Urinary placement catheter for intravesical devices - Patents.com

Abstract

An inserter assembly (200) for disposing an intravesical device within a patient's bladder includes a placement catheter (210), a receiving funnel (220), and a stylet (230). The placement catheter defines a lumen extending from a proximal catheter end to an exit opening. The receiving funnel is secured to the placement catheter. The stylet is removably received within the lumen and through the receiving funnel. The stylet includes a stylet body and a paddle (238). The stylet body is dimensioned to guide the intravesical device through the lumen and the exit opening into the bladder. The paddle is attached to the stylet body about the proximal stylet end and engageable with the receiving funnel. The paddle optionally includes a fitting (242) lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 292,063, filed December 21, 2021, which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present disclosure is generally in the field of medical devices for introduction into a patient's body, and more specifically, in the field of inserter devices and methods for disposing an intravesical device in the bladder through the urethra. [Background technology]

[0003] Intravesical devices can be used to deliver drugs into the bladder or to sense conditions within the bladder. Devices and systems for placing such devices within a patient's bladder are described, for example, in U.S. Patent No. 8,721,621, which is incorporated herein by reference. Summary of the Invention [Means for solving the problem]

[0004] In one aspect, an inserter assembly for disposing an intravesical device within a patient's bladder is provided, the inserter assembly comprising: a placement catheter defining a lumen extending from a proximal catheter end to an exit opening; a receiving funnel secured to the placement catheter at the proximal catheter end; and a stylet removably received through the receiving funnel within the lumen of the placement catheter, the stylet comprising: (i) a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body dimensioned to guide the intravesical device through the lumen and the exit opening into the bladder; and (ii) a paddle attached to the stylet body about the proximal stylet end, the paddle being engageable with the receiving funnel.

[0005] In another aspect, an inserter assembly for disposing an intravesical device within a patient's bladder is provided, the inserter assembly comprising: a placement catheter defining a lumen extending from a proximal catheter end to an exit opening; a stylet removably received through the lumen of the placement catheter, the stylet having a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body dimensioned to guide the intravesical device through the lumen and into the bladder; and a paddle attached to the stylet body about the proximal stylet end, the paddle comprising a central body portion surrounding the proximal stylet end, a thumb rest defined at the proximal paddle end, and a pair of wing portions extending laterally from the central body between the thumb rest and the distal paddle end.

[0006] In yet another aspect, a method is provided for placing an intravesical device in a bladder using an inserter assembly including a placement catheter and a stylet, the method including: (i) introducing the intravesical device into a lumen of the placement catheter through a receiving funnel of the inserter assembly, where an exit opening of the placement body is within an interior volume of the bladder; (ii) introducing a distal stylet end of the stylet through the receiving funnel and into the lumen of the placement catheter to contact the intravesical device within the lumen; and (iii) advancing the stylet distally through the receiving funnel to guide the intravesical device along the lumen toward the exit opening and releasing the intravesical device into the bladder through the exit opening. [Brief description of the drawings]

[0007] Various embodiments may utilize elements and / or components other than those illustrated in the drawings, and some elements and / or components may not be present in various embodiments. Elements and / or components shown in the drawings are not necessarily drawn to scale. Throughout this disclosure, singular and plural terms may be used interchangeably, where appropriate in context. [Figure 1A] FIG. 1 is a top view of one embodiment of an inserter assembly including a delivery catheter, a receiving funnel, and a stylet. [Figure 1B] FIG. 1B is a cross-sectional view of the deployment catheter of FIG. 1A taken along line AA. [Figure 2A] FIG. 1 is a front view of a deployment catheter of an inserter assembly according to one embodiment of the present disclosure. [Figure 2B] FIG. 2B is a side view of the inserter assembly of FIG. 2A. [Figure 3A] FIG. 1 is a perspective view of a hub portion of an inserter assembly including a proximal end portion of a delivery catheter, a receiving funnel, and a stylet according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a top end view of the inserter assembly of FIG. 3A. [Figure 3C] FIG. 3B is a plan view of the proximal portion of the inserter assembly of FIG. 3A. [Figure 4A] FIG. 13 is a perspective view of a proximal portion of an inserter assembly including a proximal end portion of a deployment catheter having a hub with an asymmetric receiving funnel and a stylet in accordance with another embodiment of the present disclosure. [Figure 4B] 4B is a plan view of the proximal portion of the inserter assembly of FIG. 4A in a first configuration with the stylet partially inserted into the delivery catheter. FIG. [Figure 4C] 4B is a plan view of the proximal portion of the introducer assembly of FIG. 4A in a second configuration, with the stylet fully inserted into the delivery catheter. FIG. [Figure 4D] 4D is a partial cross-sectional view of the proximal portion of the inserter assembly of FIG. 4C showing a snap-fit ​​engagement between the hub / funnel and the fitting on the paddle of the stylet. [Figure 5A] 4A-4D illustrate manual manipulation of the proximal portion of the inserter assembly. [Figure 5B] 4A-4D illustrate manual manipulation of the proximal portion of the inserter assembly. [Figure 6A] 1A and 1B are side and top views, respectively, of a proximal portion of an inserter assembly including a hub with an asymmetric receiving funnel and a stylet having a paddle with a curved thumb rest at its end, according to one embodiment of the present disclosure. [Figure 6B] 1A and 1B are side and top views, respectively, of a proximal portion of an inserter assembly including a hub with an asymmetric receiving funnel and a stylet having a paddle with a curved thumb rest at its end, according to one embodiment of the present disclosure. [Figure 7A] 1A and 1B are side and top views, respectively, of a proximal portion of an inserter assembly including a hub with a symmetrical receiving funnel and a stylet with a paddle having a flat end. [Figure 7B] 1A and 1B are side and top views, respectively, of a proximal portion of an inserter assembly including a hub with a symmetrical receiving funnel and a stylet with a paddle having a flat end. [Figure 8]FIG. 13 is a partial side view of one embodiment of an inserter assembly including a delivery catheter and a stylet, without a fitting and without a receiving funnel. [Figure 9] 1 is a block diagram of an embodiment of a method for disposing an intravesical device within a patient's bladder. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] It would be desirable to provide an improved inserter device that provides better and more reliable user handling of the inserter device components, facilitates handling of lubricants used with the inserter device, provides better cooperation between the lumen body and the stylet, provides improved operational feedback including certainty of intravesical device placement, or provides a combination thereof.

[0009] An improved inserter device has been developed for placing an intravesical device within a patient's bladder. The device is an assembly of a placement catheter component and a stylet component that cooperate to release the intravesical device from a contained position within the lumen of a placement catheter to a deployed position outside the placement catheter.

[0010] The intravesical device used with the inserter device of the present disclosure may be any medical device suitable for placement in a patient's bladder. In some embodiments, the intravesical device is a drug delivery device. Examples of such drug delivery devices are described in U.S. Pat. Nos. 10,543,166, 9,283,361, 10,729,823, 10,315,019, 10,737,078, and 11,020,575, which are incorporated herein by reference. In some embodiments, the intravesical device includes diagnostic components such as cameras and sensors. Examples of such devices are described in U.S. Pat. No. 11,065,426 and U.S. Patent Publication No. 2021 / 0196124, which are incorporated herein by reference.

[0011] The terms "distal" or "distally" generally refer to a direction toward the patient, while the terms "proximal" or "proximally" generally refer to a direction away from the patient, toward the clinician. A patient may be a human in need of medical diagnosis, treatment, or prophylaxis.

