Handle cartridge system for medical intervention

Abstract

The present invention provides a device for treating tissues or anatomical structures within the body of a human or animal patient by transmitting mechanical energy from a handle to a cartridge for the purpose of treating a disease or disorder. [Solution] The handle and cartridge of the present invention have a safety interlock.

Description

Technical Field

[0001] The present invention generally relates to medical instruments, particularly medical instrument systems including a handle and a replaceable cartridge. In such a system, mechanical energy of the handle is transmitted to the cartridge for the purpose of treating a disease or disorder to treat tissue or anatomical structures within the body of a human or animal as a patient.

Background Art

[0002] Benign prostatic hyperplasia (BPH) is one of the most common conditions found in men, particularly older men. In the United States, more than half of all men exhibit histopathological evidence of BPH by age 60, and nearly 9 out of 10 men are affected by this condition by age 85. Furthermore, the incidence and prevalence of BPH are expected to increase as the average lifespan of the populations of developed countries increases.

[0003] The prostate gland enlarges throughout a man's life. In some people, the prostatic capsule around the prostate may prevent further enlargement of the prostate. This causes the inner region of the prostate to constrict the urethra. This pressure exerted on the urethra increases the resistance to the flow of urine through the region of the urethra surrounded by the prostate. Thus, the bladder must exert a higher pressure to push out urine due to the increased resistance of the urethra. Due to chronic overwork, the muscular wall of the bladder becomes deformed and hardened. The combination of the increased resistance of the urethra to the flow of urine and the stiffening and thickening of the bladder wall thus causes various lower urinary tract symptoms (LUTS) that can significantly reduce the quality of life of the patient. These symptoms include decreased urine force or interruption of the urine stream during urination, a sense of urgency during urination, hesitation before the start of the urine flow, a feeling that the bladder is not completely empty even after urination (a feeling of residual urine), dripping (drip) or subsequent urine leakage at the end of urination, particularly an increase in the frequency of urination at night, and a sense of urgency to urinate.

[0004] In addition to patients with BPH, LUTS may also occur in patients with prostate cancer, prostate infections, and chronic use of certain medications that cause urinary retention, particularly in men with benign prostatic hyperplasia (e.g., ephedrine, pseudoephedrine, phenylpropanolamine, antihistamines such as diphenhydramine and chlorpheniramine).

[0005] Although BPH is rarely life-threatening, it can lead to a variety of clinical conditions, including urinary retention, renal failure, recurrent urinary tract infections, incontinence, hematuria, and bladder stones.

[0006] In developed countries, the majority of the patient population receives treatment for BPH symptoms. By age 80, approximately 25% of men in the United States have received some form of BPH treatment. Currently, available treatment options for BPH include observation, medication (phytotherapy and prescription drugs), surgery, and minimally invasive procedures.

[0007] For patients who choose the observation option, immediate treatment is not provided, but they undergo regular checkups to monitor the course of their illness. This is typically done for patients with minimal symptoms that are not particularly troublesome.

[0008] Surgical procedures to treat BPH symptoms include transurethral resection (TURP), transurethral electrovaporization of the prostate (TVP), transurethral incision of the prostate (TUIP), laser prostatectomy, and open prostatectomy.

[0009] Minimally invasive procedures for treating BPH symptoms include transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), intratissue laser coagulation (ILC), and prostate stent placement.

[0010] Many current methods for treating BPH carry a high risk of side effects. These methods and devices either require general or spinal anesthesia, or the procedures are performed in an operating room, potentially leading to negative consequences that necessitate the patient's subsequent hospitalization. BPH treatments with a lower risk of postoperative adverse effects are also associated with a reduction in symptom scores. While some of these procedures can be performed in a clinic setting with local pain management, patients do not experience immediate relief; in fact, symptoms often worsen for several weeks after the procedure until the body begins to recover. In addition, many instrumental methods require the insertion of a urinary catheter into the bladder, sometimes for several weeks. Catheterization is sometimes necessary because this therapy actually causes obstruction for a period after the procedure, and in some cases, catheterization is indicated due to postoperative bleeding or potentially obstructive blood clot formation. While drug administration in pharmaceutical treatment is easy, the results are often not very impressive, requiring a considerable amount of time to achieve effectiveness, and frequently accompanied by undesirable side effects.

[0011] Novel instruments and methods have been developed for various procedures to lift, compress, support, return to normal position, cauterize, or otherwise modify prostate tissue, either in separate procedures or in combination with the treatment of BPH. Such instruments and methods are described in U.S. Patents Nos. 7,645,286, 7,758,594, 7,766,923, 7,905,889, 7,951,158, 8,007,503, 8,157,815, 8,216,254, 8,333,776, 8,343,187, and 8,394,110. This is disclosed in the following specifications: No. 8,425,535, No. 8,663,243, No. 8,715,239, No. 8,715,298, No. 8,900,252, No. 8,936,609, No. 8,939,996, No. 9,320,511, No. 9,549,739, No. 10,105,132, and No. 10,299,780. [Prior art documents] [Patent Documents]

[0012] [Patent Document 1] U.S. Patent No. 7,645,286 [Patent Document 2] U.S. Patent No. 7,758,594 [Patent Document 3] U.S. Patent No. 7,766,923 [Patent Document 4] U.S. Patent No. 7,905,889 [Patent Document 5] U.S. Patent No. 7,951,158 [Patent Document 6] U.S. Patent No. 8,007,503 [Patent Document 7] U.S. Patent No. 8,157,815 [Patent Document 8] U.S. Patent No. 8,216,254

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Summary of the Invention

Problems to be Solved by the Invention

[0013] There is a need for a mechanical design and system for transmitting energy from the handle of such an instrument to the cartridge with high reliability, reproducibility, and efficiency. The present invention addresses these needs.

Means for Solving the Problems

[0014] Aspects of the present invention relate to mechanical designs and configurations for transmitting mechanical energy from a handle to a cartridge in order to treat tissues and anatomical structures or other structures within the body of a human or animal patient for the purpose of treating a disease or disorder.

[0015] In one view, the cartridge has a sliding cutter block connected to a sliding pusher block via a tension spring, and the cutter block and pusher block are configured to slide linearly within the cartridge body. The cartridge further has a rotatable implant actuator located within the cartridge body, the rotatable implant actuator engaging with the pusher block so that the implant actuator prevents the pusher block from sliding when the implant actuator is in a first position. The spring is in an extended position, exerting a force that pulls the cutter block and the pusher block toward each other. The cartridge has a knob, which moves from an unlocked position to a locked position, the locked position being such that it secures the cartridge to the handle. The cartridge has a pusher safety tab on the knob, which is configured to engage with the implant actuator when the knob is in the unlocked position, preventing the implant actuator from rotating while engaged. The pusher safety tab on the knob is configured to disengage from the implant actuator when the knob is in the locked position, thereby allowing the implant actuator to rotate. The cartridge has cutter claws located within the cartridge body and between the cutter block and the pusher block. The cutter claws have an engagement position with the cutter block to prevent the cutter block from sliding toward the pusher block, and a disengagement (unengaged) position from the cutter block to allow the cutter block to slide toward the pusher block. The pusher block is configured to slide and contact the cutter claws, thereby causing the cutter claws to rotate and disengage from the cutter block. The cartridge has an indicator window provided in the cover of the cartridge body. The indicator window displays the position of the cutter block. The indicator window is configured to serve as an access means for sliding the cutter block.The cartridge has an access window provided in the knob, which serves as an access means to the cutter jaws, allowing the cutter jaws to be moved from the engaged position to the disengaged position while the pusher block is not in contact with the cutter jaws.

