Atraumatic trocar

Abstract

Tri -partite devices, kits, and methods (e.g., pull techniques) for subcutaneous implantation of a therapeutic pellet within pre-determined sites in a subject in need thereof are provided. The tri-partite devices are atraumatic devices comprising a cannula barrel, a unitary medication loading system, and a detachable and retractable obturator with or without a coated tip.

Description

Atty. Dkt. No.: 643355-2000ATRAUMATIC TROCARCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 709,379, filed October 18, 2024, the content of which is hereby incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure generally relates to drug delivery devices, and more particularly to ergonomically designed tri-partite therapeutic pellet delivery devices that can facilitate an efficient and precise implantation of a therapeutic pellet into a subject.BACKGROUND

[0003] Diverse routes of therapeutic administration have been developed to improve patient compliance to therapeutic regimens and to improve the therapeutic efficacy of therapeutic products. Some well-known routes of therapeutic administration include oral, nasal, subcutaneous, and intravenous pathways. Among these routes, the subcutaneous route is generally highly effective and more economical. In particular, the subcutaneous route can enhance the bioavailability of the therapeutic products by bypassing the degradative effects of the gastrointestinal tract. In addition, self-administration is readily available and the physiological barrier is easy to penetrate. Indeed, implantable drug delivery devices and long- acting drug formulations are being developed to further enhance patient compliance using subcutaneous administration.

[0004] Subcutaneous implant placement, a 10-25 minutes in-office surgical procedure, is an exemplary form of a subcutaneous administration route. The most commonly used tool for subcutaneous implant placement is a trocar. Trocars are specialized medical devices that can be used in a variety of procedures, such as laparoscopic surgery and subcutaneous therapeutic drug implant. In a simple form, a trocar is a two-piece medical device that comprises a cannula and an obturator. However, there are a wide range of trocar designs with specialist features depending on the nature of the surgical procedure.-1-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0005] However, subcutaneous administration of therapeutic products remains a challenge at least because of the induction of foreign body reactions (FBR) for various reasons including the surgical tools. FBR is an inflammatory response to the therapeutic product in the subcutaneous layer. It is caused by the recruitment of inflammatory cells (e.g., neutrophils and monocytes infiltration), immune cells (e.g., macrophages activation), host proteins (e.g., fibrinogen or extracellular matrix deposition), and the generation of foreign-body giant cells to the subcutaneous administration site (e.g., implantation site). This reaction causes the formation of a dense hypocellular vascular collagen-rich sheath around the subcutaneously administered therapeutic product and pain. This collagen-rich sheath can also restrict the interaction of the therapeutic products with the bioenvironment.

[0006] During subcutaneous implant placement, the design of a trocar and the method of using the trocar can trigger or enhance the induction of foreign body reactions. For example, a cutting trocar, with a sharp tip may cause accidental punctures, bleeding, stress, and / or injury to nearby structures.

[0007] As such, there is a need for optimized, convenient, and effective subcutaneous therapeutic delivery strategies, including novel trocar designs and novel subcutaneous implant placement methods, with minimal post-surgical complications. The present disclosure addresses this need.SUMMARY OF THE INVENTION

[0008] The present disclosure provides a tri-partite device (i.e., tri-partite trocar) for an efficient and precise implantation of a therapeutic pellet into a subject in need thereof, methods of using the tri-partite device for subcutaneous implantation of a therapeutic pellet, and kits comprising the tri-partite device.

[0009] One aspect of the present disclosure provides a tri-partite device e.g., a trocar, a tripartite trocar, a blunt trocar, or a blunt tri-partite trocar) for implantation of a therapeutic pellet in a subject in need thereof. The tri-partite device comprises, consists of, or consist essentially of (a) a bi-partite cannula and (b) a detachable and retractable obturator.-2-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0010] In some embodiments, the bi-partite cannula comprises:(i) a cannula barrel comprising an open posterior end, an open anterior end, sidewalls between the posterior end and the anterior end, and a lumen forming an interior barrel, and (ii) a unitary medication loading system comprising a pellet chamber disposed at the anterior end of the unitary medication loading system, a cannula hub / handle disposed at the posterior end, a lumen forming an interior barrel, and an external threading anterior to the pellet chamber, wherein the interior lumen of the cannula barrel is continuous with the interior barrel of the unitary medication loading system.

[0011] In some embodiments, the detachable and retractable obturator comprising a distal end with a tip, a proximal blunt-end stylet (cap) comprising an internal threading, an internal protruding portion, and a shaft connecting the tip and the blunt-end stylet, where the shaft is fixedly coupled to the internal protruding portion of the blunt-end stylet. The detachable and retractable obturator is configured to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, thereby pushing a content of the pellet chamber to the open posterior end of the cannula barrel. The external threading of the unitary medication loading system releasably engages the internal threading of the blunt- end stylet (cap) of the detachable and retractable obturator.

[0012] In some embodiments of the tri-partite device described herein, the posterior end of the cannula barrel comprises, consists of, or consists essentially of a blunt end or beveled, optionally wherein the posterior end of the cannula barrel is coated with an atraumatic material. In that embodiments, the blunt end is curved.

[0013] In some embodiments of the tri-partite device described herein, the cannula barrel is fixedly molded to the posterior end of the unitary medication loading system. In some embodiments of the tri-partite device described herein, the cannula barrel is removably affixed to the posterior end of the unitary medication loading system.

[0014] In some embodiments of the tri-partite device described herein, the tip of the obturator is blunt, sharp, rounded, beveled, or curved. In some embodiments, the tip is coated with an atraumatic material.-3-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0015] In some embodiments of the tri-partite device described herein, the cannula barrel has a length of about 4 cm to about 7 cm.

[0016] In some embodiments of the tri-partite device described herein, the unitary medication loading system has a length of about 3 cm to about 6 cm.

[0017] In some embodiments of the tri-partite device described herein, the tri-partite device has a length of about 8 cm to about 15 cm.

[0018] In some embodiments of the tri-partite device described herein, the cannula barrel has a length of about 4 cm to about 7 cm; the unitary medication loading system has a length of about 3 cm to about 6 cm; and the tri-partite device has a length of about 8 cm to about 15 cm.

[0019] In some embodiments, the cannula barrel, the medication loading system, and the detachable and retractable obturator are made from the same material or different materials.

[0020] In some embodiments of the tri-partite device described herein, (a) the cannula barrel and the shaft of the detachable and retractable obturator are made of the same material; or (b) the unitary medication loading system and the blunt-end stylet (cap) of the detachable and retractable obturator are made of the same material. In some embodiments of the tri-partite device described herein, (a) the cannula barrel and the shaft of the detachable and retractable obturator are made of the same material; and (b) the unitary medication loading system and the blunt-end stylet (cap) of the detachable and retractable obturator are made of the same material.

[0021] In some embodiments, the material is selected from polyamide, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, nylon, copolyester, styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics, or combinations thereof.

[0022] In some embodiments, the cannula barrel or the shaft of the detachable and retractable obturator is made of a metallic material selected from the group consisting of nitinol, steel,-4-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content and a low relative proportion of iron or combinations thereof.

[0023] In some embodiments, the unitary medication loading system or the blunt-end stylet (cap) of the detachable and retractable obturator is made of a material selected from polyamide, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0024] In some embodiments of the tri-partite device described herein, the cannula hub / handle is configured to fit between an index and a middle finger during the operation of the tri-partite device.

[0025] In some embodiments of the tri-partite device described herein, the lumen of the unitary medication loading system, and the lumen of the cannula barrel have a depth at least equal to or larger than a diameter of the therapeutic pellet.

[0026] In some embodiments of the tri-partite device described herein, the pellet chamber comprises a medial opening for loading a therapeutic pellet and wherein the medial opening exposes the interior barrel of the unitary medication loading system.

[0027] In some embodiments of the tri-partite device described herein, the pellet chamber is arranged to dispense one or more therapeutic pellets into the lumen of the cannula barrel through the posterior end of the cannula barrel.

[0028] In some embodiments, the pellet chamber receives one or more pellets per implantation cycle. In some embodiments, the pellet chamber receives at least two pellets per implantation cycle.

[0029] Another aspect of the present disclosure provide a subcutaneous pellet implantation method in a subject in need thereof, the method comprising, consisting of, or consisting essentially of: (a) inserting the tri-partite device described herein into an exposed soft tissue of a surgical incision within a scar free target tissue at about 90-degree angle until the tip of the open posterior end of the cannula barrel is buried into a subcutaneous fat layer of the-5-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 exposed soft tissue; (b) positioning the angle of the tri-partite device from the about 90- degree angle to about 30-degree with gentle rotation until the cannula hub / handle abuts the skin; (c) exposing the pellet chamber by pulling the detachable and retractable obturator backward and loading the pellet chamber with two or more therapeutic pellets; (d) holding the cannula hub / handle between an index and a middle finger while pushing the blunt-end stylet of the detachable and retractable obturator with the thumb and pulling the cannula hub / handle back toward the thumb with the index and the middle finger; (e) maintaining a thumb pressure forward to allow the detachable and retractable obturator to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, to push the two or more therapeutic pellets toward the open posterior end of the cannula barrel under the subcutaneous fat layer of the exposed soft tissue; (f) pulling out the tri-partite device downward and out from the surgical incision while applying pressure to a skin surface area above the insertion site of the tri-partite device with a free hand; and (g) obtaining hemostasis at surgical site by holding pressure on the skin surface area above the insertion site of the tri-partite device.

[0030] In some embodiments, exposing the pellet chamber, holding the cannula hub / handle, and maintaining the thumb pressure are repeated at least twice, at three times, or more to one or more pre-determined target implantation sites. In some embodiments, exposing the pellet chamber, holding the cannula hub / handle, and maintaining the thumb pressure constitute an implantation cycle.

[0031] In some embodiments, the one or more target implantation sites (e.g., switching implantation cycle) is changed by wriggling the tri-partite device into a new pre-determined site without removing the tri-partite device from the surgical incision site.

[0032] In some embodiments, the one or more pellets (e.g., hormone pellets, a testosterone pellets, or estradiol pellets) are implanted in a flank or a hip of the subject.

[0033] Another aspect of the present disclosure provides a subcutaneous pellet implantation method (e.g., using a pull technique) in a subject in need thereof, the method comprising: (a) inserting the tri-partite device described herein into an exposed soft tissue of a surgical incision toward a first predetermined tract at about 30-degree angle until the tip of the open-6-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 posterior end of the cannula barrel is buried into a subcutaneous fat layer of the exposed soft tissue; (b) gently rotating the tri-partite device until the hub abuts the skin; (c) exposing the pellet chamber and loading the pellet chamber with two or more therapeutic pellets; (d) holding the hub between an index and a middle finger of a nondominant hand, and pushing the blunt-end stylet of the obturator with the thumb of the dominant hand; (e) maintaining a thumb pressure forward to allow the obturator to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, to push the two or more therapeutic pellets toward the open posterior end of the cannula barrel and under the subcutaneous fat layer of the exposed soft tissue; (f) pulling back the tri-partite device with the nondominant hand while the dominant hand holds steady pressure on the blunt-end stylet of the obturator; (g) locking the tri-partite device by threading the obturator and the bi-partite cannula together with the dominant hand in preparation for a second pass; (h) advancing the locked tri-partite device with gently rotation of the tri-partite device toward an adjacent second predetermined tract until the hub abuts the skin; and (i) repeating step (c) to step (f) (e.g., second implantation cycle); (j) pulling back the tri-partite device downward and out from the surgical incision while applying pressure to a skin surface area above the insertion site of the tri-partite device with the nondominant hand; and (k) obtaining hemostasis at the insertion site by applying pressure on the skin surface area above the insertion site; and (1) closing the insertion site.

[0034] In some embodiments, the method further comprises, consists of, or consists essentially of, repeating step (c) to step (i) for implanting one or more pellets at an adjacent third predetermined tract (e.g, third implantation cycle).

[0035] In some embodiments, the further comprises, consists of, or consists essentially of repeating step (c) to step (i) for implanting one or more pellet at an adjacent fourth predetermined tract (e.g, fourth implantation cycle).

[0036] In some embodiments, the first, second, third or fourth predetermined tract is an anesthetic tract.

[0037] In some embodiment of the method described herein, exposing the pellet chamber comprises the step of: (a) resting the nondominant hand under the hub of the tri-partite-7-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 device; (b) unthreading the obturator from the tri-partite device with the dominant hand; and (c) pulling the obturator backward.

[0038] In some embodiments, resting the nondominant hand under the hub of the tri-partite device comprises holding the hub between the index and the middle finger.

[0039] In some embodiments of the method disclosed herein, loading the pellet chamber comprises: (a) bringing a pellet container under the bi-partite cannula with the dominant hand; (b) grabbing the pellet container with the thumb of the nondominant hand while resting the nondominant hand under the hub of the bi-partite cannula; (c) loading the one or more pellets from the container into the pellet chamber with the dominant hand; and (d) returning the pellet container to a sterile field.

[0040] In some embodiments, the one or more pellets are implanted in a flank or a hip of the subject. In some embodiments, the one or more pellets are hormone pellets.

[0041] In some embodiments, the hormone is selected from the group consisting of testosterone, estrogen, estradiol, progesterone, progestin, and gonadotropin-releasing hormone (GnRH).

[0042] Another aspect of the present disclosure provide a method of treating a subject suffering from a hormone deficiency or a hormone imbalance, the method comprising, consisting of, or consisting essentially of, subcutaneously implanting into the patient a hormone pellet (e.g., one or more hormone pellets) using a method described herein.

[0043] In some embodiments, the hormone is testosterone.

[0044] In some embodiments of any method described herein, the subject in need thereof has suffered discomfort following a procedure using a commercially available trocar. In some embodiments, the subject in need thereof has a history of pellet extrusion or is at high-risk of pellet extrusion.