[0012] The inserter assembly of the present invention includes a placement catheter, a receiving funnel, and a stylet. The placement catheter defines a lumen extending from a proximal catheter end to an exit opening at or near the distal end of the placement catheter. An intravesical device may be advanced, guided by the stylet, through the lumen to the exit opening and into the bladder.

[0013] The stylet is configured to guide one or more intravesical devices through a lumen of the positioning catheter and into the bladder. For example, the intravesical device may be present or introduced within the lumen, and the stylet may be introduced into the lumen to guide the intravesical device along the lumen. In particular, the distal end of the stylet presses against a surface, such as an end of the intravesical device, to displace the intravesical device within the lumen toward and through the exit opening of the positioning catheter.

[0014] The receiving funnel includes a hub that is secured to the deployment catheter at the proximal catheter end. The receiving funnel may, for example, facilitate the introduction of a stylet into the proximal end of the catheter without requiring precise alignment between the catheter and the stylet. For example, the tip or end of the stylet may be guided into the lumen of the catheter along the interior of the funnel toward the proximal opening. Similarly, the receiving funnel may also facilitate the introduction of an intravesical device into the lumen of the catheter, for example, prior to the introduction of the stylet. Additionally, the receiving funnel may beneficially aid the clinician in introducing a lubricant into the lumen without requiring the use of a syringe to direct the lubricant into the catheter lumen. For example, precise placement of a fine or narrow opening in the lumen may not be required to introduce the lubricant because the interior and surface of the funnel directs the lubricant to the opening.

[0015] The stylet is removably received within the lumen of the delivery catheter through the receiving funnel, the stylet includes a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body being dimensioned to guide an intravesical device through the lumen and through the exit opening into the bladder.

[0016] The stylet further advantageously includes a paddle at the proximal stylet end to aid in safe handling and manipulation of the stylet, which may be particularly needed where the clinician's gloved fingers may have lubricant on them. The paddle defines two opposing surfaces extending between the paddle ends, e.g., surfaces that may be grasped, pinched, or held. The surface of the paddle may include ridges or texture to facilitate a user's gripping it. The paddle is sometimes referred to as the "hub" of the stylet.

[0017] In some embodiments, the paddle includes a fitting configured to lockingly engage with the receiving funnel to removably secure the stylet to the positioning catheter. The fitting can provide clear (tactile and / or audible) feedback to the clinician when the stylet is fully inserted into the catheter. For example, the lockably engageable fitting may include one or more mechanical features for snap-lock engagement with complementary mechanical features on the receiving funnel. In preferred embodiments, the lockable engagement features can be manipulated to unlock and disengage the stylet (e.g., the fitting) from the positioning catheter (e.g., the receiving funnel).

[0018] In some other embodiments, the paddle does not include a locking feature. The deployment catheter and stylet may be configured such that the fitting of the stylet is engageable with the receiving funnel during insertion of the stylet. For example, the fitting may be brought into stopping contact with the inner surface within the receiving funnel without locking, after which the stylet can be freely withdrawn from the deployment catheter.

[0019] The stylet has a sufficient length to guide the intravesical device completely out through the exit opening when the stylet is fully inserted. Thus, the clear feedback also provides a clear indication that the intravesical device is disposed within the bladder. The paddle-to-funnel engagement, or the optional lockable engagement of the fitting with the funnel, can also prevent overinsertion of the stylet into the catheter, which can prevent unintentional introduction of the stylet beyond the end of the catheter into the bladder, or unintentional contact of the stylet with the bladder wall. The paddle-to-funnel engagement can take the form of the distal face end of the paddle surrounding the stylet interfacing with the proximal end face of the deployment catheter, thereby completing / stopping the insertion.

[0020] The intravesical device may be placed in the patient's bladder using one of the inserter assemblies described herein. In some embodiments, the method includes introducing the intravesical device in an elongated arrangement into the lumen of the positioning catheter through a receiving funnel. The exit opening is within the interior volume of the bladder. The method further includes introducing a distal stylet end into the lumen of the positioning catheter through the receiving funnel and contacting the intravesical device in the lumen. The method further includes advancing the stylet distally through the receiving funnel to guide the intravesical device along the lumen toward the exit opening and releasing the intravesical device through the exit opening into the bladder. The method optionally further includes engaging a paddle of the stylet with the receiving funnel, which may serve to indicate that the distal end of the stylet has reached a position at or near the exit opening, thereby indicating that the intravesical device has been released into the bladder. In some other embodiments, the paddle does not need to engage the funnel for the intravesical device to be released from the positioning catheter.

[0021] Embodiments of the introducer assembly are shown in Figures 1A-8. In general, the introducer assembly includes a delivery catheter designed to pass through the patient's urethra and a stylet introduceable into the delivery catheter.

[0022] FIG. 1A shows an inserter assembly 1 including a placement catheter 10, a receiving funnel 20, and a stylet 30. FIG. 1B shows a cross-section taken along line AA of the placement catheter 10 shown in FIG. 1A. The inserter assembly 1 may be used to place an intravesical device 40. The intravesical device 40 is shown placed within the lumen of the placement catheter 10. The intravesical device 40 may or may not be initially present within the inserter assembly 1. For example, a clinician may introduce the intravesical device 40 into the placement catheter 10 of the inserter assembly 1 during or immediately prior to placement. In some embodiments, the intravesical device 40 may be provided as part of the inserter assembly 1, for example, within the placement catheter 10, without the need for the clinician to introduce the intravesical device 40 into the inserter assembly 1. The cross-sectional shape of the lumen 12 may match the cross-sectional shape of the intravesical device 40.

[0023] In some embodiments, the inserter assembly 1 includes a delivery catheter 10, a receiving funnel 20, and a stylet 30. The delivery catheter 10 defines a lumen 12 extending from a proximal catheter end 14 to an exit opening 16. In some embodiments, the exit opening 16 may be adjacent to a distal catheter end 18. The exit opening 16 is in communication with the lumen 12 in a manner that facilitates smooth passage of an intravesical device 40 from the lumen 12 and through the exit opening 16.

[0024] In some other embodiments, the exit opening may be at the distal end of the delivery catheter and may be aligned with the lumen.

[0025] The wall 11 of the delivery catheter 10 generally defines a lumen 12. The wall 11 is formed from a biocompatible polymeric material and has a thickness that provides suitable column strength to prevent buckling of the wall while the delivery catheter is inserted through the urethra. The material is preferably suitable for conventional sterilization processes such as, for example, gamma irradiation or ethylene oxide sterilization. In certain embodiments, the delivery catheter 10 is transparent or translucent for visually determining the position of the stylet 30 and / or intravesical device 40 within the lumen 12.

[0026] Lumen 12 may have a circular, oval, or elliptical cross-sectional profile, or any other suitable profile. An intravesical device 40 may be positioned within lumen 12 and ready for deployment. Thus, in certain embodiments, intravesical device 40 may be preloaded within lumen 12 of deployment catheter 10. For example, intravesical device 40 may be preloaded or loaded by a clinician or machine prior to use into lumen 12 through outlet opening 16, or through a proximal opening of lumen 12 through receiving funnel 20, or in an alternative embodiment (not shown) through a slit along wall 11.

[0027] Generally, the distal catheter end 18 and the distal portion of the delivery catheter 10 are configured to traverse the urethra without trauma to the urethral tissue or with minimal trauma to the urethral tissue, while the proximal catheter end portion 14 and the proximal portion of the delivery catheter 10 remain outside the body and provide access for a user, such as a medical professional.

