HK1249721B - Anchor delivery system - Google Patents

Description

Anchor delivery system

This application is a divisional application of the invention patent application entitled “Anchor Delivery System”, with an international application date of March 16, 2014, an international application number of PCT/US2014/021040, and a national application number of 201480021090.0.

Background Art

The present invention relates generally to medical devices and methods and, more particularly, to systems and related methods for manipulating or contracting tissue and anatomical or other structures within a human or animal subject in order to treat a disease or disorder.

An example of a condition that requires lifting, compressing or otherwise removing pathologically enlarged tissue is benign prostatic hyperplasia (BPH). BPH is one of the most common medical conditions affecting men, especially older men. It is reported that in the United States, by the age of 60, more than half of men have histopathological signs of BPH, and by the age of 85, about nine in ten men suffer from the condition. In addition, the incidence and prevalence of BPH increase with the growth of the average age of the population in developed countries.

Throughout a man's lifespan, the prostate gland continues to enlarge. In some men, the prostate capsule surrounding the prostate gland prevents further growth. This causes the inner end of the prostate to press against the urethra. This pressure on the urethra increases the resistance to urine flow through the end of the urethra, which is surrounded by the prostate. As a result, the bladder must exert greater pressure to force urine to overcome the increased resistance in the urethra. Chronic excessive force causes the muscle wall of the bladder to reshape and become stiff. The resulting increased resistance to urine flow through the urethra and bladder enlargement cause various lower urinary tract symptoms (LUTS) that can seriously reduce a patient's quality of life. These symptoms include a weak or intermittent urine stream during urination, straining during urination, pauses before the urine stream begins, a feeling that the bladder is not completely empty after urination, dripping at the end of urination or subsequent leakage, increased urination frequency (especially at night), and an urgent need to urinate.

In addition to patients with BPH, LUTS may also occur in patients with prostate cancer, prostate infections, and long-term use of certain medications that can cause urinary retention, especially in men with an enlarged prostate (e.g., ephedrine, pseudoephedrine, phenylpropanolamine, antihistamines such as diphenhydramine, chlorpheniramine, etc.).

Although BPH is rarely life-threatening, it can cause numerous clinical complications, including urinary retention, renal insufficiency, recurrent urinary tract infections, incontinence, hematuria, and bladder stones.

In developed countries, a large proportion of the affected population undergoes symptomatic treatment for BPH. It is estimated that by the age of 80, approximately 25% of the American male population will have undergone some form of BPH treatment. Currently, effective BPH treatment options include watchful waiting, medical treatment (herbal remedies and prescription drugs), surgery, and minimally invasive surgery.

For patients who choose the watchful waiting option, they will not be treated immediately, but will undergo regular checkups to monitor the progression of the disease. This is usually used for patients whose symptoms are minimal and not causing any inconvenience.

Surgeries used to treat the symptoms of BPH include transurethral resection of the prostate (TURP), transurethral vaporization of the prostate (TVP), transurethral incision of the prostate (TUIP), laser prostatectomy, and open prostatectomy.

Minimally invasive procedures used to treat BPH symptoms include transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), interstitial laser coagulation (ILC), and prostate stenting.

The most effective methods for treating BPH currently have a very high risk of adverse effects. These methods and devices all require general or spinal anesthesia, or have potential adverse effects that require the patient to be hospitalized after surgery in the operating room. Methods for treating BPH with a lower risk of adverse effects also correspond to a lesser reduction in symptom scores. Although some of these operations can be performed under local anesthesia in an outpatient setting, the patient will not feel relieved immediately and will actually experience more severe symptoms in the weeks following the operation until the body begins to recover. In addition, all devices require a urinary catheter to be placed in the bladder, and in some cases, it is necessary to place it for several weeks. In some cases, it is necessary to insert a catheter because the treatment actually produces obstruction within a period of time after surgery, and in other cases, it is necessary to insert a catheter because of postoperative bleeding and the obstructive clots that may be produced. Although drug treatment is easy to carry out, the results fail to reach the best, require a long time to take effect, and usually cause undesirable side effects.

Progress has been made in the development of minimally invasive devices and methods for elevating and repositioning tissue. However, further advances are needed to ensure access to difficult-to-reach body structures.

There remains a need for new devices and methods for deploying multiple anchors from a single delivery device to improve the user experience and minimize patient discomfort. There is also a need for the ability to access anatomical structures using minimally invasive instruments while simultaneously viewing the interventional procedure. Furthermore, various structures that ensure an efficient access procedure, such as implants with structural memory features, have been found to be helpful in certain treatment approaches.

The present invention addresses these and other needs.

Summary of the Invention

Briefly summarized, the present invention relates to apparatus and methods for deploying anchors within a patient's body to facilitate interventional procedures. A delivery device is provided for accessing the target anatomy for an interventional procedure. Some embodiments of the delivery device include a mechanism for deploying one or more anchor assemblies without removing the device from the interventional site.

The delivery device of the present invention includes various subassemblies that are activated via an actuator or other manual access mechanism. The operation of the subassemblies is coordinated and synchronized to ensure accurate and precise implantation of the anchor assembly. In one embodiment, the delivery device is included in a tissue access assembly configured to treat BPH.

In one particular aspect, the present invention relates to a delivery device that enables delivery of a first or distal anchor assembly component to a first location within a patient's body and a second or proximal anchor assembly component to a second location within the patient's body. In addition, the delivery device can include a mechanism for effectively reloading the anchor assembly to minimize patient discomfort and improve ease of use. The device can also apply tension to the connector during delivery to support it while attaching the proximal anchor in place. The procedure can be viewed using a scope inserted into the device. The scope can have various configurations and can employ supplemental structures to assist in viewing. In addition, the delivery device can be sized and shaped to be compatible with a sheath of up to 24 French, preferably a 19 French or 20 French sheath or smaller.

The anchor assembly can be configured to approximate, retract, elevate, compress, support, reshape, or reposition tissue within a human or animal subject. Additionally, the device configured to position the anchor assembly and the anchor assembly itself are configured to complement and cooperate with body anatomical structures.

In one aspect, a system for treating a prostate includes a cannula, a handle configured to receive the cannula, and a delivery device. The cannula includes a distal anchor, a connector, and a proximal anchor, and the handle includes an actuator and a spring mechanism loaded with mechanical energy. The delivery assembly includes a member mating with the cannula to transfer mechanical energy from the spring mechanism to the cannula, and the actuator is configured to reload the mechanical energy.

In one aspect, a system for deploying an anchor assembly includes: a cannula that carries the anchor assembly; and a handle configured to couple with the cannula such that mechanical energy loaded in at least one spring mechanism within the handle is transferred to the cannula to deploy the anchor assembly. The system includes an actuator configured to initiate the transfer of mechanical energy and return a majority of the mechanical energy to the spring mechanism.

In one aspect, a method for delivering multiple anchor assemblies includes inserting a cannula into a handle assembly. The handle assembly includes an actuator and a drive mechanism having a first loaded configuration characterized by a total stored energy and an unloaded configuration. The cannula includes at least one anchor assembly and a piercing member. The at least one anchor assembly and the piercing member are configured to extend from a distal end of the cannula. The method includes placing the distal portion of the cannula at an intervention site near a prostate, and operating the actuator to cycle the drive mechanism from the loaded configuration to the unloaded configuration and then to a second loaded configuration characterized by a total stored energy. Operating the actuator to simultaneously deliver the at least one anchor assembly to the prostate by transferring a load from the drive mechanism to the cannula. The method includes removing the cannula.

Various alternatives can be used. The disclosed devices can be used to improve the flow of body fluids through body cavities, change the size or shape of body cavities or lumens, treat prostate enlargement, treat urinary incontinence, support or maintain the position of tissue, close tissue wounds, organs or implants, perform elevating or repositioning plastic surgery, form anastomotic connections, and/or treat various other disorders in which natural or pathological tissue or organs squeeze or interfere with adjacent anatomical structures. In addition, the present invention has many other possible surgical, therapeutic, plastic or reconstructive applications, such as when it is necessary to approach, shrink, elevate, reposition, compress or support tissue, organs, implants or other materials.

Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a coronal section through the lower abdomen of a man with BPH, illustrating an enlarged prostate.

FIG. 1B illustrates a coronal section through the lower abdomen of a man with BPH, showing an enlarged prostate being treated using one embodiment of the device of the present invention.

FIG. 1C illustrates a side view of one embodiment of the retainer shown in FIG. 1B .

FIG. 1D illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1E illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1F illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1G illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1H illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1I illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

FIG. 1J illustrates various steps of a method for treating a prostate using the retainer shown in FIG. 1C .

2 is a perspective view depicting one embodiment of an anchor delivery system.

3 is a right side view depicting the anchor delivery system of FIG. 2 .

4 is a perspective view, partially in section, depicting partial advancement of the needle assembly.

5 illustrates an embodiment of a handle assembly of an anchor delivery system with no preloaded energy in the spring when the device is in a stored state.

6 illustrates an embodiment of a handle assembly of an anchor delivery system with no preloaded energy in the spring when the device is in a stored state.

7A is a cross-sectional view of a feature for detecting a damaged needle.

7B is a cross-sectional view of a feature for detecting a damaged needle.

8 is a cross-sectional view of two embodiments of a portion of an elongated member for an anchor delivery system.

9 is a perspective view of a sight glass lock according to certain embodiments.

10 is a perspective view depicting features of one embodiment of a cutter assembly of a delivery device.

11 is a perspective view depicting features of one embodiment of a cutter assembly of a delivery device.

12 is a perspective view depicting features of one embodiment of a cutter assembly of a delivery device.

13 is a cross-sectional view depicting placement of an anchor within the cutter assembly.

FIG. 14 is a different view depicting additional features of the cutter assembly.

FIG. 15 is a different view depicting additional features of the cutter assembly.

FIG. 16 is a different view depicting additional features of the cutter assembly.

FIG. 17 is a different view depicting additional features of the cutter assembly.

FIG. 18 is a different view depicting additional features of the cutter assembly.

19 is a perspective view depicting features of a suture guide.

20 is a perspective view depicting features of a suture guide.

21 is a perspective view depicting features of a thruster assembly.

22 is a perspective view depicting features of the thruster assembly.

23 is a perspective view depicting features of the thruster assembly.

24A is a perspective view depicting the features and operation of a single assembly that functions as both an advancer assembly and a cutter assembly.

24B is a perspective view depicting the features and operation of a single assembly that functions as both an advancer assembly and a cutter assembly.

24C is a perspective view depicting the features and operation of a single assembly that functions as both an advancer assembly and a cutter assembly.

24D is a perspective view depicting the features and operation of a single assembly that functions as both an advancer assembly and a cutter assembly.

24E is a perspective view depicting the features and operation of a single assembly that functions as both an advancer assembly and a cutter assembly.

25A is a different view of an anchor delivery system including a handle configured to receive a cannula.

25B is a different view of an anchor delivery system including a handle configured to receive a cannula.

25C is a different view of an anchor delivery system including a handle configured to receive a cannula.

25D is a different view of an anchor delivery system including a handle configured to receive a cannula.

25E is a different view of an anchor delivery system including a handle configured to receive a cannula.

25F is a different view of an anchor delivery system including a handle configured to receive a cannula.

25G is a different view of an anchor delivery system including a handle configured to receive a cannula.

25H is a different view of an anchor delivery system including a handle configured to receive a cannula.

251 is a different view of an anchor delivery system including a handle configured to receive a cannula.

25J is a different view of an anchor delivery system including a handle configured to receive a cannula.

26A is a different view of an anchor delivery system including a cannula configured to be placed at the distal end of an elongated member of the anchor delivery system.

26B is a different view of an anchor delivery system including a cannula configured to be placed at the distal end of an elongated member of the anchor delivery system.

26C is a different view of an anchor delivery system including a cannula configured to be placed at the distal end of an elongated member of the anchor delivery system.

26D is a different view of an anchor delivery system including a cannula configured to be placed at the distal end of an elongated member of the anchor delivery system.

26E is a different view of an anchor delivery system including a cannula configured to be placed at the distal end of an elongated member of the anchor delivery system.

DETAILED DESCRIPTION

Referring now to the accompanying drawings, which are provided by way of example only and not limitation, the present invention relates to a device configured to deliver a plurality of anchor assemblies into a patient's body for therapeutic purposes. The disclosed device can be used for a variety of medical purposes, including but not limited to shrinking, elevating, compressing, approximating, supporting, reshaping, or repositioning tissue, organs, anatomical structures, grafts, or other materials present in a patient's body. The purpose of such tissue manipulation is to facilitate the treatment of a disease or disorder, such as displacement, compression, and/or shrinkage of body tissue.

In one aspect of the present invention, a delivery device includes a handle assembly supporting an elongated member. The elongated member defines a low profile suitable for traversing body anatomy to reach an interventional site. A substructure is provided to maintain the longitudinal profile of the elongated member so that the interventional procedure can be performed as planned.

In another aspect, a portion of an anchor assembly or graft is placed and implanted against a first segment of an anatomical structure. Thereafter, a second portion of the anchor assembly or graft is placed and implanted proximate a second segment of the anatomical structure for contracting, elevating, compressing, approximating, supporting, reshaping, or resetting the second segment of the anatomical structure relative to the first segment of the anatomical structure, and for contracting, elevating, compressing, approximating, supporting, reshaping, or resetting the first segment of the anatomical structure relative to the second segment of the anatomical structure. It should also be understood that the first and second portions of the anchor assembly can be configured to accomplish the desired contraction, elevating, compressing, approximating, supporting, reshaping, or resetting of the anatomical structure during delivery via a tensioning force supplied via a connecting assembly secured to the first and second portions of the anchor assembly or graft during delivery. The delivery device can include an endoscope capable of viewing the interventional procedure.

FIG1A shows a coronal section through the lower abdomen of a man with BPH (i.e., a section taken approximately in the plane of the coronal suture or parallel to the coronal suture), showing an enlarged prostate. As depicted in FIG1A , the bladder UB is a hollow, muscular organ that temporarily stores urine. It is located behind the pubic bone PB. The lower region of the bladder has a narrow, muscular opening called the bladder neck, which leads to a soft, elastic, tubular organ called the urethra UT. The muscle around the bladder neck is called the internal urethral sphincter. The internal urethral sphincter is usually shrunken to prevent urine leakage. The bladder gradually fills with urine until it is full, at which point the sphincter relaxes. This causes the bladder neck to open, thereby releasing urine stored in the bladder into the urethra. The urethra guides urine from the bladder to the outside of the body. The urethra begins at the bladder neck and ends at the end of the penis. The prostate PG is located around the urethra at the junction of the urethra and bladder. In FIG1A , the prostate is enlarged (enlarged). This causes the prostate to press against an area of the urethra. This in turn creates an undesirable obstruction to the flow of urine through the urethra.