[0045] Another aspect of the present disclosure provides a kit comprising the tri-partite device described herein. In some embodiments, the kit further comprises, consists of, or-8-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 consists essentially of a complete set of procedure tools, and / or instructions for performing a subcutaneous therapeutic pellet implantation method described herein.

[0046] The foregoing summary and the following description of the drawings and detailed description are exemplary and explanatory. They are intended to provide further details of the disclosure, but they are not to be construed as limiting. Other objects, advantages, and novel features will be readily apparent to those skilled in the art from the following detailed description of the invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] FIG. 1 shows a perspective view from the top of a unitary medication loading system comprising a hub ( / .< ., handle), and a pellet chamber, and a blunt-end stylet ( / .< ., cap) of the obturator of the tri-partite trocar.

[0048] FIG. 2 shows a perspective view from the bottom of a unitary medication loading system comprising a hub ( / .< ., handle), and a pellet chamber, and a blunt-end stylet ( / .< ., cap) of the obturator of the tri-partite trocar.

[0049] FIG. 3 shows a side view from the bottom of a unitary medication loading system comprising a hub ( / .< ., handle), and a pellet chamber, and a blunt-end stylet ( / .< ., cap) of the obturator of the tri-partite trocar.

[0050] FIG. 4A shows an image of the tri-partite trocar with a bi-partite cannula comprising a cannula barrel coupled to a unitary medication loading system and a detachable obturator.

[0051] FIGs. 4B -C show images of a bi-partite cannula comprising a cannula barrel coupled to a unitary medication loading system and a threading anterior to the unitary medication loading system.

[0052] FIGs. 4D -E show images of a detachable obturator comprising a tip, a cap (e.g., a blunt-end stylet), and a shaft connecting the tip and the cap.

[0053] FIG. 5 shows an image of the tri-partite trocar with the obturator inside the interior barrel of the unitary medication loading system and the lumen of the cannula barrel.-9-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0054] FIG. 6A shows a back of a male patient in a lateral recumbent position for a flank subcutaneous implant procedure illustrating an upper border and a lower border landmarks (e.g., the upper border can be the 12thrib and the lower border can be the iliac crest) for pellet insertion.

[0055] FIG. 6B shows a back of a male patient in a lateral recumbent position for a flank subcutaneous implant procedure and the trocar insertion site, the anesthetic injection sites, and predetermined therapeutic pellets implantation sites.

[0056] FIG. 7 shows a hip of a male patient in a lateral recumbent position for a hip subcutaneous implant procedure and the trocar insertion site, the anesthetic injection sites, and predetermined therapeutic pellets implantation sites.

[0057] FIGs. 8A-B show two different trocar designs. FIG. 8A discloses one embodiment of a trocar and a method of using the trocar for an implantation of a therapeutic pellet into a subject.

[0058] FIG. 8B shows an illustrative view of a novel ergonomically designed tri-partite trocar and a method of using the tri-partite trocar for an implantation of a therapeutic pellet into a subject.

[0059] FIG. 9 shows an exemplary long roll for therapeutic pellet insertion site closure following a subcutaneous implant procedure in a subject.

[0060] FIGs. 10A-B show illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for a flank subcutaneous implant procedure.

[0061] FIGs. 11A-B show illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for a hip subcutaneous implant procedure.

[0062] FIG. 12 shows illustrative anesthetic placement steps for an atraumatic subcutaneous therapeutic pellet implantation method.-10-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0063] FIG. 13 shows illustrative prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method.

[0064] FIGs. 14A-B show illustrative insertion steps for an atraumatic subcutaneous therapeutic pellet implantation method.

[0065] FIG. 15 shows illustrative insertion site closure steps for an atraumatic subcutaneous therapeutic pellet implantation method.

[0066] FIG. 16A shows a hip of a male patient in a lateral recumbent position for a hip subcutaneous implant procedure and a trocar insertion site, and anesthetic injection sites for a wider implantation area.

[0067] FIG. 16B shows illustrative alternative anesthetic placement steps for an atraumatic subcutaneous therapeutic pellet implantation method for a wider implantation area.

[0068] FIG. 17A shows a hip of a male patient in a lateral recumbent position for a hip subcutaneous implant procedure and a tri-partite device ( / .< ., trocar) insertion site, anesthetic injection sites, therapeutic pellets implantation sites, and predetermined therapeutic pellets and / or anesthetic tracts for a wider implantation area.

[0069] FIG. 17B shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for covering a wider implantation area.

[0070] FIG. 17C shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for hip procedure using a wider implantation area.

[0071] FIGs. 18A-B show illustrative trocar insertion steps for an atraumatic subcutaneous therapeutic pellet implantation method for a wider implantation area.

[0072] FIGs. 19A-B show a back of a male patient in a lateral recumbent position for a flank subcutaneous implant procedure using a male pellet pull technique; and illustrate an upper border and a lower border landmarks (e.g., the upper border can be the 12thrib and the lower-11-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 border can be the iliac crest) (FIG. 19A); and the trocar insertion site, the anesthetic injection sites, and predetermined therapeutic pellets implantation sites (FIG. 19B).

[0073] FIG. 19C shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for a flank subcutaneous implant procedure using a male pellet pull technique.

[0074] FIGs. 20A-C show images of a hip of a patient in a lateral recumbent position for a hip implant procedure using a male pellet pull technique and illustrate the landmarks for trocar insertion away from the gluteal cleft (FIG. 20A), the soft fatty spot for trocar insertion (FIG. 20B); and marked trocar insertion site ( / .< ., the wheal), anesthetic injection sites, and predetermined therapeutic pellets implantation sites (FIG. 20C).

[0075] FIG. 20D shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique for a hip subcutaneous implant procedure.

[0076] FIG. 21 shows illustrative implantation area cleaning steps for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.

[0077] FIG. 22A shows illustrative steps for placing an anesthetic wheal for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.

[0078] FIG. 22B shows an image illustrating the placement of the anesthetic wheal of FIG. 22A.

[0079] FIG. 23A shows a hip of a patient in a lateral recumbent position marked with anesthetic tracts (e.g., arrows connecting #1 and #3) for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.

[0080] FIG. 23B shows illustrative steps for placing anesthetic for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.

[0081] FIG. 24 shows illustrative steps for preparing supplies for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.-12-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0082] FIG. 25 shows illustrative steps for sterilizing a patient for an atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique.

[0083] FIGs. 26A-D show images illustrating techniques for making an incision (FIG. 26A), inserting the tri-partite trocar (FIG. 26B), holding the tri-partite trocar with a nondominant hand position (FIG. 26C); and holding the tri-partite trocar and the pellet container (FIG. 26D) during an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.

[0084] FIG. 27A shows an image illustrating the technique for loading the pellet chamber with one or more therapeutic pellets while holding the tri-partite trocar and the pellet container during an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.

[0085] FIG. 27B shows an image illustrating the pull back technique for changing pellet placement sites during an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.

[0086] FIGs. 27C-D show images illustrating bandages following the insertion site closure.

[0087] FIG. 27E shows an image of an exemplary gauge pad long roll for putting pressure on the tract ( / .< ., space) between insertion point and pellets.

[0088] FIG. 28 shows illustrative steps for tri-partite trocar insertion during an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.

[0089] FIGs. 29A-B show illustrative steps for multiple pellet placements during an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.

[0090] FIG. 30 shows illustrative steps for pellet insertion site closure following an atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique.-13-4899-7405-1951.1Atty. Dkt. No.: 643355-2000DETAILED DESCRIPTIONI. Overview

[0091] The present disclosure provides tri-partite devices (or tri-partite trocar; atraumatic trocar) for an efficient and a precise manipulation during implantation of a therapeutic pellet into a subject in need thereof, methods of using the tri-partite device for subcutaneous implantation of a therapeutic pellet, and kits comprising the tri-partite devices. The tri-partite devices disclosed herein have several advantages over devices known in the prior art.

[0092] One advantage of the tri-partite device ( / .< ., the tri-partite trocar or the trocar) disclosed herein is its ergonomic design (FIG. 8B) that can enhance the efficient and precise manipulation of the trocar during a subcutaneous therapeutic pellet implant procedure in a subject. The ergonomically designed device can fit in the flat of the hand and can allow for a comfortable holding of the hub / handle during a therapeutic pellet implant procedure (FIG. 8A vs FIG. 8B). To facilitate the comfortable holding of the hub / handle during implantation, the device is composed of three pieces: a two-piece cannula and a detachable and retractable obturator (FIG. 4A and FIG. 5). The two-piece cannula comprises: a cannula barrel fixedly or removably attached to a unitary medication loading system (FIGs. 4B-C). The unitary medication loading system comprises a hub / handle and a pellet chamber (FIGs. 1-3). The detachable and retractable obturator comprises a distal end with a tip (optionally coated with an atraumatic material), a proximal blunt-end stylet ( / .< ., a cap) comprising an internal threading, and a shaft fixedly coupled to the proximal blunt-end stylet (FIGs. 4D-C). Thus, the tri-partite device disclosed herein comprises a two piece cannula with an attached handle, and the handle is molded / machined as one piece to include the pellet chamber (slot) and a treaded coupling for the obturator.

[0093] This is in contrast to trocars known in the art which require a cannula, an insertion obturator, and a delivery obturator. In addition, trocars known in the art can be longer and can require two hands during operation. Furthermore, trocars known in the art do not have coated tips.

[0094] Another advantage of the tri-partite device disclosed herein is its threaded design. Specifically, the unitary medication loading system further comprises an external threading -14- 4899-7405-1951.1Atty. Dkt. No.: 643355-2000 anterior to the pellet chamber (e.g., a treaded coupling for the obturator) that can releasably engage an internal threading found in the proximal blunt-end stylet ( / .< ., a cap) of the obturator. The obturator and bi-partite cannula can lock up in a secure manner, due to threaded coupling, thereby preventing handle / hub slipping in relation to the pellet chamber (or medication chamber) during operation.

[0095] Another advantage of the tri-partite device disclosed herein is the one-piece unitary medication loading chamber, which can allow for the removal of approximately 50% of the metal cannula barrel, thereby shortening the entire length of the tri-partite device (e.g., tripartite trocar or trocar). Furthermore, the metal can be associated with the traumatic aspect of trocars known in the art. The one-piece unitary medication loading chamber can further eliminate the need for machining the unitary medication chamber (i.e., slot) and the coupling end into the cannula barrel during manufacturing, thereby reducing the manufacturing time and cost. For example, the one-piece unitary medication loading system (or unitary handle apparatus) can be easy to manufacture via injection molding or any related manufacturing processes known to those of skill in the art.

[0096] The novel tri-partite trocar with a threaded design (e.g., blunt tip trocar) has many benefits for patients and practitioners.

[0097] Patients who have undergone an atraumatic subcutaneous therapeutic pellet implantation procedure using the novel tri-partite trocar disclosed herein reported less bruising, less hematomas, increased comfort, and less trauma to the tissue when compared to patients who have undergone the same procedure using a trocar of the prior art. Patients have also reported decreased pain, which might have been a result of less trauma to the tissue.

[0098] Practitioners were particularly pleased with the ease of use of the novel tri-partite trocar that can be locked into one piece. Specifically, the threaded design (i.e., locking mechanism) prevented the separation of the cannula and the obturator during the procedure, specifically when using the pellet pull technique (MPPT) described herein. This led to a much smoother tissue dissection resulting in less tissue trauma during the procedure. Because of the locking mechanism, the tri-partite trocar moved less during a procedure, which led to less tissue inflammation from the procedure.-15-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0099] Furthermore, clinical data showed less scar tissue formation, which led to a positive patient experience. Thus, additional advantage is that keeping the cannula and the obturator together can lessen scar tissue formation in patients. The novel design described herein is ideal for use with the pull technique ( / .< ., male pellet pull technique (MPPT) or pull-back technique) described herein.

[0100] In some embodiments, the novel tri-partite trocar disclosed herein can be reusable or disposable. In some embodiments, the tri-partite trocar is reusable. In some embodiments, the tri-partite trocar is disposable. In some embodiments, the subject in need thereof can be a subject who has suffered discomfort following a procedure using a commercially available trocar.

[0101] Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents, which may be included within the invention as defined by the appended claims.II. Definitions

[0102] Unless defined otherwise, all technical and scientific terms used herein generally have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. As used in this specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents unless the content clearly dictates otherwise. “A and / or B” is used herein to include all of the following alternatives: “A”, “B”, “A or B”, and “A and B”.

[0103] Where values are described as ranges, it will be understood that such disclosure includes the disclosure of all possible sub-ranges within such ranges, as well as specific numerical values that fall within such ranges irrespective of whether a specific numerical value or specific sub-range is expressly stated.

[0104] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,”-16-4899-7405-1951.1Atty. Dkt. No.: 643355-2000“greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0105] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0106] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number. If the degree of approximation is not otherwise clear from the context, “about” means either within plus or minus 10% of the provided value, or rounded to the nearest significant figure, in all cases inclusive of the provided value. In some embodiments, the term “about” indicates the designated value ± up to 10%, up to ± 5%, or up to ± 1%. Numeric ranges are inclusive of the numbers defining the range. The term about is used herein to mean plus or minus ten percent (10%) of a value. For example, “about 100” refers to any number between 90 and 110.

[0107] Headings, e.g., (a), (b), (i) etc., are presented merely for ease of reading the specification and claims. The use of headings in the specification or claims does not require the steps or elements to be performed in alphabetical or numerical order or the order in which they are presented.