[0016] From another perspective, the cartridge has a cartridge body connected to a shaft assembly having a long axis (hereinafter also referred to as the "longitudinal axis"), and the distal portion of the shaft assembly has a lumen extending through this distal portion. The lumen has a lumen curvature radius determined by the curvature of the lumen when it extends in a first direction parallel to the longitudinal axis, and thus extends in a second direction perpendicular to the longitudinal axis. The needle assembly is slidably provided within the shaft assembly and the cartridge body, and this needle assembly includes a distal portion of the needle, which is configured to exit the shaft assembly from an exit port where the lumen terminates. The distal portion of the needle has a needle curvature radius determined by the curvature of the needle when the needle extends in a first direction parallel to the longitudinal axis, and thus extends in a second direction perpendicular to the longitudinal axis, and the lumen curvature radius and the needle curvature radius are different. The cartridge has a notch in the shaft assembly, which is configured to allow at least a portion of the distal portion of the needle to flex through the notch. The cartridge has an additional notch in the shaft assembly, which is configured to allow at least a portion of the distal portion of the needle to flex through the additional notch. The cartridge has a desired distal lumen wall with a wall radius of curvature that is in contact with the desired exit trajectory of the distal portion of the needle.

[0017] A system including a handle and a cartridge includes a cam wheel, which is housed within the handle and coupled to a trigger assembly also housed within the handle. A wheel actuator is coupled to the cam wheel, and as a result, a feature on the cam wheel is configured to rotate the wheel actuator in a first direction when the feature contacts the wheel actuator. The wheel actuator has a flex that engages with the wheel actuator when it rotates in the first direction and rotates the wheel actuator in a second direction opposite to the first direction when the feature no longer contacts the wheel actuator. The system includes a sliding pusher block or implant actuator, each housed within the cartridge. The implant actuator engages with the pusher block to prevent it from sliding. The wheel actuator disengages the implant actuator from the pusher block when it rotates in the first direction.

[0018] The system, including the handle and cartridge, includes a trigger assembly located within the handle and a locking tab located within the trigger assembly, the locking tab being configured to retract into the cartridge bay of the handle when the trigger is in the working position, and as a result, the cartridge cannot be secured in the cartridge bay when the locking tab is at least partially located within the cartridge bay. The system includes a locking surface located on the cartridge, the locking surface being configured to engage with the locking tab to prevent the cartridge from being removed from the cartridge bay when the trigger is in the working position. The cartridge can be removed from the cartridge bay when the trigger is in the initial position.

[0019] The system delivers the implant formed by the distal anchor component, the suture portion, and the proximal anchor component. The system includes a pusher block configured to push the proximal anchor component onto the suture portion and a cutter block configured to cut the suture portion.

[0020] Other features and advantages of embodiments of the present invention will become apparent from the following description made in conjunction with the accompanying drawings, which illustrate certain principles of the present invention as examples. [Brief explanation of the drawing]

[0021] [Figure 1] This is a perspective view of one embodiment of a system including a handle and cartridge for treating benign prostatic hyperplasia. [Figure 2A] This is a perspective view of the handle of one embodiment of a system for treating benign prostatic hyperplasia, showing the state after the cartridge has been removed. [Figure 2B] This is a perspective view of a cartridge removed from the handle of one embodiment of a system for treating benign prostatic hyperplasia. [Figure 3] This is a perspective view of one embodiment of an anchor assembly. [Figure 4A] This is an isometric view of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 4B] This is an isometric view of a needle assembly housed in a cartridge of one embodiment of a system for treating benign prostatic hyperplasia. [Figure 5A] This is a side view of a portion of the distal tip component of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 5B] This is a cross-sectional isometric view of the distal tip component of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 6A] This is a side view of a portion of the distal end of the handle and cartridge of one embodiment of a system for treating benign prostatic hyperplasia. [Figure 6B] This is a bottom view of a portion of the distal end of the handle and cartridge of one embodiment of a system for treating benign prostatic hyperplasia. [Figure 7A] This is a cross-sectional perspective view of the distal portion of a cartridge in another embodiment of a system for treating benign prostatic hyperplasia. [Figure 7B] This is a cross-sectional perspective view of the distal portion of a cartridge in another embodiment of a system for treating benign prostatic hyperplasia. [Figure 7C] This is a cross-sectional perspective view of the distal portion of a cartridge in another embodiment of a system for treating benign prostatic hyperplasia. [Figure 8] This is an isoangular view of the distal portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 9] This is an isometric view of the disassembled and assembled handle of a system for treating benign prostatic hyperplasia. [Figure 10] This is an isometric view of an exploded assembly of one example of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 11A] This is a left side view of a cam wheel provided within one embodiment of the handle of a system for treating benign prostatic hyperplasia. [Figure 11B] This is a right side view of a cam wheel provided within one embodiment of the handle of a system for treating benign prostatic hyperplasia. [Figure 12A] This is a left side view of a cam wheel and certain other mechanical features provided within one embodiment of a handle and cartridge for a system to treat benign prostatic hyperplasia. [Figure 12B] This is a left side view of a cam wheel and certain other mechanical features provided within one embodiment of a handle and cartridge for a system to treat benign prostatic hyperplasia. [Figure 13A] This is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 13B]This is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 14] This is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 15A] This is an exploded assembly plan view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 15B] This is a disassembled and assembled perspective view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 16A] This is a perspective view of a portion of the handle of one embodiment of a system for treating benign prostatic hyperplasia, showing the state after the cartridge has been removed. [Figure 16B] This is a side view of a portion of the handle of one embodiment of a system for treating benign prostatic hyperplasia, showing the state after the cartridge has been removed. [Figure 17] This is a side view of a portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 18A] This is a perspective view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 18B] This is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 19A] This is a side view of a portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 19B] This is a side view of a portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. [Figure 19C] This is a perspective view of a cartridge cover of one embodiment of a system for treating benign prostatic hyperplasia. [Figure 20A]This is a disassembled and assembled perspective view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Figure 20B] This is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system used to treat benign prostatic hyperplasia. [Modes for carrying out the invention]

[0022] Generally, embodiments of the system of the present invention relate to a mechanical design and configuration for transmitting mechanical energy from a handle to a cartridge to treat tissues and anatomical structures or other structures within the body of a human or animal patient for the purpose of treating a disease or disorder. The handle and cartridge cooperate to deliver an implant or anchor assembly into the tissue. The cartridge is configured to carry the components of the anchor assembly. Multiple cartridges can be used with a single handle, and as a result, multiple anchor assemblies can be deployed into the tissue using this single handle during a procedure on an individual patient.

[0023] Referring now to the figures provided as examples rather than limitations of the present invention, Figure 1 is a perspective view of one embodiment of System 1 for treating benign prostatic hyperplasia, System 1 comprising a handle 100 and a cartridge 200. The handle 100 has a mechanical energy source that transmits energy to the cartridge 200 to deploy an anchor assembly housed within the cartridge 200. The handle 100 is configured to restore energy by adding it to these mechanical energy sources while a first cartridge is being used and / or prior to the insertion of a second cartridge. The handle 100 is designed to deliver energy sequentially and reliably to multiple cartridges until a new handle is required. By using the handle 100 multiple times, constraints specific to the mechanical features of the handle 100 are added, facilitating highly reliable and reproducible transmission from the handle to the cartridges.