FIG1B illustrates a coronal section through the lower abdomen of a man with BPH, showing an enlarged prostate being treated using one embodiment of the device of the present invention. It has been found that an enlarged prostate can compress and contract, thereby reducing pressure on the urethra. According to one embodiment of the present invention, a retaining device can be placed through the prostate to reduce pressure on the urethra. In FIG1B , retainer 10 is implanted in the prostate. Retainer 10 includes a distal anchor 12 and a proximal anchor 14. Distal anchor 12 and proximal anchor 14 are connected by a connector 16. The radial distance between the urethra and distal anchor 12 is greater than the radial distance between the urethra and proximal anchor 14. The distance or tension between the anchors is sufficient to compress, displace, or change the orientation of the anatomical region between distal anchor 12 and proximal anchor 14. Connector 16 can be inelastic, thereby maintaining a constant force or distance between the proximal and distal anchors, or elastic, thereby attempting to pull the proximal and distal anchors together. In the embodiment shown in FIG1B , the distal anchor 12 is located on the outer surface of the prostate capsule CP and serves as a capsule anchor. Alternatively, the distal anchor 12 may be embedded within the tissue of the prostate PG or in structures surrounding the prostate, such as the pelvic periosteum, the bone itself, the pelvic fascia, the Cooper's ligament, or the muscles that run through the pelvis or urethra wall. Furthermore, in the embodiment shown in FIG1B , the proximal anchor 14 is located on the inner wall of the urethra UT and serves as a urethral anchor. Alternatively, the proximal anchor 14 may be embedded within the tissue of the prostate PG or in the aforementioned surrounding structures. The distal anchor 12 and the proximal anchor 14 are implanted in the anatomical structure so as to generate the desired distance and tension in the connector 16. This causes the distal anchor 12 and the proximal anchor 14 to contract or compress an area of the prostate PG to reduce the obstruction shown in FIG1A . In FIG1B , two retainers 10 are implanted in the prostate PG. Each retainer 10 is implanted in a lateral lobe (paralobe) of the prostate PG. The various methods and devices disclosed herein can be used to treat a single lobe or multiple lobes of the prostate or other anatomical structures. Similarly, two or more devices disclosed herein can be used to treat a single anatomical structure. For example, two retainers 10 can be used to treat the lateral lobes of the prostate PG. One or more retainers can be positioned at a specific angle relative to the urethral axis to target one or more lateral lobes and/or the middle lobe of the prostate. In one embodiment, the retainer 10 is positioned between the 1 o'clock and 3 o'clock positions relative to the urethral axis to target the left lobe of the prostate. In another embodiment, the retainer 10 is positioned between the 9 o'clock and 11 o'clock positions relative to the urethral axis to target the right lobe of the prostate. In another embodiment, the retainer 10 is positioned between the 4 o'clock and 8 o'clock positions relative to the urethral axis to target the middle lobe of the prostate.

FIG1C illustrates a side view of one embodiment of the retainer shown in FIG1B . FIG1C shows retainer 10 comprising distal anchor 12 and proximal anchor 14. Distal anchor 12 and proximal anchor 14 are connected by connector 16. In the embodiment shown in FIG1C , distal anchor 12 comprises a tube 18 having an inner lumen. Tube 18 can be made of a suitable elastic or inelastic material, including but not limited to metal, polymer, and the like. Typical examples of such materials include but are not limited to 304 stainless steel, 316 stainless steel, nickel titanium alloy, titanium, Pebax, polyimide, braided polyimide, polyurethane, nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE, shape memory polymers such as polyester polyurethane, polyether polyurethane, polyether polyester, polyether polyamine, or a combination of oligocaprolactone diol and oligodioxanone diol polymers. Connector 16 is attached to tube 18. In one embodiment, connector 16 is a USP size 0 polypropylene monofilament suture. In the embodiment shown in Figure 1C, the distal region of connector 16 is located in the lumen of tube 18 so that the distal tip of connector 16 emerges from one end of the lumen of tube 18. The distal tip of connector 16 is enlarged so that the diameter of the enlarged distal tip of connector 16 is greater than the inner diameter of tube 18. In one embodiment, the diameter of connector 16 is 0.014 inches and the diameter of the enlarged distal tip of connector 16 is 0.025 inches. In one embodiment, the enlarged distal tip of connector 16 is formed by controlled melting of the distal tip of connector 16. This attaches connector 16 to tube 18. Tube 18 may include one or more additional attachment mechanisms that attach the distal region of connector 16 to tube 18. In one embodiment, the distal region of connector 16 is attached to tube 18 by a suitable biocompatible adhesive. In the embodiment shown in FIG. 1C , the distal region of the connector 16 is attached to the tube 18 by one or more inwardly opening tabs 20 cut into the material of the tube 18. The tabs 20 grip the connector 16, thereby preventing relative movement between the connector 16 and the tube 18. The angle between one of the tabs 20 and the connector 16 can be between 1 and 90 degrees. The tube 18 also includes a longitudinal slot 22. The longitudinal slot 22 extends from one end to approximately the middle section of the tube 18. The connector 16 emerges from this longitudinal slot 22. Thus, when the connector 16 is pulled in a proximal direction, the distal anchor 12 assumes a T-shape, which helps anchor the distal anchor 12 to the anatomical structure. The distal anchor 12 can include a sharp edge to help the distal anchor 12 penetrate the anatomical structure. In a preferred embodiment, the distal anchor 12 is constructed by laser cutting and electropolishing a nickel-titanium alloy (e.g., Nitinol) tube made of 50.8% nickel and 49.2% titanium. In a preferred embodiment, the outer diameter of the tube 18 is 0.026 inches, the inner diameter of the tube 18 is 0.015 inches, the length of the tube 18 is 0.315 inches, and the length of the longitudinal slot 22 is 0.170 inches.

In the embodiment shown in FIG1C , the proximal anchor 14 comprises a tube 24 having an inner lumen. Tube 24 can be made of a suitable elastic or inelastic material, including but not limited to metals, polymers, and the like. Typical examples of such materials include but are not limited to 304 stainless steel, 316 stainless steel, nickel titanium alloy, titanium, Pebax, polyimide, braided polyimide, polyurethane, nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, ePTFE, shape memory polymers such as polyester polyurethane, polyether polyurethane, polyether polyester, polyether polyamine, or a combination of oligocaprolactone diol and oligodioxanone diol polymers. An outwardly opening tab 26 is cut through the material of tube 24. Tab 26 is folded over the outer surface of tube 18, as shown in FIG1C . This creates an opening in the inner lumen of tube 24, contoured by the atraumatic edge of the folded tab 26. Connector 16 enters tube 24 through this opening, reaching the inner lumen of tube 24. The proximal anchor 14 also includes an attachment member for attaching the connector 16 to the tube 24. The connector 16 can be made of a suitable elastic or inelastic material, including but not limited to metal, polymer, etc. Other proximal and distal anchors are contemplated within the scope of the present invention, such as a V-shaped proximal anchor that is press-fitted onto the connector. Typical examples of such materials include but are not limited to 304 stainless steel, 316 stainless steel, nickel titanium alloy, suture material, titanium, silicone, nylon, polyamide, polyglycolic acid, polypropylene, Pebax, PTFE, ePTFE, silk, catgut, or any other braided or monofilament material. In a preferred embodiment, the tube 24 has a length of 0.236 inches, an outer diameter of 0.027 inches, and an inner diameter of 0.020 inches. The length of the lumen opening to the tube 24 is approximately 0.055 inches. In a preferred embodiment, the attachment mechanism includes a locking pin that frictionally engages the connector 16 to the tube 24. The locking pin and the tube 24 are made of 316L stainless steel. In a preferred embodiment, the tube 24 is laser cut or stamped and then electro-polished. The locking pin is constructed using EDM (Electrical Discharge Machining) and then passivated.

Figures 1D to 1J illustrate the various steps of a method for treating a prostate using the retainer shown in Figure 1C. Similar methods can also be used to place retainers or compression devices in other anatomical structures. In the step shown in Figure 1D, a sheath 28, such as a standard prostatectomy sheath, is introduced into the urethra (transversely across the urethra). The sheath 28 is advanced through the urethra UT so that the distal end of the sheath 28 is positioned adjacent to the region of the urethra UT obstructed by the enlarged prostate PG. A distal anchor delivery device 30 is introduced through the sheath 28. The distal anchor delivery device 30 can be placed into the sheath 28 after the distal end of the sheath 28 is positioned adjacent to the obstructed region of the urethra UT, or the distal anchor delivery device 30 can be preloaded into the sheath 28 before placement. The distal anchor delivery device 30 is advanced through the sheath 28 so that the distal end of the distal anchor delivery device 30 emerges from the distal end of the sheath 28. The distal anchor delivery device 30 is oriented so that the working channel opening of the distal anchor delivery device 30 is directed toward the lateral lobe of the prostate PG.