[0028] The dimensions of the delivery catheter 10 may be selected based at least in part on the dimensions of the anatomical structure that the inserter assembly 1 is designed to navigate. The delivery catheter 10 can have any suitable length. In certain embodiments, the delivery catheter 10 has a length of at least 10 cm, or at least 20 cm, or at least 30 cm, or at least 40 cm, and less than 60 cm, or less than 80 cm. In certain embodiments, the delivery catheter has a length of between 10 cm and 40 cm.

[0029] The delivery catheter 10 can have any suitable outer diameter. In certain embodiments, the delivery catheter has an outer diameter of 5 Fr (1.67 mm outer diameter) to 18 Fr (6 mm outer diameter). In some other embodiments, the delivery catheter can have an outer diameter outside the range of 5 to 18 Fr, for example, 20 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, or 30 Fr.

[0030] One or both of the stylet 30 and the intravesical device 40 may be introduced into the lumen 12 of the delivery catheter 10 via or through the receiving funnel 20. The receiving funnel 20 may have a shape that expands from a narrow end to a wide end. In some embodiments, the receiving funnel 20 may define an opening adjacent the narrow end that is fluidly coupled to the lumen 12 of the delivery catheter. The receiving funnel 20 may have a height that is shallower than one or both of the funnel's length or width. In some embodiments, the receiving funnel may have a height to width ratio of 0.25 to 0.5.

[0031] The receiving funnel 20 may be removably securable to the delivery catheter 10 by any suitable attachment mechanism, such as by one or more clips, a friction fit, or a pressure sensitive adhesive. In certain embodiments, the receiving funnel 20 is formed of a material that is softer than the material of the delivery catheter 10, such that the receiving funnel can be elastically or plastically pressed, deformed, or delivered about the delivery catheter 10. In certain embodiments, the receiving funnel 20 is permanently secured to the delivery catheter 10, such as by molding, overmolding, or a permanent adhesive, or any suitable mechanism that secures the receiving funnel 20 to the delivery catheter 10 in a manner that cannot be non-destructively removed.

[0032] In certain embodiments, the receiving funnel 20 is overmolded around the delivery catheter 10 at the proximal catheter end 14. In certain embodiments, the receiving funnel 20 is integral with the delivery catheter 10 at the proximal catheter end 14. As used herein, the terms "integral" and "integrally formed" refer to the funnel and delivery catheter being part of the same monolithic structure / material, e.g., co-molded. The receiving funnel 20 may be secured to the delivery catheter 10 at the proximal catheter end 14, adjacent to the proximal catheter end, or around the proximal catheter end. In certain embodiments, the receiving funnel 20 is integrally formed with the delivery catheter 10. For example, a rear or proximal portion of the delivery catheter may be formed as the receiving funnel 20.

[0033] The receiving funnel 20 extends between a proximal funnel end 22 and a distal funnel end 24. The receiving funnel 20 may be comprised of a single or integral unit extending between the proximal funnel end 22 and the distal funnel end 24. In certain embodiments, two or more units may be formed separately and secured together to form the receiving funnel 20. For example, the receiving funnel 20 may include a funnel portion 26 and a hub 28 which may be integrally formed as a single unit, or may be formed separately and secured together. The hub 28 may be sized to be secured to or about the proximal catheter end 14 of the delivery catheter 10. The funnel portion 26 may be sized to flare proximally away from the proximal catheter end 14 to facilitate receipt of fluids, such as a stylet 30, an intravesical device 40, or a lubricant, within the lumen 12 of the delivery catheter 10.

[0034] 1A, the narrowest width of funnel portion 26 is wider than the width of hub 28. In certain embodiments, the width of hub 28 may increase to smoothly transition to the width of funnel portion 26. Thus, the outer surface of funnel portion 26 may extend smoothly into the outer surface of hub 28.

[0035] The receiving funnel 20 may have any suitable profile, such as a profile defined by a curve, a contour, a polygon, a linear or piecewise linear path, or a combination thereof. In certain embodiments, the receiving funnel 20 has a circular or elliptical profile. In certain embodiments, the receiving funnel 20 is flattened such that the receiving funnel 20 has a shorter minor axis and a wider major axis in a direction transverse to the receiving funnel 20. In certain embodiments, the receiving funnel is sized to receive at least 0.1 mL, or at least 0.5 mL, or at least 1 mL of liquid or gel, e.g., lubricant.

[0036] The funnel portion 26 defines a funnel volume that is fluidly coupled to the lumen 12 of the delivery catheter 10. Thus, the receiving funnel 20 may be used to direct components or fluids into the lumen 12 without requiring precise determination of the location or alignment of the proximal opening of the lumen 12. The proximal catheter end 14 may extend to and be aligned with the interface of the funnel portion 26 and the hub 28, as shown in FIG. 1A. Thus, the proximal opening of the lumen 12 may be aligned with that interface. In certain embodiments, the proximal catheter end 14 may not extend to that interface, but may instead terminate at a location along the hub 28.

[0037] In certain embodiments, the receiving funnel 20 is flexible, e.g., elastically deformable in response to a force applied by the clinician, while in other embodiments, the receiving funnel 20 is rigid and substantially retains its shape in response to a force applied by the clinician.

[0038] A proximal portion of the stylet 30 adjacent the proximal stylet end 34 is configured to remain outside the patient's body and receive a guiding force from a clinician or device, and a distal portion adjacent the distal stylet end 36 is configured to guide the intravesical device 40 out of the exit opening 16.

[0039] The stylet 30 is removably received within the lumen 12 of the delivery catheter 10 through the receiving funnel 20. The stylet 30 includes a stylet body 32 extending between a proximal stylet end 34 and a distal stylet end 36. The stylet body 32 is dimensioned to guide the intravesical device 40 through the lumen 12 and the exit opening 16 into the patient's bladder.

[0040] The overall shape and configuration of the stylet 30 allows the stylet 30 to apply a guiding force to the intravesical device 40 without substantial friction between the placement catheter 10 and the stylet 30 and without the stylet 30 causing trauma to the placement catheter 10 or the intravesical device 40.

[0041] The dimensions of the stylet 30 may be selected based at least in part on the dimensions of the delivery catheter 10 lumen and the size of the intravesical device. The stylet 30 may be slightly longer than the delivery catheter 10. When inserted into the delivery tool, the stylet proximal end 34 remains outside the proximal catheter end 14 of the delivery catheter 10 and the distal stylet end 36 reaches the distal catheter end 18 of the delivery catheter 10. Such a configuration allows the stylet 30 to be inserted along the entire length of the delivery catheter 10 to guide the intravesical device 40 out of the exit opening 16.

[0042] The outer diameter of the stylet 30 is smaller than the inner diameter of the delivery catheter 10 so that the stylet 30 can be inserted into the delivery tool without having to overcome frictional forces along the entire length of the delivery catheter 10. In some embodiments, the stylet body has an outer diameter that is about 1 mm smaller than the inner diameter of the lumen of the delivery catheter.

[0043] The stylet 30 is formed from a suitable material having suitable column strength to resist buckling during insertion into the delivery catheter lumen and guidance of the intravesical device. The material may be a biocompatible polymer, such as silicone, polyethylene, or polyurethane, and is preferably one that is suitable for conventional sterilization procedures. The stylet 30 may be formed, for example, by extrusion or molding processes known in the art.

