Patent Description:
Benign prostatic hyperplasia (BPH) affects a large majority of older men, and traditional solutions to address the condition are not without significant issues. It is estimated that over <NUM>% of men in their <NUM> have BPH, over <NUM>% of men in their <NUM> have the condition, and approximately <NUM>% of men over the age of <NUM> have it. BPH is a non-cancerous enlargement of the prostate gland that causes an increasing stricture of the urethra as the prostate grows, resulting in lower urinary tract symptoms (LUTS) such as frequent urination, urge incontinence, increased frequency of urination at night, and a weak stream with difficulty starting urination - symptoms that are familiar to older men and their loved ones. If left untreated, BPH can worsen over time and cause permanent kidney and bladder damage.

Currently, LUTS due to BPH often are managed medically with alpha-1a-adrenergic receptors blockers and <NUM>-alpha-reductase inhibitors (SARI). These medications cause the prostate tissue to be less contractile and shrink in size, respectively, thus attempting to reduce LUTS. While easy to administer, these drugs are not without complications that can lead to patient dropout. They can take up to six months for initial relief, and the majority of patients do not experience a clinically significant improvement in symptoms. More importantly, side effects of these medications can include headaches, dizziness, nasal congestion, and ejaculatory and erectile disfunction, leading to patient nonadherence.

On the other end of the treatment spectrum, the alternatives to drugs are surgical options to completely excise the prostatic tissue that is impinging on the urethra. Surgical BPH procedures are lengthy and performed in an operating-room setting, with general or extensive spinal anesthesia required. The gold-standard treatment for BPH is transurethral resection of the prostate (TURP), an invasive procedure in which prostate tissue is removed through the urethra using an electrocautery tool. Other surgical options involve ablation of prostate tissue by microwave, laser, or heat energy. For all of these procedures, several weeks of recovery are required, and it can take up to six months for patients to experience symptom relief. Morbidities such as temporary difficulty urinating, prolonged heavy bleeding, pain, and permanent sexual side-effects can occur post-procedure and affect patient satisfaction with their treatment choice.

In between medical management and surgical tissue removal are minimally-invasive options that mechanically displace the impinging prostate tissue and open the urethra. Vascular stent-like devices have been tried, but implant migration and excessive tissue ingrowth have proved problematic and limited interest in these approaches. Other configurations of minimally-invasive devices for displacing prostate tissue have been explored. Currently, only one such device is commercially available to patients, but it has important limitations. For example, removability of the device post-deployment is challenging. Additionally, the device lacks a means for achieving a desired degree of tissue retraction to meet a patient's specific needs.

A need therefore exists for improved implantable devices and methods for retracting prostatic tissue of a patient, which may overcome one or more of the above-mentioned problems associated with existing devices and their use.

<CIT> disclose a method for providing a synthetic barrier made of biocompatible polymeric materials in vivo. <CIT> discloses a catheter device for control of liquid discharge from the urinary bladder. <CIT> discloses devices, systems and methods for compressing, cutting or altering the composition of tissues or anatomical structures. <CIT> discloses an anchor that secures to a connector as part of an anchor assembly.

According to the present invention, there is provided an implantable device for retracting prostatic tissue of a patient, the implantable device comprising:.

In some embodiments, the proximal balloon may be positioned at the proximal end of the shaft, and the distal balloon may be positioned at the distal end of the shaft. In some embodiments, the intermediate balloon may be positioned closer to the distal balloon than the proximal balloon. In some embodiments, the shaft further may include a second lumen in fluid communication with the reservoir of the intermediate balloon and in fluid isolation from the reservoir of the proximal balloon and the reservoir of the distal balloon. In some embodiments, the shaft may have a first diameter in a direction perpendicular to the longitudinal axis, the proximal balloon may be configured to expand to an expanded configuration in which the proximal balloon has a second diameter in the direction perpendicular to the longitudinal axis, and the second diameter may be greater than the first diameter. In some embodiments, the proximal balloon may have a length in the direction of the longitudinal axis when the proximal balloon is in the expanded configuration, and the second diameter may be greater than the length. In some embodiments, the shaft may have a first diameter in a direction perpendicular to the longitudinal axis, the distal balloon may be configured to expand to an expanded configuration in which the distal balloon has a second diameter in the direction perpendicular to the longitudinal axis, and the second diameter may be greater than the first diameter. In some embodiments, the distal balloon may have a length in the direction of the longitudinal axis when the distal balloon is in the expanded configuration, and the second diameter may be greater than the length. In some embodiments, the shaft may have a first diameter in a direction perpendicular to the longitudinal axis, the intermediate balloon may be configured to expand to an expanded configuration in which the intermediate balloon has a second diameter in the direction perpendicular to the longitudinal axis, and the second diameter may be greater than the first diameter. In some embodiments, the intermediate balloon may have a length in the direction of the longitudinal axis when the intermediate balloon is in the expanded configuration, and the second diameter may be less than the length.

These and other aspects and improvements of the present disclosure will become apparent to one of ordinary skill in the art upon review of the following detailed description when taken in conjunction with the several drawings and the appended claims.

The detailed description is set forth with reference to the accompanying drawings. The drawings are provided for purposes of illustration only and merely depict example embodiments of the disclosure. The drawings are provided to facilitate understanding of the disclosure and shall not be deemed to limit the breadth, scope, or applicability of the disclosure. The use of the same reference numerals indicates similar, but not necessarily the same or identical components. Different reference numerals may be used to identify similar components. Various embodiments may utilize elements or components other than those illustrated in the drawings, and some elements and/or components may not be present in various embodiments. The use of singular terminology to describe a component or element may, depending on the context, encompass a plural number of such components or elements and vice versa.

In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, and components have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

As discussed above, BPH is a non-cancerous enlargement of the prostate gland that causes an increasing stricture of the urethra as the prostate grows. <FIG> illustrate the prostate P and the urethra U of a patient having normal anatomy. In contrast, <FIG> illustrate the prostate P and the urethra U of a patient having BPH. As shown, BPH involves a narrowing of the urethra, which may result in LUTS such as frequent urination, urge incontinence, increased frequency of urination at night, and a weak stream with difficulty starting urination. Embodiments of implantable devices and methods for retracting prostatic tissue of a patient are provided herein. The implantable devices may be implanted in an outpatient setting, without the need for general anesthesia or an overnight hospital stay, and may provide rapid, effective, and durable relief from LUTS caused by BPH. Specifically, the implantable devices may be implanted in a minimally-invasive manner.

According to various embodiments described herein, the implantable devices may address one or more of the above-mentioned problems associated with existing devices and their use. For example, some embodiments of the implantable devices may be easily removable post-deployment, if needed. In some embodiments, the implantable devices may be capable of adjusting or dialing-in an appropriate level of tissue retraction to meet a patient's specific needs. In some embodiments, the implantable devices may be MR safe and may reduce the overall procedure time for implantation. In some embodiments, the implantable devices may be implanted with a reloadable delivery system that allows multiple implantable devices to be easily deployed during a procedure, thereby improving user experience and making the system more cost-effective.

As compared to existing devices for addressing LUTS caused by BPH, the implantable devices described herein may improve the ease, effectiveness, and economics of using the devices, making the devices more suitable for both developed and emerging economies, and potentially improving the clinical effect and durability of the therapy. Additionally, the tissue-sparing and removable attributes of the implantable devices would not preclude their use in patients that may continue with medical management or elect to have additional minimally-invasive or surgical BPH therapies at a later time. Ultimately, the implantable devices may provide faster, sustained relief of LUTS without the side-effects of drugs or surgical options. Still other benefits and advantages of the implantable devices provided herein over conventional devices and techniques will be appreciated by those of ordinary skill in the art from the following description and the appended drawings.