[0108] Use of ordinal terms such as “first”, “second”, “third”, etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim-17-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 elements. Similarly, the use of these terms in the specification does not by itself connote any required priority, precedence, or order.III. Tri-partite Trocar

[0109] One aspect of the present disclosure provides a tri-partite device (e.g., a tri-partite trocar) comprising: a cannula barrel, a unitary medication loading system, and a detachable and retractable obturator. The tri-partite device can comprise a bi-partite cannula and a detachable and retractable obturator. The bi-partite cannula can comprise a cannula barrel and a unitary medication loading system. The cannula barrel can comprise an open posterior end, an open anterior end, sidewalls between the posterior end and the anterior end, and a lumen forming an interior barrel.

[0110] The unitary medication loading system can comprise a pellet chamber (also known as a medication chamber or a therapeutic pellet chamber) disposed at the anterior end of the unitary medication loading system, a cannula hub / handle disposed at the posterior end, a lumen forming an interior barrel, and an external threading anterior to the pellet chamber. When connected to the cannula barrel (e.g., cannula body), the interior lumen of the cannula barrel can be continuous with the interior barrel of the unitary medication loading system.

[0111] The detachable and retractable obturator can comprise a distal end with a tip, a proximal blunt-end stylet (cap) comprising an internal threading, an internal protruding portion, and a shaft connecting the tip and the blunt-end stylet. The shaft can be fixedly coupled to the internal protruding portion of the blunt-end stylet.

[0112] The detachable and retractable obturator can be configured to slide through the interior barrel (or the lumen) of the unitary medication loading system, and the lumen of the cannula barrel, thereby pushing any content, if present, of the pellet chamber to the open posterior end of the cannula barrel. The external threading of the unitary medication loading system can releasably engage the internal threading of the blunt-end stylet (cap) of the detachable and retractable obturator.

[0113] The tri-partite device (e.g., tri-partite trocar) is ergonomically designed to fit in the palm of the user for an efficient and precise implantation of a therapeutic pellet in a subject in-18-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 need thereof. The subject in need thereof can be a subject who has suffered discomfort following a procedure using a commercially available trocar. The ergonomically designed device can fit in the flat of the hand and can allow for a comfortable holding of the hub / handle during a therapeutic pellet implant procedure (FIGs. 8A-B). The design can improve the manipulation of the device during subcutaneous therapeutic pellet implant procedure (procedure 1400, 1800, or 2900) in a subject.

[0114] FIG. 1 illustrates a unitary medication loading system 100 comprising a hub ( / .< ., handle) 105, a pellet chamber 110, an external threading 115, and lumen (barrel) 120. The unitary medication loading system 100 can be one-piece unitary apparatus comprising the handle 105, the pellet chamber 110, and the threaded coupling 115. The one-piece unitary medication loading system 100 can allow for removal of approximately 50% of the cannula material (e.g., metal) of trocar known in the art. The one-piece unitary medication loading system 100 can further eliminate the need for machining the pellet chamber 110 and coupling the end of the pellet chamber 110 into a canonical cannula body.

[0115] The unitary medication loading system 100 can be made of a single continuous piece. The one-piece unitary medication loading system 100 can be easy to manufacture via injection molding. The design of the one-piece unitary medication loading system 100 can remove any concern that a hub / handle 105 would slip in relation to a pellet chamber 110, and / or a threaded coupling 115 during operation. In the illustrative embodiment, the unitary medication loading system 100 is molded or machined as one piece to include the hub 105, the pellet chamber 110, and the threaded coupling for the obturator 115.The hub

[0116] The hub 105 can be disposed at the posterior end of the unitary medication loading system 100. The hub 105 can be configured to fit between an index and a middle finger of a user during the operation of the tri-partite device (e.g., the tri-partite trocar). In some embodiments, the hub 105 can comprise an interior thread that can engage a corresponding thread on the cannula barrel (e.g., cannula body). In that embodiment, the unitary medication loading system 100 can be removably affixed to the cannula barrel. In other embodiment, the unitary medication loading system 100 can be fixedly coupled to the cannula barrel.-19-4899-7405-1951.1Atty. Dkt. No.: 643355-2000Pellet chamber

[0117] The pellet chamber 110 can be disposed at the anterior end of the unitary medication loading system 100. The pellet chamber 110 can comprise a medial opening on the unitary medication loading system 100. The medial opening can expose the interior barrel of the unitary medication loading system 120. The pellet chamber 110 can connect the interior lumen 120 to the exterior of the unitary medication loading system 100 to the hub 105. The pellet chamber 110 can be an interior cavity that can be continuous with the lumen or interior barrel 120 of the unitary medication loading system 100. The lumen or interior barrel 120 of the unitary medication loading system can have a depth that is at least equal to and / or larger than a diameter of the therapeutic pellet. In some embodiments, the diameter can be about 1mm to about 4.5 mm. In some embodiments, the diameter can be about 1mm, about 2 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.2 mm, about 3.25 mm, about 3.5 mm, about 3.75 mm, about 4.0 mm, about 4.25 mm, about 4.5 mm, about 4.75 mm, about 5.0mm or more. In some embodiments, the tri-partite trocar is about 2.5 mm, 3.0 mm, 3.2 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 5.6 mm, or 6.0 mm. In some embodiments, the tripartite trocar is about 3.5 mm or 4.5 mm.

[0118] The pellet chamber 110 can be configured to receive two or more therapeutic pellets. The pellet chamber 110 can be arranged to dispense one or more pellets into the lumen of the cannula barrel and through the posterior end of the cannula barrel. In some embodiments, the pellet chamber 110 can allow the two or more therapeutic pellets to slide toward the cannula barrel. The two or more therapeutic pellets can be loaded in the pellet chamber 110 during operation. The two or more therapeutic pellets can be aligned in a longitudinal row inside the pellet chamber 110.

[0119] In some embodiments, the pellet chamber 110 can be loaded with any therapeutic pellets. The therapeutic pellet can have a diameter of about 0. 01mm to about 4.5 mm, about 0. 01 mm to about 2.0 mm, about 0. 5 mm to about 3.0 mm, about 2 mm to about 4.5 mm, about 2 mm to about 3.5 mm, about 3.0 mm to about 4.5 mm, about 2.5 mm to about 4.5 mm, about 2.5 mm to about 4.0 mm, about 3.0 mm to about 4.0 mm, about 2.5 mm to about 3.0 mm.-20-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0120] The therapeutic pellets can have a diameter of about 1 mm, 1.5mm, about 2 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.5 mm, about 3.75 mm, or about 4 mm.

[0121] In some embodiments, the therapeutic pellets can have a length of about 5mm to about 15 mm, about 5mm to about 10 mm, about 5mm to about 8 mm, about 10 mm to about 15 mm, about 7 mm to about 15 mm, about 5mm to about 15 mm, or about 12 mm to about 15 mm. The therapeutic pellets can have a length of about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, or about 15mm.

[0122] The therapeutic pellets can be from about 1 mm to 5 mm in length and have a diameter of about 0.01 to about 2 mm.

[0123] In some embodiments, the therapeutic pellet can be about 1 mg to about 300 mg, about 1 mg to about 90 mg, about 30 mg to about 200 mg, about 50 mg to about 300 mg, or about 50 mg to about 90 mg. Specifically, the pellet can be about 25 mg, about 30mg, about 40 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 78 mg, about 80 mg, about 90 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, or about 300 mg.

[0124] The therapeutic pellet can be equal to or less than about 100 mg. In that embodiment, a trocar of about 3.00 mm to about 3.5 mm can be used for implantation. A trocar used to implant a pellet of less than 100 mg can be referred to as a female trocar. In some embodiments, the therapeutic pellet can be between 100 mg-250 mg. In that embodiment, a trocar of about 4.0 to about 5.0 mm can be used. A trocar used to implant a pellet of about 100 mg to about 250 mg can be referred to as a male trocar.

[0125] The pellet can be a hormone pellet. The hormone can be selected from the group consisting of testosterone, estrogen, estradiol, progesterone, progestin, and gonadotropinreleasing hormone (GnRH). The pellet can be an estradiol pellet. The pellet can be a testosterone pellet. In one embodiment, the pellet can be 100 mg testosterone pellet or less. In one embodiment, the pellet can be a 100 mg testosterone pellet. In one embodiment, the testosterone pellet can be between 100 mg and 200 mg. In one embodiment, the testosterone pellet can be 200mg. In one embodiment, the testosterone pellet can be 250mg.-21-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0126] In some embodiments, the pellet chamber 110 can receive one or more therapeutic pellets per implantation cycle as described herein. The pellet chamber 110 can receive two therapeutic pellets per implantation cycle as described herein.

[0127] The unitary medication loading system 100 can have a length of about 1 cm to about 10 cm; about 1 cm to about 6 cm, about 2 cm to about 8 cm; about 1 cm to about 5 cm; about 3 cm to about 6 cm, about 4 cm to about 6 cm; or about 3 cm to about 10 cm.

[0128] In some embodiments, the unitary medication loading system 100 can be made of a material selected from stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys, ceramics and composites thereof, thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, nylon, or epoxy.

[0129] The unitary medication loading system 100 can be made of a material selected from composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, or other resorbable polymers. The calcium based ceramics can be a calcium phosphate, a tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, and / or calcium sulfate. The other resorbable polymers can be polyaetide, polyglycolide, polytyrosine carbonate, polycaprolactone and any combinations thereof.

[0130] Superelastic metallic alloys can be Nitinol, or super elasto-plastic metals, such as e.g., GUM METAL® (Toyota Material Incorporated of Japan). A ceramic composites can be a calcium phosphate (e.g., SKELITE™). The material can be thermoplastics selected from polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, or PEEK-BaSCU polymeric rubbers.

[0131] In some embodiments, the unitary medication loading system 100 can be from polyamide, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric-22-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 olefin, nylon, copolyester, styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0132] In a preferred embodiment, the unitary medication loading system 100 can be made of a material selected from polyamide, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof. In some embodiments, the unitary medication loading system 100 can be made of nylon.

[0133] The unitary medication loading system 100 can be disposable or reusable. In some embodiments, the unitary medication loading system 100 can be disposable. In that embodiment, the unitary medication loading system 100 can be made of a plastic material. In some embodiments, the unitary medication loading system 100 can be reusable. In that embodiment, the unitary medication loading system 100 can be made of an autoclavable material. For example, the unitary medication loading system 100 can be made of a metallic material selected from the group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content and a low relative proportion of iron or combinations thereof.

[0134] FIG. 1 further illustrates a blunt-end stylet ( / .< ., cap) 125 of the obturator of the tripartite trocar. The blunt-end stylet 125 can ease the manipulation of the tri-partite device during a procedure. For example, the blunt-end stylet ( / .< ., cap) 125 can allow a user to push the obturator inside the interior barrel of the unitary medication loading system 110 and the lumen of the cannula barrel. The illustrated embodiment shows the blunt-end stylet of the obturator as a cap. In some embodiments, the blunt-end stylet 125 can also be knob or a dial. In some embodiments, the unitary medication loading system 110, and the blunt-end stylet 125 can be made from the same material. The unitary medication loading system 110, and the blunt-end stylet 125 can be made from different materials as illustrated in FIG. 1. In a preferred embodiment, the unitary medication loading system 110, and the blunt-end stylet 125 can be made from the same material. In that embodiment, the material is a non-metal material (e.g., a nylon).-23-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0135] FIG. 2 shows a perspective view from the bottom of a unitary medication loading system 200 comprising a hub (z.e., handle) 205, a pellet chamber 210, and the posterior end of the lumen or interior barrel 220 of the unitary medication loading system 200. The external threading 215 is also shown. The unitary medication loading system 200 can be one-piece unitary apparatus comprising the handle 205, the pellet chamber medication 210, and the threaded coupling 215.

[0136] FIG. 2 also shows a perspective view from the bottom of the inside of the blunt-end stylet 225 (z.e., cap) of the obturator of the tri -partite trocar. The blunt-end stylet 225 can comprise an internal threading 235 and an internal protruding portion 230. The shaft of the obturator (FIGs. 4A, D -E and 5; 450 and 535) can be coupled to the internal protruding portion 230 of the blunt-end stylet 225. The shaft of the obturator 450 and 535 can be fixedly coupled to the internal protruding portion 230 of the blunt-end stylet 225. The internal threading 235 of the blunt-end stylet (cap) of the detachable and retractable obturator can releasably engage the external threading 215 of the unitary medication loading system.

[0137] In some embodiments, the blunt-end stylet (cap) 225 of the detachable and retractable obturator can be releasably engaged to the unitary medication loading system 200 by equivalent means. The equivalent means can comprise chemical means, threads, tracks, clips, ribs, projections, indentations, or frictions. The internal threading 235 of the blunt-end stylet (cap) can allow the obturator, the unitary medication loading system 200, and cannula barrel to lock up in a secure manner. The internal threading 235 of the blunt-end stylet (cap) engagement with the external threading 215 of the unitary medication loading system 200 can prevent slippage of the cannula hub / handle 205 in relation to pellet chamber 210.

[0138] FIG. 3 shows a side view from the bottom of a unitary medication loading system 300 comprising a hub (z.e., handle) 305, and a pellet chamber 310 as described above for FIG. 2. The barrel / lumen 320 of the unitary medication loading system 300 is also shown in relation to the internal protruding portion 330 of the blunt-end stylet (z.e., cap) 325 of the obturator of the tri-partite trocar, the internal protruding portion 330 of the blunt-end stylet 225. Thus, the shaft of the obturator fixedly coupled to the internal protruding portion 330 of the blunt-end stylet (z.e., cap) 325 can be slidably received over the longitudinal axis of the unitary medication loading system 300. In this way, when therapeutic pellets are loaded inside the-24-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 pellet chamber 310, and the obturator is inserted inside the lumen 320 of the unitary medication loading system 300, the obturator 425 ( or 530) can push a therapeutic pellet through the lumen 320 toward the cannula barrel 525 or 420.Cannula barrel

[0139] FIG. 4A shows an image of the tri-partite trocar with a bi-partite cannula 460 and a detachable and retractable obturator 440. FIGs. 4B-C show images of a bi-partite cannula comprising a cannula barrel coupled to a unitary medication loading system and a threading anterior to the unitary medication loading system.

