Integrated handle assembly for anchor delivery system

Integrated systems and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods, and more particularly to integrated systems and associated methods for manipulating or retracting tissues and anatomical or other structures within the body of human or animal subjects for the purpose of treating diseases or disorders and/or for cosmetic or reconstructive or other purposes.

BACKGROUND OF THE INVENTION

There are a wide variety of situations in which it is desirable to lift, compress or otherwise reposition normal or aberrant tissues or anatomical structures (e.g., organs, ligaments, tendons, muscles, tumors, cysts, fat pads, etc.) within the body of a human or animal subject. Such procedures are often carried out for the purpose of treating or palliating the effects of diseases or disorders (e.g., hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses, herniations, stenoses, constrictions, compressions, transpositions, congenital malformations, etc.) and/or for cosmetic purposes (e.g., face lifts, breast lifts, brow lifts, etc.) and/or for research and development purposes (e.g., to create animal models that mimic various pathological conditions). In many of these procedures, surgical incisions are made in the body and laborious surgical dissection is performed to access and expose the affected tissues or anatomical structures. Thereafter, in some cases, the affected tissues or anatomical structures are removed or excised. In other cases, various natural or man made materials are used to lift, sling, reposition or compress the affected tissues.

One example of a condition where it is desirable to lift, compress or otherwise remove a pathologically enlarged tissue is Benign Prostatic Hyperplasia (BPH). BPH is one of the most common medical conditions that affect men, especially elderly men. It has been reported that, in the United States, more than half of all men have histopathologic evidence of BPH by age 60 and, by age 85, approximately 9 out of 10 men suffer from the condition. Moreover, the incidence and prevalence of BPH are expected to increase as the average age of the population in developed countries increases.

The prostate gland enlarges throughout a man's life. In some men, the prostatic capsule around the prostate gland may prevent the prostate gland from enlarging further. This causes the inner region of the prostate gland to squeeze the urethra. This pressure on the urethra increases resistance to urine flow through the region of the urethra enclosed by the prostate. Thus the urinary bladder has to exert more pressure to force urine through the increased resistance of the urethra. Chronic over-exertion causes the muscular walls of the urinary bladder to remodel and become stiffer. This combination of increased urethral resistance to urine flow and stiffness and hypertrophy of urinary bladder walls leads to a variety of lower urinary tract symptoms (LUTS) that may severely reduce the patient's quality of life. These symptoms include weak or intermittent urine flow while urinating, straining when urinating, hesitation before urine flow starts, feeling that the bladder has not emptied completely even after urination, dribbling at the end of urination or leakage afterward, increased frequency of urination particularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patients with prostate cancer, prostate infections, and chronic use of certain medications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine, antihistamines such as diphenhydramine, chlorpheniramine etc.) that cause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerous clinical conditions including urinary retention, renal insufficiency, recurrent urinary tract infection, incontinence, hematuria, and bladder stones.

In developed countries, a large percentage of the patient population undergoes treatment for BPH symptoms. It has been estimated that by the age of 80 years, approximately 25% of the male population of the United States will have undergone some form of BPH treatment. At present, the available treatment options for BPH include watchful waiting, medications (phytotherapy and prescription medications), surgery and minimally invasive procedures.

For patients who choose the watchful waiting option, no immediate treatment is provided to the patient, but the patient undergoes regular exams to monitor progression of the disease. This is usually done on patients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy and prescription medications. In phytotherapy, plant products such as Saw Palmetto, African Pygeum, Serenoa Repens (sago palm) and South African star grass are administered to the patient. Prescription medications are prescribed as first line therapy in patients with symptoms that are interfering with their daily activities. Two main classes of prescription medications are alpha-1a-adrenergic receptors blockers and 5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockers block that activity of alpha-1a-adrenergic receptors that are responsible for causing constriction of smooth muscle cells in the prostate. Thus, blocking the activity of alpha-1a-adrenergic receptors causes prostatic smooth muscle relaxation. This in turn reduces urethral resistance thereby reducing the severity of the symptoms. 5-alpha-reductase inhibitors block the conversion of testosterone to dihydrotestosterone. Dihydrotestosterone causes growth of epithelial cells in the prostate gland. Thus 5-alpha-reductase inhibitors cause regression of epithelial cells in the prostate gland and hence reduce the volume of the prostate gland which in turn reduces the severity of the symptoms.

Surgical procedures for treating BPH symptoms include Transurethal Resection of Prostate (TURP), Transurethral Electrovaporization of Prostate (TVP), Transurethral Incision of the Prostate (TUIP), Laser Prostatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practiced surgical procedure implemented for the treatment of BPH. In this procedure, prostatic urethral obstruction is reduced by removing most of the prostatic urethra and a sizeable volume of the surrounding prostate gland. This is carried out under general or spinal anesthesia. In this procedure, a urologist visualizes the urethra by inserting a resectoscope, that houses an optical lens in communication with a video camera, into the urethra such that the distal region of the resectoscope is in the region of the urethra surrounded by the prostate gland. The distal region of the resectoscope consists of an electric cutting loop that can cut prostatic tissue when an electric current is applied to the device. An electric return pad is placed on the patient to close the cutting circuit. The electric cutting loop is used to scrape away tissue from the inside of the prostate gland. The tissue that is scraped away is flushed out of the urinary system using an irrigation fluid. Using a coagulation energy setting, the loop is also used to cauterize transected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms is Transurethral Electrovaporization of the Prostate (TVP). In this procedure, a part of prostatic tissue squeezing the urethra is desiccated or vaporized. This is carried out under general or spinal anesthesia. In this procedure, a resectoscope is inserted transurethrally such that the distal region of the resectoscope is in the region of the urethra surrounded by the prostate gland. The distal region of the resectoscope consists of a rollerball or a grooved roller electrode. A controlled amount of electric current is passed through the electrode. The surrounding tissue is rapidly heated up and vaporized to create a vaporized space. Thus the region of urethra that is blocked by the surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms is Transurethral Incision of the Prostate (TUIP). In this procedure, the resistance to urine flow is reduced by making one or more incisions in the prostate gland in the region where the urethra meets the urinary bladder. This procedure is performed under general or spinal anesthesia. In this procedure, one or more incisions are made in the muscle of the bladder neck, which is the region where the urethra meets the urinary bladder. The incisions are in most cases are deep enough to cut the surrounding prostate gland tissue including the prostatic capsule. This releases any compression on the bladder neck and causes the bladder neck to spring apart. The incisions can be made using a resectoscope, laser beam etc.

Another example of a surgical procedure for treating BPH symptoms is Laser Prostatectomy. Two common techniques used for Laser Prostatectomy are Visual Laser Ablation of the Prostate (VLAP) and the Holmium Laser Resection/Enucleation of the Prostate (HoLEP). In VLAP, a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablate tissue by causing coagulation necrosis. The procedure is performed under visual guidance. In HoLEP, a holmium: Yttrium-aluminum-garnet laser is used for direct contact ablation of tissue. Both these techniques are used to remove tissue obstructing the urethral passage to reduce the severity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms is Photoselective Vaporization of the Prostate (PVP). In this procedure, laser energy is used to vaporize prostatic tissue to relieve obstruction to urine flow in the urethra. The type of laser used is the Potassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser is highly absorbed by oxyhemoglobin. This laser vaporizes cellular water and hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms is Open Prostatectomy. In this procedure, the prostate gland is surgically removed by an open surgery. This is done under general anesthesia. The prostate gland is removed through an incision in the lower abdomen or the perineum. The procedure is used mostly in patients that have a large (greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms include Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA), Interstitial Laser Coagulation (ILC), and Prostatic Stents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy is used to generate heat that destroys hyperplastic prostate tissue. This procedure is performed under local anesthesia. In this procedure, a microwave antenna is inserted in the urethra. A rectal thermosensing unit is inserted into the rectum to measure rectal temperature. Rectal temperature measurements are used to prevent overheating of the anatomical region. The microwave antenna is then used to deliver microwaves to lateral lobes of the prostate gland. The microwaves are absorbed as they pass through prostate tissue. This generates heat which in turn destroys the prostate tissue. The destruction of prostate tissue reduces the degree of squeezing of the urethra by the prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPH symptoms is Transurethral Needle Ablation (TUNA). In this procedure, heat induced coagulation necrosis of prostate tissue regions causes the prostate gland to shrink. It is performed using local anesthetic and intravenous or oral sedation. In this procedure, a delivery catheter is inserted into the urethra. The delivery catheter comprises two radiofrequency needles that emerge at an angle of 90 degrees from the delivery catheter. The two radiofrequency needles are aligned at an angle of 40 degrees to each other so that they penetrate the lateral lobes of the prostate. A radiofrequency current is delivered through the radiofrequency needles to heat the tissue of the lateral lobes to 70-100 degree Celsius at a radiofrequency power of approximately 456 KHz for approximately 4 minutes per lesion. This creates coagulation defects in the lateral lobes. The coagulation defects cause shrinkage of prostatic tissue which in turn reduces the degree of squeezing of the urethra by the prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPH symptoms is Interstitial Laser Coagulation (ILC). In this procedure, laser induced necrosis of prostate tissue regions causes the prostate gland to shrink. It is performed using regional anesthesia, spinal or epidural anesthesia or local anesthesia (periprostatic block). In this procedure, a cystoscope sheath is inserted into the urethra and the region of the urethra surrounded by the prostate gland is inspected. A laser fiber is inserted into the urethra. The laser fiber has a sharp distal tip to facilitate the penetration of the laser scope into prostatic tissue. The distal tip of the laser fiber has a distal-diffusing region that distributes laser energy 360° along the terminal 3 mm of the laser fiber. The distal tip is inserted into the middle lobe of the prostate gland and laser energy is delivered through the distal tip for a desired time. This heats the middle lobe and causes laser induced necrosis of the tissue around the distal tip. Thereafter, the distal tip is withdrawn from the middle lobe. The same procedure of inserting the distal tip into a lobe and delivering laser energy is repeated with the lateral lobes. This causes tissue necrosis in several regions of the prostate gland which in turn causes the prostate gland to shrink. Shrinkage of the prostate gland reduces the degree of squeezing of the urethra by the prostate thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPH symptoms is implanting Prostatic Stents. In this procedure, the region of urethra surrounded by the prostate is mechanically supported to reduce the constriction caused by an enlarged prostate. Prostatic stents are flexible devices that are expanded after their insertion in the urethra. They mechanically support the urethra by pushing the obstructing prostatic tissue away from the urethra. This reduces the constriction of the urethra and improves urine flow past the prostate gland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient from symptoms of BPH, they have disadvantages. Alpha-1a-adrenergic receptors blockers have side effects such as dizziness, postural hypotension, lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculation can also occur. 5-alpha-reductase inhibitors have minimal side effects, but only a modest effect on BPH symptoms and the flow rate of urine. In addition, anti-androgens, such as 5-alpha-reductase, require months of therapy before LUTS improvements are observed. Surgical treatments of BPH carry a risk of complications including erectile dysfunction; retrograde ejaculation; urinary incontinence; complications related to anesthesia; damage to the penis or urethra, need for a repeat surgery etc. Even TURP, which is the gold standard in treatment of BPH, carries a high risk of complications. Adverse events associated with this procedure are reported to include retrograde ejaculation (65% of patients), post-operative irritation (15%), erectile dysfunction (10%), need for transfusion (8%), bladder neck constriction (7%), infection (6%), significant hematuria (6%), acute urinary retention (5%), need for secondary procedure (5%), and incontinence (3%) Typical recovery from TURP involves several days of inpatient hospital treatment with an indwelling urethral catheter, followed by several weeks in which obstructive symptoms are relieved but there is pain or discomfort during micturition.