In some embodiments, an implantable device may be provided as a pre-assembled (i.e., not assembled in situ) balloon device for treatment of LUTS caused by BPH. The device may be positioned in the prostate as a complete, unexpanded system. Balloons of the device then may be filled with a fluid (e.g., gas or liquid) to expand the balloons for the purpose of: (i) securing the device in place, and/or (ii) retracting the prostatic tissue that is obscuring the urethra to improve urine flow. In some embodiments, the device may include a proximal balloon that is configured to reside in the urethra, a distal balloon that is configured to reside outside of the prostatic capsule, and an intermediate balloon that is configured to reside between the distal balloon and the proximal balloon. Various configurations, shapes, and biocompatible materials may be used for constructing the device. Example materials may include nitinol, PEEK, Pebax, stainless steel, and PTFE, although other biocompatible materials may be used. A tubular shaft and at least one fluid lumen may connect the balloons. After filling the balloons, the lumen(s) may be sealed by an elastomeric material or a mechanical crimp.

During implantation, an obturator or cannula may be used to create a channel in the prostate from the urethra to the prostatic capsule through which the device would be inserted and positioned in the unexpanded state. The obturator or cannula may be provided as a component of a device delivery system. The proximal balloon may be designed such that, when inflated, its diameter is large enough to prevent the balloon from entering the channel in the prostate, but such that the overall length or profile of the balloon is minimized to reduce any obstruction of the urethra lumen as much as possible. The intermediate balloon likewise may have a diameter that prevents it from entering the prostatic channel and may have a configuration and height such that, when filled, it expands lengthwise in the area between the prostatic capsule and the distal balloon, thus pulling the proximal balloon radially outward and retracting the prostate tissue. The distal balloon may be designed such that it minimizes any interaction with the tissue surrounding the prostate and is large and sturdy enough to interact properly with the intermediate balloon. The implantable device may be placed using a vascular interventional-style delivery system under visualization with a cystoscope. In some embodiments, the implantable device may be delivered through the working channel of the sheath used for the cystoscope. Alternatively, a specifically designed scope/sheath/delivery system may be used to deploy the device. In some embodiments, such a delivery system may have a scope channel built into it so that implantation could be visualized. With any delivery system, the scope and sheath may be advanced to the area of the prostatic urethra where the device is to be implanted to retract tissue. The obturator or cannula then may be advanced out of the tip of the delivery device and into the prostate, creating the channel in the prostate from the urethra to the prostate capsule into which the device is inserted. According to various embodiments, the balloon-style implantable device advantageously may provide the ability to adjust the expanded device to a patient's anatomy to create optimal tissue retraction, ease of implant removal post implantation, low metal content and MR safety attributes, and/or reloadability of the delivery system in situ (i.e., a new delivery system does not need to be placed for each implantable device in the case where multiple devices are to be implanted).

In some embodiments, an implantable device may be provided as a splint-like implant that spans the lumen of the urethra and compresses the prostate tissue to open the urethra lumen for treatment of LUTS secondary to BPH. The implantable device may include a slightly curved metal or polymer rod or shaft that is configured to extend from one side of the prostate, across the urethra lumen, and into the other side of the prostate tissue. A degree of the curvature may be optimized to limit occlusion of the urethra lumen and retraction of the prostate tissue. In some embodiments, the device may not extend outside of the prostatic capsule on either end. In other embodiments, the device may be configured to extend to or through the prostatic capsule and interact with the capsule using a balloon or other feature in order to secure the device in place on at least one side, as may be desired. To achieve the tissue retraction and open the urethra, the implantable device may include a pair of movable, locking tabs that are configured to interact with mating features of the rod. The locking tabs may be configured to be slid outward toward the respective ends of the rod until they achieve contact with the urethral lumen tissue and are adjusted to positions where the desired tissue retraction is achieved. The locking tabs may be capable of sliding only in the outward direction, as the mating features of the rod may inhibit movement of the locking tabs in the inward direction.

During implantation of such a locking-tab-style implantable device, a delivery system may be used to deploy the device as a complete, pre-assembled device. The two ends of the implant may be guided into the prostate tissue, and then the locking tabs may be slid into place along the rod, interacting with the mating features of the rod to keep the tabs in contact with the tissue and create the compressive forces to keep the urethra lumen open. For embodiments including a capsular balloon, the balloon may be filled with a fluid after the rod is placed into the prostate tissue. According to various embodiments, the locking-tab-style implantable device advantageously may provide the ability to adjust the expanded device to a patient's anatomy to create optimal tissue retraction at the time of initial implantation as well as at later revision procedures as desired. Additionally, the locking-tab-style implantable device may be particularly well suited for treating a prostate with an enlarged medial lobe, whereas current implantable devices are more suited to treating enlarged lateral lobes.

Further details, functionality, and advantages of various embodiments of implantable devices, such as balloon-style implantable devices, locking-tab-style implantable devices, movable-barb-style implantable devices, hydraulic-style implantable devices, deformable-style implantable devices, and jack-style implantable devices, and methods of implanting the same will be appreciated from the example devices depicted in the drawings and described below.

Referring now to <FIG>, an example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") is depicted. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some embodiments, the device <NUM> may be implanted in a minimally-invasive manner. An example placement of the implantable device <NUM> is depicted in <FIG>. In some embodiments, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a shaft <NUM> and a plurality of balloons. For example, the device <NUM> may include a proximal balloon <NUM>, a distal balloon <NUM>, and an intermediate balloon <NUM>, as shown in <FIG>. The shaft <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the shaft <NUM>. In some embodiments, the shaft <NUM> may be formed of a flexible material and at least a portion of the shaft <NUM> may be configured to be elastically deformed from a natural undeformed configuration to a deformed configuration. Example materials may include nitinol, PEEK, Pebax, stainless steel, and PTFE, although other biocompatible materials may be used. In some embodiments, the shaft <NUM> may have a linear shape when the shaft <NUM> is in the natural undeformed configuration. In some embodiments, the shaft <NUM> may have a curved or otherwise contoured shape when the shaft <NUM> is in the natural undeformed configuration. As shown, the shaft <NUM> may be configured to extend through prostatic tissue PT of the patient.

The proximal balloon <NUM> may be fixedly attached to the shaft <NUM> and positioned closer to the proximal end <NUM> than the distal end <NUM>. In some embodiments, the proximal balloon <NUM> may be positioned at the proximal end <NUM> of the shaft <NUM>. The proximal balloon <NUM> may be configured to reside within the prostatic urethra U of the patient. In some embodiments, as shown, the proximal balloon <NUM> may be configured to contact the wall of the prostatic urethra U when the device <NUM> is in an implanted state. The proximal balloon <NUM> may be expandable from an unexpanded configuration to an expanded configuration, for example, by filling a reservoir of the proximal balloon <NUM> with a fluid.

The distal balloon <NUM> may be fixedly attached to the shaft <NUM> and positioned closer to the distal end <NUM> than the proximal end <NUM>. In some embodiments, the distal balloon <NUM> may be positioned at the distal end <NUM> of the shaft <NUM>. The distal balloon <NUM> may be configured to reside outside of the prostatic capsule PC of the patient. The distal balloon <NUM> may be expandable from an unexpanded configuration to an expanded configuration, for example, by filling a reservoir of the distal balloon <NUM> with a fluid.

The intermediate balloon <NUM> may be fixedly attached to the shaft and positioned between the proximal balloon <NUM> and the distal balloon <NUM>. In some embodiments, as shown, the intermediate balloon <NUM> may be positioned closer to the distal balloon <NUM> than the proximal balloon <NUM>. In some embodiments, the intermediate balloon <NUM> may be positioned adjacent to the distal balloon <NUM>. The intermediate balloon <NUM> may be configured to reside outside of the prostatic capsule PC of the patient. In some embodiments, as shown, the intermediate balloon <NUM> may be configured to contact the prostatic capsule PC when the device <NUM> is in an implanted state. The intermediate balloon <NUM> may be expandable from an unexpanded configuration to an expanded configuration, for example, by filling a reservoir of the intermediate balloon <NUM> with a fluid.

The shaft <NUM> may include a plurality of lumens configured to facilitate expansion of the balloons <NUM>, <NUM>, <NUM>. In some embodiments, the shaft <NUM> may include a first lumen <NUM> and a second lumen <NUM>. The first lumen <NUM> may be in fluid communication with the reservoir of the proximal balloon <NUM> and the reservoir of the distal balloon <NUM> and in fluid isolation from the reservoir of the intermediate balloon <NUM>. In this manner, the proximal balloon <NUM> and the distal balloon <NUM> may be expanded simultaneously while the configuration of the intermediate balloon <NUM> is unchanged. The second lumen <NUM> may be in fluid communication with the reservoir of the intermediate balloon <NUM> and in fluid isolation from the reservoir of the proximal balloon <NUM> and the reservoir of the distal balloon <NUM>. In this manner, the intermediate balloon <NUM> may be expanded while the configurations of the proximal balloon <NUM> and the distal balloon <NUM> are unchanged.