[0140] The bi-partite cannula 460 comprises a cannula 435 and the unitary medication loading system 430. The unitary medication loading system 430 is as described in FIGs. 1-3. Specifically, the unitary medication loading system 430 comprises a hub 405 disposed at the posterior end, a pellet chamber 410 disposed at the anterior end and an external threading 415 anterior to the pellet chamber 410. The unitary medication loading system 430 further comprises a lumen forming an interior barrel (e.g., channel).

[0141] The cannula 435 comprises an open posterior end, an open anterior end, sidewalls forming a barrel 420 between the posterior end and the anterior end, and a lumen forming an interior channel of the barrel 420. When connected to the unitary medication loading system 430, the interior channel of the barrel 420 can form a continuous channel with the interior barrel of the unitary medication loading system 430. The shaft 450 of the obturator can slide through the lumen of the bi-partite cannula 460 as shown in FIG. 5. The posterior end of the cannula barrel 420 can comprise an end 425. In some embodiments, the end 425 can be a blunt end. The end 425 can also be a curve end. The end 425 can be beveled.

[0142] In some embodiments, the end 425 of the cannula barrel 420 can be coated with an atraumatic material. The atraumatic material can be a non-metal alloy material. For example, the atraumatic material can be polyamide, silicone, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof. The tip 425 can be coated with thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, -25-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, nylon, or epoxy.

[0143] In some embodiments, the end 425 of the cannula can be coated. For example, the end 425 of the cannula can be coated with silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, or rigid polymers. Preferably, the end 425 of the cannula can be blunt, curved or beveled and coated with silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, or rigid polymers.

[0144] The tip 425 can be coated with silicone. In some embodiments, the end 425 can be a silicone coated blunt end. The end 425 can also be a silicone coated curve end. The end 425 can be a silicone coated beveled end.

[0145] The cannula barrel 435 can have a length of about 3 cm to about 10 cm, about 4 cm to about 10 cm, about 5 cm to about 10 cm, about 3 cm to about 9 cm, about 3 cm to about 7 cm, about 4 cm to about 7 cm; about 5 cm to about 7 cm, or about 3 cm to about 6 cm. In some embodiment, the cannula barrel has a length of about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, or about 10 cm.

[0146] In some embodiments, the unitary medication loading system 430 can have a length of about 2 cm to about 8 cm, about 3 cm to about 6 cm, about 2 cm to about 6 cm, about 2 cm to about 5 cm, about 2 cm to about 4 cm, about 3 cm to about 5 cm, or about 3 cm to about 4 cm. The unitary medication loading system 430 can have a length of about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, or about 10 cm.

[0147] The unitary medication loading system 430 can be fixedly linked to the cannula barrel 435. The unitary medication loading system 430 can be removably affixed to the posterior end of the cannula barrel 435. The unitary medication loading system 430 can be removably affixed to the posterior end of the cannula barrel 435 by a thread, a chemical mean, a track, a -26-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 clip, a rib, a projection, an indentation, or a friction. The unitary medication loading system 430 can be removably affixed to the posterior end of the cannula barrel 435 by a thread.

[0148] In some embodiments, the cannula 420 can have a diameter of about 2.0 mm to about 4.5 mm; about 2.0 mm to about 3.5 mm; about 3.0 mm to about 5.0 mm; about 3.5 mm to about 5.0 mm; or about 3.0 mm to about 4.6 mm. In some embodiments, the cannula 420 can have a diameter of about 2.0 mm, about 2.5 mm about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4.0 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, or about 5.0 mm.

[0149] The cannula barrel 420 and the unitary medication loading system 430 can be made from the same material. The cannula barrel 420 and the unitary medication loading system 430 can be made from different materials.

[0150] The cannula barrel 420 can be made of a material selected from stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys, ceramics and composites thereof, thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, nylon, or epoxy.

[0151] The cannula barrel 420 can be made of a material selected from composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, or other resorbable polymers. The calcium based ceramics can be a calcium phosphate, a tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, and / or calcium sulfate. The other resorbable polymers can be polyaetide, polyglycolide, polytyrosine carbonate, polycaprolactone and any combinations thereof.

[0152] Superelastic metallic alloys can be Nitinol, or super elasto-plastic metals, such as e.g., GUM METAL®. A ceramic composites can be a calcium phosphate (e.g., SKELITE™). The -27-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 material can be thermoplastics selected from polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, or PEEK-BaSCU polymeric rubbers.

[0153] The cannula barrel 420 can be made of a material selected from polyamide, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, nylon, copolyester, styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0154] The cannula barrel 420 can be made of a metallic material selected from the group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content, and a low relative proportion of iron or combinations thereof.

[0155] The cannula barrel 420 can be made of a metallic material selected from the group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content and a low relative proportion of iron or combinations thereof; and the unitary medication loading system 430 can be made of a material selected from polyamide, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof. In some embodiments, the cannula barrel 420 can be made of a metallic material and the unitary medication loading system 430 can be made of nylon.A detachable and retractable obturator

[0156] FIG. 4 further discloses the detachable and retractable obturator 440. FIGs. 4D-E show images of the detachable obturator 440. The obturator 440 can comprise a distal end with a tip 455, a proximal blunt-end stylet (cap) 445, and a shaft 450. The obturator 440 can be connected to the unitary medication loading system 430 via a blunt-end stylet 445. The blunt-end stylet 445 can connect with the unitary medication loading system 430 using a connecting feature. The connection feature can be affixed to the blunt-end stylet 445. The connection feature affixed to the blunt-end stylet 445 can match a connecting feature found on the unitary medication loading system 430. The connection feature can be a thread, a-28-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 chemical mean, a track, a clip, a rib, a projection, an indentation, or a friction. The proximal blunt-end stylet (cap) 445 is as described in FIGs. 1-3. In some embodiments, the illustrated proximal blunt-end stylet (cap) 445 can comprise an internal threading. The internal threading of the blunt-end stylet (cap) 445 of the detachable and retractable obturator 440 can be configured to releasably engage the external threading 415 of the unitary medication loading system 430 as described herein.

[0157] The shaft 450 can connect the tip 455 and the blunt-end stylet 445. The shaft 450 can be fixedly coupled to an internal protruding portion of the blunt-end stylet 445. The shaft 450 can be longer than the unitary medication loading system 430 and / or the cannula 435. The shaft 450 can be longer than the unitary medication loading system 430 and the cannula 435. The shaft 450 can be at least about 0.25 cm to about 1 cm, at least about 0.25 cm to about 0.75 cm, at least about 0.25 cm to about 0.635 cm, at least about 0.4 cm to about 0.75 cm, or at least about 0.5 cm to about 1 cm longer than the combination of the unitary medication loading system 430 and the cannula 435.

[0158] In some embodiments, the shaft 450 can be at least about 0.25 cm, at least about 0.3 cm, at least about 0.4 cm, at least about 0.5 cm, at least about 0.55, at least about 0.6 cm, at least about 0.635, at least about 0.650, at least about 0.7 cm, at least about 0.75, at least about 0.80, at least about 0.9, at least about 0.95, or about 1 cm longer than the combination of the unitary medication loading system 430 and the cannula 435.

[0159] In some embodiments, the detachable and retractable obturator 440 can have a length of at least about 8 cm to about 15 cm; at least about 9 cm to about 13 cm; at least about 10 cm to about 15 cm; at least about 8 cm to about 12 cm; at least about 8 cm to about 13 cm; or at least about 9 cm to about 14 cm. The detachable and retractable obturator 440 can have a length of at least about 10 cm to about 12 cm.

[0160] The detachable and retractable obturator 440 can have a length of at least about 8 cm, at least about 9 cm, at least about 10 cm, at least about 11 cm, at least about 11.5 cm, at least about 12 cm, at least about 13 cm, at least about 14 cm, at least about 15 cm, at least about 16cm, at least about 17 cm, at least about 18 cm, at least about 19 cm, or at least about 20 cm. The detachable and retractable obturator 440 can have a length of at least about 11.5 cm.-29-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0161] In that embodiment, the blunt-end stylet 445 can have a length of about 0.5 cm to about 3 cm; about 0.5 cm to about 1.5 cm; about 1 cm to about 1.75 cm, or about 1 cm to about 2 cm. The blunt-end stylet 445 can have a length of about 0.5 cm, about 0.6 cm, about 0.7 cm, about 0.8 cm, about 0.9 cm, about 1.0 cm, about 1.1 cm, about 1.2 cm, about 1.3 cm, about 1.4 cm, about 1.5 cm, about 1.6 cm, about 1.7 cm, about 1.8 cm, about 1.9 cm, or about 2.0 cm.

[0162] The detachable and retractable obturator 440 can be configured to slide through the interior barrel or lumen of the unitary medication loading system 430, and the lumen of the cannula barrel 435, thereby pushing a content of the pellet chamber 410 to the open posterior end of the cannula barrel 425.

[0163] In some embodiments, the detachable and retractable obturator 440 can have a diameter of about 3.0 mm to about 5.0 mm; about 3.5 mm to about 5.0 mm; or about 3.0 mm to about 4.6 mm.

[0164] The detachable and retractable obturator 440 can slide inside a cannula barrel 420 having a diameter of about 2.0 mm, about 2.5 mm about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4.0 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, or about 5.0 mm.

[0165] The cannula barrel 420, the unitary medication loading system 430, and the detachable and retractable obturator 440 can be made from the same material. The cannula barrel 420, the unitary medication loading system 430, and the detachable and retractable obturator 440 can be made from different materials. In some embodiments, the cannula barrel 420 and the shaft 450 of the detachable and retractable obturator 440 are made of the same material. In some embodiments, the unitary medication loading system 430 and the blunt-end stylet (cap) 445 of the detachable and retractable obturator 440 are made of the same material. In some embodiments, the cannula barrel 420 and the shaft 450 of the detachable and retractable obturator 440 are made of the same material; and the unitary medication-30-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 loading system 430 and the blunt-end stylet (cap) 445 of the detachable and retractable obturator 440 are made of the same material.

[0166] The shaft 450 and the blunt-end stylet 445 can be made of the same material. The shaft 450 and the blunt-end stylet 445 can be made of different material. The blunt-end stylet 445 can be made of the same material as the unitary medication loading system 430. The shaft 450 and the cannula barrel 420 can be made of the same material.

[0167] The shaft 450 can be made of a material selected from stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys, ceramics and composites thereof, thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, nylon, or epoxy.

[0168] The shaft 450 can be made of a material selected from composites of metals and calcium -based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, or other resorbable polymers. The calcium based ceramics can be a calcium phosphate, a tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, and / or calcium sulfate. The other resorbable polymers can be polyaetide, polyglycolide, polytyrosine carbonate, polycaprolactone and any combinations thereof.

[0169] Superelastic metallic alloys can be Nitinol, or super elasto-plastic metals, such as e.g., GUM METAL®. A ceramic composites can be a calcium phosphate (e.g., SKELITE™). The material can be thermoplastics selected from polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, or PEEK-BaSCU polymeric rubbers.

[0170] The shaft 450 can be made of a material selected from polyamide, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, nylon, copolyester, styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal-31-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0171] The shaft 450 can be made of a metallic material selected from the group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content, and a low relative proportion of iron or combinations thereof.

[0172] The shaft 450 can be made of a metallic material selected from the group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content and a low relative proportion of iron or combinations thereof; and the blunt-end stylet 445 can be made of a material selected from polyamide, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0173] In some embodiments, the cannula barrel 420 and the shaft 450 can be made of a metallic material. The blunt-end stylet 445 and the unitary medication loading system 430 can be made of non-metallic material (e.g., nylon). In some embodiments, the cannula barrel 420 and the shaft 450 can be made of a metallic material; and the blunt-end stylet 445 and the unitary medication loading system 430 can be made of non-metallic material (e.g., nylon).

[0174] The tip 455 of the obturator can be blunt, sharp, beveled, curved, or rounded. The tip 455 of the obturator 440 can be blunt. The tip 455 of the obturator 440 can be sharp. The tip 455 of the obturator 440 can be beveled. The tip 455 of the obturator 440 can be curved. The tip 455 of the obturator 440 can be rounded. The tip 455 of the obturator 440 can be capable of penetrating the subcutaneous tissue in a subject. In any of these embodiments, the tip 455 can be coated with an atraumatic material. The atraumatic material can be a non-metal alloy material. For example, the atraumatic material can be polyamide, silicone, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0175] The tip 455 can be coated with thermoplastics, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, -32-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, nylon, or epoxy. The coat can cover the entire tip 455 that protrude beyond the cannula barrel.

[0176] FIG. 5 shows an image of a fully assembled tri-partite trocar of the disclosure. The illustrative embodiment of the tri-partite trocar shows the detachable and retractable obturator inserted inside the lumen or interior barrel of the unitary medication loading system and the lumen of the cannula barrel 520.

[0177] In the illustrated closed configuration, a portion of the shaft 535 of the obturator is shown through the medial opening of the pellet chamber 510. The tip 525 of the obturator can protrude beyond the end 530 of the cannula barrel 520. In some embodiments, the end 530 is a blunt end as described herein.

[0178] The tip 525 can protrude beyond the end 530 of the cannula barrel 520 by at least about 0.25 cm to about 1 cm, at least about 0.25 cm to about 0.75 cm, at least about 0.25 cm to about 0.635 cm, at least about 0.4 cm to about 0.75 cm, or at least about 0.5 cm to about 1 cm. In some embodiments, the end 530 is a blunt end as described herein.