The reduction in the symptom score after minimally invasive procedures is not as large as the reduction in symptom score after TURP. Up to 25% of patients who receive these minimally invasive procedures ultimately undergo a TURP within 2 years. The improvement in the symptom score generally does not occur immediately after the procedure. For example, it takes an average of one month for a patient to notice improvement in symptoms after TUMT and 1.5 months to notice improvement after ILC. In fact, symptoms are typically worse for these therapies that heat or cook tissue, because of the swelling and necrosis that occurs in the initial weeks following the procedures. Prostatic stents often offer more immediate relief from obstruction but are now rarely used because of high adverse effect rates. Stents have the risk of migration from the original implant site (up to 12.5% of patients), encrustation (up to 27.5%), incontinence (up to 3%), and recurrent pain and discomfort. In published studies, these adverse effects necessitated 8% to 47% of stents to be explanted. Overgrowth of tissue through the stent and complex stent geometries have made their removal quite difficult and invasive.

Thus the most effective current methods of treating BPH carry a high risk of adverse effects. These methods and devices either require general or spinal anesthesia or have potential adverse effects that dictate that the procedures be performed in a surgical operating room, followed by a hospital stay for the patient. The methods of treating BPH that carry a lower risk of adverse effects are also associated with a lower reduction in the symptom score. While several of these procedures can be conducted with local analgesia in an office setting, the patient does not experience immediate relief and in fact often experiences worse symptoms for weeks after the procedure until the body begins to heal. Additionally all device approaches require a urethral catheter placed in the bladder, in some cases for weeks. In some cases catheterization is indicated because the therapy actually causes obstruction during a period of time post operatively, and in other cases it is indicated because of post-operative bleeding and potentially occlusive clot formation. While drug therapies are easy to administer, the results are suboptimal, take significant time to take effect, and often entail undesired side effects.

Many women experience loss of bladder control following childbirth or in old age. This condition is broadly referred to as urinary incontinence (UI). The severity of UI varies and, in severe cases, the disorder can be totally debilitating, keeping the patient largely homebound. It is usually associated with a cystocele, which results from sagging of the neck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengthening exercises (e.g., Kegel exercises), drug therapy, electrical stimulation of the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option. In general, the surgical procedures used to treat UI attempt to lift and support the bladder so that the bladder and urethra are returned to their normal positions within the pelvic cavity. The two most common ways of performing these surgeries is through incisions formed in the abdominal wall or though the wall of the vagina.

A number of different surgical procedures have been used to treat UI. The names for these procedures include the Birch Procedure, Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-Vaginal Tape Procedure, Urethral Suspension, Vesicourethral Suspension. These procedures generally fall into two categories, namely a) retropubic suspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made in the abdominal wall a few inches below the navel and a network of connectors are placed to support the bladder neck. The connectors are anchored to the pubic bone and to other structures within the pelvis, essentially forming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of the vagina and a sling is crafted of either natural tissue or synthetic (man-made) material to support the bladder neck. Both ends of the sling may be attached to the pubic bone or tied in front of the abdomen just above the pubic bone. In some sling procedures a synthetic tape is used to form the sling and the ends of the synthetic tape are not tied but rather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significant discomfort as the incisions heal and may require a Foley or supra-pubic urinary catheter to remain in place for at least several days following the surgery. Thus, there exists a need in the art for the development of minimally invasive (e.g., non-incisional) procedures for the treatment of UI with less postoperative discomfort and less requirement for post-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting, compressing or repositioning of natural tissue, natural tissue or artificial grafts or aberrant tissue. For example, surgical procedures such as face lifts, brow lifts, neck lifts, tummy tucks, etc. have become commonplace. In many cases, these procedures are performed by creating incisions through the skin, dissecting to a plane beneath muscles and fascia, freeing the muscles, fascia and overlying skin from underlying structures (e.g., bone or other muscles), lifting or repositioning the freed muscles, fascia and overlying skin and then attaching the repositioned tissues to underlying or nearby structures (e.g., bone, periostium, other muscles) to hold the repositioned tissues in their new (e.g., lifted) position. In some cases excess skin may also be removed during the procedure.

There have been attempts to develop minimally invasive devices and methods for cosmetic lifting and repositioning of tissues. For example, connector suspension lifts have been developed where one end of a standard or modified connector thread is attached to muscle and the other end is anchored to bone, periostium or another structure to lift and reposition the tissues as desired. Some of these connector suspension techniques have been performed through cannulas or needles inserted though relatively small incisions of puncture wounds.

For example, barbed threads known as Aptos threads may be inserted through a hollow trocar and used to lift tissues of the face in a procedure that is performed commercially under the name Featherlift™ (KMI, Inc. 2550 West Rowland Anaheim, Calif. 92804).

Another barbed thread that is useable for minimally invasive cosmetic lifting procedures is marketed under the name Contour Threads™ (Surgical Specialties Corporation, 100 Dennis Drive Reading, Pa. 19606).

There remains a need for the development of new devices and methods that may be used for various procedures where it is desired to lift, compress, support or reposition tissues or organs within the body with less intraoperative trauma, less post-operative discomfort and/or shorter recovery times. Moreover, there is an opportunity to take advantage of aspects of anatomy and to employ structures configured to cooperate with such anatomy. In this way, an interventional site within a patient's body can be more easily accessed as well as heal more easily and completely and the body can more readily return to normal operation. Furthermore, there is a distinct need for an integrated system for accomplishing various steps involved in both implanting and assembling devices at interventional sites.

The present invention addresses these and other needs.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed towards an apparatus and method for deploying an anchor assembly within a patient's body. In a particular aspect, the present invention is directed towards various embodiments of integrated anchor delivery devices. In one aspect, the delivery devices accomplish the delivery of a first or distal anchor assembly component at a first location within a patient's body and the delivery of a second or proximal anchor assembly component at a second location within the patient. The devices also accomplish imparting a tension during delivery and a tension between implanted anchor components as well as cutting the anchor assembly to a desired length and assembling the proximal anchor in situ. The procedure can be viewed employing a scope incorporated into the device.

The present invention also contemplates a reversible procedure as well as an anchor assembly with sufficient visibility when viewed ultrasonically. In one aspect, the implant procedure is reversible by severing a connector of an anchor assembly and removing an anchor of the anchor assembly such as by so removing a proximally placed anchor previously implanted in an urethra. Moreover, the anchor assemblies can be formed of structures facilitating ultrasound viewing.

The anchor assembly can be configured to accomplish retracting, lifting, compressing, supporting or repositioning tissue within the body of a human or animal subject. Moreover, the apparatus configured to deploy the anchor assembly as well as the anchor assembly itself are configured to complement and cooperate with body anatomy. Further, the anchor assembly may be coated or imbedded with therapeutic or diagnostic substances or such substances can be introduced into or near an interventional site by the anchor deployment device or other structure.

In another aspect, structure of the anchor assembly is designed to invaginate within or complement tissue anatomy to thereby facilitate healing and minimize infection risk. Moreover, the anchor delivery device includes structure to form desired angles between an extended position of the needle assembly relative to the device. Additionally, it is contemplated that a distal end portion of the anchor delivery device be configured to facilitate the testing of the effectiveness of positioning of an anchor assembly. In this regard, the distal end portion is configured in a manner to mimic the effect a second anchor member will have prior to its implantation.

In one embodiment, the anchor delivery device includes a handle assembly with a plurality of actuators or triggers attached thereto. A first actuator is associated with a body of the handle assembly and is operatively attached to the needle assembly and structure that advances the first anchor member. A second actuator attached to the handle assembly is operatively associated with structure that accomplishes assembling first and second parts of the second anchor member to each other and to the connector member. Also, the handle assembly is equipped with a third actuator that is configured in one contemplated embodiment, to effect the cutting of the anchor assembly to a desired length and deployment of the structure at an interventional site.

In a specific embodiment, the anchor delivery device includes a generally elongate tubular housing assembly member extending distally from a handle assembly including a plurality of actuators. The proximal end of the handle assembly is equipped with mounting structure configured to receive a telescope or other endoscopic viewing instrument. A bore sized to receive the telescope extends distally through a body of the handle assembly and continues through an outer tubular cover member forming the generally elongate member. Housed within the tubular housing assembly are a telescope tube having an interior defining a distal section of the bore sized to receive the telescope, an upper tubular member assembly sized to receive a plurality of first components of the second anchor member and a needle housing configured to receive the needle assembly. Moreover, the generally elongate tubular housing includes a terminal end portion defined by a nose assembly which retains a plurality of second components of the second anchor members.

Moreover, in a preferred embodiment the first anchor member includes a body having a generally tubular portion from which a first partial cylinder portion extends proximally. Attached to a midpoint of the body is a spring in the form of a second partial cylinder portion that is complementary to the first partial cylinder portion. Extending from the opposite end of the spring is a generally tubular collar. In a compressed configuration, the first anchor member defines a generally straight member and when unconstrained, the first anchor member forms generally a T-structure with the body defining the cross-member of the T-structure.

Further, in the preferred embodiment, the first part of the second anchor member is embodied in a pin having a first distal end equipped with a pair of spaced arms and a second proximal end including grooves facilitating pushability. The arms of the first distal end are designed to receive the connector structure and to be placed into locking engagement with the second part of the second anchor member. The second part has a generally tubular configuration and an internal bore sized to receive the first component.

The present invention also contemplates a number of alternative designs for the first and second anchor members and connectors as well as structures for advancing and deploying the anchor members and cutting the connector. Additionally, it is contemplated that various embodiments can incorporate one or more sensors into the deployment device to facilitate proper positioning of the device and anchor deployment.

Moreover, various alternative methods of use are also contemplated. That is, in some applications of the invention, the invention may be used to facilitate volitional or non-volitional flow of a body fluid through a body lumen, modify the size or shape of a body lumen or cavity, treat prostate enlargement, treat urinary incontinence, support or maintain positioning of a tissue, organ or graft, perform a cosmetic lifting or repositioning procedure, form anastomotic connections, and/or treat various other disorders where a natural or pathologic tissue or organ is pressing on or interfering with an adjacent anatomical structure. Also, the invention has a myriad of other potential surgical, therapeutic, cosmetic or reconstructive applications, such as where a tissue, organ, graft or other material requires retracting, lifting, repositioning, compression or support.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and not limitation, the present invention is embodied in a device configured to deliver anchor assemblies within a patient's body. As stated, the present invention can be employed for various medical purposes including but not limited to retracting, lifting, compressing, supporting or repositioning tissues, organs, anatomical structures, grafts or other material found within a patient's body. Such tissue manipulation is intended to facilitate the treatment of diseases or disorders. Moreover, the disclosed invention has applications in cosmetic or reconstruction purposes or in areas relating the development or research of medical treatments.

