US20220142649A1 - Sleeve for delivery of embolic coil - Google Patents

Abstract

An endovascular treatment system includes a delivery sleeve that is insertable into an intravascular catheter. A therapeutic device is housed coaxially within the delivery sleeve and both are advanced within the catheter in combination. An advancement mechanism is connected to the therapeutic device to advance the therapeutic device out of the delivery sleeve and into a patient. The delivery sleeve includes a stop positioned on the proximal end. The stop contacts the proximal end of the catheter, limiting the distance the delivery sleeve is inserted into a catheter.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of priority of U.S. provisional application No. 62/209,736 filed 25 Aug. 2015 entitled “Sleeve for delivery of embolic coil,” which is hereby incorporated herein by reference in its entirety for the purposes of PCT Rules 4.18 and 20.6.
TECHNICAL FIELD
• The disclosure herein relates generally to medical devices used with intravascular catheters. More particularly, it relates to a sleeve that contains embolic devices for delivery through the catheters.
BACKGROUND
• Intravascular catheters are common medical devices that are manufactured by numerous companies. The various companies provide catheters that have different physical performance attributes that physicians find attractive for the purposes of accessing a targeted vessel in the highly tortuous/varied vascular anatomy of each patient. The various catheters are provided in numerous length options and are provided with numerous pre-curved tip shapes and mechanical structure (e.g., bending stiffness/softness and “torqueability” to orient the tip shape remotely). Additionally, catheters are provided with variations in their internal lumen in both diameter size and surface material. In some medical procedures, the vascular catheter is routinely used to deliver embolic devices such as endovascular embolization coils to a particular target location in the vasculature to conduct vascular occlusions or embolizations to stop the blood flow in a vessel or isolate a vascular area from blood flow.
• The various differences in physical attributes of the catheters, for example, relative roughness or friction coefficient of the material forming the interior surface, impacts the potential compatibility of using certain catheters with different manufacturers' embolic devices. For example, Boston Scientific contraindicates the use of its Interlock embolic coil products with any polyurethane, soft-tip catheter, for example, Terumo Glide catheters or AngioDynamics Soft-Vu catheters. These limitations detrimentally impact the ability of the embolic coil manufacturer to gain clinical use of their coil when the physician wants to use one of these catheters due to the feature benefits of the catheter in accessing the target vessel. In some instances, the physician may be forced to “exchange” one catheter for another over the guidewire to achieve a compatible catheter for deployment of the embolic device, which is a costly and inefficient method.
• With current technology, embolic devices (such as coils) use an introducer tube to advance the coil into the catheter. The function of the introducer tube is to hold the device straight (i.e., in an uncoiled form) outside of the catheter and facilitate “introducing” the device into the catheter. In this structure, the embilic device is fed directly into the catheter, necessitating compatibility between the embolic device and the catheter, e.g., compatibility between outer diameter of the embolic device and inner diameter and surface of the catheter lumen and material compatibility between the material forming the embolic device and the catheter material to ensure smooth advancement of the embolic device through the catheter lumen. Thus, cost is increased and physician alternatives are reduced.
• Clinicians utilize various imaging modalities such as fluoroscopy to direct the embolic device to the end of the catheter and into the targeted area for treatment. However, this reliance on the imaging modalities while the embolic device travels through the catheter requires additional cost and time, which results in heightened risk to the patient. As such, these risks and costs represent the insufficiency of typical solutions and room for improvements in the industry.
• The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded subject matter by which the scope of the invention is to be bound.
SUMMARY
• In order to address the shortcomings of the status quo, the following disclosure presents device that may be used in conjunction with catheters to aid in the delivery of a therapeutic device, e.g., one or more embolic coils, through a catheter which might otherwise be contraindicated for such delivery due to an incompatibility as discussed above. The device may take the form of a sleeve made, in part, of a material having a low coefficient of friction in which the device is housed or otherwise retained until delivery. The sleeve may provide a more appropriate environment for delivery of the therapeutic device than the lumen of the catheter. For example, the delivery sleeve may provide a lower friction interface with the therapeutic device allowing the therapeutic device to easily slide as it is pushed through the sleeve to the end of the deliver catheter instead of possibly getting caught on or damaged by the wall of the delivery catheter. The delivery sleeve may further provide structural support, radial compressive or resistive force along the length of the therapeutic device, thereby providing longitudinal strength and support to the therapy device such that it can be advanced along thecatheter60 without bucking, kinking, or crushing.
• In one implementation, an endovascular apparatus includes a delivery sleeve, a therapeutic device, an advancement mechanism, and a stop. The delivery sleeve has a longitudinal lumen extending between a proximal end and a distal end. The therapeutic device may be housed within and extend substantially an entire length of the delivery sleeve. The advancement mechanism may be configured to engage the therapy device to advance the therapy device into a patient. A stop may be positioned on the proximal end of the delivery sleeve and is operable to limit a distance the delivery sleeve is inserted into a catheter. An outside diameter of the delivery sleeve is sufficiently small such that the delivery sleeve may be inserted into a catheter and a diameter of the lumen is sufficiently large such that the lumen is able to coaxially receive the therapeutic device and the advancement mechanism therein but sufficiently small that the delivery sleeve adds longitudinal strength to the therapeutic device.