[0024] Figure 2A is a perspective view of a handle 100 of one embodiment of a system for treating benign prostatic hyperplasia, and Figure 2B is a perspective view of its cartridge 200. Figures 2A and 2B show the handle 100 and cartridge 200 separated from each other. The handle 100 has a cartridge bay 101 into which the cartridge 200 can be securely inserted. The cartridge 200 has a cartridge body 201 that can be positioned to securely fit the cartridge 200 into the cartridge bay 101 of the handle 100. The handle 100 has a scope tube 102, which is designed to receive an endoscopic instrument within the lumen of the scope tube 102. The scope tube 102 facilitates visualization of the treatment site when the system is used to deploy the anchor assembly to tissue. The cartridge 200 has a shaft assembly 202, which includes components of other assemblies (for example, the needle assembly 210, the suture assembly 220, and the cutter assembly 230, which are described in more detail herein). The scope tube 102 and the shaft assembly 202 are configured to connect with each other when the handle 100 and the cartridge 200 are engaged with each other. Thus, the handle 100 and the cartridge 200 are securely engaged with each other by the interaction of the cartridge bay 101 and the cartridge body 201 and the interaction of the scope tube 102 and the shaft assembly 202. Turning the cartridge knob 203 from the unlocked position to the locked position ensures that the cartridge 200 and the handle 100 are connected.

[0025] Figure 2B shows the distal needle portion 212 extending from the distal shaft portion 204. The needle assembly 210 is configured to move between a fully retracted position where the entire needle assembly is located within the shaft assembly 202 and cartridge body 201, and a fully extended position where the distal needle portion 212 extends from the distal shaft portion 204. The distal needle portion 212 houses the components of the anchor assembly that are delivered into the tissue.

[0026] Figure 3 is a perspective view of one embodiment of the anchor assembly. In the unconstrained configuration, the distal anchor component 70 has a head portion 72 that is perpendicular as a whole to the tail portion 74. The distal anchor component 70 is constrained to an upright configuration as a whole while housed within the distal portion 212 of the needle and before deployment to the target field, and only then takes on an unconstrained (i.e., perpendicularly oriented) configuration when deployed from the needle assembly 210.

[0027] In a particular embodiment, the distal anchor component 70 is formed from a nitinol substrate, which is a material that can be shaped to be tubular overall and to include a right-angle insertion configuration of the head portion 72 to the tail portion 74. A suture 78 is attached to the distal anchor component 70. In one embodiment, a polyethylene terephthalate (PET) suture portion 78 is thermoformed onto a lock feature within the distal anchor component 70. The distal anchor component 70 is preferably locally heated to reflow bond the suture to the end of the distal anchor component 70 and into a notch provided in the distal anchor component 70. The distal anchor component 70 may be attached to the suture portion 78 by any of several known techniques for bonding PET material to nitinol material.

[0028] In one embodiment, an intermediate section 80 of the distal anchor component 70 constitutes a structural transition from the head portion 72 to the tail portion 74, and this intermediate section forms a portion of the side wall from which the vicinity of the intermediate section 80 has been removed. Another portion of the side wall has been removed to form a connector section 82 of the tail portion 74, which extends from the intermediate section 80. In one embodiment, this connector section 82 has a bend that produces a vertically oriented configuration. Thus, the anchor assembly may include the distal anchor component 70 in its pre-implantation configuration, and the initial engagement state of this distal anchor component and the suture portion 78 is coaxial as a whole.

[0029] Still referring to Figure 3, in one embodiment, the proximal anchor component 84 has branches 96 that grasp the suture portion 78. The internal structure of the branches 96 functions to rub against the surface of the suture portion 78, and these branches 96 receive the suture portion 78 in an impinged state and compress the suture portion 78 between the branches 96. It is preferable that tabs 98 extend from one or more of the branches 96 to help create a secure engagement between the proximal anchor component 84 and the suture portion 78.

[0030] In a particular embodiment, the proximal anchor component 84 is separate from and detached from the distal anchor component 70 and suture portion 78, which are housed in the needle assembly 210 in an engaged state, and resides within the shaft assembly 202. After the distal anchor component 70 and suture portion 78 are positioned in the tissue, the proximal anchor component 84 is firmly engaged with the suture portion 78 to form a fully assembled anchor assembly. To facilitate the engagement of the proximal anchor component 84 with the suture portion 78, the proximal anchor component 84 has a rigid, cylindrical rear end portion 95. This rigid, cylindrical rear end portion 95 allows the proximal anchor component 84 to be pushed and engaged with the suture device 78 by the transmission of mechanical energy from the handle 100.

[0031] Figure 4A is an isometric view of a cartridge 200 of one embodiment of a system for treating benign prostatic hyperplasia, and Figure 4B is an isometric view of a needle assembly 210 housed within such cartridge 200. The needle assembly 210 comprises a distal needle portion 212, a needle shaft 214, and a proximal needle portion 216. In one embodiment, the distal needle portion 212 is made of nitinol and is shaped to a curved form when unrestrained. The needle assembly 210 is configured to slide along the long axis (also called the "longitudinal axis") of the shaft assembly 202 of the cartridge 200. Initially, the needle assembly 210 is in a fully retracted position, with the entire needle assembly located within the shaft assembly 202 and the cartridge body 201. When the needle assembly 210 is slid distally along the longitudinal axis of the shaft assembly 202 from its initial position, the distal portion of the needle 212 extends from the distal portion of the shaft 204 and eventually reaches the fully extended position. The needle assembly 210 can be slid proximal, thereby retracting the distal portion of the needle 212 and returning it to its position within the shaft assembly 202. The majority of the proximal length of the distal portion of the needle 212 can take a substantially straight form when the distal portion of the needle 212 is located within the shaft assembly 202. As will be described in more detail in the specification, the proximal portion of the needle 216 interacts with various mechanisms in the handle to transfer energy from the handle to the needle assembly 210, thereby deploying and retracting the distal portion of the needle 212.

[0032] In certain embodiments, there may be a considerable amount of friction acting between the needle assembly 210 and the shaft assembly 202 when the needle assembly 210 slides against the shaft assembly 202. In some cases, the friction acting between the needle assembly 210 and the shaft assembly 202 may make it difficult for the distal portion of the needle 212 to move through the distal portion of the shaft 204. In some cases, such friction may slow down the speed of the distal portion of the needle 212 as it exits the distal portion of the shaft 204, thereby impairing effective treatment of the patient. That is, when treating benign prostatic hyperplasia, the distal portion of the needle 212 needs to penetrate the tissue at a speed sufficient to allow the distal tip of the needle 212 to penetrate the capsule, which is a tough tissue surrounding the prostate.

[0033] There are various sources of friction between the needle assembly 210 and the shaft assembly 202 when the needle assembly 210 slides against the shaft assembly 202. For example, discontinuities or defects along the inner surface of the shaft assembly 202 and / or the outer surface of the needle assembly 210 may increase the friction between the needle assembly 210 and the shaft assembly 202. One important source of friction is the constraining force acting on the distal needle portion 212 to ensure that it is substantially straight along most of its proximal length. That is, the shaping configuration of the distal needle portion 212 includes a predetermined radius of curvature that the distal needle portion 212 takes when it is unconstrained. This predetermined radius of curvature is designed so that the distal needle portion 212 penetrates tissue at a specific angle (or range of angles) and at a specific position (or range of positions) relative to the distal exit point of the distal needle portion 212 as viewed from the distal shaft portion 204. The method for treating benign prostatic hyperplasia carried out by the embodiments of the system described herein relies on a lateral path for the needle as a whole through the tissue relative to the longitudinal axis of the shaft assembly 202.

[0034] Due to a predetermined radius of curvature, the distal portion of the needle 212 can penetrate tissue along such a lateral path as a whole. However, as described herein, most of the proximal length of the distal portion of the needle 212 is constrained to be substantially straight when the distal portion of the needle 212 is located within the distal portion of the shaft 204. Although the distal portion of the needle 212 is relatively flexible, the constraint of the distal portion of the needle 212 creates numerous contact points along the inner surfaces of the shaft assembly 202 and the distal portion of the shaft 204.