[0044] In the illustrated embodiment, the stylet 30 has a substantially cylindrical outer surface, although other configurations are possible.

[0045] In certain embodiments, the stylet body 32 has a solid cross-section throughout the stylet body 32. In other embodiments, the stylet body 32 may be hollow. For example, the stylet body 32 may define a lumen extending from the proximal stylet end 34 to the distal stylet end 36. In some such embodiments, the lumen of the stylet body 32 may be used to allow the passage of fluid into and out of the delivery catheter lumen and / or the bladder. In some embodiments, the lumen may extend through the paddle.

[0046] The stylet 30 further includes a paddle 38 at, adjacent to, or about the proximal stylet end 34. The paddle 38 is engageable with the receiving funnel 20, such as by contact between a surface of the paddle 38 and a surface of the receiving funnel 20. Optionally, the paddle 38 is lockably engageable with the receiving funnel 20 to removably secure the stylet 30 to the receiving funnel 30, and ultimately to the delivery catheter 10.

[0047] The paddle 38 optionally includes at least one attachment 42 for facilitating lockable engagement of the paddle 38 to the funnel 20. The attachment 42 may include at least one clip, e.g., one, two or more clips. In certain embodiments, the attachment 42 includes at least one clip removably securable to the receiving funnel 30. For example, the at least one clip may be securable to a surface or feature of the receiving funnel 30, e.g., a lip, rim, contour, protrusion, channel, ridge, opening, or any suitable feature complementary to the at least one clip (or to the attachment 42 generally). In certain embodiments, the attachment 42 is removably securable to or at an inner surface of the receiving funnel 20, e.g., adjacent the proximal catheter end 14. The fitting 42 may apply a biasing or securing force such that the stylet 30 is fully engaged and secured to the receiving funnel 20 (and thus to the delivery catheter 10) and remains secured to the delivery funnel 20 until at least a minimum threshold removal force is applied to the stylet 30 in a proximal direction away from the delivery catheter 10.

[0048] In certain embodiments, the fitting 42 generates tactile or audible feedback upon engagement. In certain embodiments, the stylet 30 itself is configured to generate audible or tactile feedback during engagement with the receiving funnel 20, for example, by snapping or tapping against the receiving funnel 20. Thus, the fitting 42 can facilitate full engagement and fixation of the stylet 30 to the delivery catheter 10 until intentionally released by the clinician.

[0049] Instead of, or in addition to, a clip-containing fitting 42, the inserter assembly 1 may include other mechanisms for securing the stylet 30 to the delivery catheter 10. For example, one of the fitting 42 or the receiving funnel 20 may define a peripheral ridge, and the other of the fitting 42 or the receiving funnel 20 may define a peripheral channel that is dimensioned to matingly engage the peripheral ridge. The mating ridge and channel may be suitably resilient and dimensioned to provide a "snap-fit" locking engagement.

[0050] In some other embodiments, the fitting 42 and receiving funnel 20 may be securable by a luer lock or a twist lock.

[0051] 1A, the fitting 42 is associated with the stylet 30, however, in other embodiments, the fitting may be provided on one or both of the stylet 30 (e.g., at the paddle 38) and the receiving funnel 20, which is securable to the other of the stylet 30 (or paddle 38) and the receiving funnel 20. In certain embodiments, the fitting 42 extends distally from the distal paddle end and includes two clips securable to the inner funnel lip. Further description of the fitting and funnel engagement is provided below with reference to FIGS. 3A-7B.

[0052] In certain other embodiments, the inserter assembly may not include a fitting, as described below with reference to FIG.

[0053] The paddle 38 may be secured to the stylet body 32 by, for example, a friction or interference fit, molding, overmolding, or a permanent adhesive, or any suitable mechanism that secures the paddle 38 to the stylet body 32 in a manner that cannot be removed by, for example, a clinician. The proximal stylet end 34 may extend to and align with the end of the paddle 38. Thus, the proximal ends of the stylet body 32 and the paddle 38 may be flush or aligned. In certain embodiments, the proximal stylet end 34 may not extend in such a manner and may instead terminate at a location within the interior of the paddle 38, as shown in FIG. 1A. In certain embodiments, the paddle 38 is overmolded around the stylet body 32 at the proximal stylet end 34. In certain embodiments, the paddle 38 may be coupled to the stylet body by an adapter. In certain embodiments, the paddle 38 is integrally formed with the stylet body 32. For example, the stylet body 32 and paddle 38 may be molded together or as a single unit or piece.

[0054] The paddle 38 is sized to engage with the receiving funnel 20. For example, the paddle 38 may be wider or larger in at least one dimension than the receiving funnel 20 such that the paddle 38 may be secured to or about an outer surface, rim, or lip of the receiving funnel 20. In certain embodiments, the paddle 38 is narrower or smaller in at least one dimension than the receiving funnel 20 such that the paddle 38 is at least partially received within and engaged against an inner surface of the funnel portion 26. In certain such embodiments, a portion of the paddle 38 may extend proximally outside the funnel portion 26 such that a clinician can grasp, pinch, or grab the extended portion and apply a pulling force to the paddle 38 to disengage or remove the paddle 38 (and thus the stylet 30) from the receiving funnel 20. In certain embodiments, no portion of the paddle 38 extends out of the receiving funnel 20, so that a clinician cannot easily manually remove or disengage the paddle 38 (and thus the stylet 30) without the use of a tool such as, for example, forceps. Such a configuration may be used to prevent or avoid unintentional disengagement or removal of the stylet 30 from the delivery catheter 10.

[0055] In certain embodiments, the delivery catheter 10 defines a rounded, atraumatic tip at the distal catheter end 18, as shown, for example, in Figure 1A. In other embodiments, the distal end of the delivery catheter 10 may have a relatively flat or tapered tip, so long as it is suitably configured to permit insertion into / through the urethra.

[0056] One or more of the delivery catheter 10, paddle 38, receiving funnel 20, and stylet 1 may be formed from the same or different polymeric materials. In certain embodiments, the inserter assembly 1 includes a radio marker. For example, the delivery catheter 10 or the stylet body 32 may include a radiopaque material or marker.

[0057] The inserter assembly 1 may be used to guide and position the intravesical device 40. Further embodiments of the inserter assembly or components thereof are described with reference to Figures 2A-8, where like numbered reference numerals indicate like elements. It will be understood that the inserter assembly 1 may include modified components according to such and other embodiments.

[0058] 2A-2B illustrate one embodiment of the deployment catheter 110 of the inserter assembly 100. The deployment catheter 110 has a rounded, atraumatic tip that includes a dogleg bend. If the dogleg bend is present, the dogleg bend may be aligned at an angle (e.g., aligned or perpendicular) to the long axis of the retrieval funnel such that the orientation of the retrieval funnel indicates the orientation of the dogleg bend. In certain embodiments, the deployment catheter 110 may include depth markings to indicate the insertion depth and the orientation of the exit opening, as shown in FIG. 2B.

[0059] One preferred embodiment of the inserter assembly 200 is shown in Figures 3A-3C. The delivery catheter 210 may be generally similar to the delivery catheter 10 described with reference to Figures 1A-1B, or the delivery catheter 110 described with reference to Figures 2A-2B. The funnel portion 226 of the receiving funnel 220 has an elliptical profile, as seen in Figures 3B and 3C. A rim 229 may be present at the exterior interface of the funnel portion 226 and the hub 228.