The shaft <NUM> may have an outer diameter in a direction perpendicular to the longitudinal axis of the shaft <NUM>. In some embodiments, the diameter of the shaft <NUM> may be constant along the length thereof. When in its expanded configuration, the proximal balloon <NUM> may have an outer diameter (in the direction perpendicular to the longitudinal axis) that is greater than the diameter of the shaft <NUM>. In this manner, after insertion of the shaft <NUM> through a channel formed in prostatic tissue PT, the proximal balloon <NUM> may be expanded to inhibit the balloon <NUM> from entering the channel, thereby securing placement of the device <NUM>. In some embodiments, the proximal balloon <NUM> may have a length in the direction of the longitudinal axis when the proximal balloon <NUM> is in the expanded configuration, and the diameter of the balloon <NUM> may be greater than the length. In this manner, the obstruction of the urethra lumen by the proximal balloon <NUM> may be minimized. Similarly, when in its expanded configuration, the distal balloon <NUM> may have an outer diameter (in the direction perpendicular to the longitudinal axis) that is greater than the diameter of the shaft <NUM>. In this manner, after insertion of the shaft <NUM> through the channel, the distal balloon <NUM> may be expanded to inhibit the balloon <NUM> from entering the channel, thereby securing placement of the device <NUM>. In some embodiments, the distal balloon <NUM> may have a length in the direction of the longitudinal axis when the distal balloon <NUM> is in the expanded configuration, and the diameter of the balloon <NUM> may be greater than the length. In this manner, the interaction between the distal balloon <NUM> and tissue surrounding the prostate P may be minimized.

When in its expanded configuration, the intermediate balloon <NUM> may have an outer diameter (in the direction perpendicular to the longitudinal axis) that is greater than the diameter of the shaft <NUM>. In this manner, the expanded configuration of the intermediate balloon <NUM> also may inhibit the balloon <NUM> form entering the channel. In some embodiments, the intermediate balloon <NUM> may have a length in the direction of the longitudinal axis when the intermediate balloon <NUM> is in the expanded configuration, and the diameter of the balloon <NUM> may be less than the length. As discussed further below, expansion of the intermediate balloon <NUM> may cause retraction of the prostatic tissue PT disposed between the intermediate balloon <NUM> and the proximal balloon <NUM>. In some embodiments, a degree of expansion of the intermediate balloon <NUM> may correspond to a degree of retraction of the prostatic tissue PT. In other words, greater expansion of the intermediate balloon <NUM> may be used to provide greater retraction of the prostatic tissue PT. In this manner, by selectively expanding the intermediate balloon <NUM>, the degree of retraction of the prostatic tissue PT may be adjusted to suit the anatomy of a particular patient.

After the balloons <NUM>, <NUM>, <NUM> are expanded, the lumens <NUM>, <NUM> of the device <NUM> may be sealed such that the balloons <NUM>, <NUM>, <NUM> are maintained in their respective expanded configurations. In some embodiments, the device <NUM> may include one or more self-sealing ports <NUM> for sealing the respective ends of the lumens <NUM>, <NUM>, as shown in <FIG>. The self-sealing ports <NUM> may be provided at or near the proximal end <NUM> of the device <NUM>. In some embodiments, a first self-sealing port <NUM> may be provided for the first lumen <NUM>, and a second self-sealing port <NUM> may be provided for the second lumen <NUM>. Each self-sealing port <NUM> may include an elastomeric member that is configured to be moved between an open configuration for filling the balloons <NUM>, <NUM>, <NUM> via the respective lumens <NUM>, <NUM> and a closed configuration for sealing the lumens <NUM>, <NUM> to maintain the balloons <NUM>, <NUM>, <NUM> in their expanded configurations. For example, the elastomeric members may be formed as one-way valves. In other embodiments, the lumens <NUM>, <NUM> of the device <NUM> may be sealed by a mechanical crimp <NUM>, as shown in <FIG>, such that the balloons <NUM>, <NUM>, <NUM> are maintained in their respective expanded configurations. Various other means for sealing the lumens <NUM>, <NUM> of the device <NUM> and maintaining the balloons <NUM>, <NUM>, <NUM> in their expanded configurations may be used in other embodiments. In some embodiments, the proximal balloon <NUM> may be omitted, and securement of the device <NUM> at its proximal end may be provided by a flange, tab or similar structure, or the self-sealing ports <NUM> that are used for expanding the balloons <NUM>, <NUM>.

<FIG> illustrate example methods of implanting the implantable device <NUM> to retract prostatic tissue PT of a patient. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. As shown in <FIG>, a sheath <NUM> may be inserted through the urethra U of the patient and positioned about the prostate P. The implantable device <NUM> may be passed through the sheath <NUM>, via a working lumen <NUM> of the sheath <NUM>, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen <NUM> of the sheath <NUM>. In some embodiments, an obturator or cannula <NUM> may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other embodiments, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. The device <NUM> may be positioned such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC, as shown in <FIG>. In some embodiments, as shown, the shaft <NUM> may be positioned within the prostatic tissue PT, the proximal balloon <NUM> may be positioned within the prostatic urethra U, and the distal balloon <NUM> and the intermediate balloon <NUM> may be positioned outside of the prostatic capsule PC. The distal balloon <NUM> and the intermediate balloon <NUM> may be passed through the prostatic tissue PT while the distal balloon <NUM> is in its collapsed configuration and the intermediate balloon <NUM> is in its collapsed configuration. The proximal balloon <NUM> also may be in its collapsed configuration while the device <NUM> is passed through the prostatic tissue PT. In some embodiments, the device <NUM> may be positioned within the cannula <NUM> such that the device <NUM> is passed through the prostatic tissue PT while the cannula <NUM> forms the channel, and then the cannula <NUM> may be retracted such that the device <NUM> is deployed in the prostatic tissue PT. In some embodiments, the obturator or cannula <NUM> may not be used to form the channel, and the device <NUM> may be passed directly into the prostatic tissue PT and positioned in the prostate P. After positioning the device <NUM>, the proximal balloon <NUM> and the distal balloon <NUM> may be expanded, as shown in <FIG>. As described above, expansion of the proximal balloon <NUM> and the distal balloon <NUM> may secure the device <NUM> relative to the prostatic tissue PT. As shown, the proximal balloon <NUM> and the distal balloon <NUM> may be expanded while the intermediate balloon <NUM> is maintained in its collapsed configuration. In some embodiments, the proximal balloon <NUM> and the distal balloon <NUM> may be expanded simultaneously, for example, via a common lumen. After expansion of the proximal balloon <NUM> and the distal balloon <NUM>, the intermediate balloon <NUM> may be expanded, as shown in <FIG>. <FIG> shows the device <NUM> in an implanted state, after removal of the delivery system. As shown, the expansion of the intermediate balloon <NUM> may cause the prostatic tissue PT to be compressed between the proximal balloon <NUM> and the intermediate balloon <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. In some embodiments, a single device <NUM> may be used. In other embodiments, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

<FIG> illustrates another example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") having a balloon-style configuration. The implantable device <NUM> generally may be configured in a manner similar to the implantable device <NUM> described above. In <FIG>, corresponding features are identified using corresponding reference numbers. As shown, the device <NUM> may include a shaft <NUM> having a proximal end <NUM> and a distal end <NUM>, a self-sealing port <NUM>, a proximal balloon <NUM>, and a distal balloon <NUM>. As compared to the device <NUM>, the device <NUM> may not include an intermediate balloon. Instead, the distal balloon <NUM> may perform the functions of both initially securing the device <NUM> relative to the prostatic tissue PT and retracting the prostatic tissue PT. The distal balloon <NUM> may be configured to expand radially and longitudinally with respect to the shaft <NUM>. In some examples, the distal balloon <NUM> may be configured to expand radially and then to expand longitudinally. In this manner, radial expansion of the distal balloon <NUM> may inhibit the balloon <NUM> from entering the channel formed in the prostatic tissue PT, thereby securing the device <NUM>, while longitudinal expansion of the distal balloon <NUM> may cause the prostatic tissue PT disposed between the proximal balloon <NUM> and the distal balloon <NUM> to be compressed. In some examples, the device <NUM> may include a first lumen <NUM> that is in fluid communication with the reservoir of the proximal balloon <NUM> and in fluid isolation from the reservoir of the distal balloon <NUM>, and a second lumen <NUM> that is in fluid communication with the reservoir of the distal balloon <NUM> and in fluid isolation from the reservoir of the proximal balloon <NUM>. In this manner, the balloons <NUM>, <NUM> may be separately expanded, and a degree of expansion of the distal balloon <NUM> may be adjusted to accommodate the anatomy of a particular patient. In some examples, the proximal balloon <NUM> may be omitted, and securement of the device <NUM> at its proximal end may be provided by a flange, tab or similar structure, or the self-sealing port <NUM> that is used for expanding the distal balloon <NUM>.