[0035] Figure 5A is a side view of a portion of the distal tip component of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia, and Figure 5B is an isometric cross-sectional view of the distal tip component. The distal shaft portion 204 has a distal shaft portion exit port 205, and the distal needle portion (not shown) emerges from this exit port when the distal needle portion is extended from the distal shaft portion 204. The distal shaft portion exit port 205 is the distal end of the distal shaft portion lumen 207. The distal shaft portion lumen 207 has a specific effective radius of curvature where the lumen transitions from extending along the longitudinal axis of the shaft assembly to extending laterally relative to the longitudinal axis of the shaft assembly. One aspect of this transition is the internal exit wall 208 of the distal shaft portion, which is essentially the most distal portion of the distal shaft portion lumen 207. Thus, when the needle assembly is located inside the shaft assembly, the effective radius of curvature of the distal portion lumen 207 and the distal portion internal outlet wall 208 of the shaft may have a significant effect on the amount of friction the needle assembly experiences when sliding against the shaft assembly.

[0036] Figure 6A is a side view of a portion of the distal end of the handle and cartridge of one embodiment of a system for treating benign prostatic hyperplasia, and Figure 6B is a bottom view thereof. Figures 6A and 6B show the needle assembly in a retracted position within the shaft assembly 202 and the distal shaft portion 204. That is, the needle assembly is constrained to be substantially straight compared to its shape-setting configuration, which has a radius of curvature that positions the distal tip of the needle laterally with respect to the longitudinal axis of the needle assembly. However, the distal shaft portion notch 206 forms an opening between the inside and outside of the distal shaft portion 204, and a portion of the distal needle portion 212 protrudes through the distal shaft portion notch 206. The notch 206 in the distal shaft portion allows at least a portion of the distal needle portion 212 to flex through a portion of the bottom surface of the distal shaft portion 204, thereby allowing the distal needle portion 212 to have a smaller radius of curvature than would be possible without the notch 206. In other words, the notch 206 reduces the restraining force applied to the distal needle portion 212. The distal needle portion 212 does not contact the hard interior surface of the distal shaft portion 204, thereby reducing the number of surfaces that the distal needle portion 212 contacts while moving relative to the distal shaft portion 204. Fewer surface contacts can mean less overall friction during motion. Furthermore, by accepting a portion of the shaping radius of curvature, the notch 206 can help maintain a favorable exit trajectory for the distal needle portion 212. In some embodiments, the notch is preferably located along the rest of the shaft assembly 202. These notches can also reduce the number of surfaces that the needle assembly contacts with the shaft assembly 202 as it moves.

[0037] Figures 7A, 7B, and 7C are cross-sectional perspective views of the distal portions of cartridges in various embodiments of a system for treating benign prostatic hyperplasia. These embodiments show various configurations of the inner outlet wall 208 of the distal portion of the shaft. These embodiments are intended to reduce the friction experienced by the needle assembly when it is in contact with and / or sliding against the shaft assembly. In Figure 7A, the inner outlet wall 208 of the distal portion of the shaft has a radius of curvature that is tangential to the desired exit trajectory of the needle. In Figure 7B, the inner outlet wall 208 of the distal portion of the shaft has a straight section, the entire straight section is angled to be tangential to the desired exit trajectory of the needle. In Figure 7C, the inner outlet wall 208 of the distal portion of the shaft has a partial outlet wall and an upper notch 2009 provided on the upper surface of the distal portion of the shaft. The upper notch 209 of the distal portion of the shaft is designed to reduce the number of contact points between the distal portion of the shaft lumen and the needle assembly. Furthermore, the inner outlet wall 208 of the distal portion of the shaft is formed to minimize the presence of surface discontinuities, such as burrs, burrs, or sharp edges.

[0038] Figure 8 is a resected perspective view of the distal portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. Figure 8 shows one embodiment of the configuration of the distal portion lumen 207 of the shaft when it is curved toward the distal portion exit port 205 of the shaft. In this embodiment, the curved section of the distal portion lumen 207 of the shaft has tapered cross-sectional dimensions such that the cross-sectional area of ​​the distal portion lumen 207 of the shaft is larger at the proximal end of the curved section than at the distal end of the curved section. In one embodiment, the cross-sectional area and cross-sectional shape of the distal portion exit port 205 of the shaft are progressively larger than the outer diameter of the proximal portion of the needle. In one embodiment, the curvature of the curved section of the distal portion lumen 207 of the shaft matches the desired exit trajectory of the proximal portion of the needle.

[0039] Figure 9 is an isometric view of an exploded assembly of one embodiment of a handle for a system to treat benign prostatic hyperplasia. The handle 100 has a right handle case 103, a left handle case 104, and a cartridge bay 101 formed in the left handle case 104. The handle 100 is designed to enable patient treatment by transmitting energy stored in several springs (not shown) provided within the handle 100 to the cartridge. This energy is transmitted by the interaction of various mechanisms provided within the handle 100. A removable scope seal 105 covers the cartridge bay 101 while coupled to the scope tube 102.

[0040] The mechanism within the handle 100 includes a handle trigger assembly 110, which is operatively coupled to a handle trigger spring (not shown) that provides sufficient force to return the handle trigger assembly 110 to its initial position after it has been pulled and released by the user. A ratchet 114 coupled to a ratchet spring (not shown) influences the movement of the handle trigger assembly 110, preventing it from returning to its initial position before it has been moved to a predetermined position (e.g., pulled) by the user. A safety device 112 is coupled to the handle trigger assembly 110 to prevent accidental activation of the handle trigger assembly 110. The handle trigger assembly 110 is coupled to a drive gear 113 which is coupled to a cam wheel 120.

[0041] The cam wheel 120 rotates around its central axis and, via structural and feature parts provided on the cam wheel, triggers a specific movement within the handle 100 when the cam wheel 120 rotates. There are numerous skids operationally connected to the cam wheel 120, which move linearly along the lateral axis of the handle 100. Numerous springs are provided to exert force on the skids, thereby providing sufficient mechanical energy to feed out the implant. The cartridge has numerous tab assemblies, which engage with the skids via slots provided on the skids, so that the energy exerted by the operation of the mechanism (e.g., springs) within the handle is transmitted to the mechanism within the cartridge.

[0042] A wheel actuator 125 is operatively connected to a cam wheel 120 and an implant skid 160, the implant skid 160 being connected to an implant spring that provides energy associated with the feeding of the implant. A needle skid 140 is operatively connected to a cam wheel 120 and a spindle 145, the needle skid spring providing energy associated with the feeding of the implant. A suture skid 150 is operatively connected to a cam wheel 120, the suture skid spring providing energy associated with the feeding of the implant.

[0043] The handle 100 has various other parts for assembling the handle, such as a cover plate 130, a scope lock 170, a sheath lock 180, and various screws and / or fasteners. The cover plate 130 serves as the internal base for the cartridge bay 101. The scope tube 102, scope lock 170, scope seal 105, and sheath lock 180 function to mount the endoscope and other auxiliary equipment (e.g., a surgical sheath) to facilitate the performance of the procedure.

[0044] Figure 10 is an isometric view of an exploded assembly of one embodiment of a cartridge for a system to treat benign prostatic hyperplasia. In this embodiment, the cartridge 200 has a cartridge cover 299 coupled to a cartridge base 298. These two components are coupled to a shaft support 297 to form the cartridge body. A cartridge knob 203 is coupled to the cartridge cover 299.

[0045] The shaft support 297 is attached to the shaft assembly 202, and the shaft assembly 20 2 includes the distal shaft portion 204. A non-destructive tape 296 is present on the surface of the distal shaft portion 204, and this non-destructive tape helps reduce tissue trauma that may result from tissue interacting with various openings and joints provided in the distal shaft portion 204 (e.g., the openings and joints shown in Figures 5A and 5B). The proximal anchor component 84 is housed within the distal shaft portion 204 in a form separate from and detached from the distal anchor component 70 and the suture portion (as described herein with reference to Figure 3).