• In another implementation, an endovascular system includes a catheter, a delivery sleeve, a therapy device, an advancement mechanism, and a stop. The catheter may have a proximal catheter end and a distal catheter end with a longitudinal catheter lumen extending therebetween. The delivery sleeve may have a proximal end and a distal end with a longitudinal lumen extending therebetween. The delivery sleeve may be coaxial with and movable within the catheter lumen. The therapeutic device may extend substantially an entire length of the delivery sleeve, or even slightly beyond the distal length, and may be located coaxially within the lumen of the delivery sleeve and movable therein. The advancement mechanism may be connected to the therapy device and configured to advance the therapy device into a patient. The stop may be positioned on the proximal end of the delivery sleeve which contacts the proximal end of the catheter to limit the distance the delivery sleeve is inserted into a catheter. The stop may be part of a deployment handle that controls advancing the therapy device into a patient.
• In a further implementation, a method for delivering a therapeutic treatment to a patient is disclosed. A catheter may be provided having a proximal catheter end and a distal catheter end with a longitudinal catheter lumen extending therebetween. A therapeutic delivery device apparatus may be provided including a delivery sleeve, a therapeutic device, an advancement mechanism, and a stop. The delivery sleeve may have a proximal end and a distal end with a longitudinal lumen extending therebetween. The delivery sleeve may be coaxial with and longitudinally movable within the catheter lumen. The therapeutic device may extend substantially an entire length of the delivery sleeve, or even slightly beyond the distal end, and may be enclosed coaxially within the lumen of the delivery sleeve and longitudinally movable therein. The advancement mechanism may be connected to the therapeutic device and configured to advance the therapy delivery device into a patient. The stop may be positioned on the proximal end of the delivery sleeve which contacts the proximal catheter end of the catheter, limiting a distance the delivery sleeve is inserted into the catheter. The method may further include inserting the therapeutic delivery device into the catheter until the stop comes into contact with the proximal end of the catheter.
• This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the present invention as defined in the claims is provided in the following written description of various embodiments and implementations and illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates an exploded view of an endovascular system in accordance with various embodiments.
• FIG. 2A illustrates a perspective view of an endovascular system in accordance with various embodiments.
• FIG. 2B illustrates a detailed cross-section view of the endovascular system ofFIG. 2A taken alongsection2B-2B.
• FIG. 3A illustrates a perspective view of a delivery sleeve with a therapeutic device positioned therein in accordance with various embodiments.
• FIG. 3B illustrates a detailed cross-section view of the endovascular system ofFIG. 3A taken alongsection3B-3B.
• FIG. 4A illustrates an exploded view of an endovascular system with a plurality of parallel embolic coils in accordance with various embodiments.
• FIG. 4B illustrates a perspective view of an endovascular system with a plurality of parallel embolic coils in accordance with various embodiments.
• FIG. 4C illustrates a detailed cross-section view of the endovascular system ofFIG. 4B taken alongsection4C-4C.
• FIG. 5 illustrates a flow chart of a method of using an endovascular system in accordance with various embodiments.
DETAILED DESCRIPTION
• Various embodiments related to systems and methods for treating patients via intravascular catheters are disclosed herein. However, in contrast to traditional catheter configurations, a temporary, disposable sleeve may be used to separate the catheter from the particular therapy device being delivered through the catheter. The sleeve may minimize the effects of the inner lumen characteristics of different catheter materials, geometries, and construction on devices or instruments passed through the catheter to provide the desired therapy. The sleeve may reduce variability between different catheter designs and provide a stable, regular lumen of known physical and performance characteristics. This may enable development of therapeutic products without the limitation and complexity of having to design for use with all catheters and minimizes the limitations of indicating (or contra-indicating) specific catheters for use. Such devices or instruments may include embolic devices and, in particular, examples may be embolic coils for administering a vascular embolization or occlusion.
• The sleeve may be formed from a flexible tube made up of a bio-compatible material or constructed of multiple layers of biocompatible materials. The sleeve may have a thin-wall, flexible structure formed of a material operable to slide easily through the lumen of a catheter. The sleeve may have a construction, such as including a wire or fiber braid, that provides mechanical support such as radial or longitudinal rigidity, or both. Similarly, a lumen of the sleeve may be formed of a material that allows a therapeutic device to slide easily along the length of the sleeve. The therapeutic device is loaded into the sleeve ex-vivo, for example, by the manufacturer of the therapeutic device at the time of manufacture. The sleeve may function to hold the therapeutic device in a state for delivery through the catheter, e.g., in a restrained state, that changes to an unrestrained state upon delivery from the sleeve and the catheter in vivo. For example, the sleeve may contain an embolic coil in a stretched, linear form while within the sleeve, which converts to a coil shape upon delivery from the sleeve and catheter. The sleeve with the therapeutic device housed therein may be inserted into and line the inner wall of the catheter. The therapeutic device may then be delivered through a lumen extending along the longitudinal length of the sleeve.