In one particular aspect, the anchor assembly of the present invention is contemplated to be formed of a structure which is visible by ultrasound. Accordingly, the anchor assembly can be viewed during ultrasonic body scans such as during normal trans-rectal ultrasound when a medical professional is conducting diagnoses or treatment associated with conditions like prostate cancer.

In such applications, one portion of an anchor assembly is positioned and implanted against a first section of anatomy. A second portion of the anchor assembly is then positioned and implanted adjacent a second section of anatomy for the purpose of retracting, lifting, compressing, supporting or repositioning the second section of anatomy with respect to the first section of anatomy. It is also to be recognized that both a first and second portion of the anchor assembly can be configured to accomplish the desired retracting, lifting, compressing, supporting or repositioning of anatomy due to tension supplied thereto via a connector assembly affixed to the first and second portions of the anchor assembly.

Referring now toFIG. 1, there is shown one embodiment of an integrated anchor delivery device20. This device is configured to include structure that is capable of both gaining access to an interventional site as well as assembling and implanting an anchor device, anchor assembly within a patient's body. The device further includes structure configured to receive a conventional remote viewing device (e.g., an endoscope) so that the steps being performed at the interventional site can be observed.

The integrated anchor delivery device20includes a handle assembly22and a tubular housing assembly24extending from the handle assembly22. The handle assembly22is sized and shaped to fit comfortably within an operator's hand and can be formed from conventional materials.

The proximal end of the delivery device20includes a mount26for receiving an endoscope or telescope28or other imaging device. The mount26includes an internal bore (not shown) sized and shaped to receive the telescope28. As indicated, the telescope28is intended to provide the operator with the ability to view the operation of the delivery device20at an interventional site.

The handle assembly22of the delivery device20also includes a plurality of activators or triggers associated with the handle assembly22. The body30includes a first or upper portion32extending generally perpendicularly with respect to a second or lower portion34. The second portion is intended to be sized and shaped to fit within the palm of an operator's hand. Pivotably affixed to the second portion34is a first actuator36. Although it can come in a myriad of forms, the first actuator36includes a hooped portion sized and shaped to receive one or more fingers of the operator's hand. The hooped portion extends from an arm which is pivotably connected to the handle22, the arm and hooped portion defining an acute angle with respect to the second portion34of the handle assembly22when inactivated. As will be described in more detail below, the first actuator36is operatively associated with a needle assembly and structure configured to advance and place a first component of an anchor assembly at an interventional site.

A second trigger or actuator38is pivotably connected adjacent the first body portion32. Although it can come in a myriad of forms, the second actuator38defines a generally finger-like projection and is positioned longitudinally distally from the body30with respect to the first actuator36. The second actuator38also defines an acute angle respecting the second portion34of the handle assembly22and is sized and shaped to comfortably receive one or more fingers of the operator. Upon actuation, the second actuator38is configured to accomplish the assembly of an anchor device by attaching a second anchor component to a connector affixed to the first anchor component.

A third trigger or actuator40is connected and configured to pivotably rotate with respect to a top side of upper body portion30. Although it can come in a myriad of forms, in one embodiment, the third actuator40defines a relatively straight member with a rounded substructure formed at its free terminal end. In this way, the third actuator40is easily manipulated by a free digit of the operator's hand. The third actuator40rotates from a forward position where it forms an acute angle with the tubular housing assembly24to a rearward position where the member defines an obtuse angle with respect to the tubular housing assembly24. In one embodiment, the third actuator40is intended to retract portions of the tubular housing assembly24as well as accomplish cutting the connector of the anchor assembly and deploying the anchor assembly at an interventional site.

As stated, the tubular housing assembly24extends from the handle assembly22. In one aspect, the tubular housing assembly24is mounted to a front face of the upper portion32of the handle assembly22and extends parallel to a longitudinal axis of the upper portion32. At its proximal end, the tubular housing assembly24includes a mount42from which an outer sheath44extends in a distal direction. The mount42includes one or more conventional stop cock assemblies46which provide fluid communication with an interior of the tubular housing assembly. One stop cock assembly46is intended to provide the anchor delivery device20with a continuous flow irrigation. Another stop cock46is contemplated to be used to accomplish a suction function through the device. Either of these assemblies can further be employed to deliver therapeutic or diagnostic substances to the interventional site. For example, in a procedure to treat a prostate gland, substances that cause the prostate to decrease in size such as 5-alpha-reductase inhibitors can be introduced at the treatment site. Other substances but not limited thereto, which may be introduced at the site include various scarring agents, rapamycin and its analogues and derivatives, paclitaxel and its analogues and derivatives, phytochemicals, alpha-1a-adrenergic receptor blocking agents, smooth muscle relaxants and other agents that inhibit the conversion of testosterone to dihydrotestosterone.

A terminal end portion48of the tubular housing assembly24of the anchor deployment device20includes a nose assembly50shaped to provide an atraumatic surface as well as one which facilitates desired positioning of components of an anchor assembly (SeeFIG. 2A). That is, by including structure that can mimic the ultimate position of a proximally oriented component of an anchor assembly, an operator can test the effect of the anchor assembly prior to implantation. Once the operator confirms that the subject anchor component will be positioned as desired, the implantation of the anchor is then undertaken and accomplished.

Once implanted, the anchor assembly51(SeeFIGS. 2Band C) of the present invention accomplishes desired tissue manipulation, compression or retraction as well as cooperates with the target anatomy to provide an atraumatic support structure. In particular, as shown inFIG. 2C, the shape and contour of the anchor assembly51can be configured so that the assembly invaginates within target tissue, such as within natural folds formed in the urethra by the opening of the urethra lumen by the anchor assembly. In fact, in situations where the anchor assembly is properly placed, wispy or pillowy tissue in the area collapses around the anchor structure. Eventually, the natural tissue can grow over the anchor assembly51and new cell growth occurs over time in the areas shown inFIG. 2C. Such cooperation with target tissue facilitates healing and avoids unwanted side effects such as calcification at the interventional site.

Furthermore, in addition to an intention to cooperate with natural tissue anatomy, the present invention also contemplates approaches to accelerate healing or induce scarring. Manners in which healing can be promoted can include employing abrasive materials, textured connectors, biologics and drugs.

It has been observed that placing the anchors at various desired positions within anatomy can extract the best results. For example, when treating a prostate, one portion of an anchor can be placed within an urethra. It has been found that configuring such anchors so that ten o'clock and two o'clock positions (when looking along the axis of the urethra) are supported or retained, effectively holds the anatomy open and also can facilitate invagination of the anchor portion within natural tissue. This is particularly true in the regions of anatomy near the bladder and the juncture at which the ejaculatory duct connects to the urethra.

Additionally, the terminal end portion48(FIG. 2A) includes a plurality of spring biased, vertically stacked ring anchor components52strategically positioned with respect to telescoping structure of the tubular housing assembly for the purpose of assembling an anchor device. As will be apparent from further description below, the stacked anchor component52is one of two parts which form a second anchor component. To accomplish the biasing of the anchor components52, a leaf spring54is placed in apposition with the anchor component52that is at the bottom of the stack of components. Internal molded walls and bosses of the nose assembly48form a space to both receive the stacked anchor components52as well as provide an area to retain the leaf spring54and provide a base structure against which force supplied by the leaf spring can be generated and transmitted to the anchor components52.

As can be seen fromFIG. 2A, terminal end portions of an upper tubular member56, a needle housing58and a telescope housing60are positioned within the nose assembly. Referring now toFIG. 2D, one can better see the internal components forming the tubular housing assembly. For representation purposes, the outer sheath44is not depicted inFIG. 2Aand the internal components of the tubular housing assembly are shown separate from the nose assembly and handle assembly. As shown, the upper tubular member56, the needle housing58and telescope housing60extend longitudinally. The outer sheath (not shown inFIG. 2A) covers a substantial length of each of the upper tubular member56, needle housing58and telescope housing60. Each of these structures also include internal bores, the upper tubular member56sized to slideably receive a pusher assembly (described in more detail below) and the needle housing58sized to slideably receive a needle assembly58(also described in more detail below). Further, the telescope housing60is sized to receive a conventional telescope (not shown), which in one approach, fills the entire space provided by the internal bore of the housing60. A cross-sectional view of a portion of the tubular housing assembly attached to the handle assembly22(with the nose assembly removed) is shown inFIG. 2F.

Turning now toFIGS. 2E and 2F, the internal components of the handle assembly will be described. In one preferred embodiment, the handle assembly22houses a needle assembly advancement and retraction subassembly66that interacts with the movement of the first actuator. The first actuator includes a projection68extending through the housing assembly22and is placed in operative association with the advancement and retraction subassembly66.

The needle assembly advancement and retraction subassembly66includes an outer collar70configured about an inner collar72. Configured between the outer collar70and an internal front surface74of the handle assembly22is a first compressor spring75. Placed within the outer collar68and between the inner collar72and an internal front surface76is a second compression spring77. Additionally, attached to the outer collar70is a lock assembly78which rotates between locked and unlocked positions.

While the first actuator is in an open position (SeeFIG. 1), the compression springs75,76assume expanded configurations (SeeFIGS. 2Eand F). Also, the lock assembly78is in a disengaged or unlocked configuration. It is at this stage that the needle assembly (described below) is in its retracted state and housed completely within the needle housing58.

One preferred embodiment of a first or distal component82is shown inFIGS. 3A and 3B. In an unconstrained configuration, the first component forms a generally T-configuration (FIG. 3B). When constrained within an anchor delivery device, the first component defines a substantially straight member (FIG. 3A). While the component can be formed from a number of materials and manufactured using various conventional approaches, it is contemplated that the component82be cut from a nitinol tube using a laser. Using a superelastic material such as nitinol provides the component82with the resiliency to transform between a flipped T-configuration and a straight configuration.

As shown, the first component82includes a first portion84which at one end defines a cylindrical structure and at the other a partial cylindrical structure. When unconstrained, this first portion84forms a T-bar or top of the first component82. A complementary partial cylindrical structure forms a mid-section or second portion86of the first component82and operates as a spring to accomplish the flipping of the first portion84between constrained and unconstrained configurations. When the component is in its constrained, straight form, the second portion is positioned adjacent the first portion84. A third portion88is also cylindrical in shape and extends from the second portion86away from the first portion84of the first anchor component82. The third portion88slides freely with respect to a connector, the connector being attached to the first portion84and a second anchor component as will be described below.

One part of the second anchor component52is best seen inFIG. 3C(previously depicted as stacked anchor components inFIG. 2A). This component is generally cylindrical in form and includes integrally formed rings90spaced along an outer surface of the device, such spacing can be varied as necessary for a particular purpose. The device further includes a internal bore92which extends the entire length thereof. A proximal end93of this part of the second anchor component52includes an opening to the internal bore92. The opening to the bore92is surrounded by a first ring90and is sized to receive in a locking arrangement the connector which will attach the first anchor82to the second anchor component52. Additional rings90are spaced longitudinally along an outside surface of the component.