In the step shown in FIG1E , a needle 32 is introduced through the distal anchor delivery device 30. After the distal anchor delivery device 30 is advanced through the sheath 28, the needle 32 may be positioned within the distal anchor delivery device, or the needle 32 may be preloaded within the distal anchor delivery device 30. In one embodiment, the needle 32 is a 20-gauge needle. The needle 32 is advanced through the distal anchor delivery device 30, exiting through the working channel opening. The needle 32 is further advanced, piercing the tissue of the prostate PG and exiting the distal end of the needle 32 from the prostate capsule CP.

1F , the distal anchor 12, coupled to the connector 16, is advanced through the needle 32. The distal anchor 12 may be preloaded in the needle 32 or may be loaded into the needle 32 after the needle 32 has been advanced through the distal anchor delivery device 30. The distal anchor 12 is advanced through the needle 32 such that it exits the distal end of the needle 32. In an alternative embodiment, the distal anchor is held in place by a pusher or connector while the needle is retracted, thereby exposing the distal anchor.

In the step shown in FIG. 1G , the needle 32 is removed from the distal anchor delivery device 30 by pulling the needle 32 in a proximal direction.

1H, the distal anchor delivery device 30 is removed from the sheath 28 by pulling the distal anchor delivery device 30 in a proximal direction. Additionally, the connector 16 is pulled so that the distal anchor 12 is oriented perpendicular to the connector 16.

1I , the connector 16 is passed through the proximal anchor 14 located on the proximal anchor delivery device 34. The proximal anchor delivery device 34 is advanced through the sheath 28 so that the distal end of the proximal anchor delivery device 34 exits the distal end of the sheath 28. The desired pulling force is introduced into the connector 16 so that the connector 16 pulls the distal anchor 12 with the desired force. Alternatively, the proximal anchor can be visualized by endoscopy or fluoroscopy and the proximal anchor is advanced along the connector until the desired tissue contraction is achieved. In other embodiments, the proximal anchor is a v-shaped or clothespin-shaped member that is pressed onto (in some cases, at high speed) the connector to securely engage the connector.

In the step shown in Figure 1J, the connector 16 is attached to the proximal anchor 14. The proximal anchor 14 is also released from the proximal anchor delivery device 34, thereby placing the proximal anchor 14 in the anatomical structure. The proximal anchor delivery device 34 and the sheath 28 are removed from the anatomical structure. The retainer 10 includes a distal anchor 12, a proximal anchor 14 and a connector 16, which is used to shrink, elevate, support, reposition or compress the prostate PG area located between the distal anchor 12 and the proximal anchor 14. This method can be used to shrink, elevate, support, reposition or compress multiple areas or lobes of the prostate PG. In the method shown in Figures 1D to 1J, the distal anchor 12 is placed on the outer surface of the prostate capsule CP. Therefore, the distal anchor 12 serves as a capsule anchor. Alternatively, the distal anchor 12 can be placed within the tissue of the prostate PG or outside the prostate, as previously outlined. 1D to 1J , the proximal anchor 14 is positioned on the inner wall of the urethra UT and serves as a urethral anchor. Alternatively, the proximal anchor 14 may be positioned within the tissue of the prostate PG.

The tissue access anchor shown in FIG1C is designed to be usable in a doctor's office setting with a delivery tool (as opposed to requiring a hospital setting). In a preferred embodiment, the delivery tool is used through a 19F or 20F sheath. In addition, the material selection and construction of the tissue access anchor also allow for subsequent TURP procedures to be performed on the prostate, if desired. In this suture-based tissue access technique, a needle delivery mechanism is used to implant the anchor assembly.

Reference is now made to Figures 2-4, which illustrate one embodiment of a delivery device 100. This device is configured to include structure that enables both access to the intervention site and the assembly and implantation of one or more anchor assemblies or grafts into the patient's body. The delivery device 100 can be configured to assemble and implant a single anchor assembly, or to implant a single anchor or multiple anchors or anchor assemblies. Furthermore, it is contemplated that the device can be used with a 19F or 20F sheath. Furthermore, the device includes structure that is configured to receive a conventional remote viewing device (e.g., an endoscope) so that the steps being performed at the access site can be observed.

Before using the device 100, patients typically undergo a five-day course of antibiotics. Interventional procedures can be performed using local anesthesia. Patients can take oral analgesics containing sedatives or hypnotic ingredients. Additionally, local anesthesia, such as lidocaine liquid or gel, can be applied to the bladder and urethra.

The anchor delivery device 100 includes a handle assembly 102 connected to an elongated member 104. The elongated member 104 can accommodate the components used to construct the anchor assembly and is sized to fit within a 19F or 20F cystoscope sheath, which is tolerated by the patient during an awake procedure rather than under general anesthesia. The assembly is designed to include features that allow it to remain within the anatomy.

The anchor delivery device 100 also includes a number of subassemblies. The handle box assembly 106 includes mating handle parts that form part of the handle assembly 102. The handle assembly 102 is sized and shaped to fit comfortably in the operator's hand and can be formed from conventional materials. A window can be formed in the handle box assembly 106 to provide access to the internal mechanisms of the device so that the operator can manually undo it if it is necessary to abandon the interventional procedure.

In one embodiment, the delivery device 100 is equipped with various activatable components that facilitate assembly and delivery of the anchor assembly at the intervention site. A needle actuator 108 is provided and, as described in detail below, enables advancement of the needle assembly to the intervention site. In one approach, the needle assembly moves through a curved trajectory and exits the needle housing, aligning with the handle element, and in certain embodiments, with the handle. In various other embodiments, the needle housing is oriented so that the needle exits the housing at the 2 o'clock or 10 o'clock position relative to the vertical handle. A needle retraction lever assembly 110 is also provided, which, when actuated, causes the needle assembly to retract and expose the anchor assembly.

In one specific, non-limiting use for treating prostate problems, the elongated member 104 of the delivery device is positioned within the urethra (UT) leading to the patient's bladder (UB). In one method, the delivery device can be positioned within a guide sheath (not shown) pre-placed in the urethra, or alternatively, the delivery device can be inserted directly into the urethra. When a guide sheath is employed, the sheath can be attached to a sheath mounting assembly (described below). The patient can undergo a lithotomy. The elongated member 104 is advanced within the patient's body until its leading end reaches the prostate (PG). In a specific method, as the device is extended through the bladder and rotated accordingly, the side (or lobe) of the prostate to be treated is selected. The inner side of the prostate, including the adenoma, is spongy and compressible, while the outer surface of the prostate, including the sac, is solid. While viewing through the endoscope, the doctor can press the urethra into the prostate, compressing the adenoma and creating the desired opening through the urethra. To achieve the aforementioned results, the doctor rotates the tool. The doctor then pivots the tool laterally around the pubic symphysis (PS) relative to the patient's midline.

At this stage, the delivery device is configured in a ready state. The needle actuator 108 and the needle retraction lever 110 are in an inactive position.

When the needle actuator 108 is depressed, the needle 230 (see FIG4 ) advances within the elongated member 104. The needle can be configured so that it bends backward toward the handle when ejected. When used in a prostate interventional procedure, the needle advances through and beyond the prostate gland (PG). A spring mechanism helps ensure that the needle quickly penetrates the tough outer prostate capsule without "tent-ing" the capsule or failing to puncture the capsule. In one approach, the needle can be made of Nitinol tubing and can be coated with Parylene N. This coating helps compensate for friction or environmental losses (such as moisture) that can reduce the effectiveness of the needle's penetration.

Some anchor delivery devices include a spring as part of a mechanism that drives a needle or piercing member, places an anchor, cuts a connector, or performs other functions associated with device delivery. The device may include a spring that is preloaded with potential energy when the user removes the device from its packaging. Preloaded springs, when in a loaded state, whether in tension or compression, tend to weaken over time. Spring weakening can affect the shelf life of the device. Furthermore, spring weakening can affect the consistency of the device because the spring force can change over time. Furthermore, loaded components may deform due to the continued pressure.