• As shown in the exploded view ofFIG. 1, anexemplary endovascular system10 may include atherapy delivery device20 and acatheter60. Thetherapy delivery device20 may include atherapy device30. Thetherapy device30 may be connected to anadvancement device40 via aconnection mechanism37. Thetherapy device30 may be insertable and movably positioned within adelivery sleeve50. Thetherapy delivery device20 may be movably positioned within thecatheter60. Thedelivery sleeve50 may be connected to thecatheter60. Theendovascular system10 may include anextension70 that is positioned on a proximal end of thecatheter60 to accommodate adelivery sleeve50 that is longer in length than thecatheter60.
• Thecatheter60 may be any type of intravascular catheter known in the industry suitable to be placed in the body of a patient. For example, thecatheter60 may include a single lumen66 (seeFIG. 2B) or thecatheter60 might include multiple lumens (not shown). Thecatheter60 may be operable to follow a tortuous path to reach a target site. Thecatheter60 may have a firstdistal end63 with respect to the user. Thedistal end63 may include anoutlet64 operable to deliver thetherapy device30 near the target therapy site within the patient. Thecatheter60 may have aproximal end61 with respect to the user. Theproximal end61 may include anattachment mechanism62. Theattachment mechanism62 may be in the form of a luer fitting operable to connect with other medical devices.
• As indicated above, thetherapy delivery device20 may include thetherapy device30 and adelivery sleeve50. Thedelivery sleeve50 is a component that may be used in conjunction with thetherapy device30. Thedelivery sleeve50 may include a single lumen56 (seeFIG. 3B) extending between adistal end53 and aproximal end51. Thedelivery sleeve50 may be sufficiently flexible to follow thelumen66 of thecatheter60. Thedistal end53 of thedelivery sleeve50 may include anoutlet54 configured to be positioned near thedistal end63 of thecatheter60 adjacent to the target therapy site and allow thetherapy device30 to exit both theoutlet54 of thedelivery sleeve50 and theoutlet64 of thecatheter60 proximal to the target therapy site within the patient.
• Theproximal end51 of thedelivery sleeve50 may include astop52 that is positioned to limit the travel of thedelivery sleeve50 into thelumen66 of thecatheter60. In some embodiments, thestop52 may be an attachment mechanism suitable to connect to theproximal end61 of thecatheter60. In one example, the attachment mechanism of thestop52 may be a luer fitting operable to connect with the luerfitting attachment mechanism62 on thecatheter60 or operable to connect to other medical devices. As shown inFIG. 2A, thetherapy delivery device20 may be positioned within the catheter60 (the advancement device and the sleeve cap are the portions of thedelivery device20 shown inFIG. 2A.) The positioning may be coaxial. In this configuration, thedelivery sleeve50 may extend through thelumen66 of thecatheter60.
• Thedelivery sleeve50 may be made of a flexible, low-friction material suitable to glide easily through thelumen66 of thecatheter60. The low-friction material may be, for example, a bio-compatible material such as a polytetrafluoroethylene (PTFE) material formed as a tube defining thelumen56. The material is not limited to PTFE, but may include any other bio-compatible materials with sufficient lubricity such as other flouropolymers or modified polymers having a lubrication agent or lubricating coatings. For the purposes of this disclosure, materials with a low coefficient of friction suitable for forming, lining, or coating the lumen of thedelivery sleeve50 may have a coefficient of friction ≤0.1. In various embodiments, the material provides a lubricious surface on both the outside and inside of thedelivery sleeve50. The outside surface of thedelivery sleeve50 interacts with theinterior lumen66 of thecatheter60 during deployment of thedelivery sleeve50. The inside surface defining thelumen56 of thedelivery sleeve50 interacts with the exterior of thetherapy device30. In one exemplary embodiment, thedelivery sleeve50 may be an unreinforced, natural, single-wall PTFE tube. In another exemplary embodiment, thedelivery sleeve50 may be a reinforced, composite structure incorporating a PTFE inner lumen, a stainless steel wire braid, and a polyimide outer jacket.
• In some exemplary embodiments, the inner and outer surfaces of thedelivery device50 may be made of different material to optimize the interaction with the opposing surface (catheter60 or therapy device30). The thickness of the wall of thedelivery sleeve50 may be from about 0.001 to about 0.01 inches (about 0.025 mm to about 0.25 mm) thick. More particularly, the wall of thedelivery sleeve50 may be about 0.002 inches (about 0.05 mm) thick. The wall of thedelivery sleeve50 may be sufficiently fluid tight to allow fluid flushing through the length of thedelivery sleeve50. The material forming thedelivery sleeve50 may be made kink resistant, including by reinforcing the tubing utilizing coils, braids, spirals, fibers, or composite materials such as co-polymers. Other materials may be used as reinforcement of the wall of thedelivery sleeve50 as well including metallic ones. While thedelivery sleeve50 is sufficient flexible for endovascular travel, it is also sufficiently strong such that is can be advanced through thecatheter60 as a column.
• Thedelivery sleeve50 may be manufactured in a number of diameters depending on the vascular application. In one example, thedelivery sleeve50 may have about a 0.04 inch (about 1.02 mm) outside diameter and about a 0.036 inch (about 0.91 mm) inside diameter resulting in a wall thickness of about 0.002 inch (0.0508 mm). Such sizes may provide suitable compatibility with 4 French to 5 French catheter applications. In various other examples, the sleeve may include about 0.035-0.038 inch (about 0.09 mm-0.1 mm) inside diameters and/or 0.039-0.042 inch (about 0.1 mm-0.11 mm) outside diameters. While these various examples may be used, it may be preferable to size the delivery sleeve35 according to the preferred catheter/therapy device combination.
• The inside diameter of thedelivery sleeve50 may also be sized to add longitudinal compressive strength to thetherapy device30 such that it can be advanced along thecatheter60 easier without kinking or crushing. Thedelivery sleeve50 may provide a homogeneous and consistent surface for delivery of thetherapy device30 through the catheter. In contrast, the inner surface of the catheter varies from catheter to catheter and manufacturer to manufacturer.