[0046] When the proximal anchor component 84 is connected to the distal anchor component 70 and the suture portion 78 as part of the implant deployment process, this connection is made by the action of a pusher assembly, which includes a pusher 242 connected to a pusher block 244. A cutter assembly, which cuts the suture 222 to produce the suture portion 78 during the implant deployment process, includes a cutter 232 and a cutter block 234. The movements of the cutter assembly and the pusher assembly are coordinated with each other by the interaction of the cutter claws 236, the implant actuator 246, and the implant spring 248, as will be described in more detail herein.

[0047] The suture assembly includes a suture 222, a suture support tube 224, a suture safety device 226, and a proximal suture portion 228. The distal anchor component 70 is attached to the distal end portion of the suture 222 as described herein with reference to Figure 3. The distal portion of the suture assembly and the distal anchor component 70 are housed within the distal portion 212 of the needle assembly, which remains housed within the shaft assembly until the distal portion 212 of the needle assembly is moved into the tissue during the implant deployment process. The movement of the proximal portion 216 of the needle assembly and the proximal portion 228 of the suture assembly is coordinated by the interaction of these features with a mechanism provided within the handle 100, as described in detail herein.

[0048] Returning to the implant deployment process and referring to Figures 3, 4A, 4B, and 10, the anchor assembly (or implant) is deployed in a series of steps. The distal portion of the needle 212 extends from the distal portion of the shaft 204 to its fully extended position, so that at least a portion of the distal portion of the needle 212 penetrates the patient's tissue surface, for example, the outer capsule of the prostate. The distal portions of the distal anchor component 70 and the suture 222 move with the distal portion of the needle 212 while being housed within the distal portion of the needle 212 to penetrate the tissue.

[0049] Next, while the distal anchor component 70 and the distal portion of the suture 222 are held in place, the needle assembly 210 moves proximally, resulting in the distal portion of the needle 212 moving to a partially retracted position. That is, the distal portion of the needle 212 moves proximally relative to its fully extended position, but is not yet fully retracted into the shaft assembly 202. The suture support tube 224 helps maintain the position of the distal anchor component 70 and the distal portion of the suture 222 while the needle assembly 210 is moving proximally. Thus, the distal anchor component 70 and the distal portion of the suture 222 remain located near the tissue surface and are no longer inside the distal portion of the needle 212.

[0050] In the next step, the needle assembly 210 moves further proximal so that it is retracted into the shaft assembly 202, while the suture assembly also moves proximal. The tail portion 74 of the distal anchor component 70 is pulled and pressed tightly against the tissue surface, thereby causing the distal anchor component 70 to rotate around the intermediate section 80, so that the distal anchor component 70 is now positioned laterally relative to the distal portion of the suture 222.

[0051] In the next step, the pusher assembly moves distally, pushing the proximal anchor component onto the distal portion of the suture 222, and this movement causes the suture portion 78 to become a component of the final anchor assembly implanted in the patient's body. Next, the cutter assembly moves proximal, drawing the cutting edge into the suture. At this point, the anchor assembly is now completely detached from the cartridge handle system (also known as the handle cartridge system).

[0052] The handle cartridge system allows for a number of steps in deploying the anchor assembly by the user pulling the handle trigger assembly multiple times. That is, the relative movement of all the mechanisms within the handle and cartridge, and the timing of these relative movements, are caused by pulling the handle trigger assembly multiple times. Referring now to Figure 9, the handle trigger assembly 110 interacts with the cam wheel 120 via the drive gear 113 and ratchet 114. The cam wheel 120 is the main mechanism in which the handle trigger assembly 110 drives the movement and timing of the various mechanisms within the handle cartridge system.

[0053] Figures 11A and 11B are side views of a cam hole provided within one embodiment of the handle of a system for treating benign prostatic hyperplasia. The cam wheel 120 is mounted on a spindle molded in the right handle case. The left side of the cam wheel 120 shown in Figure 11A has raised features 121a, 121b, and 121c. The raised features 121a, 121b, and 121c interact with other mechanisms in the handle (e.g., various curves) to facilitate the movement of various assemblies in the cartridge (e.g., needle assemblies, suture assemblies, pusher assemblies, and cutter assemblies). The right side of the cam wheel 120 shown in Figure 11B has cam wheel gear teeth 123, which interact with a drive gear 113 (shown in Figure 9) to convert the overall linear motion of the handle trigger assembly 110 into a circular motion of the cam wheel 120.

[0054] Figure 12A is a left side view of a cam wheel and certain other mechanical features provided within one embodiment of a handle and cartridge for a system to treat benign prostatic hyperplasia. Figure 12B is identical to Figure 12A, except that the cam wheel and other mechanical features are in a different configuration than those shown in Figure 12A. In this embodiment, the raised feature 121c of the cam wheel 120 is designed to interact with the wheel actuator 125 to release the pusher block 244 and then reset the wheel actuator 125. When the cam wheel 120 rotates as a result of the user pulling the handle trigger assembly, the raised feature 121c pushes the wheel actuator head portion 126, thereby causing the wheel actuator 125 to rotate around the wheel actuator axis 129. While the wheel actuator 125 is rotating, the wheel actuator tail portion 127 interacts with the implant actuator 246, thereby causing the implant actuator 246 to rotate. As the implant actuator 246 rotates, the pusher block 244 is released from its holding position, thereby moving distally and pushing the proximal anchor component onto the suture as described elsewhere in this specification. Further rotation of the cam wheel 120 causes the raised feature 121c as a whole to pass the wheel actuator head portion 126, and as a result, the wheel actuator 125 is able to rotate back to its original position. The force required to return the wheel actuator 125 to its original position is provided by the wheel actuator deflection portion 128, which deflects and strikes the handle case during the rotation of the wheel actuator 125. By deflecting the wheel actuator deflection portion 128, spring energy is stored, and this spring energy is released to move the wheel actuator 125 back to its original position when the wheel actuator head portion 126 passes the raised feature 121c. Thus, the wheel actuator 125 is reset so that it can interact with the next cartridge implant actuator 246, which mechanically engages with the handle.

[0055] The implant actuator 246 and pusher block 244 (as well as the proximal anchor component and sutures) are located within the cartridge while the cam wheel 120 and wheel actuator 125 are located within the handle. Figures 12A and 12B illustrate the operation of these features when the cartridge and handle are mechanically engaged as described elsewhere in this specification. For clarity, other features are not shown in Figures 12A and 12B, although certain features are shown in Figures 13A and 13B.

[0056] Figure 13A is a side view of a specific mechanical feature located within one embodiment of a cartridge for a system to treat benign prostatic hyperplasia. Figure 13B is identical to Figure 13A, but the mechanical feature has a different configuration than that shown in Figure 13A. The pusher block 244 is coupled to the cutter block 234 by an implant spring 248. Both the pusher block 244 and the cutter block 234 are constrained to move linearly along the longitudinal axis of the cartridge by the cartridge base 298 and shaft support 297 (each shown in Figure 10), which constitute the cartridge body. The implant spring 248 is a tension spring located between the pusher block 244 and the cutter block 234 in an extended state, exerting a force that pulls the pusher block 244 and the cutter block 234 toward each other. The implant actuator 246 prevents the pusher block 244 from moving under the force of the implant spring 248 when the implant actuator 246 is in the configuration shown in Figure 13A (and Figure 12A). The distal end of the cutter claw 237 prevents the cutter block 234 from moving under the force of the implant spring 248 when the cutter claw 236 is in the configuration shown in Figure 13A. When the implant actuator 246 is configured to rotate as described herein with reference to Figures 12A and 12B, the pusher block 244 moves distally to push the proximal anchor component onto the suture as described elsewhere herein (i.e., the pusher assembly moves in the direction of arrow “P”). During this movement, which is brought about by the force of the implant spring 248, the pusher block 244 interacts with the proximal end of the cutter claw 238, thereby causing the cutter claw 236 to rotate as shown in Figure 13B. The inclined front surface of the pusher block 244 and the curved surface of the proximal end 238 of the cutter claw interact to produce this rotational motion. When the cutter claw 236 rotates, the distal end 237 of the cutter claw detaches from the cutter block 234, thereby allowing the cutter block 234 to move proximal to the force of the implant spring 248.The proximal movement of the cutter block 234 allows the suture to be cut and the suture portion of the anchor assembly to be formed. That is, the cutter assembly moves in the direction of arrow "C" to complete the anchor assembly and remove it from the cartridge handle system.