As shown inFIG. 3D, a second part98of the second anchor component52can be sized and shaped to both engage a connector and to lockingly engage the first part. Although various forms of the second part98are contemplated and described below, in one approach, the second part is generally cylindrical and includes a pair of spaced arms, the outer profile being sized to fit within the internal bore92of the first part.

The connector94(SeeFIG. 3E) can be formed from any material which provides the desired holding force between first and second components. In one preferred embodiment, the connector is formed from conventional connector material for example monofilament polyester. In a preferred embodiment, the connector94is monofilament polyethylene terephthalate (PET). The connector material embodies desirable flexibility as well as tensile strength. The monofilament PET size 2-0 is preferred because of high tensile strength when tensioned and high column strength to push the series of parts82through and out the needle. In addition, the monofilament helps reduce or eliminate the possibility of infection. As such, when used as a connector94, such material can be flexed at sharp angles to access various anatomical structures and surfaces and can also be relied upon to transmit necessary forces between the first and second anchor assemblies. One or more first anchor components82can be affixed along a length of the connector94. Further, various approaches can be employed to attach a first anchor component82to the connector. For example, the components can be affixed by an adhesive or can include tabs or other structure which is deformed into a locking arrangement with the connector94. Moreover, the anchor component82can simply be crimped directly to the connector94or the connector itself can include structure which is complementary to that of the component to accomplish affixation. It may be advantageous to employ an assembly capable of handling a connector equipped with a plurality of anchor components spaced along the connector since such a system has the ability to assemble and deliver multiple anchor assemblies without needing to reload.

One embodiment of a completely assembled anchor assembly92is depicted inFIG. 3F. In the embodiment shown, the assembly includes a single first anchor component82. In certain applications, however, it may be desirable to employ a device having a plurality of spaced first anchor components. Such spacing can be varied as desired for a particular application.

It is also contemplated that the completed anchor assembly is formed from components which are held together magnetically. For example, the first anchor component82and the second anchor component52,98can be held in place through magnetism and without the need of a connector. In such an approach, either both or one of the anchor components can be a magnet.

Moreover, as can be seen fromFIG. 3F, the second anchor component embodies the first part52which can be deployed from the stacked group of such members housed within the terminal end portion48of the tubular housing assembly24(SeeFIG. 2A), as well as the second part98which, by operation of the anchor delivery device20(described below), lockingly engages the first part52.

As previously mentioned, a completed anchor assembly96can be employed to manipulate tissue and other structure found within a patient's body for various purposes. In order to do so, the first anchor component82is initially positioned in an apposition with a first body structure, such as the outer surface of the prostate capsule, and the second anchor component assembly (52,98) is placed against a second body structure, such as the inner surface of the urethra, the connector94holding the desired spacing between the two body structures to accomplish the desired manipulation.

Additionally, it is contemplated that all components of the anchor assembly96or selected portions thereof (of any of the anchor assemblies described or contemplated), may be coated or embedded with therapeutic or diagnostic substances (e.g. drugs or therapeutic agents). Again, in the context of treating a prostate gland, the anchor assembly96can be coated or imbedded with substances such as 5-alpha-reductase which cause the prostate to decrease in size. Other substances contemplated include but are not limited to phytochemicals generally, alpha-1a-adrenergic receptor blocking agents, smooth muscle relaxants, and agents that inhibit the conversion of testosterone to dihydrotestosterone. In one particular approach, the connector95can for example, be coated with a polymer matrix or gel coating which retains the therapeutic or diagnostic substance and facilitates accomplishing the timed release thereof. Additionally, it is contemplated that bacteriostatic coatings can be applied to various portions of the anchor assemblies described herein. Such coatings can have various thicknesses or a specific thickness such that it along with the connector itself matches the profile of a cylindrical portion of an anchor member affixed to the connector. Moreover, the co-delivery of a therapeutic or diagnostic gel or other substances through the implant deployment device or another medical device (i.e. catheter), and moreover an anchor assembly including the same, is contemplated. In one such approach, the deployment device includes a reservoir holding the gel substance and through which an anchor device can be advance to pick up a desired quantity of therapeutic or diagnostic gel substance.

The connector94can have associated therewith various structures which facilitate the attachment of anchor structures. Although intended for the first anchor component82, such structure can also be used for the second anchor component52,98. In one approach (FIG. 3G), the connector94is coined100in a manner that provides structure to which an anchor member can form a locking engagement. As shown inFIG. 3H, structure facilitating a locking engagement with anchor structure also can also be in the form of a ball-chain102. Furthermore, a connector94can be equipped with crimped metal or other structures104for this purpose.

Turning now toFIGS. 4A-4I, various alternatives of first anchor components82are presented. In particular, those depicted inFIGS. 4A-Ieach include a structure which flips to assume an angled or generally lateral configuration when the component is unconstrained. In a constrained configuration, these components define a generally cylindrical profile (as shown inFIG. 4A).

Moreover, each of the various alternative embodiments can be formed from conventional materials. In one aspect, the components can be formed by laser cutting a nitinol tube. However, it is to be recognized that other materials and manufacturing approaches are also contemplated for example EDM of stainless steel.

For example, the connector shown inFIG. 4Aincludes a proximally oriented collar106which is intended to be slid along a connector as the second portion flips or rotates. A spring member86defines a bar arm which forms a bridge between the collar106and a second portion108which flips or rotates with respect to the collar106when the device is unconstrained as shown inFIG. 4B. In another approach (FIGS. 4C and 4D), the spring member86forms a bridge between the collar106and a second portion108which includes a pair of members which in a constrained configuration extend in opposite directions along the connector94and when unconstrained, form a T-bar structure. In yet another approach (FIGS. 4E-F), the anchor component82can include a pair of collars106configured between which are first and second springs86. Attached to each spring86is a second portion108, each of which assume angled or lateral positions to thereby form an overall cross-like structure when unconstrained. Like the other embodiments, the component defines a generally straight, cylindrical structure when constrained.

FIGS. 4G-Idepict further embodiments of structures that can be employed as first anchor components82or alternatively, can be used solely as structures for advancing the anchor assembly sub-components within the anchor delivery device or a patient's body. Each of these depicted structures include various forms of tails110which can be employed to advance the anchor components82through direct engagement with a terminal end of a pusher assembly (not shown) or for registering within slots formed in a pusher assembly. These tails also help to flip, turn or angle the component82relative to connector94. One embodiment of the tail (FIG. 4G) is a simple extension of a partial cylindrical member which is bent away from the connector94. Another approach (FIG. 4H) involves a long tail110which is folded against the connector94and yet another approach (FIG. 4I) involves a tail110that rather than folded against the connector includes a narrowed section which is bent away from the connector and terminates to assume a beaver tail-like shape.

With reference now toFIG. 4J, yet another embodiment of a first anchor component82is presented. In this embodiment, the first anchor component includes a full tube portion107connected to a half tube portion109by a coiled portion111. The device can further include connector attachment points formed along the full tube portion109. The coiled portion111provides flexibility in multiple planes and thus facilitates pushing the device through bends or angles formed in the deployment device employed to deliver the first anchor component82.

In a first step to deliver and deploy an anchor assembly for the purpose of manipulating tissue or other anatomical structures, the telescope device is employed to view the positioning of the device20at the interventional site, for example, the tubular housing assembly24of the device is inserted into the penis of a patient and advanced until the distal end48is adjacent an interventional site in the urethra (UT) adjacent the bladder (UB; SeeFIG. 5A). It has been found that a mechanical solution to the treatment of BPH such as that of the present invention, can be more compatible with patients recovering from prostate cancer compared to energy-based solutions. Furthermore, the present invention also contemplates steps for sizing the anatomy. As it relates to BPH treatment, the present invention also involves the placement of an ultrasonic or other device in the patient's body, such as in the rectum, to measure the necessary depth of insertion of the anchor deployment device within the patient's body. This information can be used to set or create a depth stop for the needle assembly so that the operator can readily determine whether desired sections of the patient's anatomy have been accessed. After so positioning the deployment device within the patient, the first actuator36of the delivery device20(SeeFIG. 1) is then caused to be pivoted towards the handle assembly22. Doing so causes the needle assembly112to be advanced distally and then laterally through a terminal end of the needle housing58. The lock assembly78retains the needle in the advanced configuration (SeeFIGS. 5Cand D). It is to be noted that the lock assembly78can be configured to automatically unlock or to require manipulation to disengage from a locking position. In a procedure to treat the prostate gland (PG) the needle assembly112is advanced through the prostate gland to a first implant position (SeeFIG. 5E). Moreover, it is to be recognized that first forked member113is translatable longitudinally either by hand or through action of a trigger or activator. InFIG. 5D, the first forked member113is shown retracted to more easily represent other system components, but in use, at this stage of deployment, the member113is contemplated to be in an advanced position into engagement with slot115. Further, it is to be understood that for ease of system representation, second forked member119is shown in a truncated form, in that at this stage of deployment the terminal end of the member119extends beyond the vertical stack of second anchor components52, thereby holding the stack in a staged configuration. Finally, the present invention also contemplates a single member replacing the forked members113,119depicted, such a part of member56which can have portions which provide the function accomplish by the terminal ends of the members113,119.

Notably, the needle assembly112has a generally tubular shape and terminates with a sharp point114. A lumen extending the length of the needle assembly112is sized to receive both components of the anchor assembly as well as structure for advancing the assembly through and out of the terminal end114. Although various materials are contemplated, the needle assembly112is intended to be formed from resilient material such as nitinol or other materials or polymeric substances. Moreover, although various angles are contemplated, in one approach the needle housing58includes a distal section angled such that the needle projects at angles approaching or at 90 degrees with respect to a longitudinal axis of the tubular housing assembly24.

Once access is made at an interventional site to target tissue or anatomical structure and the first actuator is manipulated to advance the needle assembly114to a desired position, the actuator is further manipulated to release the lock assembly78as well as to cause the internal compression springs to retract the needle assembly. Note that the position of the first actuator36will return to the open position (SeeFIGS. 1,2E and2F). The result of this action is depicted inFIGS. 5F, G, H, I and J. (Again, note that member113and119are shown in retracted or truncated forms inFIGS. 5F, G and H for clarity of representation.) That is, as the needle assembly112is retracted, the first anchor component82and connector94remain in an advanced configuration (FIGS. 5Iand J). It is at this stage that the first anchor component has been positioned as desired against a first anatomical body structure (SeeFIG. 5J).

Contemporaneously with the retraction of the needle assembly112, is the withdrawal of the structure used to advance the first anchor component82and connector structure94within the needle housing58. In one embodiment (SeeFIG. 5K), the advancing structure is in the form of a pusher assembly116. The pusher116can assume a generally cylindrical tube formed form a metallic or polymeric material which is sized and shaped to directly engage the first anchor component82. Moreover, the pusher116could define a solid elongate member of polygonal or circular cross-section. Also, it can be configured to directly engage the connector94directly or other structure formed on the connector94(SeeFIGS. 3G-I). In another aspect, the pusher can be sized to surround the first anchor member82and to engage a tail (SeeFIGS. 4G-I) for example, of the anchor member once the pusher is pulled proximally with respect to the anchor member. When the pusher116initially surrounds the anchor member (or other structure formed directly on the connector94), the tail is held in compression, only to be released to extend laterally from the connector when the pusher is moved proximally. In this way, the pusher assembly116can both be withdrawn when desired and advance the anchor member82and connector structure94when necessary. In another approach, the tail can be held in compression by the internal surface of the needle (not shown).