• As noted above, thetherapy delivery device20 may include anadvancement mechanism40 that connects to thetherapy device30 to push thetherapy device30 through thelumen56 of thedelivery sleeve50. Thetherapy device30 may be coupled with theadvancement mechanism40 by aconnection system37. Theconnection system37 may comprise any of a number of known systems with opposingfeatures32,42 that interconnect atherapy device30 to an advancement mechanism40 (e.g., an embolic coil device to a pusher wire). The internal diameter of thelumen56 of thedelivery sleeve50 may be sized to assist in maintaining engagement between the opposing features32,42 of theconnection system37 by providing a consistent cross-sectional area within and along thelumen56 of thedelivery sleeve50. The diameter of thelumen56 of thedelivery sleeve50 may thus be optimized to maintain sufficient pressure on theconnection system37 to limit premature release. Thedelivery sleeve50 thus provides an advantage, which is not provided by the various catheters on the market.
• Thedelivery sleeve50 may extend through thecatheter lumen66 until thestop52 engages with theproximal end61 of thecatheter60. This engagement may be configured to position thedistal end51 of thedelivery sleeve50 at a desired location within thecatheter60. For example, in some embodiments, thedelivery sleeve50 may have a length that extends approximately to thedistal end63 of thecatheter60 when thestop52 engages theproximal end61 of thecatheter60. As shown inFIG. 2B, thedistal end53 of thedelivery sleeve50 may extend approximately the same distance as thedistal end63 of thecatheter60. Any difference in length may be nominal such as caused by a difference in tolerances of the two devices or use of catheter or therapeutic device accessories.
• Thedistal end33 of thetherapy device30 may likewise extend to thedistal end53 of thedelivery sleeve50. Preferably, thedistal end33 of thetherapy device30 is adjacent and proximal to thedistal end53 of thedelivery sleeve50, which extends to a point immediately proximal to thedistal end63 of thecatheter60. In some exemplary embodiments, the length of thetherapy device30 may be coextensive with the length of thedelivery sleeve50. In various exemplary embodiments, thestop52, which limits the distance that thedistal end53 of thedelivery sleeve50 extends within thecatheter60, may be a female luer fitting5. Thestop52 may removably connect to theattachment mechanism62, which may be a male luer fitting. Thedistal end53 of thedelivery sleeve50 may extend from thestop52 approximately to thedistal end63 of thecatheter60. By sizing thedelivery sleeve50 in accordance with thecatheter60 such that the distal ends53,63 extend to approximately the same length, thedelivery sleeve50 may be inserted into thecatheter60 and extended to thedistal end63 without the use of an imaging modality such as fluoroscopy to determine its location. For example, a 100 cm delivery sleeve length would be designed for use with a 100 cm catheter length, enabling the precise placement of thedistal end53 of thedelivery sleeve50 without need for using an imaging modality.
• In accordance with another exemplary embodiment, thedelivery sleeve50 may be longer than thecatheter60. In such an embodiment, the precise placement of thedistal end53 of thedelivery sleeve50 relative to thedistal end63 of the catheter may still be accomplished by pairing thedelivery sleeve50 with anextender70. If a user desired to use acatheter60 that is shorter than the length of thedelivery sleeve50, when thestop52 on thedelivery sleeve50 abuts theattachment mechanism62 on theproximal end61 of thecatheter60, thedistal end53 of thedelivery sleeve50 would extend outward beyond thedistal end63 of thecatheter60 and into the patient. Such a situation could increase the procedural risk of damaging a vessel, thereby harming the patient and require that the clinician use fluoroscopy to navigate thedistal end53 of thedelivery sleeve50 through the length of thecatheter60 to ensure that it does not enter into the vessel, thus increasing the time needed to perform the procedure.
• However, it is possible for thelonger delivery sleeve50 to be used with a desired shorter catheter by using theextender70. Theextender70 may include adistal end73 with respect to the user and aproximal end71 with respect to the user. Each end of theextender70 may have anattachment mechanism72,74 such as a luer fitting. In various embodiments theattachment mechanism72 at theproximal end71 may be a male luer as shown and theattachment mechanism74 at thedistal end73 may be a female luer fitting (although each end may use ether type of fitting, male or female as long as the opposing fitting mates). Theextender70 defines a lumen extending between theproximal end71 and thedistal end73 that is sized similarly or the same as thelumen66 of thecatheter60. Theextender70 may have a length that is about equal to the length that thedelivery sleeve50 extends beyond thecatheter60 in response to the delivery sleeve stop52 (e.g., a luer fitting) engaging theproximal end61 of thecatheter60.
• It should be appreciated that when using theextender70, thedelivery sleeve stop52 does not directly engage theproximal end61 of thecatheter60. Instead, thedelivery sleeve stop52 may engage theproximal end71 of theextender70. For example, thestop52 in the form of a luer fitting may engage the attachment mechanism72 (e.g., and opposing luer fitting) with thedelivery sleeve50 extending through theextender70 lumen. Thedistal end73 of theextender70 may then be connected to theproximal end61 of thecatheter60. Thedistal attachment mechanism74 of theextender70 may connect to theattachment mechanism62 at theproximal end61 of thecatheter60.
• For example, if the user desires to use a shorter catheter60 (e.g., a 65 cm catheter) with a longer delivery sleeve50 (e.g., a 100 cm delivery sleeve), then thedelivery sleeve50 will be too long for thecatheter60 without increasing the aforementioned risks. However, by connecting anextender70 sized to the difference between the catheter length and the delivery sleeve length, theextender70 takes up the additional length required by theshorter catheter60 and thelonger delivery sleeve50. Pursuant to this example, the 65 cm catheter can be connected to a 35cm extender70, which in combination form a 100 cm delivery device for the delivery sleeve50 (i.e., 35 cm+65 cm=100 cm). Thus, the extender-catheter combination has a length about the same as thedelivery sleeve50. In this way, thedelivery sleeve50 may be inserted into theextender70 and further through the attachedcatheter60 until theproximal end61 of the delivery sleeve connects to theproximal end71 of the extender and thedistal end53 of thedelivery sleeve50 will be located approximately at thedistal end64 of thecatheter60. The location of thedistal end53 of thedelivery sleeve50, and thus thedistal end33 of thetherapeutic device30 contained therein, is positioned adjacent thedistal end63 of thecatheter60 without need for fluoroscopy or other imaging to guide thetherapeutic device30 to that point.