[0057] As described elsewhere in this specification, in some embodiments, multiple cartridges can be used in a continuous manner with a single handle. The steps and mechanisms shown and described with reference to Figures 12A, 12B, 13A, and 13B disclose how the push-cutting step of forming an anchor assembly can be repeatedly performed for multiple engagements of a series of cartridges with a single handle. One notable feature is that the implant spring is in its extended state as its initial state. In this case, it is important that the cartridge has a feature that prevents accidental release of energy from the implant spring during cartridge handling.

[0058] Figure 14 is a side view of a specific mechanical feature located within one embodiment of a cartridge for treating benign prostatic hyperplasia. Figure 14 shows the mechanism shown in Figure 13A (forming the configuration of Figure 13A), with the addition of a cartridge knob 203 to illustrate the operational relationship between these features. Figure 14 shows the cartridge knob 203 in the storage position. In the storage position, the grip section 292 is lateral to the longitudinal axis of the cartridge compared to the engagement position shown in Figure 1, and in this case, the grip section 292 is aligned with the longitudinal axis of the cartridge. When the cartridge knob 203 is in the storage position, it functions as a safety interlock that prevents movement by the pusher block 244. In the storage position shown in Figure 14, the pusher safety tab 293 on the cartridge knob 203 engages with the distal end of the implant actuator 246, preventing the implant actuator 246 from rotating and releasing the pusher block 244 (as shown and described with reference to Figures 12A and 12B). The pusher safety tab 293 allows the cartridge to be safely handled and stored while the implant spring is in its extended state.

[0059] Figure 15A is an exploded assembly plan view of a specific mechanical feature located within one embodiment of a cartridge for treating benign prostatic hyperplasia, and Figure 15B is an exploded assembly perspective view of the same feature. Figures 15A and 15B show another safety interlock, a cutter safety tab 286, located on the cutter claw 236. The cutter safety tab 286 engages with the cartridge knob 203 when the cartridge knob 203 is in the storage position, and this cutter safety tab prevents the cutter claw 236 from rotating and releasing the cutter block (as shown and described with reference to Figures 13A and 13B). The cutter safety tab 286 allows the cartridge to be safely handled and stored while the implant spring is in its extended state. Figures 15A and 15B are shown in exploded assembly views to clarify the relevant feature. However, in operation, the cutter claw 236 is tightly engaged with the cartridge knob 203 to produce the mechanical interaction described herein.

[0060] The pusher safety tab 293 and cutter safety tab 286 solve the problem of accidental ignition (activation) of the pusher assembly and / or cutter assembly within the cartridge by correlating the safety interlock with the storage position of the cartridge knob 203.

[0061] Figures 16A, 16B, 17, 18A, and 18B illustrate another embodiment of a safety interlock mechanism within a handle cartridge system. Figure 16A is a perspective view of a portion of the handle 100, and Figure 16B is a side view of the handle 100. The handle 100 has a cartridge bay 101, which is shown empty as a cartridge has been removed. In this embodiment, the handle trigger assembly 110 includes a cartridge lock tab 111 that protrudes into the cartridge bay 101 when the handle trigger assembly 110 rotates away from the handle grip 115. The presence of the cartridge lock tab 111 within the cartridge bay 101 prevents the cartridge from engaging with the handle 100, as the cartridge cannot physically fit into the cartridge bay 101 with the cartridge lock tab 111 positioned within the cartridge bay 101. This mechanism prevents the cartridge from being inserted into the handle, except when it is in the proper state, which is when the handle trigger assembly 110 is in its initial position, closest to the handle grip 115. This initial position corresponds to the mechanism located within the handle, all of which are reset to these initial positions.

[0062] Figure 17 is a side view of a portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. In Figure 17, the cartridge cover has been removed, thereby exposing the cartridge base 298. The cartridge knob 203 is also shown. A cartridge lock surface 291 is provided on the shaft support 297, and this cartridge lock surface extends below the cartridge base 298 in this side view of the portion of the cartridge.

[0063] Figures 18A and 18B are perspective and side views, respectively, of a specific mechanical feature located within one embodiment of a cartridge for treating benign prostatic hyperplasia. Figures 18A and 18B show the interaction between a cartridge lock tab 111 located on a handle trigger assembly 110 and a cartridge lock surface 291 located on a shaft support 297. When the handle trigger assembly 110 is rotated away from the handle grip, the cartridge lock tab 111 prevents the cartridge from being removed from the cartridge bay by physically obstructing its removal. In this embodiment, the cartridge lock surface 291 is located on the shaft support 297, but a similar lock surface may be located on another part of the cartridge, such as the cartridge base 298, and this similar lock surface can function substantially in the same way.

[0064] A cartridge lock tab 111 provided on the handle trigger assembly 110 provides a method for preventing cartridge insertion until the handle is reset to its initial state, and this cartridge lock tab prevents cartridge removal (by interaction with the cartridge lock surface 291) when the handle cartridge system is in use. Alternative embodiments exist for preventing cartridge removal and / or insertion. For example, the cartridge may have a lock receiving feature, and the handle may accommodate an additional wheel along with a series of locking features. When the handle trigger is pulled, the additional wheel rotates, causing the locking features to engage with the locking receiver. If it is necessary to pull the trigger multiple times throughout the entire planting cycle, the additional wheel has enough locking features to keep the cartridge locked for the entire cycle. At the end of the cycle, a portion of the additional wheel without locking features aligns with the locking receiver. Thus, the cartridge is unlocked and removable from the handle. In another embodiment, the user may move a lock slider to lock the cartridge in the handle. When the trigger is pulled, the slider is mechanically engaged to prevent it from moving until the cycle is complete.

[0065] Figures 19A and 19B are side views of a portion of a cartridge in one embodiment of a system for treating benign prostatic hyperplasia. A cartridge knob 203 engages with a cartridge cover 299, which has a cartridge indicator window 290. In Figure 19A, the cutter block 234 is visible through the cartridge indicator window 290, which indicates that the cutter block 234 is still in its initial position and has not moved proximal to cut the sutures in the final step of anchor assembly formation. Figure 19A shows the cutter block 234 blocking the cartridge indicator window 290. In Figure 19B, only a small portion of the cutter block 234 is visible through the cartridge indicator window 290. That is, the cutter block 234 is no longer blocking the cartridge indicator window 290. This indicates that the cutter block 234 has moved proximal to cut the sutures in the final step of anchor assembly formation.

[0066] Figure 19C is a perspective view of a cartridge cover of one embodiment of a system for treating benign prostatic hyperplasia. Figure 19C shows the cartridge indicator window 290 cut through the distal surface of the cartridge cover 299. The cartridge indicator window 290 can perform an additional function of providing access to the cutter block 234, as a result allowing the user to move the cutter block distally with a small tool, thereby cutting the sutures even if the cutter block 234 has stopped and has not completely cut the sutures. By providing an opening in the cartridge indicator window 290 through the distal surface of the cartridge cover 299, the user can easily access the cutter block 234 with a tool even if they are not directly looking at the cartridge indicator window 290.