[0060] The stylet 230 includes a paddle 238 that includes a fitting 242. The fitting 242 includes two clips that extend distally from the fitting 238. The two clips of the fitting 242 are received within the receiving funnel 220 and are removably securable thereto.

[0061] The paddle 238 has a central body portion 231 surrounding the proximal stylet end, a thumb rest 244 defined at the proximal paddle end 237, and a pair of wing portions 235a, 235b extending laterally from the central body portion 231 between the thumb rest 244 and the distal paddle end 233. The thumb rest 244 has a concave surface 239 facing away from the central body portion 231 and an elliptical outer edge, the major axis of which extends in the same direction as the wing portions extend from the central body portion. Each of the wing portions 235a, 235b includes a taper 241 that leads to the distal paddle end 237. The paddle 238 also includes a curved finger rest 246 proximate each taper 241. The surface area of ​​the wing portions 235a, 235b optionally includes a gripping surface 248 extending between the proximal and distal paddle ends. For example, the gripping surface may include a non-slip coating material or textured areas (e.g., a plurality of ridges, grooves, raised bumps, or other surface roughening features) as known in the art. One or more of the thumb rest 244, the curved finger rest 246, and the gripping surface 248 may facilitate holding, gripping, grasping, pulling, and pushing the stylet 230 relative to the placement catheter 210 and the receiving funnel 220.

[0062] Another preferred embodiment of an inserter assembly 300 is shown in Figures 4A-4D. The inserter assembly 300 is substantially similar to the inserter assembly 200 described with reference to Figures 3A-3C, except that the receiving funnel 320 extends asymmetrically across the stylet body 330.

[0063] As shown in Figure 4A, the inserter assembly 300 includes a delivery catheter 310, an asymmetric receiving funnel 320, and a stylet 330. In a first illustrated configuration, the stylet 330 is partially inserted into the delivery catheter 310, as illustrated in Figures 4A-4B. In a second illustrated configuration, the stylet 330 is fully inserted into the lumen of the delivery catheter 310, as shown in Figures 4C-4D.

[0064] The deployment catheter 310 includes depth markings, similar to the deployment catheter 110 shown in FIGS. 2A-2B. The first funnel edge 350 of the funnel portion 326 of the receiving funnel 320 is offset proximally relative to the second funnel edge 352 and extends further proximally, as shown in FIG. 4C. The paddle 338 includes a thumb rest 344 and a gripping surface 348, as shown in FIG. 4B.

[0065] The paddle 338 can be secured to the inner rim 327 inside the funnel portion 326 and includes a fixture 342 that includes two clips received within a channel 329 adjacent the inner rim 327, as shown in FIG. 4D.

[0066] The asymmetric configuration of the receiving funnel 320 of the inserter assembly 300 can facilitate the ergonomic manual operation of the inserter assembly 300, as shown in FIGS. 5A-5B. FIG. 5A illustrates the use of the inserter assembly 300 of FIG. 4A with the stylet 330 partially inserted through the deployment catheter 310. FIG. 5B illustrates the use of the inserter assembly 300 of FIG. 4A with the stylet 330 fully inserted. As shown in FIG. 5A, the thumb of one hand of the user can rest against the asymmetric portion of the receiving funnel 320, and the thumb and fingers of the other hand of the user can grip the gripping surface 348 of the paddle 338. This configuration can be used to advance or retract the stylet 330 distally or proximally relative to the funnel 320. To fully insert the stylet 330, the thumb of one hand can finally press against the curved thumb rest 344 of the stylet 330 with the finger placed against the receiving funnel 320, as shown in FIG. 5B.

[0067] Another preferred embodiment of an inserter assembly 400 is shown in Figures 6A-6B. The inserter assembly 400 includes a delivery catheter 410, an asymmetric receiving funnel 420, and a stylet 430. The inserter assembly 400 is substantially similar to the inserter assembly 300 described with reference to Figures 4A-4D, except that the receiving funnel 420 has a pear-shaped asymmetric profile in a direction transverse to the stylet body 430. The shape of the receiving funnel 420 may facilitate holding the asymmetric funnel 420 between the fingers or between a finger and thumb, for example.

[0068] Another preferred embodiment of an inserter assembly 500 is shown in Figures 7A-7B. The inserter assembly 500 includes a delivery catheter 510, a symmetric receiving funnel 520, and a stylet 530. The inserter assembly 500 is substantially similar to the inserter assembly 200 described with reference to Figures 3A-3C, except that the paddle 538 of the inserter assembly 500 has a different shape than the paddle 238 of the inserter assembly 200. The paddle 538 has a tapered shape similar to a guitar pick, and also includes a twist lock 543 (e.g., a luer lock) securable within the interior of the receiving funnel 520.

[0069] FIG. 8 illustrates an alternative embodiment of an inserter assembly 600 including a delivery catheter 610 and a stylet 630 without a fitting or receiving funnel. Except for the absence of a fitting or receiving funnel, the inserter assembly 600 is substantially similar to the inserter assembly 200 described with reference to FIGS. 3A-3C. The stylet 630 includes a stylet body 632 extending between a proximal stylet end and a distal stylet end. The stylet 630 includes a paddle 638 attached to the stylet body 632 about the proximal stylet end. The paddle 638 defines a curved thumb rest 644 at the proximal paddle end and a curved finger rest 646 at the distal paddle end. The curved thumb rest 644 may extend along a direction transverse to the stylet body 632, for example, perpendicular to the stylet body 632 or within ±10° of a direction perpendicular to the stylet body 632. In an embodiment, as shown in FIGURE 8, the curved finger rest 646 is a first curved finger rest and the paddle 638 further defines a second curved finger rest at the distal paddle end.

[0070] The paddle 638 is attached to the stylet body 632. For example, the paddle 638 may be overmolded around the stylet body 632 at the proximal stylet end. In such an embodiment, the paddle 638 has a central body portion 639 that defines a paddle lumen through which the proximal end portion of the stylet body 632 extends. In an alternative embodiment, the paddle 638 is integrally formed with the stylet body 632, such as by an injection molding process.

[0071] In some embodiments, the inserter assembly 600 may not include a receiving funnel, as shown, for example, in FIG. 8 . In such embodiments, the paddle 638 may engage with the delivery catheter 610. For example, a distal portion of the paddle 638 may contact or engage a proximal portion of the delivery catheter 610. Thus, the clinician may stop guiding or pushing the stylet body 632 upon receiving audio or tactile feedback generated by the engagement of the paddle 638 with the delivery catheter 610. In other embodiments, the inserter assembly 600 may include a receiving funnel according to embodiments of the present disclosure, and the paddle 638 may engage with the receiving funnel.

[0072] Although embodiments of an insertion assembly have been described that include a receiving funnel, a paddle, and a locking feature or fitting, in other embodiments, the insertion assembly may include one or two of a receiving funnel, a paddle, and a locking feature or fitting. In some embodiments, one or both of the receiving funnel and the fitting may be absent from the inserter assembly. In embodiments in which a receiving funnel is not present, the paddle may engage or rest against the proximal end of the delivery catheter after advancing the stylet through the delivery catheter.

[0073] Various insertion assemblies according to the present disclosure may be provided as respective kits. For example, the kit may include a package that holds a placement catheter and a stylet. The kit may include a separate hub with an integral receiving funnel that can be secured to the placement catheter prior to use, or the receiving funnel may be glued or secured to the placement catheter. The kit may include an intravesical device that is introduced into the placement catheter, or may include an intravesical device preloaded into the placement catheter.