• In accordance with various embodiments, multiple different lengths ofextenders70 may be provided with thetherapy delivery device20 to allow compatibility withdifferent length catheters60. For example, for a 100 cm length delivery sleeve, a 35 cm length extender can be used for 65 cm length catheter compatibility. Alternatively, for a 100 cm length delivery sleeve, a 55 cm length extender can be used for 45 cm length catheter compatibility. Other lengths ofextenders70 can be provided to create similar combinations ofextenders70 andcatheters60 to accommodate the desired use ofcatheters60 of various lengths with desired lengths oftherapeutic devices30 housed indelivery sleeves50.
• Theextender70 may be made of a low-friction tubing. The low-friction tube may be formed, for example, of a polytetrafluoroethylene (PTFE) material in the tube structure forming the lumen. The tube may be securely attached toattachment mechanisms72,74 at either or both ends. As indicated above, theattachment mechanisms72,74 may be luer fittings. However, any suitable connection mechanism, particularly medically suitable mechanisms, may be used. The tubing may be reinforced for better kink-resistance. Theextender70 may have an inside diameter slightly larger than the outside diameter of thedelivery sleeve50 to allow for easy insertion of thedelivery sleeve50 therethrough. Theextender70 may have a wall thickness anywhere from 0. 01 mm to 0.10″ mm. This diameter and wall thickness may be the same as or larger than the wall thickness ofcatheter60 since theextender70 does not enter thecatheter lumen66. While theextender70 may be specifically configured to maximize its accommodation of thedelivery sleeve50, theextender70 may also or alternatively be configured to accommodate specific catheters that a physician may use. In this way, theextender70 may be formed to match the diameter and structure of thecatheter60 it is used with so there is conformity of parts. Thus, theextender70 not only provides compatibility with multiple catheter lengths, but also facilitates all procedural, performance, and safety advantages of thedelivery sleeve50.
• As indicated above, thetherapy delivery device20 may include thedelivery sleeve50 and atherapeutic device30. Thetherapeutic device30 may include any of a variety of endovascular medical devices. Thetherapeutic device30 may be preloaded into thelumen56 of thedelivery sleeve50 during manufacturing or before the catheterization procedure. In this way, the physician can remove the combination of thedelivery sleeve50 preloaded with thetherapeutic device30 from its packaging and insert thedelivery sleeve50 andtherapeutic device30 combination into thecatheter60 together. The combination may then be advanced along thecatheter60 together until thedelivery sleeve50 hits itsstop52.
• Having adelivery sleeve50 of known length commensurate with the length of thecatheter60 can minimize procedure time by reducing or eliminating fluoroscopic or other angiographic requirements until thetherapeutic device30 is deployed from theoutlet64 of thecatheter60. Thedelivery sleeve50, and thetherapeutic device30 positioned therein, can be positioned quickly and accurately because the physician does not need to monitor where the distal end of either thedelivery sleeve50 or thetherapeutic device30 is located until thestop52 on thedelivery sleeve50 engages theproximal end61 of thecatheter60. From that point, fluoroscopy (or like technique) may be used to advance only thetherapeutic device30 to the target region.
• While thetherapeutic device30 may be any endovascular medical device, as illustrated inFIGS. 1-5, thetherapeutic device30 may be an embolic device configured to form vascular occlusions within a patient. More specifically, the embolic device may be an embolic coil. In accordance with the various embodiments described herein, one or more embolic coils may be delivered through thecatheter60 by advancing the embolic coil(s) (shown inFIGS. 1-5 as therapeutic device30) anddelivery sleeve50 combination into thecatheter60 until thestop52 on thedelivery sleeve50 engages theproximal end61 of thecatheter60. This process positions theembolic coil30 for deployment into the patient. Theembolic coil30 may extend within thelumen56 of thedelivery sleeve50 in a restrained form as a linear shape and then take on a complex shape as originally formed after being deployed into the area of interest, such as an aneurysm.
• Theadvancement mechanism40 may be configured to advance theembolic coil30 via a variety of different ways. Theadvancement mechanism40 does not need to rely on a structural interlock. For example, theadvancement mechanism40 may function as an injection device thereby injecting the coil out of the sleeve. In other embodiments, a more structural interface may be incorporated. For example, as shown inFIG. 3B, aconnection mechanism37 may be provided between theembolic coil30 and the advancement mechanism40 (shown as a pusher wire). Any connector configuration or coupling mechanism may be used. In the exemplary embodiment ofFIG. 3B, theproximal end31 of theembolic coil30 may include a receiving feature32 (such as a recess, slot, aperture, or the like) and is operable to engage a linking feature42 (such as a protrusion, hook, clasp, or the like) positioned at the distal end of theadvancement mechanism40 used. The receivingfeature32 and the linkingfeature42 may be positioned on overlapping tabs that extend from thetherapeutic device30 and theadvancement mechanism40, respectively. The tabs may overlap such that theconnection mechanism37 is not larger than the outside diameters of each of thetherapy device30 and theadvancement mechanism40. To release thetherapeutic device30 from theadvancement mechanism40, theadvancement mechanism40 merely extends theconnection mechanism37 out of thedelivery sleeve50. With the external pressure from thesleeve50 removed, there is insufficient force to hold theconnection mechanism37 together and thetherapeutic device50 is released from theadvancement mechanism40. As shown inFIG. 2A, theadvancement mechanism40 may be longer than and extend out of the proximal end of thelumen56 of thedelivery sleeve50.