The implantable device <NUM> may be implanted using a method similar to that described above with respect to the implantable device <NUM>. For example, an obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, and the device <NUM> may be passed through the channel such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC. The shaft <NUM> may be positioned within the channel, the proximal balloon <NUM> may be positioned within the prostatic urethra U, and the distal balloon <NUM> may be positioned outside of the prostatic capsule PC. In some examples, the obturator or cannula may not be used, and the device <NUM> may be passed directly into the prostatic tissue PT and positioned. After positioning of the device <NUM>, the proximal balloon <NUM> may be expanded to inhibit distal movement of the device <NUM> relative to the prostatic tissue PT. Then, the distal balloon <NUM> may be expanded to secure the device <NUM> relative to the prostatic tissue PT and to cause the prostatic tissue PT to be compressed between the proximal balloon <NUM> and the distal balloon <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

Referring now to <FIG>, an example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") is depicted. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. An example placement of the implantable device <NUM> is depicted in <FIG>. In some examples, multiple devices <NUM> may be used for a single patient, as shown in <FIG>.

The implantable device <NUM> generally may include a shaft <NUM> and a plurality of locking tabs. For example, the device <NUM> may include a first locking tab <NUM> that is movably attached to the shaft <NUM> and a second locking tab <NUM> that is movably attached to the shaft <NUM>. The shaft <NUM> may have a first end <NUM> and a second end <NUM> disposed opposite one another in a direction of a longitudinal axis of the shaft <NUM>. In some examples, the shaft <NUM> may be formed of a flexible material and at least a portion of the shaft <NUM> may be configured to be elastically deformed from a natural undeformed configuration to a deformed configuration. Example materials may include nitinol, PEEK, Pebax, stainless steel, and PTFE, although other biocompatible materials may be used. In some examples, the shaft <NUM> may have a curved shape when the shaft <NUM> is in the natural undeformed configuration. In other examples, the shaft <NUM> may have an otherwise contoured shape or may have a linear shape when the shaft <NUM> is in the natural undeformed configuration. In some examples, shaft <NUM> may have a circular cross-sectional shape. In other examples, shaft <NUM> may have a non-circular cross-sectional shape (e.g., triangular, hexagonal, flat).

As shown, the shaft <NUM> may include a central portion <NUM> positioned between the first end <NUM> and the second end <NUM>, a first end portion <NUM> extending from the central portion <NUM> to the first end <NUM>, and a second end portion <NUM> extending from the central portion <NUM> to the second end <NUM>. The central portion <NUM> may be configured to reside within the prostatic urethra U of the patient. The first end portion <NUM> may be configured to reside at least partially within first prostatic tissue PT of the patient, while the second end portion <NUM> may be configured to reside at least partially within second prostatic tissue PT of the patient disposed opposite the first prostatic tissue PT. The first end portion <NUM> may include a plurality of first protrusions or recesses <NUM> configured for engaging the first locking tab <NUM>. Similarly, the second end portion <NUM> may include a plurality of second protrusions or recesses <NUM> configured for engaging the second locking tab <NUM>. In some examples, the first protrusions or recesses <NUM> and the second protrusions or recesses <NUM> may include annular protrusions each extending around a circumference of the shaft <NUM>. In some examples, the first protrusions or recesses <NUM> and the second protrusions or recesses <NUM> may include annular recesses each extending around a circumference of the shaft <NUM>. In some examples, the first protrusions or recesses <NUM> and the second protrusions or recesses <NUM> may include teeth positioned along a circumference of the shaft <NUM>. The central portion <NUM> may be devoid of any protrusions or recesses. In some examples, the shaft <NUM> may include a first tip positioned at the first end <NUM> and configured to pierce the first prostatic tissue PT, and a second tip positioned at the second end <NUM> and configured to pierce the second prostatic tissue PT. Various tip configurations for the first end <NUM> and the second end <NUM> may be used, including sharpened tips, blunt tips, square tips, rounded tips, or atraumatic tips.

The first locking tab <NUM> may be configured to reside within the prostatic urethra U and to contact the first prostatic tissue PT. In a similar manner, the second locking tab <NUM> may be configured to reside within the prostatic urethra U and to contact the second prostatic tissue PT. The first protrusions or recesses <NUM> may be configured to allow the first locking tab <NUM> to move along the first end portion <NUM> toward the first end <NUM> and to inhibit movement of the first locking tab <NUM> along the first end portion <NUM> toward the second end <NUM>. In this manner, the engagement between the first locking tab <NUM> and the first protrusions or recesses <NUM> may provide a mechanism for one-way movement of the first locking tab <NUM> toward the first end <NUM>. The second protrusions or recesses <NUM> may be configured to allow the second locking tab <NUM> to move along the second end portion <NUM> toward the second end <NUM> and to inhibit movement of the second locking tab <NUM> along the second end portion <NUM> toward the first end <NUM>. In this manner, the engagement between the second locking tab <NUM> and the second protrusions or recesses <NUM> may provide a mechanism for one-way movement of the second locking tab <NUM> toward the second end <NUM>. In some examples, the first locking tab <NUM> and the second locking tab <NUM> each may surround a circumference of the shaft <NUM>. Various shapes and configurations of the first protrusions or recesses <NUM>, the second protrusions or recesses <NUM>, and the locking tabs <NUM>, <NUM> may be used.

<FIG> illustrate example methods of implanting the implantable device <NUM> to retract prostatic tissue PT of a patient. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. As shown in <FIG>, a sheath <NUM> may be inserted through the urethra U of the patient and positioned about the prostate P. The implantable device <NUM> may be passed through the sheath <NUM> along with other components of the delivery system to facilitate positioning and deployment of the device <NUM>. As shown in <FIG> and <FIG>, an inserter tool <NUM> may be used to advance the first end <NUM> of the shaft <NUM> into first prostatic tissue PT of the patient and to advance the second end <NUM> of the shaft <NUM> into second prostatic tissue PT disposed opposite the first prostatic tissue PT. In some examples, the first prostatic tissue PT may be pierced with the first tip of the first end <NUM>, and the second prostatic tissue PT may be pierced with the second tip of the second end <NUM>. In some examples, the device <NUM> may be advanced from the sheath <NUM> and into the prostatic urethra U while the shaft <NUM> is in an elastically deformed configuration, and the shaft <NUM> may be allowed to move toward its natural undeformed configuration within the prostatic urethra U. The central portion <NUM> of the shaft <NUM> may be positioned within the prostatic urethra U of the patient. Then, as shown in <FIG>, the first locking tab <NUM> may be moved along the first end portion <NUM> of the shaft <NUM> toward the first end <NUM> and into contact with the first prostatic tissue PT, and the second locking tab <NUM> may be moved along the second end portion <NUM> of the shaft <NUM> toward the second end <NUM> and into contact with the second prostatic tissue PT such that the first prostatic tissue PT and the second prostatic tissue PT are retracted. As described above, the first protrusions or recesses <NUM> may inhibit movement of the first locking tab <NUM> toward the second end <NUM>, and the second protrusions or recesses <NUM> may inhibit movement of the second locking tab <NUM> toward the first end <NUM>. In some examples, the first locking tab <NUM> and the second locking tab <NUM> may be moved simultaneously. In some examples, the second locking tab <NUM> may be moved along the second end portion <NUM> after the first locking tab <NUM> is moved along the first end portion <NUM>. In some examples, as shown, the first locking tab <NUM> and the second locking tab <NUM> may reside within the prostatic urethra U in an implanted configuration. <FIG> shows the device <NUM> in an implanted state, after removal of the delivery system. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient, as shown in <FIG>.