As shown inFIG. 5H, the complete withdrawal of the pusher116and needle assembly112exposes the full length of connector anchor structure for use in ultimately manipulating anatomical structures. Such complete withdrawal involves both the pusher116and needle assembly to be housed completely within the needle housing58.

Alternative approaches for advancing anchor components within the anchor delivery device20are contemplated. That is, rather than having a pusher assembly which surrounds an anchor component and relies upon engagement with a tail structure of an anchor component or other structure projecting from the connector member, other structure can be employed to provide the ability to push and pull an anchor component. In one such approach (SeeFIGS. 6A-C), the delivery device can be equipped with a pusher member116in combination with a pull wire118. The pusher member116in this approach remains proximal an anchor member82to be advanced along the delivery device. Such anchor members82can be placed in a position distal the pusher, for example, by being released from a cartridge configured distal to the pusher position or the delivery device can be a single use apparatus.

The anchor member82, in turn, can include a proximal portion characterized by a pair of elastically or plastically deformable arms120which in a first configuration are held to the pull wire118and in a second configuration, are released from the pull wire118. Accordingly, the pusher member116is advanced with respect to the pull wires118to cause the arms120to become disengaged from the pull wire. In the embodiment shown inFIGS. 6Aand B, the arms120are plastically deformable whereas the arms120of the anchor member82ofFIG. 6Care elastically deformable. The elastically deformable arms120can be formed from resilient material such as nitinol. The plastically deformable arms120on the other hand can be made from less resilient material.

Further alternative embodiments of pusher members116are shown inFIGS. 6D-G. A pusher member118having a D-shaped cross-sectional profile is contemplated for certain uses. Such a profile enables the pusher member116to be placed along side the anchor component82and connector94assembly, a distal portion of the D-shaped configuration engaging complementary structure on the connector assembly.

Also contemplated is a pusher assembly116which includes a side opening122in communication with a lumen extending through the pusher116(SeeFIG. 6E). Threaded through the side opening122is a distal portion of the anchor component82and connector94assembly. In this arrangement, the distal-most anchor component82is placed against the terminal end of the pusher member116to accomplish advancement of the anchor component82and connector116assembly as the pusher116is extended distally.

In yet another approach, as shown inFIGS. 6Fand G, the pusher member116includes a terminal end123configured with a D-shaped profile suited to engage and advance an anchor/connector assembly94. A proximal section of the pusher116is equipped with a plurality of spaced detents or cavities124sized and shaped to receive anchor components82or other structure formed on the connector94. In this approach also, the pusher member116is configured to reside longitudinally adjacent the anchor/connector assembly82,94. Advancement of the anchor/connector assembly82,94is accomplished through an engagement between certain of the anchor/connector assemblies82,94and the cavities124.

Various measures can be taken to ensure proper loading of a first anchor member82within an anchor delivery device. In a first step, the anchor member82is loaded within an anchor protection cover126(FIG. 7A). A pusher member116is configured proximal to the connector94of the first anchor member82to accomplish advancement of the first anchor member82into and through the needle assembly112(SeeFIGS. 7Band C). This subassembly is insertable within a delivery device bay128. A distal portion130of an interior of the delivery device bay is equipped with a conical taper configured to receive a distal complementary portion of the anchor protection cover126thereby accomplishing the centering of anchor member within the delivery bay128. An internal lumen extends the length of the protection cover126and the cover126includes a ring seal132placed within a proximal end thereof. The ring seal132functions to hold the cover126on a pusher member116.

The delivery device bay128can further include a bayonet lock mount134that couples a spring loaded cartridge136to the delivery device bay128. Housed within the cartridge is a compression spring138configured about the pusher member116. The spring cartridge138can also include a lock-out structure140which operates to limit the tension placed on the anchor member82and connector94until the needle112is withdrawn sufficiently from the interventional site to avoid damage from the needle112inadvertently engaging the anchor/connector assembly82,94. That is, the pusher116includes a proximal end configured with an anchor deployment tab142that engages the lock-out structure140, prohibiting the compression spring138from applying tension to the anchor/connector assembly82,94before the needle assembly112is clear of the interventional site.

In another contemplated variation (FIG. 7D), the anchor delivery device can be fashioned with a multi-shooter anchor cartridge assembly144. One feature of this approach is the involvement of a manifold146including four entries which feed into a lumen extending into a needle assembly112, each entry configured to receive one anchor/connector assembly82,94. Proximal sections of the connector94are configured into spools148which are driven by a torsional spring drive shaft150. The drive shaft150is in turn, configured with complementary teeth structures154formed on each spool. The assembly further includes structure (not shown) adapted to cause lateral movement in the driveshaft150so that its teeth152indexes from spool to spool148to thereby turn the spools148and advance the anchor members82within the needle assembly112. Once the anchors82are advanced through the needle112, the torsion spring retracts excess connector94length and clears the needle112for the next anchor member82.

It is further contemplated that in certain embodiments, the anchor delivery device can include the ability to detect forces being applied thereby or other environmental conditions. Although various sections of the device can include such devices, in the depicted structure ofFIG. 7E, sensors156can be placed along the needle assembly112. In this way, an operator can detect for example, whether the needle has breached the target anatomical structure at the interventional site and the extent to which such breaching has occurred. Other sensors which can detect particular environmental features can also be employed such as blood or other chemical or constituent sensors. Moreover, one or more pressure sensors or sensors providing feedback on the state of deployment of the anchor assembly during delivery or after implantation are contemplated. For example, tension or depth feedback can be monitored by these sensors. Further, such sensors can be incorporated into the anchor assembly itself, other structure of the deployment device or in the anatomy.

In a next stage of anchor deployment, with reference toFIGS. 8A-E, after the first actuator36is completely released thereby effecting the complete withdrawal of both the needle assembly112and pusher member116, the second actuator36is pulled proximally to initiate the assembly of the second or proximal anchor member52,98(SeeFIG. 8A). Note that inFIGS. 8C, D and E, member113is shown in its advanced or forward position within slot115, wherein member119is shown with its terminal end truncated. With reference toFIG. 8B, which depicts internal components of the integrated anchor assembly associated with the second actuator (other structure being removed for better understanding), as the second actuator36is depressed, it engages a lever assembly120including a slotted portion122to drive a rack assembly124distally. The slotted portion122of the lever assembly120provides the lever with the ability to both rotate with respect to a mount126of the rack assembly124as well as advance the mount126as well as the rest of the rack assembly124distally. Various pawls130are provided to releasably lock the rack assembly124in desired stages of advancement. It is to be recognized, however, that various other approaches to manually locking or unlocking structure for advancing components of the second anchor assembly are contemplated. In the depicted embodiment, the rack assembly124, is in turn, connected to a telescoping pusher member which is configured to engage a second part of the second or proximal anchor assembly.

As shown inFIGS. 8C-E, depressing the second actuator38causes a pusher157to advance a second part98of the second or proximal anchor member to be advanced towards and into locking engagement with the first part52of the second anchor member. As the second part98is advanced, it captures the connector structure94and retains it in a locking engagement between the first52and second98parts.

It is at this stage that the connector94is severed to thereby accomplish the formation of the complete anchor assembly (SeeFIG. 3E). In one embodiment, the severing can be effected by the advancement of the telescoping pusher member via the depression of the second actuator38. Alternatively, the severing action is operatively associated with the actuation of the third actuator40. Thereafter, the second actuator38is released, automatically or manually, to permit the re-staging of both the first52and second98parts of the second anchor member. That is, in one contemplated approach, members113and119are withdrawn to allow the release and deployment of the second anchor member52,98and then advanced again after the desired staging of component52.

The present invention also contemplates a myriad of alternative embodiments of the proximal or second anchor member. In a majority of the next presented descriptions regarding these embodiments, the second anchor member is comprised of a first part52which is placed into a locking engagement with a second part98. In doing so, the first52and second parts98are affixed to the connector94. It is to be recognized that the first and second parts can be formed of any conventional materials such as metals or polymeric materials.

With reference toFIGS. 9A-C, the second anchor member includes a generally tubular first part52including a slightly flared mouth configured to receive both a portion of the connector94and a second part98. In this embodiment, the second part includes a pair of spaced arms158which capture the connector and facilitates advancing the connector within the mouth of the first part. It is contemplated that the arms158are spaced to an extent greater than an interior of the tubular first part52so that in combination with the area occupied by the connector94, a locking engagement between the first and second parts is accomplished upon the full insertion of the second part98within the first part52. Thereafter, excess connector94length can be cut away to form a complete second anchor assembly.

In a slightly modified approach (FIGS. 9D-9F), the second part98includes a spike-like terminal end portion160which can be configured to engage the connector94and insert it within an interior of a tubular first part52. The spike-like terminal end portion160defines a tapered structure, a section with an enlarging dimension of which is sized and shaped to lockingly engage with the interior of the first part52. The completed assembly is characterized by a portion of the connector94retained between the first52and second parts98.

The approach depicted inFIGS. 9Gand H is slightly different. The connector94is arranged to be threaded through a pair of oppositely arranged apertures162formed in a generally tubular first part52. The first part52further includes a mouth equipped with a plurality of proximally oriented, radially spaced arms164. The second part98also defines a generally tubular structure, one having a section with a smaller outer profile than an interior of the first part52. The second part98further includes a pair of distally oriented projections166as well as a back end equipped with a gear-like collar168. To accomplish a locking arrangement between the first52and second98parts, the second part98is inserted within the first part52so that the projections166are configured on opposite sides of the connector. The collar168is then used to rotate the second part98with respect to the first part until the connector94defines an S-shaped portion within an interior of the first part. The second part98is thereafter fully inserted into the first part, the gear-like collar being configured to register between the radially spaced arms164of the first part52to thereby lock the two parts to each other. Furthermore, it is to be recognized that these structures of the first52and second98parts can be reversed in that the first part52can assume the structure of the described second part and vice versa.

The embodiments depicted inFIGS. 9Iand J take a similar approach to that shown inFIGS. 9Gand H. That is, each take advantage of a locking engagement resulting from the rotation of one part of the second anchor member with respect to the other. Again, each of these embodiments include a first part52with pair of apertures162through which a connector94is threaded. The assembly depicted inFIG. 9Iincludes a first part52configured with internal threads168which are complementary to external threads170formed on a second part98. Thus, as the second part98is placed within the first part52, it is rotated, the complementary threaded portions forming the locking engagement between the two parts. The assembly ofFIG. 9Jtakes advantage of a second part98including arms166which are bent radially outwardly and the bent portion being sized to facilitate a locking arrangement with an interior of the first part52. This particular approach is also characterized by the first52and second98parts having rounded terminal ends which provide an atraumatic surface which can be desirable in certain situations. Again, the structures of the first and second parts can be reversed if desired as can those of the following approaches.

As shown inFIG. 9K, another approach involves a first part52including a pair of proximally oriented projections172which can be formed by splitting longitudinally the mouth to the generally tubular first part52. The connector94is captured between the distally oriented spaced projections166of the second part98and the proximally oriented projections172of the first part52as the second part98is inserted within the first part52.