• Ordinarily, using prior art devices and techniques for placement of embolic coils, to complete an occlusion procedure, the physician must sequentially reload the catheter with several additional coils through an introducer that abuts the proximal end of the catheter until it is determined the occlusion is sufficient. This procedure is traditionally performed using typical medical imaging techniques to monitor the position of the embolic coils along the entire length of the catheter. However, by prepackaging one or moreembolic coils30 within adelivery sleeve50 of known length, thedelivery sleeve50 may be advanced down thecatheter60 until thestop52 at theproximal end51 of thedelivery sleeve50 engages theproximal end61 of thecatheter60 without need for imaging. Further, if additional embolic coils are needed beyond the embolic coil(s)30 deployed from theinitial delivery sleeve50, theinitial delivery sleeve50 may be removed from thecatheter60 and anew delivery sleeve50 with additionalembolic coils30 may be inserted into and advanced down thecatheter60 without need for angiography. This procedure makes the transition between additional embolic coils much quicker, cheaper, and safer.
• There are many known variations of embolic coils, including many different types of metallic and polymer coils. Various coils are made from different materials and are designed with different means of controlling various characteristics such as enhancing thrombogenic response. Coils may be formed as a singular coil or the coils may comprise multiple coil devices packaged together and stored inside the sleeve together. By way of Example,FIGS. 4A-4C illustrate an endovascular system with a plurality of parallel embolic coils in accordance with various embodiments.FIG. 4A shows theendovascular system10 in an exploded view. Similar to other embodiments discussed herein, thisendovascular system10 may include anadvancement mechanism40 and thetherapeutic device30. Thistherapeutic device30 in such an embodiment includes a plurality of embolic coils. The plurality of embolic coils can be inserted into thedelivery sleeve50, which in turn is insertable into and through thecatheter60. The plurality of embolic coils can then be delivered from thedistal end64 of the catheter as illustrated inFIG. 4B. As illustrated in the detailed cross section ofFIG. 4C, the plurality of coils forming the therapeutic device remains organized within thedelivery sleeve50 until dispensed from the end.
• In accordance with various embodiments, as illustrated inFIG. 4C the plurality of coils may includeseparate coils30a,30b,30c,and30d.As illustrated inFIGS. 4A-4C, the coils may be bound on each end by retainingfeature15a,15b.The advancement mechanism may include one or more separate members. For example, as shown inFIGS. 4A-4C, aninner advancement member40bmay extend thedistal retaining feature15b.Anouter advancement member40amay extend the proximal retaining feature15a.Each of theseparate coils30a,30b,30c,and30d,theproximal advancement feature15a,thedistal advancement feature15b,inner advancement member40bandouter advancement member40amay all be contained within thedelivery sleeve50. The outer andinner advancement members40a,40band related proximal and distal retaining features15a,15bmay be configured as any of the types of pusher systems providing both proximal and distal control of delivery of thetherapeutic device30 as disclosed and described in U.S. Patent Application Publication No. US20140039542A1, which is hereby incorporated by reference herein in its entirety. Further, such pusher systems with proximal and distal control can be used to deliver atherapeutic device30 such as an embolic coil composed of only a single length of coil within thedelivery sleeve50 rather than a plurality of separate coils delivered in parallel as depicted in this example.
• The various embodiments and examples disclosed herein may be used with any of the known embolic coils and coils of similar purpose. Each and every therapeutic device, however, will not be discussed herein, but exemplary processes, devices, embodiments are known, and examples of some of these devices include embolic coils that may be used with embodiments of the delivery sleeve disclosed herein, which are described in U.S. Patent Application Publication No. 2012/0046687, U.S. Patent Application Publication No. US20130085518A1, Patent Cooperation Treaty international application Publication No. WO/2013/109784, and Patent Cooperation Treaty international application Publication No. WO/2014/160320. Each of these publications is hereby incorporated by reference in its entirety. Each of the various types of embolic devices described therein may be used with the delivery sleeve disclosed herein.
• For the purpose of further description herein, examples will be directed to detachable embolic coils, i.e., embolic coils that can be advanced or retracted by an advancement mechanism (e.g., a pusher wire) until the embolic coil exits the catheter. In some exemplary implementations, a number of embolic coils may be attached to each other end to end within thedelivery sleeve50 with the proximal end of the proximal embolic coil attached to the pusher wire. More particularly detachable polymer coils (DPC) are discussed herein as an example of thetherapeutic device30, but, as indicated, this is not limiting as a person of ordinary skill in the art may apply the concepts provided herein to other types of coils in addition to those incorporated by reference.
• In accordance with various embodiments, thetherapeutic device30 may be a single, long detachable polymer coil (DPC) or a series of shorter DPCs attached to each other within thedelivery sleeve50. The DPC may have a lubricious surface to aid in travel through the tighter fit of thedelivery sleeve50 as opposed to traveling through the muchlarger catheter lumen66.
• In one exemplary implementation, theproximal end31 of theembolic coil30 may have aconnection mechanism32 and thedistal end33 may be configured to engage the targeted treatment area to begin creating the occlusion structure. Theembolic coil30 may have a length commensurate with the length of thesleeve50. To provide more material at the treatment area, longer coil lengths may be desirable (e.g., longer than 100 cm). To accommodate this, longer delivery sleeve lengths may be used such that the entire length of theembolic coil30 along with theconnection mechanism37 and a portion of theadvancement mechanism40 is contained within thelumen56 of thedelivery sleeve50.