FIG5 illustrates an embodiment of a handle assembly having no preloaded energy in the springs when the device is in a stored state. Handle assembly 600 includes two springs, a needle drive spring 610 and a return spring 620. Neither needle drive spring 610 nor return spring 620 stores potential energy in their stored state. That is, during transport or storage of the device, the springs and components are not under stress resulting from spring loading.

The user utilizes a first actuator 650 (which can be a lever or a trigger) to load energy into the needle drive spring 610. In this embodiment, the user can depress the first actuator 650, such as a trigger. The first actuator 650 pivots at a pivot point 651 and causes the needle drive sled 655 to compress both the needle drive spring 610 and the return spring 620. When the needle drive spring 610 is loaded with sufficient energy to drive the needle (not shown) through the target tissue, the needle drive spring 610 is released via the mechanical action of the needle drive sled 655. For example, the ramp 656 can disengage the latch 662 on the needle drive assembly 600 and allow the needle drive spring 610 to unload its stored energy and drive the needle. Other latching mechanisms are also within the scope of the present invention.

When the user activates the first actuator 650, the return spring 620 is loaded with enough energy to force the needle drive assembly 660 back to its initial position. Returning the needle drive assembly 660 to its initial position includes forcing the latch 662 back to its latched position. In addition, returning the needle drive assembly 660 to its initial position also causes the needle to retract. Although the accompanying drawings depict the needle drive spring 610 and the return spring 620 as being compression loaded, one or both can be tension loaded and the system can achieve the same purpose. The present embodiment provides a system for: (1) avoiding the storage of energy in the spring of the delivery device, and (2) returning the needle drive mechanism to its initial state, including retracting the needle.

In another embodiment, the needle drive assembly returns to its initial state and the needle retracts by the action of a return spring. As schematically illustrated in Figure 6, the user loads the placement spring 710 by activating a first actuator (not shown), such as a lever or trigger. The placement claw 715 limits the movement of the needle drive assembly 760 until the first actuator reaches a position during its travel that disengages it from the placement claw 715. The placement claw 715 can be disconnected by various mechanical means, including the latch/unlock mechanism described above. When the placement claw 715 is disconnected, the needle drive assembly 760 drives the needle (not shown) and loads the return spring 720. In addition, when the needle drive assembly 760 drives the needle, the return claw 725 engages the proximal section of the needle drive assembly 760, and the placement spring 710 can optionally be disconnected from the needle drive assembly 760.

To load the return spring 720, the placement spring 710 must have sufficient load to drive the needle with the desired force and load the return spring 720. Advantageously, the return spring 720 allows the load required to retract the needle to be significantly less than the drive load, as the needle is being retracted. That is, the drive load must be large enough to initially penetrate tissue and overcome friction in the distal portion of the delivery system. However, the return spring 720 does not require a load sufficient to penetrate tissue, and the friction during the needle's return stroke is less than the friction during the initial drive.

The return pawl 725 is released by the user, or alternatively by mechanical action caused by the first actuator, to retract the needle using the load of the return spring 720. In some embodiments, it may be desirable to allow the user to release the return pawl 725; in other embodiments, the return pawl 725 is released directly, allowing the user to perform a procedure without using the first actuator. The return spring 720 can return the needle drive assembly past the seating pawl 715. Thus, the system returns to its initial state, in which the seating spring 710 can be reloaded by the first actuator.

Anchor delivery systems utilize needles or other piercing members to place anchors within tissue. In some placement situations, the needle may strike bone, calcified tissue, or other objects or surfaces, which can damage the needle or needle tip. For anchor delivery devices configured to place multiple anchor assemblies via multiple needle advancement devices, damaged needles can complicate placement.

In certain embodiments, a mechanism in the distal section of a delivery device is utilized to assess the mechanical integrity of a multi-use needle. FIG7A illustrates a curved section of needle tubing 235 and a needle 230 within the curved section. In this embodiment, needle tubing 235 includes a window 236 on the outer portion 231 of the curved section of needle tubing 235. Because needle 230 engages with the outer portion 231 of the curved section of needle tubing 235 as it guides the needle 230 around the curve, defects in needle 230, such as missing parts, kinks, or a bent tip, can cause needle 230 to partially enter and engage the sides of window 236. FIG7B illustrates an alternative embodiment in which a flange 237 on the inner side of the curved section 231 can similarly engage the end of a needle 230 with a defect, such as a missing part, kink, or bent tip. Consequently, a needle 230 with a missing part, kink, or bent tip cannot be advanced, and the needle's stalling will alert the user to the needle defect.

In certain embodiments, the integrity of the needle is assessed visually via the cystoscope.After placement, the needle can be partially retracted so that it is within the field of view of the cystoscope and the user can directly observe the integrity of the needle.

In certain embodiments, at least a portion of the elongated member 104 of the delivery device can be formed by a two-part clamshell design of injection molding. The two parts can be connected together by press-fitting, biting, adhesives, solvents, secondary molding, shrink tubing or other equivalent methods. Figure 8 illustrates a comparison of the cross-section of the elongated member 104 assembled by the tube and channel and the two-part injection molded elongated member 104'. Both cross-sections contain a cystoscope lumen (104a, 104a'), a needle lumen (104b, 104b') and an anchor lumen (104c, 104c'). The clamshell design can be combined along a portion or the entire length of the elongated member 104'. The injection molded section 104 can be formed by a single part that does not need to be connected. The lumen can be made by alternating cutoffs in the mold, or alternatively, the lumen is not a closed lumen. On the contrary, the lumen of the elongated member 104 provides sufficient restrictions for the members traversing it without using a full-circle lumen. This type of design makes the mold less complex.

In other embodiments, one or more parts of the two-part design are stamped. The stamped parts can be joined together by press-fitting, clinching, adhesives, solvents, overmolding, shrink tubing, or other equivalent methods. Alternatively, the entire elongated member 104 can be a single stamped part with an open lumen, but only providing sufficient restraint for components traversing the lumen to keep them within the lumen, but the open lumen allows for less complex stamping tools.

In certain embodiments, at least a portion of at least one of the three lumens of the elongated member can be eliminated. In one embodiment, a shorter tube segment can replace the entire tube segment. For example, the needle cannula can be replaced with a short tube segment in the proximal handle and at the distal end, thereby constraining the needle near the needle tip while eliminating the lumen in the majority of the middle portion of the needle. A clamp or flange can be used in addition to or in place of the short tube. Alternatively, the cystoscope tube can be eliminated or replaced with multiple tubes, clamps, or flanges.

In some embodiments, the elongated member is removable and reusable, while the proximal handle is disposable. The proximal handle can store the graft and provide the load required to drive the needle, deliver the anchor, and cut the connector. In addition, the shaft can accommodate multiple anchor components and can accommodate the needle.

The method of using the anchor delivery system can be combined with the use of a cystoscope, endoscope, or similar visualization device. In some embodiments, the proximal handle includes a scope lock with no moving parts for locking the cystoscope to the handle before performing the treatment disclosed herein. The lack of moving parts reduces cost and increases reliability and ease of use.

FIG9 illustrates a scope lock 800 according to certain embodiments. The scope lock includes a pair of stops (810, 812) at approximately the 3 o'clock and 9 o'clock positions. The scope has a light column inserted between these two stops 810, 812, on the 12 o'clock side of the scope lock ring, so that the scope cannot be twisted downward relative to the stops 810, 812 to direct the light column toward the 6 o'clock position. The scope can now only be twisted toward the 12 o'clock position. The scope lock also includes a pair of flexible ramp features (820, 822). The light column of the cystoscope rotates upward on one or the other of these ramps (820, 822) and snaps into the 12 o'clock position. The snap fit is secure enough so that the user can rotate the camera relative to the scope without overcoming the stops on the ramps.