In yet another approach (FIG. 9L), the second part98is pre-loaded with a lock ring174, which is oriented about the second part98at a proximal end portion thereof. As the second part98is advanced over a connector and into engagement with a first part, its spaced arms166enter an interior of the first part. Once the second part98is seated within the first part, the lock ring174is then advanced over the second part98to accomplish a locking arrangement.

The first part52can also define a generally tubular member having an oval cross-sectional profile. Such a structure is depicted inFIGS. 9Mand N. Further, one of the oppositely oriented apertures162formed in the first part52can further include a slotted-portion172sized to receive a portion of a connector after the first part52is placed in a locking arrangement with the second part98. The first part52further includes a pair of openings178configured on opposite lateral sides of the device. In these embodiments, the second part98defines a relatively flat member, the distally oriented arms166of which include projections180having a ramped portion. Although different structure is employed, both embodiments of the second part98further include a second pair of projections182formed at proximal end portions of the respective devices. As the second parts98of these approaches is advanced within the first part52, the first projections180act to compress the arms together then are advanced past the lateral apertures178of the first part52and are configured beyond a distal end (not shown) of the first part52. Once the second part98is fully inserted in the first part52, the second pair of projections182register within the lateral openings178formed in the first part52, thus forming a locking engagement.

The first part52can also be formed form a member having a deformable, enlarged mid-section184(SeeFIGS. 9Oand P). In one approach, the enlarged mid-section184can be formed by longitudinally cutting a portion of the first part52and separating the material forming this portion to define the opening162which is as before, intended to receive a portion of the connector. As the second part98in the form of a generally tubular sleeve is advanced over the first part52, the mid-section184is compressed, such compression effecting a locking engagement between the first and second parts.

The second part98(SeeFIGS. 9Qand R) can also include laterally spaced tabs180which slide within an interior of a generally tubular first part52. The spaced areas166capture a portion of the connector94. Once the second part98is fully inserted within the first part52, the laterally spaced tabs lock in place outside a proximal end of the first part52. In the process, the portion of the connector94captured by the arms166is compressed and held in place between the first52and second parts98.

Turning now toFIGS. 9S-U, further approaches to accomplishing a locking arrangement between first52and second98parts are presented. The embodiment ofFIG. 9Sis characterized by a first part having a generally oval cross-sectional profile and including both the first lateral apertures178as well as a pair of oppositely oriented, second lateral apertures186. The second part is a generally flat member characterized by a proximal end configured with a stop in the form of a T-bar184. As the second part98is advanced within the first part52(not shown), the tabs180formed on the second part first register within the first lateral openings178. Thereafter, the second part is further inserted within the first part52to capture the connector which is threaded through the apertures162formed in the first part52. Yet further advancement of the second part98configure the detents180within the second lateral openings186of the first part52. The proximal stop188is at this time placed in apposition with a proximal end of the first part.

In a similar approach (SeeFIGS. 9T-U), the generally flat second part98includes both the first180and second182tab structures. As the second part98is advanced within the first part52, the first tabs180initially register within lateral openings178of the first part52, which can act as a staging for subsequent advancement and capture of a connector. Upon such subsequent advancement, the first tabs180are held within an interior of the first part52and the second tabs182register within the lateral openings178of the first part52.

As shown inFIGS. 9Vand W, the first part52can also assume a pin-like structure with spaced arms190. The second part98can define a generally tubular structure including distally oriented arms166. Insertion of the first part52within the second part98causes the spaced arms190of the first part52to compress about a portion of a connector to form a locking arrangement. It is to be recognized that this approach to a locking arrangement can be modified in principle, in that, as stated above, the structures of the first52and second98parts can be reversed.

Moreover, the second part98can assume a generally tubular structure including a cutting projection192(SeeFIG. 9X) arranged to engage a connector94upon insertion of the first part52within the second part98. In this way, further action beyond placing the first52and second98parts into locking engagement, is not required to sever the connector94. Again, it is to be recognized that the structures of the first52and second98parts can be reversed to also take advantage of this approach.

In a number of related approaches (See FIGS.9Y-9AH), the second anchor component can be formed of a single integral locking member194. Certain of these members194are intended to be formed of plastically deformable material so that it can first assume a generally open configuration and then be deformed to define a closed position in a locking arrangement about a connector member. Alternatively, these members194can be formed of resilient material and be first held open and then allowed to self-collapse about a connector. In one such locking member (FIGS. 9Y), the integral member194is generally V-shaped and includes a pair of diverging arms198which can be arranged into locking contact with a connector194. Another locking member194(FIG. 9Z) is characterized by a clam shell profile, an interior of the arms196of which is suited to lock with a portion of a connector94. The locking member194of FIG.9AA is also generally V-shaped and further includes a pair of diverging arms196, one of which includes bosses198designed to mate with recesses200. A center section of one arm196is bent to provide space to receive a connector.

In FIGS.9AB-AC, there is shown a plastically deformable locking member194that is configured with a collapsible aperture202. In an undeformed configuration, the aperture202is formed by walls defining a generally hour glass shape. Applying a longitudinal compression force to the locking member194causes the aperture202to collapse about and lock with a portion of a connector94, the walls deforming inwardly and engaging the connector94.

The locking member194can also be embodied in a device including a mid-section characterized by helically arranged members204(See FIGS.9AD-AE). The opening202defined by the helical member204is sized to receive a connector member. This device can either be formed of plastically or elastically deformable materials such that collapsing the opening202about a connector can be accomplished through the application of a force to the locking member194or by removing a compression force from the member.

In still yet other approaches (FIGS.9AF-9AH), the locking member194can be embodied in a member including diverging arms196projecting from a cylindrical base204. One arm includes a boss or raised portion198sized to fit within a recess200. A mid-section of the device further includes a generally circular space206defined by semi-circular cutouts formed in the opposing arms196. This space is sized to lockingly engage a connector when the arms196are in a closed configuration. The locking member194of FIGS.9AG-AH also includes this circular space206defined by semi-circular cutouts formed in the diverging opposing arms196as well as the locking projections198. However, rather than the cylindrical base204of the embodiment of FIG.9AF, the arms196and the locking member194extend proximally beyond the circular space206. This portion of the arms196also include a complementary projection198and recess200arrangement.

In a related approach (See FIG.9AI), the locking member194can be deformed about a connector94employing an anvil210. Such an anvil custom designed for the various approaches can be employed to deform the previous disclosed embodiments of other members. As the locking member194is advanced within the anvil, angled surfaces within an interior of the anvil operate to close the arms196of the locking member194. Narrowed portions212of the locking member facilitate such closing of the arms about a portion of the connector94. Once the arms are inserted into an interior cavity214of the anvil210, a cutting blade216severs the connector94to length as desired.

Turning now to FIGS.9AJ-K, further embodiments of a second anchor member including a first part52and a second part98are presented.

In these approaches, the second part98includes arms196which are biased to an open configuration. Using an anvil210housing a first part52in the interior cavity214, the second part98is caused to be inserted and held within the first part52. In a first embodiment (FIG.9AJ), the arms196of the second part98are relatively long compared to those of a second embodiment (FIG.9AK). In both approaches, however, a generally tubular first part52retains the arms196in a closed position in locking engagement about the connector94.

Returning to the concept of a second anchor member defining a locking member194(See FIGS.9AL-AM), in still yet another approach the capturing of the connector can be accomplished using a clip-like structure. A pair of arms196begin at a proximal end of the device in a spaced arrangement. As the arms extend distally, they cross at mid-point218beyond which a distal portion of the arms are adjacently arranged in apposition. One or both arms196can include a recess providing a space to allow the arms196to cross at the mid-point218. Applying a force to the proximal, spaced portion of the arms196causes the distal portion of the arms196to open. When opened, the arms196can be configured to receive a connector. A closing force between the distal portion of the arms196of the locking member194accomplish locking the structure on a connector.

The first part52of the second anchor member can also be configured from a flat sheet of material into which a pattern is cut to form various slots and tabs (See FIGS.9AN-AO). These first parts52can be formed of material which is capable of self-forming from the flat configuration into a generally tubular configuration when unconstrained. For example, material such as nitinol which has memory properties can be used to form such structure. A first contemplated flat pattern (See FIG.9AN) includes a central five sided aperture222on either side of which are configured slots224cut in from lateral side edges of the structure. In a second pattern (FIG.9AO), the lateral slots222are replaced with cutouts which define tabs226.

Irrespective of the specific form of the anchor assembly, a next step in the context of prostate treatment involves positioning the proximal anchor assembly52, for example, within a desired section of the urethra (UT) of the patient (SeeFIG. 10A). Prior to doing so, the patient can be monitored to determine whether there has been any evidence of improvement through the placement of the anchor. One such symptom is whether there has been any urination. After so checking, the proximal anchor assembly52can be implanted. The patient is the again checked for evidence of improvement (i.e., flow improvement, visual appearance, opening of the urethra, urination, etc.). Next, the connector94is severed and the integrated anchor delivery device is withdrawn (SeeFIG. 10B) and ultimately removed from the patient's body.

Accordingly, the present invention contemplates both pushing directly on anchor portions of an anchor assembly as well as pushing directly upon the connector of the anchor assembly. Moreover, as presented above, the distal or first anchor component is advanced and deployed through a needle assembly and at least one component of the proximal or second anchor component is advanced and deployed through a generally tubular potion of the anchor deployment device. Further, both a single anchor assembly or multiple anchor assemblies can be delivered and deployed at an intervention site by the deployment device. Consequently, in the context of prostate treatment, the present invention accomplishes the compression of both the urethra and prostate gland, the delivering of an implant at the interventional site, applying tension between ends of the implant, and the invagination of the implant within natural tissue. Moreover, drug delivery is both contemplated and described as a further remedy in BPH in treatment.

An alternate embodiment of a distal portion of an anchor delivery device is shown inFIGS. 11A-C.FIG. 11Adepicts the device in a stage of operation where the needle assembly112has been extended through the needle housing60and configured to project laterally from a distal end portion48of the device and is in the process of being withdrawn over the connector94and first anchor member82assembly.FIG. 11Bshows the position of the pusher assembly116once the needle assembly has been fully retracted within the needle housing58. A retractable cover228shown in its advanced position includes a side aperture230through which the needle112and pusher116assemblies can be advanced to thereby place the connector94in a position for engagement by first and second98parts of the second anchor member. To effect longitudinal movement of the cover228, a sliding arm232is provided and placed into engagement with the cover. The sliding arm232, in turn, is operatively associated with an actuator (not shown) pivotably attached to a device handle. In a further step of use (SeeFIG. 11C), the connector94is severed and equipped at its proximal end with one embodiment of a second anchor member assembly.

In one particular approach (SeeFIGS. 12A-B), the delivery device can be equipped with an alignment tube234including inwardly directed tabs236sized and shaped to be received into complementary recesses formed in second parts98of a second or proximal anchor assembly. Such tabs230not only provide structure for advancing the second parts98but it also ensures proper rotational alignment of the second part98as they are advanced to receive a portion of the connector and to lockingly engage with a first part of the second anchor assembly.