• As indicated above, appropriate lengths ofextenders70 can also be incorporated into the system so that embolic coil lengths can be increased. Longer embolic coils30 may be retained within commensuratelylonger sleeves50. However, physicians are still able to use desiredcatheters60 of shorter lengths by usingextenders70 of appropriate lengths in conjunction with theshorter catheters60. For example, if a 200 cm DPC coil is desired, accordingly it would be provided in a 200 cmlength delivery sleeve50. If the longest catheter length used will be 100 cm, then theluer attachment mechanism62 of thecatheter60 would be around the midpoint length of the delivery sleeve50 (i.e., at about 100 cm). Thisdelivery sleeve50 configuration would be undesirable with the 100 cm catheter length, but with an extender of 100 cm the system would be modified to thereby match thesleeve50 length of 200 cm with the combination length ofcatheter60 at 100 cm and the extension tube at 100 cm. Alternatively, if the user wanted to use a 65 cm catheter length, then alonger extender70 of 135 cm would need to be attached to thedelivery sleeve50 to provide compatibility with the shorter catheter. The delivery sleeve length is preferably as long as (or longer than) thelongest coil30. When these factors are known, then the appropriate extension tube lengths can be calculated and provided.
• Theendovascular system10 may include accessories operable to provide additional therapeutic benefits to the patient. For example, theendovascular system10 may include medical device accessories that allow sending a flushing fluid or liquid therapy treatment (e.g., saline or medication) through the catheter in conjunction with thetherapy device40. Such flushing devices could include dual port luer access attachment mechanisms. Thedelivery sleeve50 may also be configured for use with a flushing system. For example, the wall of thedelivery sleeve50 may be perforated to allow flushing solution to pass through thedelivery sleeve50 such that fluid may be introduced into thedelivery sleeve50 but also reach and flush thecatheter60. It may be noted, that the addition of a medical device accessory like the dual port luer access may cause a length change to the catheter or sleeve. The difference in length may be considered minimal as discussed above or the difference length could be significant warranting the use of theextender70 discussed above.
• In accordance with the various embodiments discussed herein, thedelivery sleeve50 may improve the treatment of a patient because the user can advance thedelivery sleeve50 into thecatheter lumen66 without using fluoroscopy, as the length of thedelivery sleeve50 may be sized relative to the length of the catheter. Additionally, thedelivery sleeve50 may be secured to thecatheter60, increasing the stability of the system with thedelivery sleeve50 positioned inside thecatheter60, particularly during advancement of thetherapy device30, such as situations in which thetherapy device30 is an embolic coil system. Also, by connecting thedelivery sleeve50 to thecatheter60, continuous flush can be maintained through both thedelivery sleeve50 and thecatheter60, reducing delivery friction of thetherapy device30 within thedelivery sleeve50 andcatheter60.
• FIG. 5 illustrates a flow chart of a method of using an endovascular system in accordance with various embodiments disclosed herein. A method for delivering a therapeutic treatment to a patient may include providing a catheter having a proximal catheter end and a distal catheter end with a longitudinal catheter lumen extending therebetween (1000). The catheter may be positioned proximal to the target treatment area within the patient (1100). An endovascular therapeutic apparatus having a delivery sleeve, a therapy device, and an advancement device may be provided (1200). The delivery sleeve may have a proximal end and a distal end with a longitudinal lumen extending therebetween. The delivery sleeve may be positioned to be coaxial and movable within the catheter lumen. The therapy device may be located coaxially within the lumen of the delivery sleeve and movable therein. The advancement device may be connected to the therapy device to advance the therapy delivery device through the delivery sleeve into the patient. If the delivery sleeve is longer than the catheter, a catheter extender may be positioned on the proximal end of the catheter (1500). The catheter extender may have a proximal extender end and a distal extender end with a longitudinal extender lumen extending therebetween. The catheter extender may be attached to the proximal catheter end at the distal extender end. The catheter extender may have a length that is approximately equal to the difference in length between the delivery sleeve and the catheter length. When the proximal end of the delivery sleeve is connected to the proximal extender end, the delivery sleeve and the catheter are generally coextensive to the catheter distal end.
• The delivery sleeve may include a stop positioned on the proximal end. The stop may be positioned to limit the distance the delivery sleeve is inserted into the catheter. The endovascular therapeutic apparatus may be inserted into the catheter until the stop comes into contact with the proximal end of the catheter (1400). The method may include extending the therapy device out the distal end of the delivery sleeve and further out distal end of the catheter (1500).
• The therapy device may be an endovascular embolization coil. The endovascular embolization coil may be detachable coil. The detachable coil may be a polymer coil. The advancement mechanism may be connected to the detachable coil with a connection mechanism that is sized to be compressed or restrained by the delivery sleeve. The detachable coil may remain connected to the advancement mechanism within the delivery sleeve, but once it exits the delivery sleeve, the compression, and thereby the connection, may be released. The detachable coil may be pushed out of the end of the delivery sleeve until the detachable coil disconnects from the advancement mechanism (1600). The delivery sleeve may be withdrawn from the catheter (1700). The process may be repeated by inserting a second endovascular therapeutic apparatus into the catheter (1800).
• All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention as claimed. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected or are in fixed relation to each other. The exemplary drawings are for purposes of illustration only and the dimensions, positions, order, and relative sizes reflected in the drawings attached hereto may vary.
• The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the invention as claimed. Although various embodiments of the invention as claimed have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of the invention as claimed. Other embodiments are therefore contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the invention as defined in the following claims.

