a predetermined threshold absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention.

2. The device ofclaim 1, wherein the inner tubular member defines a lumen longitudinally extending substantially the distance from the distal end to the proximal end of the inner tubular member, which allows a guidewire to extend through the lumen thereof.

3. The device ofclaim 1, wherein the user intervention comprises displacing the outer tubular member axially relative to the inner tubular member.

4. The device ofclaim 3, wherein an audible indication follows the user intervention.

5. The device ofclaim 3, wherein a tactile indication follows the user intervention.

6. The device ofclaim 3, further comprising at least one tab formed on the stop when the stop is molded on the hypotube, which serves as the audible indication when broken during user intervention.

7. The device ofclaim 1, wherein the predetermined threshold is about between 10% and 90% deployment.

8. The device ofclaim 7, wherein the predetermined threshold is about 60% deployment.

9. The device ofclaim 3, wherein the outer tubular member when moved longitudinally relative to the inner tubular member in a proximal direction away from the selected location, releases the stent for radial self-expansion.

10. The device ofclaim 1, wherein a guidewire is coupled to a portion of the outer diameter of the outer tubular member.

11. The device ofclaim 1, wherein the inner tubular member is configured to receive an optical scope.

12. The device ofclaim 1, wherein the outer tubular member is clear.

13. the device ofclaim 1, wherein there is at least one marker coupled with a portion of the inner tubular member.

14. The device ofclaim 1, wherein the inner tubular member is of a material that is kink resistant.

15. The device ofclaim 12, wherein the outer tubular member is kink resistant.

16. The device ofclaim 1, wherein the distal tip has first, medial and second sections, the first and second sections having outer diameters that are less than that of the medial section.

17. The device ofclaim 1, wherein a portion of the inner tubular member about the proximal end further comprises a stent carrier adapted to carry a radially self-expanding stent in a radially contracted state.

18. The device ofclaim 17, further including a radially self-expanding stent carried by the stent carrier, extended along and surrounding at least part of the distal end region, and surrounded by a portion of the outer tubular member and thereby maintained in the radially contracted state.

19. A device for allowing a user to deploy a stent in an anatomical lumen of a patient, the device comprising:

a longitudinally extending outer tubular member having distal and proximal ends and a safety catch assembly disposed between the distal and proximal ends; and

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member and wherein the distal end comprises a tip, the inner tubular member further comprises at least one detent along the longitudinal expanse thereof for operative interaction with the safety catch assembly of the longitudinally extending outer tubular member;

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited to a predetermined threshold absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention.

20. A method of deploying a radially expandable stent comprising the steps of:

providing a stent deployment apparatus comprising a stent, a longitudinally extending outer tubular member having distal and proximal ends and a safety catch assembly disposed between the distal and proximal ends; and a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member and wherein the distal end comprises a tip, the inner tubular member further comprises at least one catch along the longitudinal expanse thereof for operative interaction with the safety catch assembly of the longitudinally extending outer tubular member to limit extent of stent deployment;

inserting the deployment apparatus through a portion of the anatomy of a patient;

positioning the distal tip of the inner tubular member about a target area within the patient;

displacing the outer tubular member, with respect to the inner tubular member so as to expose the stent short of its full deployment position and deploying the stent such that the stent expands forming a lumen there through that is larger than the compressed diameter of the stent.

21. The method ofclaim 19, further comprising the step of:

removing the deployment apparatus through the lumen of the deployed stent.

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