[0179] In some embodiments, the protrusion of the tip 525 beyond the blunt end 530 of the cannula barrel 520 can be at least about 0.25 cm, at least about 0.3 cm, at least about 0.4 cm, at least about 0.5 cm, at least about 0.55 cm, at least about 0.6 cm, at least about 0.635 cm, at least about 0.650 cm, at least about 0.7 cm, at least about 0.75 cm, at least about 0.80 cm, at least about 0.9 cm, at least about 0.95 cm, or about 1 cm. In any of these embodiments, the protruded tip 525 can be coated with an atraumatic material as described herein.

[0180] The blunt-end stylet 515 is fully engaged with the anterior threading 540 of the unitary medication loading system. In this illustrated configuration, the ergonomically designed device 500 can fit in the flat of the hand and allow for a comfortable holding of the hub / handle 505 during a therapeutic pellet implant procedure (FIGs. 8A-B) as described herein.IV. Methods of Using the Tri-partite Trocar-33-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0181] Another aspect of the present disclosure provides a subcutaneous therapeutic pellet implantation method into a subject in need thereof, the method comprising: (1) inserting the tri-partite device described herein into an exposed soft tissue of a surgical incision within a scar free target tissue; (2) positioning the angle of the tri-partite device; (3) exposing the pellet chamber and loading two or more therapeutic pellets into the pellet chamber; (4) holding the cannula hub / handle while pushing the blunt-end stylet of the detachable and retractable obturator; (5) maintaining a pressure on the blunt-end stylet to push the two or more therapeutic pellets toward the open posterior end of the cannula barrel under the subcutaneous fat layer of the exposed soft tissue; (6) pulling out the tri-partite device; and (7) obtaining hemostasis at surgical site by holding pressure on the skin surface area. The subject in need thereof can be a subject who has suffered discomfort following a procedure using a commercially available trocar.

[0182] FIGs. 6-8 show various illustrations of the subcutaneous therapeutic pellet implantation preparation steps in a subject in need thereof for an atraumatic procedure. The subject can be male or female. The subject can be a mammal, a primate, a non-human primate, or a human. FIGs. 10-15 show steps used for an atraumatic subcutaneous therapeutic pellet implantation methods in a subject in need thereof.Patient preparation

[0183] FIG. 6 and FIGs. 10A-B show illustrative embodiments of a patient preparation for a flank pellet implantation procedure. FIG. 6 shows an illustrative embodiment of a preparation 600 of the back of a patient 605 placed in a lateral recumbent position for a flank procedure and the positions of the trocar insertion site 610, the anesthetic injection sites 620, and the pellets implantation sites. FIGs. 10A-B show illustrative implantation area 625 prepping steps for an atraumatic subcutaneous pellet implantation method for flank procedure.

[0184] For the flank procedure, the method begins at 1005 with the position of the patient 605 in the lateral recumbent position. The patient 605 can be rotated forward 45 degrees. At step 1010, the implantation landmarks 625 are identified. Preferably, the landmarks 625 are upper border twelfth (12th) rib, lower border iliac crest of the patient 605. At step 1015, the-34-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 soft tissue area where pellets are going to be placed can be palpated to make sure it is free of scar tissue. If not, the insertion point 610 can be adjusted, if necessary, at step 1020. At step 1025, the landmark area 625 can be cleaned with an alcohol pad in a circular pattern. The alcohol pad should not be dragged back through a clean area. Optionally, at step 1030, ice can be placed on top of the alcohol pad for numbing and vasoconstriction. Then at step 1035, the landmark area 625 can be cleaned after ice removal. At step 1040, the insertion site 610 and therapeutic pellet placement 615 can be marked with a sterile pen. The pellet placement area 615 should be halfway between spine and lateral side.

[0185] Optionally the insertion site or wheal 610 and the pellet placement area 615 can be visualized mentally without markings. At step 1045, therapeutic pellets should land just behind the lateral flank, about 1.5 inches to about 2 inches (e.g., 4 finger widths) from the location of pellet placement area 615. In some embodiments, therapeutic pellets should land just behind the lateral flank, about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in.

[0186] At step 1050, mark or visualize three (3) tracts 620 to deliver anesthetic. Each track 620 can be about 1 cm to about 1.5 cm apart. As described herein, the number of tracts can depend on the size of the implantation area. In some embodiments, about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, or more tracts can be added. In some embodiments, 3 tracts can be marked. In some embodiments, 4 tracts can be marked.

[0187] FIG. 7 and FIGs. 11A-B show illustrative embodiments of a patient preparation for a hip pellet implantation procedure. FIG. 7 shows an illustrative embodiment of a preparation 700 of the hip of a patient 705 (e.g., a male) placed in a lateral recumbent position for a hip procedure and the positions of the trocar insertion site 710, the anesthetic injection sites 720, and the pellets implantation sites. FIGs. 11A-B show illustrative implantation area 735 prepping steps for an atraumatic subcutaneous pellet implantation method for hip procedure.

[0188] For the hip procedure, the method begins at 1105 with the position of the patient 705 in the lateral recumbent position. The patient 705 can be rotated forward 45 degrees with the top leg straight and the bottom leg bent. At step 1110, the implantation landmarks 735 are-35-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 identified. Preferably, the landmarks 735 can be about 1.5 inches to about 2 inches (e.g., 4 finger widths) away from the gluteal cleft of the patient 705. In some embodiments, the landmarks 735 can be about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in away from the gluteal cleft of the patient 705.

[0189] At step 1115, the soft tissue area (e.g., 715) where pellets are going to be placed can be palpated to make sure it is free of scar tissue. If not, the insertion point 710 can be adjusted, if necessary, at step 1120. At step 1125, the insertion area 735 can be cleaned with an alcohol pad in a circular pattern. The alcohol pad should not be dragged back through a clean area. Optionally, at step 1130, ice can be placed on top of the alcohol pad for numbing and vasoconstriction. Then at step 1135, the area 735 can be clean after ice removal.

[0190] At step 1140, the insertion area or wheal 610 and therapeutic pellet placement area 715 can be marked with a sterile pen. The placement pellet area 715 can be about 1.5 inches to about 2 inches (e.g., 4 finger widths) away from the gluteal cleft. In some embodiments, the pellet placement area 715 can be about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in away from the gluteal cleft.

[0191] Optionally, the insertion area or the placement wheal 710 can be visualized mentally without markings. At step 1145, therapeutic pellets should land about 1.5 inches to about 2 inches e.g., 4 finger widths) from the location of wheal 710 and in an area of soft tissue. In some embodiments, therapeutic pellets can land about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in away from the location of wheal 710.

[0192] FIG. 7 further illustrates areas 725 or 730 that can be or should be avoided for therapeutic pellets placement. Specifically, avoid placing pellets too close to the iliotibial (IT) band 725; and avoid placing pellets too low (e.g., lower than the 730 band).

[0193] At step 1155, mark or visualize three (3) tracts 720 to deliver anesthetic. Each track 720 can be about 1cm to about 1.5 cm apart. In some embodiments, each tract 720 can be-36-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 about 0.5cm, about 075cm, about 1.0 cm, about 1.25cm, about 1.5cm, about 1.75cm, about 2.0cm, about 2.25cm, about 2.50cm, about 2.75cm, or about 3.0cm.Placing the anesthetic

[0194] Following the patient preparation 600 or 700, the anesthetic can be placed using the following method 1200 for an atraumatic subcutaneous pellet implantation method. FIG. 12 shows illustrative anesthetic placement steps for the atraumatic subcutaneous pellet implantation method. At step 1205, alcohol swab can be used to prep the skin for anesthetic injection. At step 1210, a 10 cubic centimeter (cc) syringe and 18 gauge (g) needle can be used to draw up 10 cc lidocaine, optionally in combination with epinephrine, and 2cc Sodium Bicarbonate (NaHCCh). Then replace the needle with a 22-23gauge and 1.5 inch needle to use for injections. At step 1215, inject the anesthetic at insertion point / wheal 610 or 710 with needle flat / bevel up and create a raised anesthetic wheal about the size of a dime, using 0.5- Icc syringe (e.g., FIG. 22B). At step 1220, inject the anesthetic along the insertion tracts at a 30-degree angle toward the center anesthetic tract (620 or 720), using 3-4 cc syringe. At step 1225, inject the anesthetic along the left tract (anesthetic tract 620 or 720) in the same manner as step 1220 using 3 cc. At step 1230, inject along the right tract (620 or 720), in the same manner as steps 1220 and 1225, using 3cc. The remaining anesthetic can be used at the user’s discretion. At step 1240, the injected area can be massaged for 15-20 seconds to spread the anesthetic through the tissue.Prepping the Patient

[0195] The subject can be prepared for therapeutic implantation using process 1300. FIG. 13 shows illustrative prepping steps for the atraumatic subcutaneous pellet implantation method. At steps 1305 and 1310, ChloraPrep™ (e.g., 2% chi orhexi dine gluconate (CHG) and 70% isopropyl alcohol (IP A) solution; BD Biosciences) or Betadine® can be applied in a circular pattern. Starting at the area of the wheal 610 or 710 and working outward to create a softball sized sterile field. The swabs cannot be dragged back through the insertion site area or wheal 610 or 710. Generally, when applying ChloraPrep™ gentle repeated back and forth strokes can be used for approximately 30 seconds in approximately 6-inch -by-6 inch area. Allow The area is then allowed to air dry for approximately 30 seconds. At step 1315, the-37-4899-7405-1951.1Atty. Dkt. No.: 643355-2000ChloraPrep® paddle can be flipped over and steps 1305 and 1310 can be repeated. If Betadine® is used, the pattern of steps 1305 and 1310 can be repeated with second and third swabs. At step 1320, the subject can be covered with a fenestrated drape.Pellet insertion

[0196] An embodiment of a subcutaneous pellet implantation method 1400 using the ergonomically designed tri-partite trocar described herein is shown in FIGs. 14A-B. FIGs.14A-B show illustrative pellet insertion steps for an atraumatic subcutaneous pellet implantation method using the tri-partite trocar described herein. One improvement of the claimed invention is that the manipulation of the tri-partite trocar described herein can require one hand during procedure.

[0197] The pellet insertion method 1400 can begin at step 1405, with the assembly of the tripartite trocar. Specifically, the obturator 440 can be combined with or inserted into the bipartite cannula 460 to form the tri-partite trocar 500 configuration.

[0198] At step 1410, a number eleven (# 11) scalpel can be used to dissect the skin to the plastic tip and to make an opening of about 1.5 scalpel size vertically and twist blade. An incision can start at the edge of the anesthetic wheal (e.g., FIG. 22B)and the entire scalpel incision can be kept inside anesthetic wheal .

[0199] At step 1415, the tri-partite trocar 500 can be inserted with tip 525 of the obturator 535 at a 90-degree angle until the tip 525 is buried into the subcutaneous fat layer within the incision.

[0200] At step 1420, the distal end of the trocar 500 can be dropped to a 30-degree angle to follow the prepared anesthetic tract and toward the center tract 620 or 720. The trocar 500 can be gently rotated until the hub 505 abuts the skin of the subject 605 or 705.

[0201] At step 1425, the obturator 535 can be pulled out of the bi-partite cannula 460 to expose the open pellet chamber 510 on the unitary medication loading system 430. At step 1430, with the free hand, a tray holding the therapeutic pellets can be brought over, underneath the trocar 500, and forceps can be used to load about 2 pellets into the pellet-38-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 chamber (510). FIG. 8B shows an illustrative view of an ergonomically designed tri-partite trocar and a method of holding and operating the tri-partite trocar for an efficient and precise implantation of a therapeutic pellet in a subject.

[0202] Specifically, at step 1435, the hub (830) of the tri-partite trocar can be held between the index (810) and middle finger (815). The thumb (805) can be used to push the blunt-end stylet (825) of the obturator into the interior barrel of the unitary medication loading system 430 until resistance is met (e.g., tip 835 touches therapeutic pellets inside the pellet chamber 845). Continue holding pressure on the blunt-end stylet 825 of the obturator 440 with the thumb 805.

[0203] Alternatively, the hub (830) of the tri-partite trocar can be held between the thumb (805) and the index finger (810) of the nondominant hand. The thumb of the dominant hand can be used to push the blunt-end stylet (825) of the obturator into the interior barrel of the unitary medication loading system 430 until resistance is met (e.g, tip 835 touches therapeutic pellets inside the pellet chamber 845). Continue holding pressure on the blunt-end stylet 825 of the obturator 440 with the thumb 805.

[0204] At step 1445, using the index 810 and middle finger 815, pull back toward the thumb 805 while holding pressure on the end of the stylet 825 with the thumb 805. Alternatively, With the thumb (805) and index finger (810) of the nondominant hand underneath, pull back on the cannula while holding pressure on the end of the obturator (e.g, stylet (825)) with the dominant thumb.

[0205] At step 1450, keep the thumb 805 pressed forward so that the tip 835 of the obturator 440 can be pushed forward inside the barrel of the cannula 820 and the therapeutic pellets exit from the trocar. Fasten the cannula and obturator together.

[0206] At step 1455, the trocar can be positioned into the space just to the right from where the last set of pellets were placed. Then steps 1430-1450 can be repeated until all pellets are deployed and can proceed to close the pellet insertion site using method 1500.