<FIG> illustrate another example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") having a locking-tab-style configuration. The implantable device <NUM> generally may be configured in a manner similar to the implantable device <NUM> described above. In <FIG>, corresponding features are identified using corresponding reference numbers. As shown, the device <NUM> may include a shaft <NUM> having a first end <NUM>, a second end <NUM>, a central portion <NUM>, a first end portion <NUM>, and a second end portion <NUM>, a first locking tab <NUM>, and a second locking tab <NUM>. As compared to the device <NUM>, the device <NUM> also may include a balloon <NUM> positioned at the first end <NUM> or the second end <NUM> of the shaft <NUM> and fixedly attached thereto. As shown, the balloon <NUM> may be configured to reside outside of the prostatic capsule PC of the patient. In other examples, instead of the balloon <NUM>, the device <NUM> may include an end tab that is fixedly attached to the shaft <NUM> at the first end <NUM> or the second end <NUM>. The end tab may be elastically deformable or deflectable relative to the shaft <NUM> and may be configured to reside outside of the prostatic capsule PC of the patient. Upon implantation of the device <NUM>, the balloon <NUM> or the end tab may serve to further secure the device <NUM> relative to the prostatic tissue PT.

The implantable device <NUM> may be implanted using a method similar to that described above with respect to the implantable device <NUM>. For example, the first end <NUM> of the shaft <NUM> may be advanced into first prostatic tissue PT of the patient, and the second end <NUM> of the shaft <NUM> may be advanced into second prostatic tissue PT disposed opposite the first prostatic tissue PT. During such insertion, the balloon <NUM> may be in an unexpanded configuration as it passes through the prostatic tissue PT and outside of the prostatic capsule PC. The central portion <NUM> of the shaft <NUM> may be positioned within the prostatic urethra U of the patient. Then, the balloon <NUM> may be expanded to its expanded configuration such that the balloon <NUM> is inhibited from entering the channel formed in the prostatic tissue PT, thereby securing the position of the device <NUM>. The first locking tab <NUM> may be moved along the first end portion <NUM> of the shaft <NUM> toward the first end <NUM> and into contact with the first prostatic tissue PT, and the second locking tab <NUM> may be moved along the second end portion <NUM> of the shaft <NUM> toward the second end <NUM> and into contact with the second prostatic tissue PT such that the first prostatic tissue PT and the second prostatic tissue PT are retracted. In some examples, the first locking tab <NUM> and the second locking tab <NUM> may be moved after expanding the balloon <NUM>. In other examples, the first locking tab <NUM> and the second locking tab <NUM> may be moved before the balloon <NUM> is expanded. For examples in which an end tab is used instead of a balloon, the end tab may be deformed or deflected from its natural configuration to a deformed or displaced configuration as the respective end of the shaft <NUM> passes through the prostatic tissue PT and outside of the prostatic capsule PC. Upon exiting the prostatic tissue PT, the end tab may be allowed to return to or toward its natural configuration such that the end tab is inhibited from entering the channel formed in the prostatic tissue PT, thereby securing the position of the device <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient, as shown in <FIG>.

<FIG> depict examples of an example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device"). The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. An example placement of the implantable device <NUM> is depicted in <FIG>. In some examples, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a main body <NUM> and a plurality of barbs <NUM> extending outwardly from the main body <NUM>. The main body <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the main body <NUM>. As shown, the main body <NUM> may include a proximal end portion <NUM> and a distal end portion <NUM>. In some examples, the main body <NUM> may be rigid. In some examples, as shown, the main body <NUM> may have a linear shape. In some examples, the main body <NUM> may have a curved or otherwise contoured shape. In some examples, the main body <NUM> may be formed of a flexible material and at least a portion of the main body <NUM> may be configured to be elastically deformed from a natural undeformed configuration to a deformed configuration. Example materials may include nitinol, PEEK, Pebax, stainless steel, polyethylene, polypropylene, polyester, polyamide, and fluoropolymer, although other biocompatible materials may be used. In some examples, the main body <NUM> may have a linear shape when the main body <NUM> is in the natural undeformed configuration. In some examples, the main body <NUM> may have a curved or otherwise contoured shape when the main body <NUM> is in the natural undeformed configuration. In some examples, as shown in <FIG>, the main body <NUM> may be configured to extend through prostatic tissue PT of the patient. In some examples, the main body <NUM> may be configured to extend partially through prostatic tissue PT of the patient, with the distal end <NUM> of the main body <NUM> residing within the prostatic tissue PT. As shown, the implantable device <NUM> also may include a flange <NUM> that is fixedly attached to the proximal portion <NUM> of the main body <NUM> and extends outward therefrom. The flange <NUM> may be configured to reside within the prostatic urethra U of the patient and to contact the prostatic tissue PT.

As shown, the barbs <NUM> may be disposed along the distal end portion <NUM> of the main body <NUM>, while the proximal end portion <NUM> of the main body <NUM> may be devoid of barbs <NUM>. The barbs <NUM> may be configured to engage the prostatic tissue PT of the patient. Each of the barbs <NUM> may be configured to move relative to the main body <NUM>. In some examples, each of the barbs <NUM> may be fixedly attached to the main body <NUM> and configured to be elastically deformed or deflected from a first configuration to a second configuration, such as when the barbs <NUM> are advanced into or through the prostatic tissue PT. For example, the barbs <NUM> may be integrally formed with the main body <NUM> and configured to be elastically deformed or deflected relative to the main body <NUM>. In some examples, the barbs <NUM> may be separately formed from the main body <NUM> but attached to the main body <NUM> and configured to be elastically deformed or deflected relative to the main body <NUM>. For example, as shown in <FIG>, the barbs <NUM> may extend through respective openings defined in the main body <NUM>, with each of the barbs <NUM> including a base portion positioned within the main body <NUM> and a free end portion positioned outside of the main body <NUM>. In some examples, the implantable device <NUM> also may include a central pin <NUM>, as shown in <FIG>. The central pin <NUM> may be removably positioned within the main body <NUM> and configured to inhibit movement of the barbs <NUM> inward toward the longitudinal axis of the main body <NUM> when the central pin <NUM> is positioned within the main body <NUM>. In some instances, the central pin <NUM> may be removed from the main body <NUM> to allow the barbs <NUM> to move inward relative to the main body <NUM>, for example to ease removal of the device <NUM> from a patient. In some examples, the central pin <NUM> may be removably attached to the main body <NUM>, for example by a threaded connection or other means of releasable mechanical attachment.