[0067] Figure 20A is an exploded and assembled perspective view of a specific mechanical feature located within one embodiment of a cartridge for treating benign prostatic hyperplasia, and Figure 20B is a side view showing these mechanical features in their engaged configurations. As described herein with reference to Figures 13A and 13B, in normal operation, the cutter claw 236 rotates and detaches from the cutter block, thereby allowing the cutter block to move proximal to the implant spring. This proximal movement of the cutter block allows the sutures to be cut and the suture portion of the anchor assembly to be formed. However, in some situations, it may be desirable for the user to interrupt the deployment sequence after the distal anchor component has been deployed but before the proximal anchor component has been deployed and the sutures have been cut. In such situations, it is preferable to remove the handle cartridge system from the patient without fully assembling and deploying the implant.

[0068] As shown in Figures 20A and 20B, the cartridge knob 203 has a cutter manual tab 284 accessible to the user through a cutter access window 288. The cutter manual tab 284 is configured as an off-center shelf projection, so that when the cutter manual tab 284 is pushed through the cutter access window 288, a rotation (or rotation) of the cutter claw 236 perpendicular to the direction of pushing occurs. The user can push the cutter manual tab 284 using a small tool inserted through the cutter access window 288. A recess in the cartridge knob 203 near the cutter access window 288 guides the tool toward the cutter access window 288. As described herein, this rotation of the cutter claw 236 disengages the cutter claw from the cutter block, thereby allowing the cutter block to move proximal to cut the sutures under the force of the implant spring.

[0069] The disclosed device can be embodied in various therapeutic instruments employed for various medical purposes, including, but not limited to, retracting, lifting, compressing, bringing into contact with, supporting, returning to normal position, repositioning, cauterizing, or otherwise modifying tissues, organs, anatomical structures, grafts, or other objects found within the body of a human or animal patient. In certain embodiments, the therapeutic instrument is designed to displace, compress, retract, or destroy prostate tissue to facilitate the treatment of a disease or disorder, such as BPH.

[0070] Other therapeutic instruments may benefit from the use of the embodiments disclosed herein. The therapeutic instruments comprise a variety of tools for treating, cauterizing, or otherwise modifying tissue, and in such therapeutic instruments, these tools are moved, deployed, or driven by mechanical energy, and the therapeutic instruments may benefit from the use of safety interlocks and mechanisms and deployment indicators disclosed herein. Such tools include, but are not limited to, needles, cutting blades, vacuum means, gripping arm assemblies, inflatable cutting members, blunt cutting instruments, noose or ligation clips, articulated heads with integrated or retractable blades, helical blades, electrodes for delivering high-frequency energy, cutting wires or rings, electrocautery probes, or staple or suture feed heads.

[0071] In some embodiments, the system includes a cartridge carrying at least one implant and a handle configured to receive the cartridge. The handle has an actuator and at least one spring mechanism to which mechanical energy is applied. The handle further has a member that engages with the cartridge to transmit mechanical energy from the spring mechanism to the cartridge in order to deploy the implant. The handle cartridge system includes a first firing sled having a slot that aligns with a pusher tab provided on the needle assembly. The slot of the first firing sled and the pusher tab on the needle assembly are complementary mechanisms that enable the transmission of energy from the spring mechanism via the first firing sled to fire the needle in the cartridge. The handle cartridge system may further include a second firing sled having a slot that aligns with a pusher tab provided on the suture tube or connector tube. The slot of the second firing sled and the pusher tab on the suture tube are complementary mechanisms that enable the transmission of energy from the spring mechanism via the second firing sled to advance the suture tube simultaneously with the needle tube.

[0072] In a first aspect of the present invention, the system includes a handle and a cartridge, the handle configured to receive a series of cartridges and apply mechanical energy to the cartridges, thereby feeding out the implant. The cartridge has a sliding cutter block connected to a sliding pusher block via a tension spring, the cutter block and pusher block configured to slide linearly within the cartridge body. The cartridge further has a rotatable implant actuator located within the cartridge body, the rotatable implant actuator engaging with the pusher block such that the implant actuator prevents the pusher block from sliding when the implant actuator is in a first position. The spring has an extended position that exerts a force pulling the cutter block and the pusher block toward each other.

[0073] In a second aspect of the present invention, the cartridge further comprises a knob which moves from an unlocked position to a locked position, the locked position which secures the cartridge to the handle. In a third aspect of the present invention, the cartridge further comprises a pusher safety tab provided on the knob which is configured to engage with the implant actuator when the knob is in the unlocked position, preventing the implant actuator from rotating while engaged. In a fourth aspect of the present invention, the pusher safety tab provided on the knob is configured to disengage from the implant actuator when the knob is in the locked position, thereby allowing the implant actuator to rotate.

[0074] In a fifth aspect of the present invention, the cartridge further comprises a cutter claw provided within the body of the cartridge and between the cutter block and the pusher block. In a fifth aspect of the present invention, the cutter claw has an engagement position with the cutter block so as to prevent the cutter block from sliding toward the pusher block and a disengagement (unengaged) position from the cutter block so as to allow the cutter claw to slide toward the pusher block. In a sixth aspect of the present invention, the pusher block is configured to slide and contact the cutter claw, thereby causing the cutter claw to rotate and disengage from the cutter block.

[0075] In a seventh aspect of the present invention, the cartridge further comprises an indicator window provided in the cover of the cartridge body. In an eighth aspect of the present invention, the indicator window indicates the position of the cutter block. In a ninth aspect of the present invention, the indicator window is configured to serve as an access means for sliding the cutter block.

[0076] In a tenth aspect of the present invention, the cartridge has an access window provided in the knob, the access window being an access means for the cutter jaw so that the cutter jaw can be moved from the engaged position to the disengaged position when the pusher block is not in contact with the cutter jaw.

[0077] In an eleventh aspect of the present invention, the system includes a handle and a cartridge, the handle being configured to receive a series of such cartridges and to transfer mechanical energy to the cartridge to deliver an implant. The cartridge has a cartridge body coupled to a shaft assembly having a longitudinal axis, the distal portion of the shaft assembly having a lumen extending through this distal portion. The lumen has a lumen radius of curvature determined by the curvature of the lumen when it extends in a first direction parallel to the longitudinal axis, thereby extending in a second direction perpendicular to the longitudinal axis. A needle assembly is slidably provided within the shaft assembly and the cartridge body, the needle assembly including a distal needle portion, the distal needle portion being configured to exit the shaft assembly through an exit port to which the lumen terminates. The distal portion of the needle has a needle curvature radius determined by the degree of curvature of the needle when the needle extends in a first direction parallel to the longitudinal axis, and thereby extends in a second direction perpendicular to the longitudinal axis, and the lumen curvature radius and the needle curvature radius are different.

[0078] In a twelfth aspect of the present invention, the shaft assembly has a notch provided therein, which is configured to allow at least a portion of the distal portion of the needle to flex by the notch. In a thirteenth aspect of the present invention, the cartridge further has an additional notch provided therein, which is configured to allow at least a portion of the distal portion of the needle to flex by the additional notch.

[0079] In a fourteenth aspect of the present invention, the cartridge has a desired distal lumen wall having a wall curvature radius that is in contact with a desired exit trajectory of the distal portion of the needle.

[0080] In a fifteenth aspect of the present invention, a handle and a cartridge are included, the handle being configured to receive a series of such cartridges and to impart mechanical energy to the cartridges, thereby feeding out an implant. The handle has a cam wheel provided within the handle, the cam wheel being coupled to a trigger assembly provided within the handle. The handle further has a wheel actuator coupled to the cam wheel, the cam wheel having a feature portion provided on the cam wheel, which is configured to rotate the wheel actuator in a first direction when this feature portion contacts the wheel actuator. The wheel actuator has a flex portion that engages with the wheel actuator when it rotates in the first direction, and rotates the wheel actuator in a second direction opposite to the first direction when this feature portion no longer contacts the wheel actuator.