[0207] Alternatively, At step 1455, the trocar can be positioned into the space between the center and left anesthetic tract 620 or 720 and steps 1430-1450 can be repeated. Once the hub-39-4899-7405-1951.1Atty. Dkt. No.: 643355-2000830 abuts the skin, remove the obturator and repeat steps 1430-1450. At step 1465, position the trocar into the space between the center and right anesthetic tract 620 or 720 and repeat steps 1430-1450. At step 1470, position the trocar into the space aimed at the right anesthetic tract 620 or 720, and repeat Steps 1430-1450. Once therapeutic pellets have been implanted around all three prepared anesthetic tract 620 or 720, proceed to close the pellet insertion site using method 1500.Pellet insertion site closure

[0208] FIG. 15 shows illustrative pellet insertion site closure steps for the atraumatic subcutaneous pellet implantation method described herein. At step 1505, once the last set of pellets are placed, pressure can be applied to the skin on top of the tri-partite trocar 1500 with the free hand. The tri-partite trocar 1500 can be pulled downward and out of the insertion point 610 or 710. Continue holding pressure at the insertion site to obtain hemostasis at step 1510

[0209] At step 1515, clean any necessary areas with alcohol prep. If Betadine® was used, Betadine® can be wiped off with alcohol. Optionally, Benzoin can be applied horizontally across the incision (z.e., wound) at step 1520. If using, allow benzoin to dry so that the skin can feel tacky. Approximate edges of the pellet implantation by applying Steri-Strip™ onto strip. The strip can be a benzoin strip. Dermabond™ can also be used. At step 1530, use 4x4 gauge pad, folded twice to make a small square to apply over Steri-Strip™. Then, roll (2) 4x4s gauge pads into a long roll 905. Alternatively, one 4x4 gauge pad can be used and rolled into a long roll 905. FIG. 9 shows an exemplary long roll 905 for pellet site closure following implantation in a subject.

[0210] At step 1540, rolled 4x4s 905 can be laid between implanted therapeutic pellets and insertion point 610 or 710 to create pressure on the tract between therapeutic pellets and the incision (z.e., skin opening). Apply Tegaderm™ and ice pack on top of the area where therapeutic pellets are implanted.-40-4899-7405-1951.1Atty. Dkt. No.: 643355-2000V. Methods of using the tri-partite trocar for implantation in a wider area.

[0211] Another aspect of the present disclosure provides a subcutaneous therapeutic pellet implantation method in a subject in need thereof for a broader or larger implantation area. The method allows for a wider space to lay therapeutic pellets side by side. In addition, the anesthetic can also cover wider area. In some embodiments, 4 tracts of anesthetic 1620 or 1720 are provided as shown in FIGs. 16A and 17A. In addition, the anesthetic (e.g., lidocaine) can continue flowing as the user moves in and out of the implantation area. In addition, smaller needle (e.g, 22-23 gauge) and but not 21 gauge can be used. In some embodiments, bigger bore needles may not be suitable for covering a larger implantation area because they can push too much anesthetic (e.g, lidocaine) out too quickly and run out before they have finished numbing the area. In some embodiments, the subject in need thereof can be a subject who has suffered discomfort following a procedure using a commercially available trocar.

[0212] FIG. 16A shows an illustrative embodiment of a preparation 1600 of the hip of a patient 1605 placed in a lateral recumbent position for a hip procedure and the positions of the trocar insertion site 1610, the anesthetic injection sites 1620, and the pellets implantation sites for a wider implantation area. FIG. 16A further illustrates areas 1625 or 1630 that can be or should be avoided for therapeutic pellets placement. Specifically, avoid placing pellets too close to the iliotibial (IT) band 1625; and avoid placing pellets too low (e.g., lower than 1630 band).

[0213] Following the patient preparation 1600, the anesthetic can be placed using the following method 1600 for an atraumatic subcutaneous pellet implantation method for a larger area. FIG. 16B shows illustrative alternative anesthetic placement steps for an atraumatic subcutaneous pellet implantation method for a wider implantation area.

[0214] At step 1635, alcohol swab can be used to prep the skin for anesthetic injection. At step 1640, a 10 cubic centimeter (cc) syringe and 18 gauge (g) needle can be used to draw up 10 cc lidocaine, optionally in combination with epinephrine, and 2cc Sodium Bicarbonate (NaHCCh). Then replace the needle with a 22-23gauge and 1.5 inch needle for injections. At step 1645, inject the anesthetic at insertion point 1610 with needle flat / bevel up and create a-41-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 raised wheal about the size of a dime, using 0.5-lcc syringe. At step 1650, inject the anesthetic along the insertion tracts at a 30-degree angle toward the first anesthetic tract 1620, starting on left, working toward the right then inject lee as the needle is pulled out about halfway.

[0215] At step 1665, inject 2cc of the anesthetic to the 2nd anesthetic tract 1620 and inject lee on withdrawal. At step 1660, inject 2cc of the anesthetic to the 3rd anesthetic tract 1620 and inject lee on withdrawal. At step 1665, inject 2cc of the anesthetic to the 4th anesthetic tract 1620 and inject lee on withdrawal. At step 1670, the injected area can be gently massaged to allow the anesthetic to penetrate the tissue. The subject 1605 can then be prepped as described herein for implantation.

[0216] FIG. 17A shows an illustrative embodiment of a preparation 1700 of a hip of a patient 1705 placed in a lateral recumbent position for a hip procedure for a wider implantation area. The positions of the trocar insertion site 1710, the four tracts (e.g., anesthetic injection sites 1720, the pellets implantation site 1715, and anesthetic or pellet tracks 1735. FIG. 17B shows illustrative implantation area prepping steps for an atraumatic subcutaneous pellet implantation method for hip procedure for a wider implantation area.

[0217] For the hip procedure, the method begins at as described above for method 1100.

[0218] At step 1740, the insertion area or therapeutic pellet placement wheal 1710 can be marked with a sterile pen. The placement wheal 1710 can be about 1.5 inches to about 2 inches (e.g., 4 finger widths) away from the gluteal cleft.

[0219] Optionally, the insertion area or the placement wheal 1710 can be visualized mentally without markings. At step 1745, therapeutic pellets should land about 1.5 inches to about 2 inches (e.g., 4 finger widths) from the location of wheal 1710 and in an area of soft tissue. FIG. 17B further illustrates areas that can be or should be avoided for therapeutic pellets placement. Specifically, avoid placing pellets too close to the iliotibial (IT) band 1725; and avoid placing pellets too low (e.g., lower than 1730). At step 1755, mark or visualize four (4) tracks 1735 to deliver anesthetic to anesthetic tract 1720. Each track 1735 or anesthetic tract 1720 can be about 1 cm to about 1.5 cm apart.-42-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0220] FIGs. 18A-B show illustrative pellet insertion steps for the atraumatic subcutaneous pellet implantation method for a wider implantation area. The steps are substantially similar to methods 1400. In particular, steps 1805-1850 are substantially similar to steps 1405-1450. In the wider implantation areas, at step 1855, the tri-partite trocar can be wiggled into the space aimed at the left anesthetic tract 1720, and steps 1830-1850 can be repeated. Once the hub 830 abuts the skin, remove the obturator and repeat steps 1830-1850.

[0221] At step 1865, the trocar can be wiggled into the area aimed at the space in between the 1stand 2ndanesthetic tracts 1720 and steps 1830-1850 can be repeated. At step 1870, the trocar can be wiggled into the area aimed at the second anesthetic tract 1720 and Steps 1830- 1850 can be repeated. Continue to move into the next space and repeat Steps 1830-1850 until all therapeutic pellets are placed. Once therapeutic pellets have been implanted around all prepared anesthetic tracts 1620 or 1720, the pellet insertion site can be closed using method 1500VI. Methods of using the tri-partite trocar using a pull technique.

[0222] Another aspect of the present disclosure provides a subcutaneous therapeutic pellet implantation method in a subject in need thereof using a pull-back technique. As used herein, a pull technique is also referred to as a pull-back technique or a male pellet pull technique (MPPT). As disclosed herein the tri-partite trocar of the present disclosure can have two pieces: an outer piece and an inner piece. The outer piece can be a bi-partite cannula comprising a cannula barrel as described herein and a unitary medication loading system as described herein. The inner piece can comprise a detachable and retractable obturator. In some embodiments, the detachable and retractable obturator can be blunt as described herein. The tri-partite trocar of the present disclosure can be locked in place and twisted at the bottom. In some embodiments, the twist can be a threading, a chemical mean, a track, a clip, a rib, a projection, an indentation, or a friction. The tri-partite trocar is described herein.

[0223] In some embodiments, the subject in need thereof can be a subject who has suffered discomfort following a procedure using a commercially available trocar. The subject can be a male or a female with low hormone or hormonal imbalance. The subject can be in need of hormone optimization. The subject can be in need of hormone replacement therapy. For-43-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 example, the subject can be in need of bioidentical hormone replacement therapy. A bioidentical hormone is a man-made hormone.

[0224] The male pellet pull technique (MPPT) can comprise six steps: (1) a position or Landmarks identification step; (2) an alcohol and anesthetic preparation step; (3) a sterile field set up step; (4) the MPPT procedure; (5) an incision closure step; and (6) post care or discharge instructions.

[0225] (1) A Pellet placement position or anatomical landmarks identification step

[0226] In some embodiments, the male pellet pull technique (MPPT) described herein can comprise the identification of the pellet placement position and the identification of anatomical landmarks on the subject. The pellet placement position can be a flank or a glute. Generally, the patient can be placed on a side at about 45 degree (45 °C) angle and leaning forward.

[0227] Flank Procedure

[0228] In some embodiments, the pellet placement position is the flank. In that embodiment, the landmarks for the pellet placement can be between the bottom of the twelfth (12th) rib and the top of the iliac crest. FIGs. 19A-B show a back of a male patient in a lateral recumbent position for a flank subcutaneous implant procedure using a male pellet pull technique. FIG. 19 A illustrates an upper border and a lower border landmarks on the back of the patient 1905. The upper border 1930 can be around the 12thrib (e.g., the bottom of the 12thrib). The lower border 1935 can be the iliac crest (e.g., the top of the iliac crest). FIG. 19B illustrates the positions of the trocar insertion site 1910 ( / .< ., the wheal), the anesthetic injection sites 1920, and predetermined therapeutic pellets implantation sites 1915 within the upper border and the lower border landmarks on the back of the patient.

[0229] FIG. 19C shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method for a flank procedure using a male pellet pull technique (MPPT). The MPPT flank procedure can begin at step 1905 with the patient 1905 in the lateral recumbent position. The patient 1905 can be rotated forward by 45 degrees. At step 1910, the implantation landmarks 1931 and 1935 are identified. Preferably,-44-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 the landmarks are an upper border twelfth (12th) rib 1930 and a lower border iliac crest 1935. At step 1915, the soft tissue area where pellets are going to be placed can be palpated to make sure it is free of scar tissue. If a scar-free tissue cannot be found, the insertion point 1910 can be adjusted, if necessary, at step 1920. At step 1925, a soft fatty spot for insertion can be found.

[0230] At step 1930, the insertion area or the placement wheal 1910 can be marked with a sterile pen about halfway between the spine and the lateral side. Optionally, the insertion area or the placement wheal 1910 can be visualized mentally without markings at about halfway between the spine and the lateral side. At step 1935, therapeutic pellets should land just behind the lateral flank into space 1915. Space 1915 can be about 1.5 inches to about 2 inches (e.g., 4 finger widths) from wheal 1910. In some embodiments, therapeutic pellets can land just behind the lateral flank, about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in from wheal 1910. The insertion point (e.g., point # 1 or 1910) and wheal are used interchangeably.

[0231] At step 1940, four (4) tracts 1920 to deliver anesthetic from wheal 1910 can be marked with a sterile pen or mentally visualized. Each anesthetic tract 1920 can be about 1 cm to about 1.5 cm apart. As described herein, the number of anesthetic tracts can depend on the size of the implantation area. In some embodiments, about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, or more anesthetic tracts can be added. In some embodiments, 3 anesthetic tracts can be marked. In some embodiments, 4 anesthetic tracts can be marked.

[0232] Hip Procedure

[0233] In some embodiments of the atraumatic subcutaneous therapeutic pellet implantation method using a pull technique (MPPT) described herein, the pellet placement position is the glute or hip. In that embodiment, the landmarks for the pellet placement can be between the top of the gluteal cleft to over about four (4) fingers in fatty tissue. As used herein, 4 fingers or four fingers means about 1.5 inches to about 2 inches.-45-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0234] FIGs. 20A-C show images of a hip of a patient in a lateral recumbent position for a hip procedure using a male pellet pull technique. FIG. 20A illustrates the landmarks 2035 for trocar insertion away from the gluteal cleft. FIG. 20B illustrates the soft fatty spot for pellet placement. FIG. 20C illustrates a marked hip with the positions of the trocar insertion site ( / .< ., the wheal) 2010, the anesthetic injection sites 2020, and predetermined therapeutic pellets implantation sites 2015. FIG. 20C further illustrates areas 2025 or 2030 that should be avoided for therapeutic pellets placement. Specifically, avoid placing pellets too close to the iliotibial (IT) band 2025; and avoid placing pellets too low (e.g., lower than the 2030 band).

[0235] FIG. 20D shows illustrative implantation area prepping steps for an atraumatic subcutaneous therapeutic pellet implantation method using a pull technique for a hip subcutaneous implant procedure.

[0236] For the MPPT hip procedure, the method can begin at step 2005 by placing the patient 2005 in the lateral recumbent position. The patient 2005 can be rotated forward at about a 45 degree angle with the top leg straight and the bottom leg bent. At step 2010, the implantation landmarks 2035 are identified. Preferably, the landmarks 2035 can be about 1.5 inches to about 2 inches (e.g., 4 finger widths) away from the gluteal cleft 2040 of the patient 2005. In some embodiments, the landmarks 2035 can be about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in away from the gluteal cleft 2040.

[0237] A soft fatty spot for pellet placement can be found as shown in FIG. 20B. At step 2015, the soft tissue area (e.g., 2015) where pellets are going to be placed can be palpated to make sure it is free of scar tissue. If not, the insertion point 2010 can be adjusted, if necessary, at step 2020.