Claims (20)

What is claimed is:

1. An endovascular apparatus comprising

a delivery sleeve having a longitudinal lumen extending between a proximal end and a distal end;

a therapeutic device housed within and extending substantially an entire length of the delivery sleeve;

wherein the therapeutic device includes one or more detachable polymer endovascular embolization coils; and

a stop positioned on the proximal end of the delivery sleeve which is operable to limit a distance the delivery sleeve is inserted into a catheter;

wherein an outside diameter of the delivery sleeve is sufficiently small such that the delivery sleeve is insertable into the catheter.

2. The endovascular apparatus ofclaim 1, further comprising an advancement mechanism configured to engage the therapeutic device to advance the therapeutic device into a patient.

3. The endovascular apparatus ofclaim 2, a diameter of the lumen is sufficiently large such that the lumen is able to coaxially receive the therapeutic device and the advancement mechanism therein but sufficiently small that the delivery sleeve adds longitudinal strength to the therapeutic device.

4. The endovascular apparatus ofclaim 3 further comprising:

a connection mechanism that connects the advancement mechanism to the therapeutic device,

wherein the connection mechanism is sized relative to the delivery sleeve such that the connection mechanism is compressed by the delivery sleeve and remains connected while in the delivery sleeve, but once the connection mechanism exits the delivery sleeve the compression, and thereby the connection, is released; and

wherein the therapeutic device is located coaxially within the delivery sleeve; and the advancement mechanism is connected to a proximal end of the therapeutic device.

5. The endovascular apparatus ofclaim 1, wherein both an inner surface and an outer surface of the delivery sleeve are composed of a material with a low coefficient of friction.

6. The endovascular apparatus ofclaim 1, wherein the therapeutic device extends approximately to the distal end of the delivery sleeve.

7. The endovascular apparatus ofclaim 1, wherein the stop is a luer connection operable to engage an opposing luer connection on a proximal end of the catheter.

8. An endovascular system comprising:

a catheter having a proximal catheter end and a distal catheter end with a longitudinal catheter lumen extending therebetween;

a delivery sleeve having a proximal end and a distal end with a longitudinal lumen extending therebetween, wherein the delivery sleeve is coaxial with and movable within the catheter lumen;

a therapeutic device located coaxially within the lumen of the delivery sleeve and movable therein;

an advancement mechanism connected to the therapeutic device and configured to advance the therapeutic device into a patient; and

a stop positioned on the proximal end of the delivery sleeve which contacts the proximal catheter end, limiting the distance the delivery sleeve is inserted into the catheter; and

a connection mechanism that connects the advancement mechanism to the therapeutic device, wherein the connection mechanism is sized relative to the delivery sleeve such that the connection mechanism is compressed by the delivery sleeve and remains connected while in the delivery sleeve, but once the connection mechanism exits the delivery sleeve the compression, and thereby the connection, is released.

9. The endovascular system ofclaim 8, wherein the therapeutic device extends substantially an entire length of the delivery sleeve.

10. The endovascular system ofclaim 8, wherein the delivery sleeve is made of polytetrafluoroethylene.

11. The endovascular system ofclaim 8 further comprising:

a catheter extender having a proximal extender end and a distal extender end with a longitudinal extender lumen extending therebetween, wherein the distal extender end is attached to the proximal catheter end, and wherein the delivery sleeve is longer than the catheter.

12. The endovascular system ofclaim 11, wherein the catheter extender has a length that is approximately a difference in length between an entire length of the delivery sleeve and an entire length of the catheter, so that when the proximal end of the delivery sleeve is connected to the proximal extender end, the delivery sleeve and the catheter are generally coextensive to the distal catheter end.

13. The endovascular system ofclaim 8, wherein the therapeutic device is a detachable endovascular embolization coil formed of a polymer.

14. The endovascular system ofclaim 8, wherein the therapeutic device is located coaxially within the delivery sleeve; and

the advancement mechanism is connected to a proximal end of the therapeutic device.

15. The endovascular system ofclaim 8, wherein:

the advancement mechanism is further connected to a distal end of the therapeutic device; and

the therapeutic device extends approximately to the distal end of the delivery sleeve.

16. A method for delivering a therapeutic treatment to a patient comprising:

providing a catheter having a proximal catheter end and a distal catheter end with a longitudinal catheter lumen extending therebetween;

providing a therapeutic delivery device apparatus comprising:

a delivery sleeve having a proximal end and a distal end with a longitudinal lumen extending therebetween, wherein the delivery sleeve is coaxial and longitudinally movable within the catheter lumen;

a therapeutic device enclosed coaxially within the lumen of the delivery sleeve and longitudinally movable therein;

an advancement mechanism connected to the therapeutic device and configured to advance the therapeutic delivery device into a patient;

a stop positioned on the proximal end of the delivery sleeve which contacts the proximal catheter end of the catheter, limiting a distance the delivery sleeve is inserted into the catheter;

inserting the therapeutic delivery device into the catheter until the stop comes into contact with the proximal catheter end; and

wherein the therapeutic delivery device is a detachable polymer endovascular embolization coil.

17. The method ofclaim 16, wherein the therapeutic device extends substantially an entire length of the delivery sleeve.

18. The method ofclaim 16 further comprising

attaching a catheter extender to the catheter in response to the delivery sleeve being longer than the catheter, wherein

the catheter extender includes a proximal extender end and a distal extender end with a longitudinal extender lumen extending therebetween which is attached to the proximal catheter end via the distal extender end.

19. The method ofclaim 18 further comprising:

determining a difference in length between an entire length of the delivery sleeve and an entire length of the catheter; and

selecting the catheter extender such that a length of the catheter extender is approximately equal to the difference in length so that in response to the proximal end of the delivery sleeve being connected to the proximal extender end, the delivery sleeve and the catheter are generally coextensive to the distal catheter end.

20. The method ofclaim 16, wherein, in the method, the therapeutic delivery device further comprises a connection mechanism; and the method further comprises:

connecting the advancement mechanism to the therapeutic device;

compressing the connection mechanism within the delivery sleeve such that the connection mechanism remains connected while in the delivery sleeve;

releasing the connection mechanism from the delivery sleeve once the connection mechanism exits the delivery sleeve;

pushing the therapeutic device out the end of the delivery sleeve until the compression of the delivery sleeve on the connection mechanism is released and the therapeutic device disconnects from the advancement mechanism; and

withdrawing the delivery sleeve from the catheter and repeating the process with a second therapeutic delivery device.

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