With reference toFIGS. 13A-C, an integrated anchor240including a plurality of anchors82attached to each other by a connector94can also be used to manipulate anatomical structures. In this approach, a needle assembly112is utilized in a sewing motion to place various portions of the integrated anchor240on opposite sides of anatomical structures to accomplish the desired manipulation at an interventional site.

The integrated anchor240can also be cut from a pattern (FIG. 13F) to form a device which can assume a generally straight tubular configuration (FIG. 13D) for delivery to an interventional site. Once at the site, the device can be permitted to deform a generally H-shape (FIG. 13E), a first portion252being placed in apposition with a first anatomical structure and a second portion254configured against a second anatomical structure. A mid-section of the device can include a spring-like structure256which is particularly suited for applying a tension to the first252and second254portions.

One preferred embodiment of the anchor assembly of the present invention is depicted inFIGS. 14A-D. In its unconstrained configuration, the first or distal anchor component270includes a first tubular portion272which is generally orthogonal to a second tail portion274. It is to be noted, however, that while housed in a delivery assembly and prior to deployment at a target area, the first anchor component270is constrained to define a generally straight configuration, only subsequently assuming the unconstrained configuration upon deployment from the delivery device.

The tubular portion272of the first anchor component270includes a plurality of tabs276which can be deformed or deflected to accomplish affixing the component270to a connector assembly278(SeeFIG. 14B). It has been found that three such tabs276, two on one side of the tubular portion272and one on an opposite side provide a sufficient connecting force and a desired balance between the connector278and first anchor component270and to move the first anchor component270by applying a force either in the proximal or distal direction.

It is contemplated that the first anchor component270can be laser cut from a tube formed of nitinol or other appropriate material. A mid-section280of the component270provides a structural transition from the tubular portion272to the tail portion274. As such, a portion of a side wall is removed in the mid-section area280. A further portion of the side wall is removed to define a connecting section282of the tail274which extends from the mid-section280. This connector section282acts as a spring to accomplish the relative unconstrained angle assumed between the tail274and tubular portion272. A terminal end portion283of the tail274embodies structure having a surface area which is larger than that of the connector section282to thereby provide a substantial platform for engaging tissue at a target site.

As shown inFIGS. 14Cand D, the second anchor component284includes a first part286and a second part288. Once the first anchor component270is positioned at a target site by employing a delivery device such as that disclosed below (or previously), the second anchor component284is assembled in situ.

The first part286of the second anchor component284includes an internal bore290sized to receive a portion of the second part288of the second anchor component284in a locking engagement. An external surface of the first part286is sized and shaped to include a proximal collar291spaced from a mid-section292, each of which have generally cylindrical profiles. A smaller diameter, outer cylindrical portion293is configured between the proximal collar291and mid-section292of the component and a distal cylindrical portion294having yet a smaller cylindrical profile defines a distal end thereof.

The second part288of the second anchor component284includes a solid generally cylindrical back end295, extending from which are a pair of spaced prongs296. Terminal ends of the prongs296can be tapered to both facilitate the insertion of the prongs296within the internal bore290of the first part286as well as to receive a section of the connector assembly278. Notably, the prong structure commences at a narrowed slot297which steps outwardly to a wider dimension to thereby define the space between the prongs296. This narrow slot297provides the second part288with desired structural rigidity to receive the connector assembly278and to facilitate lockingly engaging the connection between the first286and second288parts.

Thus, in its pre-implanted form, the anchor assembly can include one anchor member (e.g., first anchor) whose initial engagement with a connector is generally coaxial and another anchor member (e.g., second anchor) with an initial engagement being generally perpendicular with the connector.

Turning now toFIGS. 15A-H, there is shown one particular embodiment of a linear, integrated anchor delivery device300. The anchor delivery device300includes a handle assembly portion302and an elongate barrel portion304extending from the handle assembly302(SeeFIG. 15A). While various angles between the handle assembly302and elongate barrel302are contemplated, in the embodiment depicted, the handle assembly302and elongate barrel304are generally orthogonal. However, in certain applications, it has been recognized that an obtuse angle between these structures can be advantageous when attempting to access anatomy (See for exampleFIG. 15H).

As depicted inFIGS. 15Aand B, a handle casing306encloses internal components of the handle assembly portion302. The handle casing306is sized and shaped to both fit comfortably in an operator's hand as well as protect and provide supporting structure and space and channels for the movement of the various internal components of the handle assembly302. InFIG. 15B, the casing306is removed to reveal the various gears, levers and racks which accomplish the anchor delivery function of the integrated anchor delivery device300.

InFIGS. 15C-E, outer tube308has been removed to provide a view of internal components defining the elongate barrel assembly304. In one embodiment, the outer tube308can be sized to define a 25 Fr., sheath. As will be developed below, the outer tube308is operatively associated with an outer tube connector assembly309which, in turn, is linked to levers for advancing and retracting the outer tube308.

With specific reference toFIG. 15C, the handle assembly portion includes a top mount lever310connected at a top end to a link bar assembly312and at a bottom end, includes an arcuate projection equipped with teeth configured to engage complementary teeth of a first, small gear316of a connector/needle advance gear assembly318. It is to be recognized that the connector/needle advance gear assembly318is held in place by a dowel pin or like structure passing through a center of the assembly318and in fixed relationship to the handle casing306when the delivery device300is in its fully assembled configuration. The top end of the top mount lever310is fixed within the handle assembly302to permit the lever310to pivot about the top end.

The top mount lever310further includes a looped mid-section portion320sized to receive fingers of an operator's hand. By way of its pivot-point mounting and engagement between the arcuate extension314and small gear316, as the lever310is pulled proximally, the small gear316is caused to rotate about its dowel pin mount.

The first, small gear316forms part of the connector/needle advance gear assembly which further includes a larger gear322, to which the first, small gear316is affixed. Accordingly, as the top mount lever310is depressed, both small and large gears316,322rotate. As seen inFIGS. 15C-D, teeth of large gear322are configured to engage complementary teeth of a connector carrier rack324. As the gears316,322rotate counter-clockwise, the connector carrier rack324moves vertically upward.FIGS. 15Cand D depict the movement of the carrier rack324as the trigger assembly310is progressively depressed toward the rack324.

The connector carrier rack324includes a lower end portion326which is connected to a needle return spring assembly328. The connector carrier324rack is permanently connected to the connector carrier block336. The connector carrier block336is also operatively and releasably connected to both a needle assembly330and connector assembly332which is threaded through the needle assembly330. Various of the previously described embodiments of connector assemblies (See for exampleFIGS. 3E-Iand14A-B) are contemplated for use with the anchor delivery device300. Both the needle assembly330and connector assembly332are, in turn, threaded through needle channel334. As shown in the figures, the needle channel334includes a curved portion residing in the handle assembly302and a distal section extending the length of the elongate barrel section304of the anchor delivery device300. Thus, the needle and connector assemblies are formed of axially flexible material so that they can easily navigate the turns in the needle channel334.

The connector assembly332is releasably connected within the handle assembly302to a connector carrier block336, which is itself attached to the connector carrier rack324. A releasable connection between the connector block336and connector assembly332is accomplished by way of a spring biased suture clamp (not shown) carried by the block336. Also forming part of a connector advancement assembly is a connector carrier338which can include a hypotube for receiving the connector332. A proximal end of the connector assembly332is looped about a connector tension and return spring assembly340. The connector tension and return spring assembly340can include various components such as negator spring assemblies342and a C-shaped bar arm344which provide desired tension on the connector assembly332. In one aspect, one pound of tension force can be provided by the spring assembly340; however, as little as a half pound and as much as five pounds of tension are contemplated.

From its proximal end, the connector assembly332extends downwardly through the handle assembly302about a pulley346(SeeFIG. 15E) and back vertically within the handle302. From there, the connector assembly332extends through both the connector carrier block336and needle assembly330.

Further, the needle assembly330includes a proximal end portion attached to a needle rack350. The needle rack350releasably engages the connector carrier rack324so that during a first part of the depression of the trigger310, both the connector assembly332and the needle assembly330are caused to advance distally. During the final stages of trigger310depression, the needle rack350disengages from the connector rack324, thereby allowing the relative movement of the connector assembly332with respect to the needle assembly330. In this way, the anchor structure (See for example,FIGS. 14Aand B) attached to the connector assembly332can be placed beyond a terminal end of the needle assembly330and against a target tissue within a patient's body.

In order to accomplish such action, the handle assembly302is equipped with a needle stop assembly360including a release tab362which constrain connector carrier block336thereby rigidly connecting the connector carrier block336to the needle rack350. As the connector carrier rack324is moved vertically upward the connector carrier block336moves out of contact with the release tab362thereby permitting the connector carrier block336to uncouple from the needle rack350. After the connector carrier block336is out of contact with the release tab362the needle rack350collides with the needle stop assembly360thereby causing the connector carrier block336to uncouple from the needle rack350. Thus the disengagement of the needle rack350from the connector carrier rack324allows the connector assembly332to be advanced while the advancement of the needle assembly330is ceased. The depth of deployment of the needle assembly330can be adjusted by altering the vertical position of needle stop assembly360. This may be accomplished with a spring-loaded sliding switch that connects the needle stop assembly360and the handle casing306(not shown).

As the connector carrier rack324moves vertically upward it repeatedly engages the needle advancement ratchet366which is maintained in a fixed position relative to the handle casing306. The needle advancement ratchet contains a ratchet component and a spring element (not shown) that permits only upward vertical movement of the connector carrier rack324when the spring element is in a first position. As the top mount lever310is progressively depressed, it comes in close proximity with and then engages a junction connecting a pair of toggle links368. The toggle links368each include a first end pivotally connected to the other toggle link. A second end of an upper toggle link is pivotally connected to an upper end of the connector carrier rack324. A second end of a lower toggle link is operatively associated with the needle advancement ratchet366. As the top mount lever310engages the pivot connector between toggle links368, the spring element and the ratchet component of the needle advancement ratchet366are moved into a second position that permits downward vertical movement of the connector carrier rack324thereby allowing subsequent retraction of the needle assembly330by the needle return spring assembly328.

Once a distal portion of the connector assembly332is ejected from a terminal end of the needle assembly330and placed as desired within a patient's body, the trigger320can be manipulated to permit a re-engagement between the needle rack350and connector carrier rack324. The needle return spring assembly328can then act to retract the needle assembly330back within the anchor delivery device300. During this procedure, the negator spring assembly340continues to provide a desired tension on the connector assembly332. Moreover, during this particular juncture, the connector assembly332can be disengaged from the connector block336until the block returns to a default position.

Proper placement of the distal end of the connector assembly332, as well as all steps involving the anchor delivery device300, can be observed and ensured by a scope assembly370. The scope assembly370extends from a upper back end of the handle assembly302and distally within a tube assembly372extending along structure defining the elongate barrel assembly304.

With the distal end of the connector assembly332placed at a desired interventional site and the needle withdrawn within the anchor delivery system300, the operator selects a site for delivering and implanting a proximal end of the anchor assembly. After positioning a terminal end of the elongate barrel304at the selected location, the operator actuates structure to first engage a proximal end portion of the connector assembly332extending from the anchor delivery device300with a proximal anchor assembly and then severs the connector assembly332to a desired length. The multitude of various alternatives of proximal anchor structures are depicted inFIGS. 9A-AOand14C-D.