[0238] At step 2025, the insertion area or wheal 2010 can be marked with a sterile pen. The wheal 2010 can be about 1.5 inches to about 2 inches e.g., 4 finger widths) away from the gluteal cleft 2040. In some embodiments, the wheal 2010 can be about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25in, about 2.50in, about 2.75in, or about 3.0in away from the gluteal cleft 2040.-46-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0239] Optionally, the insertion area or wheal 2010 can be visualized mentally without markings. At step 2030, therapeutic pellets can land about 1.5 inches to about 2 inches (e.g., 4 finger widths) from the location of the wheal 2010 and in an area of soft tissue 2015. In some embodiments, therapeutic pellets can land about 0.5in, about 0.75in, about l.Oin, about 1.25in, about 1.50in, about 1.75in, about 1.8in, about 1.9in, about 2.0in, about 2.25 in, about 2.50in, about 2.75inc, or about 3.0in away from the location of the wheal 2010.

[0240] In some embodiments, therapeutic pellet placement should not extend beyond area 2025 or 2030. Preferably, area 2025 or 2030 should be avoided for therapeutic pellet placement. Avoid placing pellets too close to the iliotibial (IT) band 2025. In addition, avoid placing pellets too low for example lower than the 2030 band. See also FIG. 20C.

[0241] At step 2040, four (4) anesthetic tracts can be marked or visualized to deliver anesthetic. FIG. 23A. Each tract can be about 1cm to about 1.5 cm apart. In some embodiments, each track can be about 0.5cm, about 075cm, about 1.0 cm, about 1.25cm, about 1.5cm, about 1.75cm, about 2.0cm, about 2.25cm, about 2.50cm, about 2.75cm, or about 3.0cm apart.

[0242] (2) Alcohol and anesthetic preparation step

[0243] Clean insertion site

[0244] In some embodiments of the atraumatic subcutaneous therapeutic pellet implantation method using a male pellet pull technique (MPPT) described herein, the method can comprise cleaning the tri-peptide trocar insertion site. Generally, the pellet placement area can be cleaned in circular pattern starting in the center and moving outward.

[0245] The method 2100 for cleaning the trocar insertion site can begin at step 2105. At step 2105, the landmark area 2035 can be cleaned with an alcohol pad before placing the anesthetic. The proctor should wear gloves. At step 2110, the alcohol pad can be used in a circular fashion, moving from center to outward. The alcohol pad should not be dragged back through a clean area (step 2115). Optionally, at step 2120, ice can be placed on top of the alcohol pad to induce numbing and vasoconstriction. In some embodiments, the ice can be a cold gel or a cold spray. In some embodiments, the ice can be placed for about 0.5 minute,-47-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In some embodiments, the ice can be placed for about 1 to about 10 minutes or about 1 to about 5 minutes. Then at step 2125, the landmark area 2035 can be cleaned again after ice removal.

[0246] Placing the anesthetic wheal

[0247] In some embodiments of the atraumatic subcutaneous therapeutic pellet implantation method using a pull technique (MPPT) described herein, the method can comprise placing the anesthetic prior to inserting the tri-partite trocar. The anesthetic can be placed initially with a needle with the bevel face of the needle up. The needle can be inserted under the skin to create a dime-sized wheal ( / .< ., anesthetic wheal) using about lee of anesthetic. In some embodiments, the anesthetic wheal can be about 0.9in, 0.8in, 0.7in, 0.705in, 0.6inc, 0.5inc, 0.4in, or 0.3in. The anesthetic can then be injected into about 4 tracts. In some embodiments, the injection can deliver about 2-3 cc of anesthetic in each tract. The hub of needle can be pushed into the skin. Optionally, the area can be cleaned with ChloraPrep®. FIG. 22A shows illustrative steps for placing an anesthetic wheal for an atraumatic subcutaneous therapeutic pellet implantation method using a pull technique.

[0248] The method of placing the anesthetic wheal 2200 can begin at step 2205. At step 2110, the top of an anesthetic bottle and the top of a sodium bicarbonate (NaHCCh) bottle can be cleaned with an alcohol prep. At step 2210, a 10 cubic centimeter (cc) syringe 2205 and 18 gauge (g) needle can be used to draw up 10 cc lidocaine, optionally in combination with epinephrine, and lee Sodium Bicarbonate (NaHCCh). Then at step 2120, the 18 gauge (g) needle can be replaced with a 22.5 gauge needle 2210 for creating the anesthetic wheal 2215. At step 2125, 0.5cc of the anesthetic can be injected at the insertion point 1910 or 2010 with bevel flat. The bevel can be turned to a 90 degree angle to the right and 0.5cc of the anesthetic can be injected. The bevel can then be turned to a 90 degree angle to the left and 0.5cc of the anesthetic can be injected. The series of injections can create a raised wheal 2215 about the size of a dime. In some embodiments, the anesthetic wheal can be about 0.9in, 0.8in, 0.7in, 0.705in, 0.6inc, 0.5inc, 0.4in, or 0.3in. FIG. 22B shows an image illustrating the placement of anesthetic wheal of using the method 2200.

[0249] Placing the anesthetic-48-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0250] FIG. 23A shows a hip of a patient in a lateral recumbent position marked with anesthetic tracks 2335 (e.g., arrows connecting #1 and #3) and anesthetic placement tracts 2320 for an atraumatic subcutaneous therapeutic pellet implantation method using the pull technique. FIG. 23B shows illustrative steps of the method 2300 for placing the anesthetic for the atraumatic subcutaneous therapeutic pellet implantation method using the pull technique.

[0251] The method 2300 can begin at step 2305. At step 2305, the needle can be held at a 30- degree angle from the body and can be aimed toward the first anesthetic tract 2320. Working in a clockwise direction is recommended. Starting on the left and working toward the right, 2cc of lidocaine can be injected toward the first (1st) anesthetic tract 2320. At step 2310, the needle can be pulled out about halfway ( / .< ., withdrawal) and lee of lidocaine can be injected at the hallway point.

[0252] At step 2315, the needle can be pushed forward toward the 2nd anesthetic tract 2320 and 2cc of the anesthetic can be injected toward the 2ndanesthetic tract 2320. The needle can be pulled out about halfway ( / .< ., withdrawal) and lee of lidocaine can be injected at the hallway point. At step 2320, the needle can be pushed forward toward the 3rdanesthetic tract 2320 and 2cc of the anesthetic can be injected toward the 3rdanesthetic tract 2320. The needle can be pulled out about halfway ( / .< ., withdrawal) and lee of lidocaine can be injected at the hallway point. At step 2325, the needle can be pushed forward toward the 4thanesthetic tract 2320 and 2cc of the anesthetic can be injected toward the 4thanesthetic tract 2320. The needle can be pulled out about halfway ( / .< ., withdrawal) and lee of lidocaine can be injected at the hallway point. At step 2330, the injected area can be gently massaged to allow the anesthetic to penetrate the tissue. Optionally, at step 2340, a ChloraPrep® paddle can be applied to the pellet placement area. The subject 2305 can then be prepped as described herein for pellet implantation.

[0253] (3) A sterile field set up

[0254] In some embodiments of the atraumatic subcutaneous therapeutic pellet implantation method using a pull technique (MPPT) described herein, the method can comprise setting up the sterile field and preparing the patient. Generally, the method can comprise a procedure kit-49-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 as described herein. In that embodiment, the kit can be opened. The proctor can wear sterile gloves and components of the procedure tray can be organized. For example, pellet can be dropped into the tray. An assistant can drop pellets into tray to avoid contamination (the field should not be contaminated). The pellet insertion area can be cleaned using a ChloraPrep® paddle in circular fashion. The ChloraPrep® paddle can be flipped and the area can be cleaned again starting in center and cleaning outward. Then, a sterile fenestrated drape can be applied on the patient.

[0255] Prepare tray

[0256] The method 2400 for preparing the procedure tray can start at step 2405 with setting up a tray comprising surgical elements on dominant side for easy reach to avoid crossing over during procedure. At step 2410, the sterile field can be set up and needed items can be opened onto field. In some embodiments, the tray can contain a scalpel, a 4x4 gauge, a Steri-Strip™, a drape, the tri-partite trocar described herein, one or more pellets, and a container ( / .< ., a cup) for holding pellets during the procedure. At step 2425, the medication pellets can be dropped into a container or cup on the tray by the proctor ( / .< ., practitioner) or an assistant. The pellet container should not touch the sterile field.

[0257] In some embodiments, a kit is not used. In that embodiment, surgical supplies can be dropped onto sterile field before wearing sterile gloves (Step 2420). In some embodiments, a full kit is used. In that embodiment, the kit can be opened before wearing sterile gloves. The kit contents can be touched after wearing sterile gloves (Step 2415).

[0258] Sterilize patient

[0259] The method 2500 for sterilizing the patient can start at step 2505 while wearing sterile gloves. Everything is sterile from this point onward. The patient sterilization technique is as described herein. FIG. 25 shows illustrative steps for sterilizing a patient for an atraumatic subcutaneous therapeutic pellet implantation method using a pull technique. At steps 2510, ChloraPrep™ (e.g., 2% chi orhexi dine gluconate (CHG) and 70% isopropyl alcohol (IP A) solution; BD Biosciences) or Betadine® can be applied in a circular pattern. At step 2515, ChloraPrep™ can be applied starting at the area of the wheal 2010 or 2310 and working outward to create a softball sized sterile field. At step 2520, the swabs cannot be dragged-50-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 back through the insertion site area or wheal 2010 or 2310. At step 2520, the ChloraPrep ® paddle can be flipped over and steps 2510 to 2520 can be repeated. At step 2530, the subject ( / .< ., the patient) can be covered with a fenestrated drape to preserve sterile field.

[0260] Optionally, as described herein, ChloraPrep® can be applied before opening a kit and getting sterile supplies. In that embodiment, the subject ( / .< ., the patient) can be covered with a fenestrated drape to preserve sterile field after setting up the tray.

[0261] (4) The pull technique

[0262] The pull technique or the male pellet pull technique (MPPT) for subcutaneously implanting therapeutic pellets in a subject in need thereof can comprise several uniform steps. The tri-partite trocar can be locked together. The incision can be made as described herein. The size of the incision can depend on the size of the pellet to be inserted. For example, if 100 mg of testosterone (T-100) is being implanted, the size of the incision can be about 1 blade (z.e., 1 blade for T-100). The blade can be a # 11 surgical blade or #11 blade. If about 200 mg of testosterone (T-200) is being implanted, the size of the incision can be about 1.5 blade ( / .< ., 1.5 for T-200). The tri-partite locked trocar can be inserted at a 30 degree angle and can be gently rotated side to side while advancing the hub to the skin. Once in place, the obturator can be untwisted and removed with a dominant hand, while holding the bi-partite cannula with a nondominant hand.

[0263] The container (or cup) holding pellets can be brought under the bipartite cannula with the dominant hand and can be grabbed by the nondominant hand. Forceps can then be used to load about 2 pellets into the pellet chamber of the bipartite cannula (e.g., the pellet chamber of the unitary medication loading system) with the dominant hand. The container can be laid back on the table with dominant hand. Then, the obturator can be advanced inside the lumen of the bipartite cannula until resistance is met ( / .< ., the pellets are placed within the incision) with the dominant hand.

[0264] Once the first pellets are placed, the nondominant hand can be used underneath to pull the bipartite cannula back toward the thumb. The tri-partite trocar can be twisted and locked in place again, and then the locked tri-partite trocar can be pushed toward the next position. The pellet loading, insertion, and pellet placement steps can be repeated to place next set of -51-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 pellets just to the right of the last placement until all pellets are deployed in all four marked areas 2320.

[0265] FIG. 26A shows an image illustrating the technique for making an incision on the anesthetic wheal 2615 using forceps 2605 with a #11 blade 2610. FIG. 26B shows an image illustrating the technique for inserting the tri-partite trocar inside the incision 2615. FIG. 26C shows the position of the nondominant hand 2625 for holding the tri-partite trocar 2620 after its insertion into the surgical incision 2615. FIG. 26D shows an image illustrating the technique for holding the tri-partite trocar 2620 and the pellet container 2630 with the nondominant hand 2625 prior to pellet loading.

[0266] FIG. 27A shows an image illustrating the technique for loading the pellet chamber 2770 with one or more therapeutic pellets 2735 while holding the tri-partite trocar 2720 and the pellet container 2730 with the nondominant hand. Specifically, The hub 2710 of the tripartite trocar 2720 can be held between an index 2725 and a middle finger 2780 of a user while the thumb holds the pellet container (z.e., cup) 2730 against the middle finger 2780. FIG. 27B shows an image illustrating the pull back technique for changing pellet placement sites during the procedure.

[0267] Incision and trocar insertion

[0268] FIG. 28 shows illustrative method 2800 for tri-partite trocar insertion during the atraumatic subcutaneous therapeutic pellet implantation procedure. The pull technique (MPPT) can start with the method 2800 for making an incision and inserting the tri-partite trocar. The method 2800 can begin at step 2805, with the assembly of the tri-partite trocar. Specifically, the obturator 2715 can be combined with or inserted into the bi-partite cannula 2705 to form the tri-partite trocar 500 configuration, which is locked.

[0269] At step 2810, a number eleven (# 11) scalpel 2605 can be used to dissect the skin. At step 2815, the incision can start at the lower edge of the anesthetic wheal 2215 (e.g., FIG. 22B) The entire incision made by the # 11 scalpel 2605 can be kept inside numb area (z.e., wheal 2215).-52-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0270] In some embodiment, the procedure can involve an insertion of a medication pellet over 100 mg in size (e.g., 200 mg Testosterone (T 200 procedure)). In that embodiment, at step 2825, the full depth of a # 11 scalpel blade 2610 can penetrate inside the body. In some embodiments, the procedure can involve an insertion of a medication pellet under 100 mg in size (e.g., 100 mg Testosterone (T 100 procedure)). In that embodiment, at step 2820, the skin can only be dissected for the full size of the # 11 scalpel blade 2610. At step 2830, the # 11 scalpel blade 2610 can be twisted and the # 11 scalpel 2605 can be pulled out of the incision.