In some embodiments, a removable lens or electronic imaging sensor may be integrated into the endoscopic telescope of a disposable device, into which the telescope is inserted. Alternatively, more than one lens may be positioned on the telescope and electronically selected to provide different views from the telescope. Advantageously, the removable lens or lenses may provide views from different directions, magnifications, or fields of view. Such lenses or image sensors can be integrated with a standard telescope in various ways. For example, the telescope may be a standard telescope, and the removable lens may be positioned on a transport device, such that adjusting the lens on the transport device provides different images when the telescope and transport device are mated. Alternatively, the lens on the transport device may be interchangeable to provide different views. In another example, a position-adjustable image sensor may be integrated with the transport device to capture images. Finally, a prism may be used to provide multiple views for the telescope, and an electronic image processor may be used to provide stereoscopic, composite, or selectively localized imaging for the user.

In some embodiments, the first anchor is delivered via a needle tip located at the end of a wire. The needle tip can be attached to the wire by press-fit, snap-fit, adhesive, solvent, overmolding, shrink tubing, or other equivalent methods. The connector can be routed along the side of the anchor delivery wire. Advantageously, utilizing a wire rather than a needle to route along a majority of the needle cannula reduces the cost of the needle assembly. Only the needle tip is hollow.

In some embodiments, a ribbon or sheet-like needle or wire is used in the needle assembly. Advantageously, a sheet-like needle will preferentially bend to a smaller radius in one direction over another. Thus, the needle can have sufficient strength to penetrate tissue while being sufficiently flexible in the desired bending direction.

As best shown in Figures 10 and 11, an embodiment of a cutter assembly 514 includes an elongated cutter tube 562. The distal end 568 of the cutter tube 562 is provided with a blade 569 so that once the cutter assembly 514 is retracted, the blade can sever the connector of the anchor assembly as needed. In one particular embodiment, the cutter 514 can be formed from a ground 17-4PH stainless steel billet. It is contemplated that various features will be incorporated into the cutter assembly to facilitate quick and thorough severing of the connector and to aid in assembling the proximal component of the anchor assembly onto the connector. For example, as best seen in Figure 11, the cutter blade 569 includes a cast underside that is offset approximately 0.0035+0.0010 inches relative to the bottom surface of the proximal anchor to cut a nominal 0.015-inch diameter connector. In this manner, the proximal anchor can exit the cutter without deforming or compressing the suture or connector tail, and the strength of the connector-anchor connection is maintained. Alternatively, the feature that cuts the suture may be a blunt feature.Thus, instead of cutting via a blade, the suture may be cut by the shearing action of two blunt elements as they slide past each other and create a shearing action through the suture.

As shown in Figures 12-14, cutter 514 defines a generally rectangular, elongated, single body that can be formed by stamping and bending. The interior of the body is sized and shaped to receive proximal anchor member 550. The proximal portion of cutter 564 may also include anti-buckling tabs 551 and extensions 553 that engage with the cutter block (described below). Cutting structures 555 will also be spaced apart along the cutter body to facilitate alignment of cutter 514 within the shaft assembly.

To eliminate burrs on the connector, the walls defining the needle window 557 formed in the cutter 514 can be contoured to help properly guide the connector into the suture capture area 559. As best seen in FIG15 , the proximal portion of the needle window 557 defines a gentle slope for guiding the connector within the capture area 559. In a related approach ( FIG16 ), a protrusion 561 can be formed on the connector guide structure to further assist in properly positioning the connector 352 for engagement with the proximal anchor component 555.

17 and 18, cutter 214 can further include a tilt limiting protrusion 563 extending within the generally tubular cutter 214. As best seen in FIG.

In another aspect, shown in Figures 19-20, the present device can include a suture alignment slide 570 configured to slide beneath a cover 571 and over the cutter 514. The cover 571, in turn, includes finger-like projections 573 sized and shaped to control and guide the movement of the proximal anchor 555. The alignment slide 570 directs the connector 352 to the centerline of the cutter 514. It can also pull the connector 352 proximally so that it is directed within the proximal anchor component 555, thereby improving connector capture by the anchor component 555. In other embodiments, the distal end of the needle housing itself can alternatively or additionally include a slot or notch to properly register the connector during use of the device, particularly when tension is applied to the connector.

To facilitate attachment of the proximal anchor 555 to the connector 352, a pusher assembly 575 is configured to extend within the cap 571 (see Figures 21-23). The pusher assembly 525 may include a proximal portion 577 that extends to the handle of the device (connected to the pusher block described below) and a distal portion 579 attached to the proximal portion 577. The distal portion 579 may also include an extension 581 sized to accommodate the length of the proximal anchor 555. The thickness of the extension 581 is selected to ensure a clearance of 0.004 inches between the cutter and the lower portion of the proximal anchor 555, thereby leaving a connector tail after being cut by the cutter. The cap 571 may also include an anchor stop 583, which is configured at the distal end of the cap 571. The anchor stop 583 is sized and shaped to prevent the proximal anchor 555 from becoming stuck in the cap 571 after the cap and proximal anchor 555 are engaged. Through its connection to the pusher of the pusher block 604, the pusher assembly 575 is advanced distally, which in turn causes the proximal anchor component 555 to engage the connector 352 (see also FIG. 23).

Next, pusher block 604 contacts the first end of cutter jaw 608, causing its second end to rotate and no longer engage with cutter block 565. It will be noted that the moment at which the proximal anchor member 555 is first advanced and then the connector 352 is cut to the appropriate length can be controlled by the force applied by spring 606, the distance that pusher block 604 will travel, and/or the position of the first end of cutter jaw 608. The proximal end of cutter 214 is attached to cutter block 565. As cutter block 565 moves proximally, cutter 214 is retracted.

Thus, releasing the pusher assembly advances the second member 555 of the anchor assembly into locking engagement with the connector of the anchor assembly (see FIG23 ). This action causes the pusher 575 to advance the anchor member 555 onto the connector (e.g., suture) while the tool bears against the connector with sufficient force and the anchor advances with sufficient speed and force to secure the anchor 555 with a positive retention force.

In another embodiment, the pusher assembly 575 for pushing the second anchor member 14 is eliminated by utilizing a single assembly that engages the second anchor member 14 with the connector 352 and cuts the connector 352. FIG. 24A illustrates the second anchor member 14 and the cutter block 565 in position to engage the second anchor member 14 after tensioning the connector 352. FIG. 24B illustrates the cutter block 565 being pushed distally by an actuator (which activates a load supplied by a spring, gas, or other loading method described herein). During the distal driving step, the second anchor member 14 engages the connector 352. FIG. 24C illustrates the cutter block 565 being pulled proximally by any return or retraction mechanism described herein. The second anchor member 14 remains fixed relative to the movement of the cutter block 565 because the second anchor member 14 is engaged to the connector 352. FIG. 24E illustrates the connector 352 having been severed by the sharp edge of the cutter block 565. Figure EE depicts the second anchor component 14 attached to the connector 352 and the connector 352 having been severed.

In an alternative embodiment, the second anchor may be held in place via tension, for example, when a cutter having a relatively blunt edge is retracted. The cutter will help secure the second anchor to the connector before severing the connector.

In some embodiments, one or more springs can be replaced with a gas-driven mechanism. The mechanism is driven by a gas tank, such as a _CO2 tank, or it can be driven by a compressed gas system, such as a compressed air line or compressed gas tank, or by suction or a fluid line. One or more steps of placing the needle, tightening the connector, attaching the second anchor component, and cutting the connector can be powered by the gas-driven mechanism. The gas-driven system can include a purge valve, a regulating valve, a piston, and other fluid control structures typically associated with a gas-powered device.