[0074] In certain embodiments, the deployment assembly may be housed within at least one package or kit that stores one or more of the placement catheter, the receiving funnel, the stylet, and the intravesical device. The package may protect the packaged components prior to the insertion procedure. For example, the components may be sterilized together in the package and shipped together. Either or both of the stylet or the receiving funnel may be packaged with the placement catheter, packaged separately, or omitted entirely. Regardless of which components are packaged together, the package is sterilized using gamma irradiation or ethylene oxide sterilization, for example.

[0075] 9 is a block diagram of an embodiment of a method of inserting an intravesical device into a bladder. The method of FIG. 9 may be practiced using any insertion assembly according to the present disclosure, for example, an insertion assembly including a placement catheter, a receiving funnel, and a stylet.

[0076] At block 702, a deployment catheter is inserted into the body. Inserting the deployment catheter generally involves inserting the deployment catheter into the urethra and guiding the deployment catheter forward until the distal end is positioned within the bladder, while the proximal end remains outside the body. For example, the distal stylet end may be introduced into the lumen of the deployment catheter through a receiving funnel and contact an intravesical device within the lumen.

[0077] In some embodiments, the placement catheter is inserted into the body without the use of any additional devices at block 702. In some other embodiments, the placement catheter is inserted into the body at block 702 in conjunction with a cystoscope that allows for visualization of the insertion procedure.

[0078] In some embodiments, inserting the positioning catheter into the body at block 702 further includes verifying that the distal end of the positioning catheter is positioned within the bladder. For example, the location of the distal end can be verified by transmitting urine through the positioning catheter from the distal end positioned within the bladder and / or by using depth indicator markings (e.g., numbers) on the positioning catheter. The location of the distal end can be verified by visualizing the distal end of the positioning catheter with a cystoscope, ultrasound, or x-ray.

[0079] In embodiments where the placement catheter includes a dogleg or tip, the clinician may rotate the placement catheter and then rotate the dogleg to control the orientation of the intravesical device exiting the placement catheter. For example, the dogleg may orient the exit opening toward a direction that can be controlled by rotating the placement catheter. Thus, in some embodiments, the clinician may orient, steer, or guide the intravesical device away from any anatomical features within the bladder that may impede release of the intravesical device from the placement catheter.

[0080] At block 704, the intravesical device is inserted into the positioning catheter. In some cases, inserting the intravesical device into the positioning catheter can include elastically deforming the intravesical device from a non-linear bladder-retaining shape (e.g., a coiled or S-shaped shape) to a substantially linear deployed shape. For example, block 704 can include introducing the intravesical device in an elongated deployed configuration into a lumen of the positioning catheter through a receiving funnel, with the exit opening residing within the interior volume of the bladder.

[0081] Inserting the intravesical device into the positioning catheter may include inserting the intravesical device into the distal catheter end, the proximal catheter end, or into an opening or slit along the wall of the positioning catheter. In some cases, inserting the intravesical device into the positioning catheter includes preloading the intravesical device into the positioning catheter before the positioning catheter is inserted into the body. In such cases, the order of blocks 702 and 704 is reversed. The intravesical device is typically preloaded when the device is placed into the positioning catheter through the distal end or slit, although the intravesical device can be preloaded in either case for convenience. The intravesical device may be lubricated as or before the intravesical device is inserted into the positioning catheter to reduce friction associated with guiding the intravesical device through the positioning catheter in block 706.

[0082] In block 706, the intravesical device is navigated into the bladder. In embodiments where the intravesical device is inserted into the positioning catheter through a receiving funnel into the proximal catheter end in block 704, guiding the intravesical device into the bladder includes guiding the intravesical device from the proximal catheter end, along the lumen, and through the distal catheter end until the intravesical device exits the positioning catheter and enters the bladder. In embodiments where the intravesical device is inserted into the distal catheter end in block 704, guiding the intravesical device into the bladder includes guiding the intravesical device through the distal catheter end until the intravesical device exits the positioning catheter and enters the bladder, since the intravesical device was previously navigated through the urethra upon insertion of the positioning catheter in block 702.

[0083] Guiding the intravesical device into the bladder in block 706 includes guiding the intravesical device with a stylet. The stylet may be an embodiment of the stylet described above. In such a case, guiding the intravesical device into the bladder in block 706 includes inserting a distal stylet end into a proximal catheter end portion through a receiving funnel and advancing the stylet through the positioning catheter until the distal stylet end reaches the distal catheter end. Guiding the intravesical device into the bladder in block 706 includes contacting the intravesical device with the stylet, advancing the intravesical device through the positioning catheter using the stylet, and guiding the intravesical device out of the positioning catheter with the stylet. For example, the stylet may be advanced distally through the receiving funnel to guide the intravesical device along the lumen toward the exit opening, and a fitting of the stylet or part of the paddle may optionally be engaged with the receiving funnel as an indication of complete stylet insertion and release of the intravesical device through the exit opening into the bladder.

[0084] In some embodiments in which the method is used to place an intravesical device that is configurable between a deployed shape (e.g., a linear shape) and a retained shape (e.g., a non-linear shape), the act of guiding the intravesical device from the placement catheter in block 706 removes the force of the placement catheter walls from the intravesical device. Removing this load may allow the intravesical device to elastically return to its retained shape to retain the intravesical device within the bladder for a medically indicated (e.g., therapeutic or diagnostic) period of time. In other words, guiding may remove the constraint or confinement imposed on the intravesical device by the placement catheter walls.

[0085] In some embodiments, the snap-lock engagement of the fitting to the receiving funnel provides tactile and / or audible feedback that the stylet is fully inserted, thereby ensuring that the intravesical device is properly positioned. In some embodiments, another portion of the paddle other than the fitting may contact the funnel to provide tactile and / or audible feedback of stylet insertion. For example, in some embodiments, guiding the intravesical device into the bladder at block 706 may further include viewing the intravesical device within the bladder to ensure that the device is properly positioned. For example, the device may be viewed using a cystoscope, ultrasound, or x-ray.

[0086] In some embodiments, directing the intravesical device into the bladder at block 706 further includes introducing a volume of fluid into the bladder before the device is directed into the bladder. The fluid may be, for example, water or saline. The fluid may act as a cushion within the bladder and reduce the likelihood that the intravesical device will contact the back of the bladder when deployed, thereby reducing bladder discomfort.

[0087] At block 708, the deployment catheter and stylet are removed from the body. The stylet may be removed either prior to or simultaneously with the deployment catheter. For example, the paddle may be released from the receiving funnel and the stylet may be withdrawn proximally from the catheter through the lumen. In other embodiments, the paddle may remain engaged with the receiving funnel and stylet within the lumen while withdrawing the catheter from the bladder. The intravesical device then remains disposed within the bladder for the medically indicated period of time at block 710. In embodiments where the intravesical device is a drug delivery device, the device is retained within the body at block 710 to release the drug into the body, for example, releasing the drug from the device into the bladder and into urothelial tissue and other local or regional tissues.

[0088] In some embodiments, the method includes removing the intravesical device from the body at block 712. Removing the intravesical device from the body may include inserting a removal tool into the body, positioning the deployed intravesical device within the body, grasping or otherwise securing the intravesical device, and withdrawing the intravesical device from the body using the removal tool. The removal tool may include the use of a cystoscope or catheter inserted through the urethra until its distal end reaches the bladder, and forceps or other means may be used to facilitate grasping or securing the intravesical device.