Accordingly, with reference toFIGS. 15Fand G, the handle assembly302includes a second trigger assembly380which is operatively associated with an anchor pusher assembly382which when translated, engages one component of a proximal anchor assembly against another (not shown). In one contemplated approach, depressing the second trigger380causes the pivoting of an intermediate link arm384which is connected via a slot to a projection extending to a pusher rack386. The pusher rack386is in turn connected to the anchor pusher382.

Subsequent to the depression of the second trigger and the locking of a proximal anchor component (not shown) onto the connector assembly332to form a completed anchor assembly, the connector assembly332must be cut to length. First, the second trigger is released allowing the pusher rack386to return to its home position. Next, structure is activated to advance the outer tube to sever the connector assembly332.

To accomplish the cutting of the connector assembly332, the linear integrated anchor delivery device300is provided with the outer tube assembly308. This outer tube assembly308can be translated longitudinally in directions to and away from the handle assembly302by activating a front lever390. The front lever390extends from a top of the handle assembly302and pivots front and back along a surface thereof.

Moreover, the front lever390is connected to an outer tube rack assembly392which includes an outer tube safety lever system394. A lever lock assembly398is also provided as well as a cam plate402.

Thus, once unlocked, pivoting front lever390rearward advances the outer cover. Such action accomplishes the severing of the connector assembly332to a desired length by a shearing action of a sharp integrated element of the outer cover (1086FIG. 2A). The anchor delivery device300can then be removed from the interventional site or it can be used again to implant another anchor assembly.

With reference now toFIGS. 16A-G, there is shown yet another integrated anchor delivery device500. The device500includes a handle assembly502and an elongate barrel assembly504extending from the handle assembly502. As best seen inFIGS. 16Band C, the handle assembly502includes a handle casing assembly including a left handle casing505and a right handle casing507. The handle casings505,507both enclose as well as provide substructure support and mounting structure for the internal mechanisms of the handle assembly502.

Turning now toFIG. 16D, the various internal components forming the handle assembly502will be described. As with the previously described embodiments of the integrated anchor delivery systems, the device500shown inFIG. 16Dis employed to deliver distal and proximal components of an anchor delivery device as well as to assemble the proximal component in situ. Moreover, the delivery device500includes structure to cut the anchor assembly to length and apply a tension during implantation between the distal and proximal anchor components that remain after implantation between the distal and proximal anchor components. Further, a scope is included to provide remote viewing of the process of anchor assembly and implantation.

Accordingly, the integrated anchor delivery device500includes a distal anchor trigger506including a top end rotatably mounted within the handle assembly502and a lower end equipped with an arcuate ring gear section508including teeth. The ring gear section508is configured to engage a rotatably mounted gear assembly. More particularly, the gear section508is positioned to engage a small gear510of the gear assembly. The small gear520is positioned adjacent a large gear512of the gear assembly and the small and large gears rotate in unison about a center mount.

Moreover, a cam follower514is mounted within the handle assembly502and placed in apposition with the arcuate ring gear section508. Thus, the cam follower514supports the engagement between the ring gear section508and large gear512. Further, attached to a mid-section of the trigger506is a bar arm518(See alsoFIG. 16C). This bar arm518is connected at its terminal end to a pawl assembly which will be described in more detail below.

The large gear512of the gear assembly is adapted and configured to cooperate with a vertically arranged rack520. The rack520includes a lower end including a slot to fixedly engage a needle retraction spring assembly522. The needle retraction spring assembly522includes a pair of springs, each of which are placed into engagement with the rack520. The rack520also includes an upper end portion which is configured to cooperate with a depth stop assembly (described below).

Additionally, the rack520is attached to a connector assembly carrier block524(See alsoFIG. 16B) which releasably engages a connector assembly526of an anchor assembly. Moreover, the rack520is attached to a needle rack assembly530which engages a retractable needle assembly (not shown). From its connection with the needle rack530, the needle assembly extends vertically within the handle assembly502and through a needle support532. The needle assembly then further retractably extends within a needle housing534.

The needle rack530includes a lower section which releasably mates with a needle coupling pawl540.

Further, from its connection with the connector assembly carrier524, the connector assembly526first extends downwardly and then about a pulley or spool550. The connector assembly526exiting an opposite side of the spool550extends upwardly and into engagement with a negator spring552. The negator552is in turn connected to a connector assembly tensioning system. The connector assembly tension system includes a spring554wrapped around a spring axle556.

Configured adjacent and fixed to the spring axle556is a ratchet gear558. A pawl560including an extension received within a slot562formed in the bar arm518attached to the trigger506is also provided (FIG. 16E). The pawl560cooperates with the ratchet gear558to offset retraction forces generated by the connector assembly tension system until the pawl560is removed from engagement with the gear558.

It is to be recognized that the connector assembly tensioning systems can be adjusted to provide a desired tension force. In one aspect, this force is set at approximately one pound but as little as a half a pound and as much as five pounds of force is contemplated.

The anchor delivery device500further embodies a depth stop assembly. The depth stop assembly includes three main components, namely, a depth stop rail570, a lower end of which is connected to a depth stop bottom572and an upper end of which is connected to a depth stop top574. Notably, a free end of the depth stop bottom574includes a ramped portion576sized and shaped to engage the needle coupling pawl540.

Accordingly, when the distal anchor trigger506is depressed (SeeFIGS. 16Dand E), the arcuate ring gear section508causes the small gear510to rotate. By way of its being fixed to the small gear510, the large gear512also rotates with the action of the trigger506. Rotation of the large gear512causes the rack520to move vertically upward. Through connecting structures, the movement of the rack520advances both the connector assembly526and needle assembly (not shown) through the needle housing534and out a terminal end thereof. The advancement of the connector and needle assemblies is made against the spring forces generated by the connector assembly tension spring554and needle retraction spring assembly522.

Moreover, as the trigger506is depressed, the ramped portion576of the depth stop bottom574engages the upwardly moving needle coupling pawl540of the needle rack assembly530. This engagement results in temporarily disengaging the needle rack530from the rack520being driven by the large gear512. In this way, the depth stop assembly controls the distance which the needle is advanced beyond a terminal end580of the needle housing534.

Furthermore, upon the complete activation of the trigger506, the bar arm518slides horizontally inward while the pawl560engages teeth of the ratchet gear558attached to the spring axle556of the connector assembly tension system. As the rack520is being translated vertically, the spring axle556and ratchet gear558rotate and the pawl560retains the rotational position of the axle556and gear558. The pawl560continues to hold the rotational position of the axle556and gear558until the trigger506is completely depressed at which time the extension of the pawl560reaches the end of the slot formed in the bar arm518and the pawl disengages from the gear558. At this point, the gear is permitted to rotate freely in an opposite direction in response to the spring force provided by the connector assembly tension spring assembly.

It is to be recognized that the timing of the dual advancement of the needle and connector assemblies and subsequent relative motion between the assemblies is coordinated. That is, the needle assembly first provides access to an interventional site and then the connector assembly is extended beyond a terminal end of the needle assembly through the relative motion of the needle and connector assemblies.

Moreover, it is at this stage that a distal component of the anchor assembly (not shown) is placed at a desired position within a patient's anatomy. Such a procedure can be viewed using a scope582which extends distally from a back end of the handle assembly502and through a telescope tube584. A distal terminal end of the scope582can be positioned to so view the positioning of the distal and of the anchor delivery device500.

The following will describe the steps involved in placing and/or assembling the proximal anchor component within the body as well as severing the connector portion of the assembled anchor assembly.

Thus, the integrated linear anchor delivery device500includes a second or proximal anchor trigger assembly590(SeeFIGS. 16Fand G) operatively associated with an anchor pusher assembly such as that depicted inFIG. 15C. A bottom end portion of the second trigger590is shaped to comfortably receive the finger of an operator. An upper end of the trigger590is forked, each forked member including a slotted portion592sized to receive one of a pair of horizontal extensions projecting from a pusher guide member594.

Moreover, it is to be recognized that the foregoing procedure is reversible. In one approach, the connection of an anchor assembly can be severed and a proximal (or second) anchor component removed from the patient's body. For example, the physician can simply cut the connector and simultaneously remove the second anchor previously implanted for example, in the patient's urethra.

As the second trigger590is depressed, it rotates about a mid-section pivot fixed within the handle assembly. Such rotation causes the upper end of the trigger to turn forward thereby sliding the pusher guide member594forward. The projections of the guide member594slide within the slots592provided in the upper end portion of the trigger590. By way of its direct connection thereto, a pusher (not shown) is advanced distally. The forward advancement of the pusher is contemplated to act against one component of the proximal anchor assembly to thereby assemble it to another proximal anchor component and/or to the connector assembly extending from the distal anchor component already placed within the patient.

Next, an outer cover lever600which is rotatably connected to a top end of the handle assembly is activated to sever the connector assembly. It is to be recognized that the system accordingly has the capability to sever the connector at any time before or after the delivery and/or assembly of the second anchor. The lever600is connected to a slider602having horizontal projections604located in slotted portions of the lever600. The slider602, in turn, is connected to a longitudinally translatable outer tube (not shown). Rotating the lever600forward functions to advance the outer tube forward to thereby cut the connector to a desired length. Thus, an anchor assembly is placed as desired at an interventional site within a patient's body. The anchor delivery device500can thereafter be used to implant additional anchors or it can be completely removed from the body of the patient.

An aspect that the various embodiments of the present invention provide is the ability to deliver multiple, preferably four, anchor assemblies having a customizable length and distal anchor components, each anchor assembly being implanted at a different location without having to remove the device from the patient. The various embodiments provide for variable needle depth and variable connector length for each of the multiple anchor assemblies delivered. Other aspects of the various embodiments of the present invention are load-based delivery, preferably 1 pound, of an anchor assembly, anchor assembly delivery with a device having integrated connector, (e.g. suture), cutting, and anchor assembly delivery with an endoscope in the device. The delivery device is uniquely configured to place such a load (half pound to five pounds) between spaced first anchor members as well as between or on an implanted first anchor and the delivery device. In this aspect, the needle assembly acting as a penetrating member can be cooperatively connected to a mechanism which produces a desired tension between the various anchor members while the needle assembly is retracted. Moreover, this load can be accomplished between first and second implanted anchor members.

It is to be recognized that various materials are contemplated for manufacturing the disclosed devices. Moreover, one or more components such as distal anchor, proximal anchor, connector, of the one or more anchor devices disclosed herein may be designed to be completely or partially biodegradable or biofragmentable.

Moreover, as stated, the devices and methods disclosed herein may be used to treat a variety of pathologies in a variety of tubular organs or organs comprising a cavity or a wall. Examples of such organs include, but are not limited to urethra, bowel, stomach, esophagus, trachea, bronchii, bronchial passageways, veins (e.g. for treating varicose veins or valvular insufficiency), arteries, lymphatic vessels, ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc.

Finally, it is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unpatentable or unsuitable for its intended use. Also, for example, where the steps of a method are described or listed in a particular order, the order of such steps may be changed unless to do so would render the method unpatentable or unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

Thus, it will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, as various modifications can be made without parting from the spirit and scope of the invention.