In certain embodiments, the energy load required to drive the needle must overcome friction between the needle cannula (or its equivalent in the various elongated member embodiments described herein) and the needle. Reducing the friction experienced by the needle, particularly at the bend in the distal section of the needle assembly, can reduce the load required to advance the needle. In certain embodiments, only the needle has a bend at its distal end, and the radius of curvature of the needle assembly's distal section is smaller than that of the needle's curved distal section. The needle's curvature is less severe, providing a generally right-angled trajectory from the prostate capsule to the prostatic urethra. A greater bend in the needle's distal end can make it difficult to secure the distal anchor to the prostate capsule. Furthermore, due to the low profile of the delivery system, the needle assembly must redirect the needle in a relatively small space. Therefore, its radius should be as small as possible. Balancing these opposing requirements while closely aligning the radii can reduce friction experienced by the needle. In certain embodiments, the needle's radius is approximately 0.957", while the inner and outer radii of the needle cannula are 0.805" and 0.802", respectively.

25A-H illustrate various views of an anchor delivery system handle 1000 configured to receive cannulas 1200. Each cannula 1200 contains at least one anchor assembly. The anchor delivery system handle 1000 is configured to deliver the anchor assembly and return to a loaded state, thereby allowing a spent cannula to be replaced with a new one and the placement process to be repeated without requiring the user to load mechanical energy into a spring within the device.

Preferably, the device is stored and transported without storing mechanical energy in some or all of the springs. A removable insert can be included in the cannula lumen 1010 of the anchor delivery system handle 1000. After opening the packaging containing the anchor delivery system handle 1000, the user must remove the insert before there is room in the anchor delivery system handle 1000 for inserting a new cannula 1200. The removable insert and the anchor delivery system handle 1000 are configured such that removing the removable insert applies an initial energy load to the spring 1050 or springs 1050, 1055 in the system and positions the firing sled 1060 in the cannula lumen 1010 to receive the new cannula 1200. For example, the user can pull the handle on the removable insert in a proximal direction until the insert reaches a point in the cannula lumen 1100 that allows the user to remove the insert. Once the removable insert has cleared a protrusion, cutout, or other structural feature in the anchor delivery system handle 1000, the removable insert can be pulled out.

The firing sled 1060 includes slots that align with the pusher tabs 1012, 1014 on the cannula 1200. The slots and pusher tabs are complementary mechanisms that allow energy from the spring 1050 to be transferred through the firing sled 1060 to fire the needle in the cannula 1200. The cannula 1200 snaps into place within the cannula lumen 1010 when the slots and pusher tabs are aligned and locked in place by a cavity door or latch.

To fire the needle from the distal end of cannula 1200, the user squeezes safety 1085. Squeezing safety 1085 allows cam 1100 to rotate. Cam 1100 is operatively connected to lever 1080 via drive gear 1150 and clutch 1130. Teeth on lever 1080 engage teeth on drive gear 1150. Features on drive gear 1150 engage features on clutch 1130. Because clutch 1130 mates with cam 1100 using a rack, the greater the force applied, the greater the grip. Once lever 1080 is fully gripped, it can be fully retracted to its initial position without moving cam 1100. When the user squeezes lever 1080 inward to its full travel, cam 1100 rotates 180° clockwise. Rotation of the cam 1100 ultimately releases the firing sled 1060, causing the stored energy in the spring 1050 to rapidly move the firing sled 1060 forward and eject the needle into tissue from the distal end of the cannula 1200. FIG25D illustrates the firing sled 1060 in its forward position, with the needle 230 shown extending from the distal end of the cannula 1200.

25E-25F , as the user continues to squeeze lever 1080, cam 1100 continues to rotate and pulls back firing sled 1060. As firing sled 1060 is pulled forward, connector sled 1020 remains in a forward position, ejecting the distal anchor from the end of needle 230. With continued travel of lever 1080 as the user squeezes the lever, connector sled 1020 is pulled proximally by rotating cam 1100, thereby exerting tension on the connector. Lever 1080 can now be released, returning it to its original position, while the components within anchor delivery system handle 1100 remain in place.

25G-25H , when the lever 1080 is squeezed a second time, the cam 1100 rotates and breaks the lock with the second anchor sled 1040, which is connected to the spring 1055. The spring 1055 has been loaded with energy by the rotation of the cam 1100 and now releases this energy by the rapid forward movement of the second anchor sled 1040, thereby delivering the second anchor into engagement with the connector. This step of distally launching the second anchor sled 1040 also enables the cutting of the connector by the mechanism disclosed herein.

25I-25J , as the user continues to squeeze the lever 1080, the cam 1100 continues to rotate and returns the second anchor sled 1040 to its initial position. After releasing the lever 1080 a second time, the anchor delivery system handle 1000 is again configured so that the spent cannula 1200 can be removed and a new cannula 1200' can be inserted into the handle. Rotating the cam 1100 also returns the safety device 1085 to its locked position. Alternatively, the lever 1080 and cam 1100 can be configured so that each squeeze of the lever rotates the cam 120 degrees, requiring three pulls on the lever 1080 to complete the placement sequence and return to the starting position. Alternatively, the cam 1100 and lever 1080 (and the gear arrangement) can be designed so that each squeeze of the lever rotates the cam by a different amount. For example, in a configuration where the lever is pulled three times, the design may cause the wheel to rotate 90 degrees with each of the first two lever pulls (achieving 180 degrees of rotation after the first two pulls), and then a third lever pull completes the remaining 180 degrees of rotation.

Figures 26A-26E illustrate an anchor delivery system including a tip cannula 2000. Tip cannula 2000 includes a needle 230 and an anchor assembly, which comprises a first anchor, a connector, and a second anchor. A firing shaft 2100 is configured to mate with a lumen in an elongated handle member 2200. A locking arm 2010 also mates with the elongated handle member 2200 and provides stability to the connection between the elongated handle member 2200 and the tip cannula 2000. Activating an actuator on the handle of the anchor delivery system pushes the firing shaft 2100 distally and advances the needle 230. Activating the same or another actuator retracts the needle while maintaining the connector in position within the distal anchor, thereby positioning both within the tissue. The connector is tensioned, and the same or another actuator fires a second anchor to engage the connector. Advantageously, this embodiment allows a single handle to be reused for multiple tip cannulas. This embodiment and its equivalents efficiently deliver the anchor assembly to the distal end of the device.

In some embodiments, the cannula includes an elongated shaft portion that can be attached to the distal end of the endoscope or the distal end of the sheath. This distal attachment point can help stabilize and/or fix the distal portion of the elongated portion of the cannula before or after the cannula is inserted into the handle. In some embodiments, the cannula has structural features that align the cross-sectional position of the cannula within the sheath, such as, a rack, boss, arm, strut or similar structure. Preferably, such features align the distal end of the cannula with the distal end of the sheath. In addition, in addition to or instead of being on the cannula, an alignment feature can be located on the cannula. Preferably, the alignment feature allows the flushing fluid to flow through the length of the sheath. In some embodiments, there is no need to separate or adjust the handle relative to the sheath in order to remove or install the cannula. In some embodiments, the cannula is configured so that inserting or removing the cannula changes the energy state of at least one spring mechanism in the handle.

The embodiments described herein provide several advantages, including, but not limited to, the ability to efficiently deliver multiple anchor assemblies while reducing patient discomfort and increasing ease of use. Certain embodiments provide a mechanism for delivering an anchor using a single lever or equivalent actuator and loading stored energy therein within the delivery device, thereby making the device ready or nearly ready to deliver another anchor assembly by simply replacing a cannula in the delivery system.

Thus, the present invention contemplates directly pushing the anchor portion of the anchor assembly and directly pushing the connector of the anchor assembly. Furthermore, as described above, the distal or first anchor component can be advanced and positioned via a needle assembly, and at least one of the proximal or second anchor components can extend from the needle or from a housing portion of the anchor placement device and be positioned. Furthermore, the placement device can deliver and position a single anchor assembly or multiple anchor assemblies at the access site. Furthermore, a single anchor assembly component can, for example, be placed on one side of the prostate or urethra, while multiple anchor assembly components can be placed in opposite or displaced locations along such anatomical structures. Thus, the number and position of the anchor assemblies can be equal and/or symmetrical, unequal in number and asymmetrical, or simply asymmetrically positioned. In the context of prostate treatment, the present invention is used to displace, compress, and/or shrink the prostate and open the prostatic urethra, deliver a graft to the access site, and apply tension between the graft ends. Furthermore, drug delivery is contemplated and described as another BPH therapy, treating overactive bladder, as well as treating prostate cancer and prostatitis.