The implantable device <NUM> may be implanted using a method generally similar to that described above with respect to the implantable device <NUM>. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. A sheath may be inserted through the urethra U of the patient and positioned about the prostate P. The device <NUM> may be passed through a working lumen of the sheath, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen of the sheath. In some examples, an obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other examples, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. As noted above, the barbs <NUM> may be elastically deformed or deflected when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, the device <NUM> may be positioned such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC. In some examples, as shown in <FIG>, the main body <NUM> may extend through the prostatic tissue PT, with the distal end <NUM> positioned outside of the prostatic capsule PC. In some examples, the main body <NUM> may extend only partially through the prostatic tissue PT, with the distal end <NUM> positioned within the prostatic tissue PT. In some examples, as shown in <FIG>, one or more of the barbs <NUM> may be positioned outside of the prostatic capsule PC, while other barbs <NUM> may be positioned within the prostatic tissue PT. In some examples, all of the barbs <NUM> may be positioned within the prostatic tissue PT. As shown, the flange <NUM> may be positioned within the prostatic urethra U and in contact with the prostatic tissue PT. In this manner, the prostatic tissue PT may be compressed between the flange <NUM> and the barbs <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. It will be appreciated that the extent to which the barbs <NUM> are advanced into and/or through the prostatic tissue PT may be selected to achieve a desired degree of retraction of the prostatic tissue PT for a particular patient. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

<FIG> illustrates another example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") having barbs. The implantable device <NUM> generally may be configured in a manner similar to the implantable device <NUM> described above. In <FIG>, corresponding features are identified using corresponding reference numbers. As shown, the device <NUM> may include a main body <NUM> having a proximal end <NUM>, a distal end <NUM>, a proximal end portion <NUM>, and a distal end portion <NUM>. The device <NUM> also may include a flange <NUM>, a plurality of barbs <NUM>, and a central pin <NUM>. As compared to the barbs <NUM> of the device <NUM>, the barbs <NUM> of the device <NUM> may be pivotally attached to the main body <NUM> and configured to pivot relative to the main body <NUM> from a first configuration to a second configuration, such as when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, as shown, adjacent portions of the main body <NUM> may be configured to limit a range of pivotal movement of the respective barbs <NUM> relative to the main body <NUM>. In this manner, the main body <NUM> may limit pivotal movement of the barbs <NUM> in an outward direction as well as in an inward direction. Various means may be used to form the pivotal connection between the barbs <NUM> and the main body <NUM>, such as a pin connection, a ball-and-socket connection, and the like. The implantable device <NUM> may be implanted using a method similar to that described above with respect to the implantable device <NUM>.

Referring now to <FIG>, another example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") is depicted. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. In some examples, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a distal body <NUM>, a plurality of barbs <NUM> extending outwardly from the distal body <NUM>, a proximal body <NUM>, an intermediate body <NUM> extending between the distal body <NUM> and the proximal body <NUM>, and a tether <NUM> extending between the distal body <NUM> and the proximal body <NUM>. The distal body <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the distal body <NUM>. In some examples, the distal body <NUM> may be rigid. In some examples, the distal body <NUM> may be formed of a flexible material and at least a portion of the distal body <NUM> may be configured to be elastically deformed from a natural undeformed configuration to a deformed configuration. Example materials may include nitinol, PEEK, Pebax, stainless steel, polyethylene, polypropylene, polyester, polyamide, and fluoropolymer, although other biocompatible materials may be used. The distal body <NUM> may be configured to extend at least partially through prostatic tissue PT of the patient, with the distal end <NUM> of the distal body <NUM> residing either within the prostatic tissue PT or outside of the prostatic capsule PC. The proximal body <NUM> may be configured to reside within the prostatic urethra U of the patient and to contact the prostatic tissue PT.

As shown, the barbs <NUM> may be disposed along a portion of the distal body <NUM>. The barbs <NUM> may be configured to engage the prostatic tissue PT of the patient. Each of the barbs <NUM> may be configured to move relative to the distal body <NUM>. In some examples, each of the barbs <NUM> may be fixedly attached to the distal body <NUM> and configured to be elastically deformed or deflected from a first configuration to a second configuration, such as when the barbs <NUM> are advanced into or through the prostatic tissue PT. For example, the barbs <NUM> may be integrally formed with the distal body <NUM> and configured to be elastically deformed or deflected relative to the distal body <NUM>. In some examples the barbs <NUM> may be separately formed from the distal body <NUM> but attached to the distal body <NUM> and configured to be elastically deformed or deflected relative to the distal body <NUM>. In some examples, the barbs <NUM> may be separately formed from and pivotally attached to the distal body <NUM>.

The intermediate body <NUM> may be fixedly attached to each of the distal body <NUM> and the proximal body <NUM>, as shown. In some examples, the intermediate body <NUM> may have a tubular shape that surrounds the tether <NUM>. The intermediate body <NUM> may be formed of a bioerodeable material, such as PLA, PGA, polycaprolactone, or magnesium, and thus may erode over time after implantation of the device <NUM> within a patient. In this manner, the intermediate body <NUM> may facilitate implantation of the device <NUM>, maintaining a spacing between and relative orientation of the distal body <NUM> and the proximal body <NUM> during implantation. The tether <NUM> may be fixedly attached to each of the distal body <NUM> and the proximal body <NUM>, as shown. In some examples, the tether <NUM> may be flexible. In some examples, the tether <NUM> may be or may include a non-absorbable suture. After erosion of the intermediate body <NUM>, the distal body <NUM> and the proximal body <NUM> may remain attached to one another by the tether <NUM>.

The implantable device <NUM> may be implanted using a method generally similar to that described above with respect to the implantable device <NUM>. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. A sheath may be inserted through the urethra U of the patient and positioned about the prostate P. The device <NUM> may be passed through a working lumen of the sheath, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen of the sheath. In some examples, an obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other examples, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. As noted above, the barbs <NUM> may be elastically deformed or deflected when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, the device <NUM> may be positioned such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC. In some examples, the device <NUM> may extend through the prostatic tissue PT, with the distal end <NUM> of the distal body <NUM> positioned outside of the prostatic capsule PC. In some examples, the device <NUM> may extend only partially through the prostatic tissue PT, with the distal end <NUM> of the distal body <NUM> positioned within the prostatic tissue PT. In some examples, the intermediate body <NUM> may extend partially through the prostatic tissue PT, and the tether <NUM> may extend partially through the prostatic tissue PT. In some examples, one or more of the barbs <NUM> may be positioned outside of the prostatic capsule PC, while other barbs <NUM> may be positioned within the prostatic tissue PT. In some examples, all of the barbs <NUM> may be positioned within the prostatic tissue PT. The proximal body <NUM> may be positioned within the prostatic urethra U and in contact with the prostatic tissue PT. In this manner, the prostatic tissue PT may be compressed between the proximal body <NUM> and the barbs <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. It will be appreciated that the extent to which the barbs <NUM> are advanced into and/or through the prostatic tissue PT may be selected to achieve a desired degree of retraction of the prostatic tissue PT for a particular patient. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

<FIG> depicts an example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") that utilizes a hydraulic mechanism. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. In some examples, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a distal body <NUM>, a plurality of barbs <NUM> extending outwardly from the distal body <NUM>, a proximal body <NUM>, and a flange <NUM>. The distal body <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the distal body <NUM>. In some examples, the distal body <NUM> may be rigid. In some examples, the distal body <NUM> may be formed of a flexible material. Example materials may include nitinol, PEEK, Pebax, stainless steel, polyethylene, polypropylene, polyester, polyamide, and fluoropolymer, although other biocompatible materials may be used. The distal body <NUM> may be configured to extend at least partially through prostatic tissue PT of the patient, with the distal end <NUM> of the distal body <NUM> residing either within the prostatic tissue PT or outside of the prostatic capsule PC. The proximal body <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the proximal body <NUM>. In some examples, the proximal body <NUM> may be rigid. In some examples, the proximal body <NUM> may be formed of a flexible material. Example materials may include nitinol, PEEK, Pebax, stainless steel, polyethylene, polypropylene, polyester, polyamide, and fluoropolymer, although other biocompatible materials may be used. The proximal body <NUM> may be configured to extend at least partially through prostatic tissue PT of the patient, with the distal end <NUM> of the proximal body <NUM> residing within the prostatic tissue PT and the proximal end <NUM> residing within the prostatic urethra U of the patient. As shown, the flange <NUM> may be fixedly attached to the proximal body <NUM> at the proximal end <NUM> thereof. In this manner, the flange <NUM> may be configured to reside within the prostatic urethra U of the patient and to contact the prostatic tissue PT.

As shown, the barbs <NUM> may be disposed along a portion of the distal body <NUM>. The barbs <NUM> may be configured to engage the prostatic tissue PT of the patient. Each of the barbs <NUM> may be configured to move relative to the distal body <NUM>. In some examples, as shown, the barbs <NUM> may be separately formed from the distal body <NUM> but attached to the distal body <NUM> and configured to pivot relative to the distal body <NUM>. In some examples, the barbs <NUM> may be separately formed from the distal body <NUM> but attached to the distal body <NUM> and configured to be elastically deformed or deflected relative to the distal body <NUM>. In some examples, the barbs <NUM> may be integrally formed with the distal body <NUM> and configured to be elastically deformed or deflected relative to the distal body <NUM>.