[0089] Some embodiments of the present disclosure can be described in consideration of one or more of the following.

[0090] Embodiment 1. An inserter assembly for disposing an intravesical device within a patient's bladder, the inserter assembly comprising: (i) a placement catheter defining a lumen, the lumen extending from a proximal catheter end to an exit opening; (ii) a receiving funnel secured to the placement catheter at the proximal catheter end; and (iii) a stylet removably received within the lumen of the placement catheter through the receiving funnel, the stylet comprising: (a) a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body being dimensioned to guide the intravesical device through the lumen and the exit opening into the bladder; and (b) a paddle attached to the stylet body about the proximal stylet end, the paddle being engageable with the receiving funnel.

[0091] Embodiment 2. An inserter assembly as described in embodiment 1, wherein the paddle is overmolded around the stylet body at the proximal stylet end.

[0092] Embodiment 3. An inserter assembly as described in embodiment 1 or 2, wherein the paddle is integral with the stylet body.

[0093] Embodiment 4. An inserter assembly described in any one of embodiments 1 to 3, wherein the paddle defines a curved thumb rest at the proximal end.

[0094] Embodiment 5. The inserter assembly of embodiment 4, wherein the paddle further defines a curved finger rest opposite the curved thumb rest.

[0095] Embodiment 6. An inserter assembly according to any one of embodiments 1 to 5, wherein the paddle has a gripping surface.

[0096] Embodiment 7. An inserter assembly according to any one of embodiments 1 to 6, wherein the paddle is dimensioned to be received within the receiving funnel.

[0097] Embodiment 8. An inserter assembly described in any one of embodiments 1 to 7, wherein the paddle comprises a fitting lockably engagable with the receiving funnel to removably secure the stylet to the placement catheter.

[0098] Embodiment 9. The inserter assembly of embodiment 8, wherein the fitting is engagable with an inner surface of the receiving funnel.

[0099] Embodiment 10. An inserter assembly as described in embodiment 8 or 9, wherein one or both of the fitting and the receiving funnel are provided with at least one clip securable to the other of the fitting and the receiving funnel.

[0100] Embodiment 11. An inserter assembly as described in embodiment 10, wherein the fitting extends distally from the distal paddle end and comprises two clips securable to the inner funnel lip.

[0101] Embodiment 12. An inserter assembly described in any one of embodiments 8 to 11, wherein the fitting defines a peripheral ridge and the receiving funnel defines a peripheral channel dimensioned for mating engagement with the peripheral ridge.

[0102] Embodiment 13. An inserter assembly described in any one of embodiments 8 to 12, wherein the attachment is configured to generate audible and / or tactile feedback during engagement with the receiving funnel.

[0103] Embodiment 14. An inserter assembly according to any one of embodiments 1 to 13, wherein the receiving funnel is overmolded around the proximal catheter end.

[0104] Embodiment 15. An inserter assembly according to any one of embodiments 1 to 14, wherein the receiving funnel is integral with the delivery catheter at the proximal catheter end.

[0105] Embodiment 16. An inserter assembly according to any one of embodiments 1 to 15, wherein the receiving funnel has one or both of an elliptical outer shape and an elliptical perimeter.

[0106] Embodiment 17. An inserter assembly described in any one of embodiments 1 to 16, wherein the receiving funnel extends asymmetrically in a direction transverse to the stylet body.

[0107] Embodiment 18. An inserter assembly as described in any one of embodiments 1 to 17, wherein the receiving funnel defines a funnel lumen configured to transport a lubricant from the receiving funnel to the lumen of the delivery catheter.

[0108] Embodiment 19. The inserter assembly of embodiment 18, wherein the receiving funnel is dimensioned to receive at least 1 mL of lubricant.

[0109] Embodiment 20. The inserter assembly of embodiment 18 or 19, wherein the receiving funnel is shaped to facilitate transfer of the lubricant from the bag into the lumen of the delivery catheter.

[0110] Embodiment 21. An inserter assembly described in any one of embodiments 1 to 20, wherein the stylet body has a solid cross-section throughout the stylet body.

[0111] Embodiment 22. An inserter assembly described in any one of embodiments 1 to 21, wherein the placement catheter is transparent or translucent for visually determining the position of the intravesical device or stylet within the lumen.

[0112] Embodiment 23. An inserter assembly described in any one of embodiments 1 to 22, wherein the distal catheter end of the deployment catheter comprises a rounded, atraumatic tip.

[0113] Embodiment 24. An inserter assembly described in any one of embodiments 1 to 23, wherein the distal catheter end of the delivery catheter comprises a dogleg bend.

[0114] Embodiment 25. An inserter assembly as described in embodiment 24, wherein the dogleg bend is aligned with the long axis of the retrieval funnel such that the orientation of the retrieval funnel dictates the orientation of the dogleg bend.

[0115] Embodiment 26. An inserter assembly described in any one of embodiments 1 to 25, wherein the placement catheter includes depth markings indicating the insertion depth and the orientation of the exit opening.

[0116] Embodiment 27. An inserter assembly described in any one of embodiments 1 to 26, wherein the delivery catheter has a length of 10 cm to 40 cm.

[0117] Embodiment 28. An introducer assembly described in any one of embodiments 1 to 27, wherein the placement catheter has an outer diameter of 5 Fr (1.67 mm outer diameter) to 30 Fr (10 mm outer diameter).

[0118] Embodiment 29. An inserter assembly described in any one of embodiments 1 to 28, wherein one or both of the delivery catheter and the stylet include a radio marker.

[0119] Embodiment 30. An inserter assembly described in any one of embodiments 1 to 29, wherein one or more of the placement catheter, paddle, receiving funnel, and stylet are formed from the same or different polymeric materials.

[0120] Embodiment 31. An inserter assembly described in any one of embodiments 1 to 30, further comprising an intravesical device loaded within the lumen of the delivery catheter.

[0121] Embodiment 32. An inserter assembly as described in any one of embodiments 1 to 31, wherein the paddle comprises a central body portion surrounding the proximal stylet end, a thumb rest defined at the proximal paddle end, and a pair of wing portions extending laterally from the central body portion between the thumb rest and the distal paddle end.

[0122] Embodiment 33. An inserter assembly as described in embodiment 32, wherein the thumb rest has a concave surface facing away from the central body, an elliptical outer edge, or both a concave surface facing away from the central body and an elliptical outer edge.

[0123] Embodiment 34. An inserter assembly as described in embodiment 32 or 33, wherein each of the wing portions has a taper leading to the distal paddle end.

[0124] Embodiment 35. An inserter assembly as described in embodiment 34, wherein the paddle further comprises a curved finger rest adjacent each taper.

[0125] Embodiment 36. An inserter assembly described in any one of embodiments 32 to 35, wherein the paddle is overmolded around the stylet body at the proximal stylet end.

[0126] Embodiment 37. An inserter assembly described in any one of embodiments 32 to 35, wherein the paddle is integral with the stylet body.

[0127] Embodiment 38. An inserter assembly for disposing an intravesical device within a patient's bladder, the inserter assembly comprising: a placement catheter defining a lumen extending from a proximal catheter end to an exit opening; a stylet removably received through the lumen of the placement catheter, the stylet having a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body being dimensioned to guide the intravesical device through the lumen and into the bladder, and a paddle attached to the stylet body about the proximal stylet end, the paddle comprising a central body portion surrounding the proximal stylet end, a thumb rest defined at the proximal paddle end, and a pair of wing portions extending laterally from the central body between the thumb rest and the distal paddle end.