Once implanted, the anchor assembly of the present invention can achieve desired tissue manipulation, approximation, compression or contraction, and collaborate with the target anatomical structure to provide an atraumatic support structure. In a preferred embodiment, the shape and contour of the anchor assembly are configured so that the assembly enters the target tissue, such as the folds formed in the urethra when the anchor assembly opens the urethral lumen. In the desired placement, delicate or soft tissue in the area collapses around the anchor structure. Finally, natural tissue can grow on the anchor assembly and, over time, grow new cells. This collaboration with the target tissue aids in healing and avoids undesirable side effects, such as calcification or infection at the intervention site.

Following the interventional procedure, the patient may be instructed to take appropriate medications or therapeutic agents, such as alpha blockers and anti-inflammatory drugs.

Furthermore, in addition to the intention to cooperate with natural tissue anatomy, the present invention also contemplates methods of accelerating healing or inducing healing. Methods that may promote healing may include the use of abrasive materials, textured connectors, bodily actions, and drugs.

In addition, it is contemplated that components of the anchor assembly or selected portions thereof (of any of the described or contemplated anchor assemblies) may be coated or embedded with a therapeutic or diagnostic substance (e.g., a drug or therapeutic agent). Again, in the context of treating prostate problems, the anchor assembly may be coated or embedded with a therapeutic or diagnostic substance, such as 5-alpha-reductase, which causes a decrease in prostate size. Other substances contemplated include, but are not limited to, phytochemicals, typically alpha-1a adrenergic receptor blockers, smooth muscle relaxants, and preparations that prevent testosterone from being converted to dihydrotestosterone. In a particular approach, the connector may, for example, be coated with a polymer matrix or gel that retains the therapeutic or diagnostic substance and helps achieve its timed release. In addition, it is contemplated that antibacterial coatings for prostatitis and analgesics and antibiotics, as well as other chemical coatings for cancer treatment, may be applied to various portions of the anchor assembly described herein. Such coatings may have various thicknesses or specific thicknesses so that they, along with the connector itself, match the profile of the cylindrical portion of the anchor member to which it is fixed. Furthermore, it is within the scope of the present invention to coordinately deliver therapeutic or diagnostic gels or other substances via an implant placement device or another medical device (i.e., a catheter) and an anchor assembly comprising the same structure, such as a radioactive loading device (such as a distal end of a catheter or implant or other therapeutic instrument for cancer). In one such method, the placement device includes a container containing a gel substance, and the anchor assembly is advanced through the container to pick up a desired amount of the therapeutic or diagnostic gel substance.

It is further contemplated that in certain embodiments, the anchor delivery device may include the ability to detect forces applied thereto or other environmental conditions. Various sections of the device may include such devices, and in one contemplated approach, sensors may be placed along the needle assembly. In this way, an operator can detect, for example, whether the needle has breached the target anatomical structure at the intervention site and the extent to which such breach has occurred. Other sensors that can detect specific environmental characteristics, such as blood or other chemical or component sensors, may also be employed. In addition, the use of one or more pressure sensors that provide feedback on the placement status of the anchor assembly during delivery or after implantation is contemplated. For example, these sensors may monitor tension or depth feedback. In addition, such sensors may be incorporated into the anchor assembly itself, into other structures of the placement device, or into anatomical structures.

Furthermore, it should be understood that the foregoing process is reversible. In one method, the connecting structure of the anchor assembly can be severed and the proximal (or second) anchor component removed from the patient's body. For example, a physician can sever the connecting structure and simultaneously remove a second anchor that was previously implanted, for example, in the patient's urethra using an electrosurgical, surgical, or laser surgical device used to perform a transurethral prostatectomy.

One aspect provided by various embodiments of the present invention is the ability to have anchor assemblies of customizable lengths, each of which can be implanted in a different location without having to remove the device from the patient. Other aspects of various embodiments of the present invention are loading-based delivery of anchor assemblies, delivery of anchor assemblies utilizing a device having an integral connector (e.g., suture), cutting, and delivery of anchors utilizing an endoscope within the device. The delivery device is uniquely configured to maintain tension on the suture during delivery to help ensure that the first anchor component is securely placed against a tissue plane (e.g., the external capsule of the prostate) and is relatively securely supported when the second anchor component is attached to the connector and delivery device. In this aspect, a needle assembly serving as a piercing member is cooperatively connected to a mechanism that pulls on the anchor when the needle assembly is retracted.

It should be understood that various materials are within the scope of the invention for use in making the disclosed devices. Additionally, one or more components of one or more anchor devices disclosed herein, such as distal anchors, proximal anchors, and connectors, may be fully or partially biodegradable or biodegradable.

Furthermore, as described above, the devices and methods disclosed herein can be used to treat various pathologies in various lumens or organs comprising lumens or walls. Examples of such lumens or organs include, but are not limited to, the urethra, intestine, stomach, esophagus, trachea, bronchioles, bronchial passages, blood vessels (e.g., for the treatment of varicose veins or valvular insufficiency), arteries, lymphatic vessels, ureters, bladder, atria or ventricles, uterus, fallopian tubes, and the like.

Finally, it should be understood that the present invention has been described above with reference to certain examples or embodiments of the invention, but that various additions, deletions, changes and modifications may be made to these examples and embodiments without departing from the spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used in another embodiment or example, unless doing so would render the embodiment or example unauthorized or unsuitable for its intended use. In addition, for example, when the steps of a method are described or listed in a particular order, the order of these methods may be changed, unless doing so would render the method unauthorized or unsuitable for its intended use. All reasonable additions, deletions, modifications and changes are to be considered equivalents of the examples and embodiments, and are to be included within the scope of the claims that follow.

It will thus be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention.

Claims (11)

1. A handle for an anchor delivery system, comprising: A lever connected to a cam, wherein the lever has a first lever position, moving the lever from the first lever position will cause the cam to rotate, and when the lever has moved through its full range of motion, the lever is able to return to the first lever position without causing the cam to rotate; The first slide plate, in its first slide plate position, engages with the cam, wherein rotation of the cam causes the first slide plate to move from the first slide plate position; and A first spring is connected to a first slide plate, wherein the movement of the first slide plate caused by the rotation of the cam loads energy into the first spring, and further rotation of the cam releases the energy loaded into the first spring by allowing the first slide plate to quickly return to its first slide plate position and advancing the retractable pin of the anchor conveying system. 2. The handle according to claim 1, further comprising a second spring connected to the second slide plate, wherein rotation of the cam loads energy into the second spring. 3. The handle according to claim 2, wherein the second slide is configured to be in a locked position when energy has been loaded into the second spring. 4. The handle according to claim 3, wherein rotation of the cam releases the second slide from the locked position, thereby causing the second slide to quickly return to the second slide position. 5. The handle according to claim 1, wherein the lever is connected to the cam via a drive gear. 6. The handle according to claim 5, wherein the lever includes lever teeth, the drive gear includes drive gear teeth, and the lever teeth mesh with the drive gear teeth. 7. The handle according to claim 1 further includes a safety device having a position capable of preventing lever operation. 8. The handle according to claim 1, wherein the handle is configured to be connected to the sleeve of the anchor delivery system. 9. The handle of claim 8, wherein the first slide plate includes a complementary mechanism for transferring energy from the first slide plate to the sleeve. 10. The handle of claim 9, wherein energy is transferred from the first slide plate to the sleeve, causing the retractable needle to be deployed from the sleeve. 11. The handle of claim 2, wherein the handle is configured to connect with a sleeve of the anchor delivery system, and the second slide plate includes a complementary mechanism for transferring energy from the second slide plate to the sleeve.