The distal body <NUM> may define a reservoir within the distal body <NUM>. The proximal body <NUM> similarly may define a reservoir within the proximal body <NUM> and in fluid communication with the reservoir of the distal body <NUM>. As shown, a fluid <NUM> may be contained within the reservoirs of the distal body <NUM> and the proximal body <NUM>. The fluid <NUM> may include any suitable biocompatible, noncompressible fluids, such as saline, water, adhesives, acrylics, epoxies, or polymethylmethacrylate. As shown, the device <NUM> may include a port <NUM> positioned at the proximal end <NUM> of the proximal body <NUM> and in fluid communication with the reservoirs of the distal body <NUM> and the proximal body <NUM>. As discussed below, the port <NUM> may facilitate withdrawal of a portion of the fluid <NUM> from the reservoirs of the distal body <NUM> and the proximal body <NUM> during implantation of the device <NUM>. In some examples, the port <NUM> may include a valve, such as a self-sealing valve. As shown, the proximal body <NUM> may be translatably attached to the distal body <NUM>. In this manner, the proximal body <NUM> may be configured to translate relative to the distal body <NUM> from an extended configuration to a retracted configuration. Specifically, the proximal body <NUM> may be configured to translate relative to the distal body <NUM> from an extended configuration to a retracted configuration when a portion of the fluid <NUM> is withdrawn from the reservoirs of the distal body <NUM> and the proximal body <NUM> via the port <NUM>. As shown, the device <NUM> may include a seal <NUM> positioned at an interface between the distal body <NUM> and the proximal body <NUM> to prevent leakage of the fluid <NUM> therebetween.

The implantable device <NUM> may be implanted using a method generally similar to that described above with respect to the implantable device <NUM>. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. A sheath may be inserted through the urethra U of the patient and positioned about the prostate P. The device <NUM> may be passed through a working lumen of the sheath, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen of the sheath. In some examples, an obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other examples, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. As noted above, the barbs <NUM> may pivot or may be elastically deformed or deflected when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, the device <NUM> may be positioned such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC. In some examples, the device <NUM> may extend through the prostatic tissue PT, with the distal end <NUM> of the distal body <NUM> positioned outside of the prostatic capsule PC. In some examples, the device <NUM> may extend only partially through the prostatic tissue PT, with the distal end <NUM> of the distal body <NUM> positioned within the prostatic tissue PT. In some examples, one or more of the barbs <NUM> may be positioned outside of the prostatic capsule PC, while other barbs <NUM> may be positioned within the prostatic tissue PT. In some examples, all of the barbs <NUM> may be positioned outside of the prostatic capsule PC. In some examples, all of the barbs <NUM> may be positioned within the prostatic tissue PT. The proximal body <NUM> may be positioned partially within the prostatic tissue PT and partially within the prostatic urethra U. The flange <NUM> may be positioned within the prostatic urethra U and in contact with the prostatic tissue PT. As noted above, a portion of the fluid <NUM> may be withdrawn from the reservoirs of the distal body <NUM> and the proximal body <NUM> via the port <NUM> such that the proximal body <NUM> translates relative to the distal body <NUM> from an extended configuration to a retracted configuration. In this manner, the prostatic tissue PT may be compressed between the flange <NUM> and the barbs <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. It will be appreciated that the amount of fluid <NUM> that is withdrawn may be selected to achieve a desired degree of retraction of the prostatic tissue PT for a particular patient. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

<FIG> depict an example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") that utilizes a deformable or peelable main body. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. In some examples, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a main body <NUM>, a flange <NUM>, and a suture <NUM>. The main body <NUM> may have a proximal end <NUM> and a distal end <NUM> disposed opposite one another in a direction of a longitudinal axis of the main body <NUM>. The main body <NUM> may be formed of a deformable or peelable material, such as Pebax, polyethylene, polypropylene, polyester, polyamide, or fluoropolymer, although other suitable materials may be used. The main body <NUM> may be configured to extend through prostatic tissue PT of the patient, with the distal end <NUM> of the main body <NUM> residing outside of the prostatic capsule PC and the proximal end <NUM> of the main body <NUM> residing within the prostatic urethra U. The main body <NUM> may include a distal end portion <NUM> that is configured to reside at least partially outside of the prostatic capsule PC, as shown in <FIG>. The distal end portion <NUM> may be configured to deform from an undeformed configuration, as shown in <FIG>, to a deformed configuration, as shown in <FIG>. The suture <NUM> may include a first end <NUM>, a second end <NUM>, and an intermediate portion <NUM> extending between the ends <NUM>, <NUM>. As shown, the ends <NUM>, <NUM> may extend from the proximal end <NUM> of the main body <NUM>.

The suture <NUM> may be configured to cause the distal end portion <NUM> of the main body <NUM> to deform from the undeformed configuration to the deformed configuration when the first end <NUM> and the second end <NUM> are pulled proximally relative to the main body <NUM>. As shown, portions of the suture <NUM> may extend through the main body <NUM>, while other portions of the suture <NUM> extend along an outer surface of the distal end portion <NUM> of the main body <NUM>. The main body <NUM> may include a plurality of openings that guide the suture <NUM> through and along the main body <NUM>. As shown, the main body <NUM> may include a plurality of proximal openings <NUM>, a distal opening <NUM>, and a plurality of side openings <NUM>. The suture <NUM> may include a plurality of segments connected in series between the first end <NUM> and the second end <NUM>, with each segment interfacing with different portions of the main body <NUM>. As shown, a first segment may extend from the first end <NUM> through a first proximal opening <NUM> and through the main body <NUM> to a first side opening <NUM>, a second segment may extend from the first side opening <NUM> and along the outer surface of the distal end portion <NUM> to the distal opening <NUM>, a third segment may extend from the distal opening <NUM> through the main body <NUM> and through a second proximal opening <NUM>, a fourth segment may extend through a third proximal opening <NUM> through the main body <NUM> and through the distal opening <NUM>, a fifth segment may extend from the distal opening <NUM> along the outer surface of the distal end portion <NUM> to a second side opening <NUM>, and a sixth segment may extend from the second side opening <NUM> through the main body <NUM> to the second end <NUM>. Alternative arrangements of the suture <NUM> may be used in other examples. When the first end <NUM> and the second end <NUM> are pulled proximally relative to the main body <NUM>, the distal end portion <NUM> may be deformed from the undeformed configuration to the deformed configuration. Specifically, such pulling of the suture <NUM> may cause the distal end portion <NUM> to deform radially outward relative to the longitudinal axis of the main body <NUM> from the undeformed configuration to the deformed configuration, as shown in <FIG>. In some examples, as shown, the deformation of the distal end portion <NUM> may include separation of respective segments of the distal end portion <NUM> from one another. In some examples, the distal end portion <NUM> may include one or more zones of weakness <NUM> configured to facilitate separation of the respective segments of the distal end portion from one another. For example, the zones of weakness <NUM> may include perforations defined in the distal end portion <NUM>.

The implantable device <NUM> may be implanted using a method generally similar to that described above with respect to the implantable device <NUM>. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. A sheath may be inserted through the urethra U of the patient and positioned about the prostate P. The device <NUM> may be passed through a working lumen of the sheath, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen of the sheath. In some examples, an obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other examples, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. In some examples, as shown in <FIG>, the device <NUM> may extend through the prostatic tissue PT, with the distal end <NUM> of the main body <NUM> positioned outside of the prostatic capsule PC. Specifically, at least a portion of the distal end portion <NUM> may be positioned outside of the prostatic capsule PC. The flange <NUM> may be positioned within the prostatic urethra U and in contact with the prostatic tissue PT. As noted above, the distal end portion <NUM> may be deformed from an undeformed configuration to a deformed configuration by pulling the ends <NUM>, <NUM> of the suture <NUM> proximally relative to the main body <NUM>. In this manner, the prostatic tissue PT may be compressed between the flange <NUM> and the deformed distal end portion <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. It will be appreciated that the extent of deformation of the distal end portion <NUM> may be selected to achieve a desired degree of retraction of the prostatic tissue PT for a particular patient. After achieving a desired degree of retraction, the free end portions of the suture <NUM> may be secured relative to the main body <NUM>. In some examples, a cap <NUM> may be used to secure the free end portions of the suture <NUM> to the main body <NUM> and/or the flange <NUM>. In some examples, the free end portions of the suture <NUM> may be tied into knots. In some examples, the free end portions of the suture <NUM> may secured by an additional capture mechanism of the device <NUM>. In some examples, the free end portions of the suture <NUM> may be cut off or otherwise removed after securing or tying. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

<FIG> illustrate another example implantable device <NUM> (which also may be referred to as a "prostatic tissue retractor," a "tissue retractor," or simply a "device") having a jack-style configuration. The implantable device <NUM> is configured for retracting prostatic tissue PT of a patient to treat LUTS caused by BPH. In some examples, the device <NUM> may be implanted in a minimally-invasive manner. An example placement of the implantable device <NUM> is depicted in <FIG>. In some examples, multiple devices <NUM> may be used for a single patient.