[0081] In a sixteenth aspect of the present invention, the system includes a slidable pusher block and an implant actuator, each provided within a cartridge. In a seventeenth aspect of the present invention, the implant actuator engages with the pusher block to prevent the pusher block from sliding. In an eighteenth aspect of the present invention, the wheel actuator disengages the implant actuator from the pusher block when the wheel actuator rotates in a first direction.

[0082] In a 19th aspect of the present invention, the system includes a handle and a cartridge, the handle configured to receive a series of such cartridges and to impart mechanical energy to the cartridge to eject an implant. The system includes a trigger assembly provided within the handle and a locking tab provided within the trigger assembly, the locking tab configured to enter the cartridge bay of the handle when the trigger is in the working position, and as a result, the cartridge cannot be fixed in the cartridge bay when the locking tab is at least partially positioned within the cartridge bay.

[0083] In a 20th aspect of the present invention, the system further includes a locking surface provided on the cartridge, which is configured to engage with a locking tab so that the cartridge cannot be removed from the cartridge bay when the trigger is in the working position. In a 21st aspect of the present invention, the cartridge can be removed from the cartridge bay when the trigger is in the initial position.

[0084] In any aspect of these aspects of the present invention, the system includes an implant having a distal anchor component, a suture portion, and a proximal anchor component. In any aspect of these aspects of the present invention, the pusher block is configured to push the proximal anchor component onto the suture portion. In any aspect of these aspects of the present invention, the cutter block is configured to cut the suture portion. In any aspect of these aspects of the present invention, the pusher block is configured to push the proximal anchor component onto the suture portion. In any aspect of these aspects of the present invention, the cutter block is configured to cut the suture portion.

[0085] While specific elements, examples, and applications of the present invention have been illustrated and described, it should be understood that the present invention is not limited thereto, as modifications can be made by those skilled in the art without departing from the scope of the invention, particularly in light of the above teachings. [Explanation of Symbols]

[0086] 1 System 70 Distal anchor components 72 Head section 74 Tail section 78. Sutures or sutured portion 80 Intermediate division 82 Connector Classification 84 Proximal Anchor Components 95 Rear end 96 Branches 98 tabs 100 Handle 101 Cartridge Bays 102 Scope tube 103 Right-hand drive case 104 Left-hand drive case 105 Scope Seal 110 Handle Trigger Assembly 111 Cartridge Lock Tab 112 Safety equipment 113 Drive gear 114 Ratchet 115 Handle Grips 120 Cam Wheel 125 Hall Actuator 126 Wheel actuator head section 127 Wheel actuator tail section 128 Wheel actuator deflection piece 129 Wheel actuator axis 130 Cover Plate 140 Needle-shaved section 145 Mandrel 150 Suture tool curved part 160 Implant curve 170 Scope Lock 180 Sealock 200 cartridges 201 Cartridge Body 202 Shaft Assembly 203 Cartridge Knob 204 Distal part of the shaft 205 Distal shaft exit port 206 Notch in the distal part of the shaft 207 lumens in the distal part of the shaft 208 Distal portion of shaft, internal outlet wall 209 Upper notch on the distal portion of the shaft 210 Needle assembly 212 needle distal part 214 Needle shaft 216 Proximal portion of the needle 220 Suture Assembly 222 Sutures 224 Suture tool support tube 226 Suture tool safety device 228 Proximal portion of the suture 230 Cutter Assembly 232 cutters 234 Cutter Blocks 236 Cutter Claws 237 Cutter jaw distal end 238 Proximal end of cutter claw 240 Pusher Assembly 242 Pusher 244 Pusher Blocks 246 Implant Actuator 248 Implant springs 284 Manual Cutter Tabs 286 Cutter Safety Tab 288 Cutter Access Window 290 Cartridge Indicator Window 291 Cartridge locking surface 292 Grip Classification 293 Pusher Safety Tab 296 Non-damaging tape 297 Shaft support 298 Cartridge Base 299 Cartridge Cover

Claims

1. A cartridge for a system, the system comprising a handle and the cartridge, the handle configured to receive a series of the cartridges and apply mechanical energy to the cartridges, thereby pushing out an implant, the cartridge is It has a slidable cutter block connected to a slidable pusher block via a tension spring, and the cutter block and the pusher block are configured to slide linearly within the cartridge body. The cartridge has a rotatable implant actuator provided within the main body, the rotatable implant actuator engages with the pusher block such that the implant actuator prevents the pusher block from sliding when the implant actuator is in a first position, The cartridge is in an extended position where the spring exerts a force that pulls the cutter block and the pusher block towards each other.

2. The cartridge according to claim 1, further comprising a knob provided on the cartridge, wherein the knob moves from an unlocked position to a locked position, and the locked position fixes the cartridge to the handle.

3. The cartridge according to claim 2, further comprising a pusher safety tab provided on the knob, wherein the pusher safety tab is configured to engage with the implant actuator when the knob is in the unlocked position, thereby preventing the implant actuator from rotating while engaged.

4. The cartridge according to claim 3, wherein the pusher safety tab provided on the knob is configured to detach from the implant actuator when the knob is in the locked position, thereby allowing the implant actuator to rotate.

5. The cartridge according to claim 1, further comprising a cutter claw provided within the main body of the cartridge and between the cutter block and the pusher block.

6. The cartridge according to claim 5, wherein the cutter claw has an engagement position with the cutter block so as to prevent the cutter claw from sliding toward the pusher block and a disengagement position from the cutter block so as to allow the cutter claw to slide toward the pusher block.

7. The cartridge according to claim 6, wherein the pusher block is configured to slide and contact the cutter claw, thereby causing the cutter claw to rotate and disengage from the cutter block.

8. The cartridge according to claim 7, further comprising an indicator window provided in the cover of the main body of the cartridge.

9. The cartridge according to claim 8, wherein the indicator window displays the position of the cutter block.

10. The cartridge according to claim 9, wherein the indicator window is configured to provide access for sliding the cutter block.

11. The cartridge according to claim 6, further comprising an access window provided in the knob, wherein the access window provides access to the cutter claw so that the cutter claw can be moved from the engaged position to the disengaged position when the pusher block is not in contact with the cutter claw.

12. It is a cartridge for delivering implants. It has a cutter block connected to a pusher block via a tension spring, and the cutter block and the pusher block are configured to move linearly within the body of the cartridge. A cartridge having a rotatable implant actuator provided within the body of the cartridge, wherein the rotatable implant actuator engages with the pusher block such that the implant actuator prevents the movement of the pusher block when the implant actuator is in a first position, and the spring is in an extended position that exerts a force pulling the cutter block and the pusher block toward each other.

13. The cartridge according to claim 12, further comprising a cutter claw provided within the main body of the cartridge and between the cutter block and the pusher block.

14. The cartridge according to claim 13, wherein the cutter claw has an engagement position with the cutter block so as to prevent the cutter claw from sliding toward the pusher block and a disengagement position from the cutter block so as to allow the cutter claw to slide toward the pusher block.

15. The cartridge according to claim 14, wherein the pusher block is configured to move and contact the cutter claw, thereby causing the cutter claw to rotate and disengage from the cutter block.

16. The cartridge according to claim 1 or 15, wherein the implant comprises a distal anchor component, a suture portion, and a proximal anchor component.

17. The cartridge according to claim 16, wherein the pusher block is configured to press the proximal anchor component onto the suture portion.

18. The cartridge according to claim 16, wherein the cutter block is configured to cut the suture portion.

Images