[0128] Embodiment 39. An inserter assembly as described in embodiment 38, wherein the thumb rest has a concave surface facing away from the central body, an elliptical outer edge, or both a concave surface facing away from the central body and an elliptical outer edge.

[0129] Embodiment 40. An inserter assembly as described in embodiment 38 or 39, wherein each of the wing portions has a taper leading to the distal paddle end.

[0130] Embodiment 41. An inserter assembly as described in embodiment 40, wherein the paddle further comprises a curved finger rest adjacent each taper.

[0131] Embodiment 42. An inserter assembly described in any one of embodiments 38 to 41, wherein the paddle is overmolded around the stylet body at the proximal stylet end.

[0132] Embodiment 43. An inserter assembly described in any one of embodiments 38 to 41, wherein the paddle is integral with the stylet body.

[0133] Embodiment 44. An inserter assembly described in any one of embodiments 38 to 43, further comprising a receiving funnel secured to the placement catheter at the proximal catheter end, the stylet being removably received through the receiving funnel.

[0134] Embodiment 45. A method for placing an intravesical device in a patient's bladder using an inserter assembly including a placement catheter and a stylet, the method comprising: (i) introducing the intravesical device into a lumen of the placement catheter through a receiving funnel of the inserter assembly, wherein an exit opening of the placement body is within the interior volume of the bladder; (ii) introducing a distal stylet end of the stylet through the receiving funnel into the lumen of the placement catheter to contact the intravesical device within the lumen; and (iii) advancing the stylet distally through the receiving funnel to guide the intravesical device along the lumen toward the exit opening and releasing the intravesical device into the bladder through the exit opening.

[0135] Embodiment 46 The method of embodiment 45, further comprising stopping distal advancement when the paddle of the stylet engages the receiving funnel.

[0136] Embodiment 47. The method of embodiment 45, further comprising ceasing distal advancement when the fitting of the stylet engages the receiving funnel.

[0137] Embodiment 48. The method of embodiment 47, wherein the attachment is part of the paddle of the stylet.

[0138] Embodiment 49. The method of any one of embodiments 46 to 48, wherein the stopping includes a locking engagement between the stylet and the receiving funnel.

[0139] Embodiment 50. The method of any one of embodiments 45-49, further comprising transurethrally advancing a distal portion of the placement catheter into the bladder prior to introducing the intravesical device into the lumen.

[0140] Embodiment 51. The method of any one of embodiments 45 to 50, further comprising withdrawing the placement catheter from the bladder.

[0141] Embodiment 52. The method of embodiment 51, wherein the stylet remains within the lumen of the placement catheter during withdrawal of the placement catheter from the bladder.

[0142] Embodiment 53. A kit of parts comprising: (i) an inserter assembly as described in any one of embodiments 1 to 44; and (ii) an intravesical device suitable for introduction into a patient's bladder using the inserter assembly.

[0143] Modifications and variations of the methods and devices described herein will be apparent to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to fall within the scope of the appended claims.

Claims

1. 1. An inserter assembly for placing an intravesical device within a patient's bladder, said inserter assembly comprising: a delivery catheter defining a lumen, the lumen extending from a proximal catheter end to an exit opening; a receiving funnel secured to the delivery catheter at the proximal catheter end; a stylet removably received within the lumen of the delivery catheter through the receiving funnel, the stylet comprising: (i) a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body being dimensioned to guide the intravesical device through the lumen and the exit opening into the bladder; and (ii) a paddle attached to the stylet body around the proximal stylet end, the paddle being engageable with the receiving funnel; An inserter assembly comprising:

2. The inserter assembly of claim 1 , wherein the paddle is overmolded around or integral with the stylet body at the proximal stylet end.

3. 10. The inserter assembly of claim 1, wherein the paddle defines a curved thumb rest at a proximal end, and optionally further defines a curved finger rest opposite the curved thumb rest.

4. The inserter assembly of claim 1 , wherein the paddle comprises a gripping surface.

5. The inserter assembly of claim 1 , wherein the paddle is sized to be received within the receiving funnel.

6. The inserter assembly of claim 1 , wherein the paddle includes a fitting lockably engageable with the receiving funnel to removably secure the stylet to the delivery catheter.

7. The inserter assembly of claim 6 , wherein the fitting is engagable with an inner surface of the receiving funnel.

8. The inserter assembly of claim 6 , wherein one or both of the fitting and the receiving funnel comprises at least one clip securable to the other of the fitting and the receiving funnel.

9. The inserter assembly of claim 6 , wherein the fitting defines a peripheral ridge and the receiving funnel defines a peripheral channel dimensioned for mating engagement with the peripheral ridge.

10. The inserter assembly of claim 6 , wherein the fitting is configured to provide audible and / or tactile feedback during engagement with the receiving funnel.

11. The inserter assembly of claim 1 , wherein the receiving funnel is overmolded around the proximal catheter end or is integral with the delivery catheter at the proximal catheter end.

12. The inserter assembly of claim 1 , wherein the receiving funnel has one or both of an oval outer shape and an oval perimeter.

13. The inserter assembly of claim 1 , wherein the receiving funnel extends asymmetrically across the stylet body.

14. 10. The inserter assembly of claim 1, wherein the receiving funnel defines a funnel lumen configured to transfer lubricant from the receiving funnel to the lumen of the delivery catheter, and optionally, the receiving funnel is sized to receive at least 1 mL of the lubricant.

15. 15. The introducer assembly of claim 14, wherein the receiving funnel is shaped to facilitate transfer of the lubricant from a pouch into the lumen of the delivery catheter.

16. The inserter assembly of claim 1 , wherein the stylet body has a solid cross section throughout the stylet body.

17. The inserter assembly of claim 1 , wherein the delivery catheter is transparent or translucent for visually determining the position of the intravesical device or the stylet within the lumen.

18. 2. The inserter assembly of claim 1, wherein the distal catheter end of the deployment catheter comprises (i) a rounded, atraumatic tip, and / or (ii) a dogleg bend, optionally aligned with a longitudinal axis of the retrieval funnel such that the orientation of the retrieval funnel indicates the orientation of the dogleg bend.

19. The introducer assembly of claim 1 , wherein the delivery catheter includes depth markings indicating insertion depth and exit opening orientation.

20. 10. The introducer assembly of claim 1, wherein the delivery catheter has (i) a length of between 10 cm and 40 cm, and / or (ii) an outer diameter of between 5 Fr (1.67 mm outer diameter) and 30 Fr (10 mm outer diameter).

21. The introducer assembly of claim 1 , wherein one or both of the delivery catheter and the stylet include a radiomarker.

22. The introducer assembly of claim 1 , wherein one or more of the delivery catheter, the paddle, the receiving funnel, and the stylet are formed from the same or different polymeric materials.

23. The paddle is a central body portion surrounding the proximal stylet end; a thumb rest defined on the proximal paddle end; a pair of wing portions extending laterally from the central body portion between the thumb rest and the distal paddle end; The inserter assembly of claim 1 , comprising:

24. 24. The inserter assembly of claim 23, wherein the thumb rest has a concave surface facing away from the central body, an oval outer edge, or both a concave surface facing away from the central body and an oval outer edge.

25. A kit of parts, comprising: An inserter assembly according to any one of claims 1 to 24; an intravesical device suitable for introduction into a patient's bladder using said inserter assembly; A kit of parts comprising:

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