The implantable device <NUM> generally may include a distal body <NUM>, a plurality of barbs <NUM> extending outwardly from the distal body <NUM>, a proximal body <NUM>, a shaft <NUM> movably attached to each of the distal body <NUM> and the proximal body <NUM>, and two pairs of link arms <NUM> extending between the distal body <NUM> and the proximal body <NUM>. As shown, the distal body <NUM> and the proximal body <NUM> each may be formed as plate-like members positioned at opposite ends of the device <NUM>, although other shapes and configurations of the distal body <NUM> and the proximal body <NUM> may be used in other examples. In some examples, the distal body <NUM> and the proximal body <NUM> may be rigid. In some examples, the distal body <NUM> and the proximal body <NUM> may be formed of a flexible material and at least portions of the distal body <NUM> and the proximal body <NUM> may be configured to be elastically deformed from a natural undeformed configuration to a deformed configuration. Example materials may include nitinol, PEEK, Pebax, stainless steel, polyethylene, polypropylene, polyester, polyamide, and fluoropolymer, although other biocompatible materials may be used. In some examples, as shown in <FIG>, the distal body <NUM> may be configured to reside outside of the prostatic capsule PC of the patient, and the proximal body <NUM> may be configured to reside within the prostatic urethra U of the patient and to contact the prostatic tissue PT.

As shown, the barbs <NUM> may be attached to the distal body <NUM> and may extend outwardly therefrom. The barbs <NUM> may be configured to engage the prostatic capsule PC or the prostatic tissue PT of the patient. Each of the barbs <NUM> may be configured to move relative to the distal body <NUM>. In some examples, as shown, each of the barbs <NUM> may be pivotally attached to the distal body <NUM> via respective hinges <NUM> and configured to pivot from a first configuration to a second configuration, such as when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, each of the barbs <NUM> may be fixedly attached to the distal body <NUM> and configured to be elastically deformed or deflected from a first configuration to a second configuration, such as when the barbs <NUM> are advanced into or through the prostatic tissue PT. For example, the barbs <NUM> may be integrally formed with the distal body <NUM> and configured to be elastically deformed or deflected relative to the distal body <NUM>.

The shaft <NUM> may be movably attached to each of the distal body <NUM> and the proximal body <NUM> and configured to adjust a spacing between the distal body <NUM> and the proximal body <NUM> and then maintain a desired spacing after such adjustment. For example, the shaft <NUM> may be threadedly attached to the distal body <NUM> and rotatably attached to the proximal body <NUM>. In this manner, the shaft <NUM> may be configured to move the distal body <NUM> toward the proximal body <NUM> when the shaft <NUM> is rotated relative to the proximal body <NUM> in a first direction, and to move the distal body <NUM> away from the proximal body <NUM> when the shaft <NUM> is rotated relative to the proximal body <NUM> in a second direction opposite the first direction. As shown in <FIG>, the shaft <NUM> may be configured to extend through the prostatic tissue PT of the patient. Each pair of the link arms <NUM> may include a first link arm <NUM> that is pivotally attached to the distal body <NUM> at a hinge <NUM>, and a second link arm <NUM> that is pivotally attached to the proximal body <NUM> at a hinge <NUM> and pivotally attached to the first link arm <NUM> at a hinge <NUM>. In this manner, the pairs of link arms <NUM> may maintain a relative orientation between the distal body <NUM> and the proximal body <NUM> as the spacing of the distal body <NUM> and the proximal body <NUM> is adjusted via the shaft <NUM>. As shown in <FIG>, the pairs of link arms <NUM> may extend through the prostatic tissue PT and outwardly away from the shaft <NUM> into the prostatic tissue PT. Although two pairs of the link arms <NUM> are shown in the illustrated examples, additional pairs of link arms <NUM> may be used in other examples.

The implantable device <NUM> may be implanted using a method generally similar to that described above with respect to the implantable device <NUM>. The device <NUM> may be implanted using a delivery system under visualization with a cystoscope, as described above. A sheath may be inserted through the urethra U of the patient and positioned about the prostate P. The device <NUM> may be passed through a working lumen of the sheath, along with other components of the delivery system to facilitate positioning and deployment of the device <NUM> under visualization through a cystoscope lumen of the sheath. In some examplesan obturator or cannula may be used to form a channel through prostatic tissue PT of the patient, with the channel extending from the prostatic urethra U to the prostatic capsule PC of the patient. In other examples, the device <NUM> may be passed through the prostatic tissue PT without first forming a channel. As noted above, the barbs <NUM> may pivot or may be elastically deformed or deflected when the barbs <NUM> are advanced into or through the prostatic tissue PT. In some examples, the device <NUM> may be positioned such that the device <NUM> extends from the prostatic urethra U to the prostatic capsule PC. In some examples, as shown in <FIG>, the shaft <NUM> and the pairs of link arms <NUM> may extend through the prostatic tissue PT, the distal body <NUM> and the barbs <NUM> may be positioned outside of the prostatic capsule PC, and the proximal body <NUM> may be positioned within the prostatic urethra U and in contact with the prostatic tissue PT. After so positioning the device <NUM>, the shaft <NUM> may be rotated in a first direction such that the distal body <NUM> moves toward the proximal body <NUM>. In this manner, the prostatic tissue PT may be compressed between the proximal body <NUM> and the distal body <NUM> and/or the barbs <NUM>. Thus, the implantable device <NUM> may retract the prostatic tissue PT of the patient to address LUTS caused by BPH. It will be appreciated that the extent to which the distal body <NUM> is moved toward the proximal body <NUM> may be selected to achieve a desired degree of retraction of the prostatic tissue PT for a particular patient. In some examples, a single device <NUM> may be used. In other examples, multiple devices <NUM> may be implanted within different portions of prostatic tissue PT of a patient.

Although specific embodiments of the disclosure have been described, one of ordinary skill in the art will recognize that numerous other modifications and alternative embodiments are within the scope of the disclosure. For example, while various illustrative implementations and structures have been described in accordance with embodiments of the disclosure, one of ordinary skill in the art will appreciate that numerous other modifications to the illustrative implementations and structures described herein are also within the scope of this disclosure.

Claim 1:
An implantable device (<NUM>) for retracting prostatic tissue of a patient, the implantable device (<NUM>) comprising:
a shaft (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>) opposite one another in a direction of a longitudinal axis of the shaft (<NUM>); characterised by
a proximal balloon (<NUM>) fixedly attached to the shaft (<NUM>), the proximal balloon (<NUM>) positioned closer to the proximal end (<NUM>) than the distal end (<NUM>);
a distal balloon (<NUM>) fixedly attached to the shaft (<NUM>), the distal balloon (<NUM>) positioned closer to the distal end (<NUM>) than the proximal end (<NUM>); and
an intermediate balloon (<NUM>) fixedly attached to the shaft (<NUM>), the intermediate balloon (<NUM>) positioned between the proximal balloon (<NUM>) and the distal balloon (<NUM>);
wherein the shaft (<NUM>) defines a first lumen (<NUM>) in fluid communication with a first reservoir of the proximal balloon (<NUM>) and a second reservoir of the distal balloon (<NUM>) and fluidically isolated from a third reservoir defined by the intermediate balloon (<NUM>).