[0271] At step 2835, the tri-partite trocar can be inserted into the incision at a 30-degree angle into the subcutaneous fat layer toward the pellet insertion area 2015. At step 2840, starting on the left side and working toward right (clockwise), the tri-partite trocar can be directed toward the 1stanesthetic tract 2320 following the anesthetic track and the tri-partite trocar can be gently rotated back and forth until the hub of the trocar abuts the skin.

[0272] Pellet placement

[0273] FIGs. 29A-B show illustrative method 2900 for multiple pellet placements using the male pellet pull technique. The method 2900 for pellet placement using the MPPT can begin at step 2905 with the stabilization of the trocar 2620 with a nondominant hand (ND) 2725 or 2625. For the MPPT, the Dominant hand (D) 2745 can be used to insert pellets 2735 and to move the pellet container 2730 back and forth during the procedure. At step 2910, the nondominant (ND) hand 2625 can rest under the trocar 2620 with fingertips facing the practitioner (FIG. 26C). At step 2915, the obturator 2715 can be unscrewed from the bipartite cannula 2705 using the dominant hand (D) hand 2745. At step 2920, the obturator 2715 can be pulled out with the dominant hand 2745 to expose the opening of the pellet chamber 2770.

[0274] At step 2930, using the dominant hand (D) 2745, the container 2730 holding pellets 2735 can be brought under the trocar 2720. While holding the hub 2710 of the trocar 2720 between the index finger and the middle finger of the nondominant hand 2725, the container 2730 can be grabbed under the trocar 2720 with the thumb of the ND hand 2725 and locked with the palm and middle finger (FIG. 26D).-53-4899-7405-1951.1Atty. Dkt. No.: 643355-2000

[0275] At step 2935, forceps / tweezers 2775 can be picked up with dominant (D) hand 2745 and can be loaded with all pellets 2735 (e.g., 2 pellets), smallest to largest, into the pellet chamber 2770. At step 2940, the container 2730 can be taken from the ND hand 2725 using the D hand 2745 and can be placed back on sterile field. At step 2945, the D hand 2745 can be used to advance the obturator 2715 inside the bipartite cannula 2705 with thumb until resistance met ( / .< ., pellets have been placed). It is recommended not to plunge the obturator 2715 inside the incision.

[0276] Pull back for multiple pellet placements

[0277] At step 2955, after the pellets have been placed, the ND hand 2725 can be used to pull trocar 2720 (e.g., cannula) back from underneath while the D hand 2745 holds steady pressure on the obturator 2715. At step 2960, the obturator 2715 can be twisted and locked with the bipartite cannula 2705 using the lock mechanism (thread) 2750. The trocar 2720 can be locked in place for insertion at the 2ndanesthetic tract 2320 (i.e., next location). At step 2965, the locked trocar 2720 can be advanced with the D hand 2745 by gently rotating back and forth to the space just to the right of the last track i.e., 1stanesthetic tract 2320) until the hub abuts the skin. At step 2970, steps 2910-2945 can be repeated to place the pellets in the second position 2320. At step 2975, the pull back steps 2955-2970 can be repeated to place the pellets toward the third anesthetic tract 2320. At step 2975, the pull back steps 2955-2970 can be repeated to place the pellets toward the fourth anesthetic tract 2320.

[0278] Once all therapeutic pellets have been implanted around all four prepared anesthetic tract 2320, proceed to close the pellet insertion site using method 3000. In some embodiments, the pellet is testosterone. In that embodiment, the patient can receive dosages ranging from lOOmg to 1,200 mg, depending on the individual's requirements.

[0279] (5) An incision closure step.

[0280] In some embodiments, the subcutaneous therapeutic pellet implantation method in a subject in need thereof using a pull technique (MPPT) can comprise the incision closure step. The incision closure step is as described herein. Generally, sterile technique can be maintained until Tegaderm™ has been applied. Sterile strips can be applied using tension. The area can then be covered with gauze folded into 4 x 4 square. Tegaderm™ can then -54-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 applied Pressure can be held at the placement site while giving discharge instructions. Ice pack can be placed over pellet placement site. Taping ice pack on top of Tegaderm™ may not be recommended.

[0281] FIG. 30 shows illustrative pellet insertion site closure method 3000 following the atraumatic subcutaneous pellet implantation method described herein. At step 3005, once the last set of pellets 2735 are placed, pressure can be applied to the skin on top of the tri-partite trocar 2720 with the free hand. The tri-partite trocar 2720 can be pulled downward and out of the incision while applying pressure at step 3010. Pressure can be held at the insertion site until hemostasis is obtained at step 3015.

[0282] At step 3020, any necessary areas can be cleaned with alcohol prep. If Betadine® was used, Betadine® can be wiped off with alcohol. Benzoin can be applied horizontally across the incision (z.e., wound), and can be allowed to dry so that the skin can feel tacky. At step 3025, while approximating the edges of the pellet implantation, Steri-Strip™ 2755 can be applied onto benzoin strip. Optionally, Dermabond™ can also be used. FIGs. 27C-D show images illustrating bandages following the insertion site closure.

[0283] At step 3030, a 4x4 gauge pad 2760 can be used to apply over Steri-Strip™ 2760. The 4x4 gauge pad can be folded twice to make a small square. At step 3045, Tegaderm™ and ice pack can be applied on top of the area where therapeutic pellets are implanted.

[0284] Optionally, prior to step 3045, at step 3035, two (2) 4x4s gauge pads can be rolled into a long roll 2765. At step 3040, rolled 4x4s 2765 can be laid between implanted therapeutic pellets and the tri-partite trocar 2720 and the insertion point to create pressure on the tract (z.e., space) between therapeutic pellets and the incision (z.e., skin opening). FIG. 27E shows an exemplary long roll 2765 for putting pressure on the tract between the insertion point and pellets following implantation in a subject.

[0285] (6) Post care or discharge instructions

[0286] Following the atraumatic subcutaneous therapeutic pellet implantation procedure using a male pellet pull technique described herein, the patient can be instructed to leave bandage on for about 7 days. The subject can be instructed to avoid submersion in water for-55-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 about 7 days ( / .< ., no bath). The subject can be instructed to shower. The subject can be instructed to avoid exercising the area of pellet placement for 7 days.VII. Kits

[0287] Another aspect of the present disclosure provides a kit comprising the tri-partite devices disclosed herein, and instructions comprising the atraumatic subcutaneous implant methods disclosed herein. The kit can comprise a bi-partite cannula as described herein and a detachable and retractable obturator as described herein. The bi-partite cannula can comprise a cannula barrel and a unitary medication loading system as described herein. The cannula barrel can be fixedly or removably linked to the unitary medication loading system. In some embodiments, when the cannula barrel is removably linked to the unitary medication loading system, the kit further comprises one or more replacement cannula barrels or unitary medication loading systems.

[0288] In some embodiments, the detachable and retractable obturator can comprise a distal end with a tip, a proximal blunt-end stylet (cap) and a shaft connecting the tip and the blunt- end stylet. The shaft can be fixedly or removably coupled to the blunt-end stylet.

[0289] In some embodiments, when the shaft is removably coupled to the blunt-end stylet, the kit further comprises one or more replacement shafts or blunt-end stylets (cap).

[0290] In some embodiments, the procedure kits disclosed herein can enhance the efficiency and precision of a subcutaneous therapeutic pellet implantation method described herein. In some embodiments, the kit can be a disposable trocar kit. The disposable trocar kit can comprise a tri-partite device for implanting a therapeutic pellet of about or less than about 100 mg. In that embodiment, the trocar can be about 3.0 mm to about 3.5 mm. The trocar can be about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, or about 3.5 mm. Optionally, the pellet can be about 100 mg testosterone pellet ( / .< ., T 100 or 3.5 mm). As used herein, a female trocar can mean a T100 trocar, a 3.5 mm trocar, or a trocar used to implant a pellet of about 100 mg or less (e.g., testosterone pellet).

[0291] The disposable trocar kit can comprise a tri-partite device for implanting a therapeutic pellet of more than 100 mg to about 300 mg. Optionally, the pellet can be about 200 mg-56-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 testosterone pellet (z.e., T 200 or 4.5mm). In that embodiment, the trocar can be about 4.0mm to about 5.8mm. As used herein, a male trocar can mean a T200 trocar, a 4.5 mm trocar, or a trocar used to implant a pellet of about 200 mg (e.g., testosterone pellet).

[0292] The disposable trocar kits can comprise a male trocar (T200; 4.5 mm) or female trocar (T100 or 3.5mm), a complete set of procedure tools, and instructions for performing a subcutaneous therapeutic pellet implantation method described herein. A complete set of procedure tools can comprise a lOcc syringe, a 18gauge needle, a 22gauge needle, a scalpel (e.g., a # 11), a 4 x4, Steri-Strip™, a drape, forceps or tweezers, a pellet container, a paddle of ChloraPrep®, Tegaderm™, and / or sterile gloves.

[0293] In some embodiments, the kit can comprise sterile forceps, gauze, a pellet container, and a male or female trocar. In some embodiments, the kit can comprise sterile forceps, gauze, a pellet container, and a male trocar, and a female trocar. Each kit can be presterilized, thereby eliminating the need for additional sterilization equipment. In some embodiments, the forceps can be a set of stainless-steel forceps.

[0294] It will be understood that the reference to the illustrative embodiments are provided for illustration purposes only and do not limit the scope of the claims. Each aspect, embodiment, or feature of the invention may be combined with any other aspect, embodiment, or feature the invention unless clearly indicated to the contrary. Unless defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by a person skilled in the art to which this invention belongs.EQUIVALENTS

[0295] The present technology is not to be limited in terms of the particular embodiments described in this application, which are intended as single illustrations of individual aspects of the present technology. Many modifications and variations of this present technology can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the present technology, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the present technology. It is to be understood that this present technology is not-57-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 limited to particular methods, reagents, compounds compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and it is not intended to be limiting.

[0296] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.INCORPORATION BY REFERENCE

[0297] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference 100% in their entireties to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.-58-4899-7405-1951.1

Claims

Atty. Dkt. No.: 643355-2000WHAT IS CLAIMED IS:

1. A tri -partite device for implantation of a therapeutic pellet in a subject in need thereof comprising:(a) a bi-partite cannula, wherein the bi-partite cannula comprises:(i) a cannula barrel comprising an open posterior end, an open anterior end, sidewalls between the posterior end and the anterior end, and a lumen forming an interior barrel, and(ii) a unitary medication loading system comprising a pellet chamber disposed at the anterior end of the unitary medication loading system, a cannula hub / handle disposed at the posterior end, a lumen forming an interior barrel, and an external threading anterior to the pellet chamber, wherein the interior lumen of the cannula barrel is continuous with the interior barrel of the unitary medication loading system; and(b) a detachable and retractable obturator comprising a distal end with a tip, a proximal blunt-end stylet (cap) comprising an internal threading, an internal protruding portion, and a shaft connecting the tip and the blunt-end stylet, wherein the shaft is fixedly coupled to the internal protruding portion of the blunt-end stylet; wherein the detachable and retractable obturator is configured to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, thereby pushing a content of the pellet chamber to the open posterior end of the cannula barrel; and wherein the external threading of the unitary medication loading system releasably engages the internal threading of the blunt-end stylet (cap) of the detachable and retractable obturator.

2. The tri-partite device of claim 1, wherein the posterior end of the cannula barrel comprises a blunt end or beveled, optionally wherein the posterior end of the cannula barrel is coated with an atraumatic material.

3. The tri-partite device of claim 2, wherein the blunt end is curved.

4. The tri-partite device of any one of claims 1-3, wherein:-59-4899-7405-1951.1Atty. Dkt. No.: 643355-2000(a) the cannula barrel is fixedly molded to the posterior end of the unitary medication loading system, or(b) the cannula barrel is removably affixed to the posterior end of the unitary medication loading system.

5. The tri-partite device of any one of claims 1-4, wherein the tip of the obturator is blunt, sharp, rounded, beveled, or curved, optionally wherein the tip is coated with an atraumatic material.

6. The tri-partite device of any one of claims 1-5, wherein:(a) the cannula barrel has a length of about 4 cm to about 7 cm;(b) the unitary medication loading system has a length of about 3 cm to about 6 cm; and / or(c) the tri-partite device has a length of about 8 cm to about 15 cm.

7. The tri-partite device of any one of claims 1-6, wherein the cannula barrel, the medication loading system, and the detachable and retractable obturator are made from a same material or different materials.

8. The tri-partite device of any one of claims 1-7, wherein:(a) the cannula barrel and the shaft of the detachable and retractable obturator are made of a same material; and / or(b) the unitary medication loading system and the blunt-end stylet (cap) of the detachable and retractable obturator are made of the same material.

9. The tri-partite device of claim 7, wherein the material is selected from polyamide, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, nylon, copolyester, styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

10. The tri-partite device of claim 7, wherein the cannula barrel or the shaft of the detachable and retractable obturator is made of a metallic material selected from the-60-4899-7405-1951.1Atty. Dkt. No.: 643355-2000 group consisting of nitinol, steel, aluminum, stainless steel, titanium, metal alloys with high nonferrous metal content and a low relative proportion of iron or combinations thereof.

11. The tri-partite device of claim 7, wherein the unitary medication loading system or the blunt-end stylet (cap) of the detachable and retractable obturator is made of a material selected from polyamide, nylon, polyurethane, polyurea, polyether(amide), polyether block amide (PEBA), thermoplastic elastomeric olefin, copolyester, styrenic thermoplastic elastomer, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

12. The tri-partite device of any one of claims 1-11, wherein the cannula hub / handle is configured to fit between an index and a middle finger during an operation of the tripartite device.

13. The tri-partite device of any one of claims 1-12, wherein the lumen of the unitary medication loading system, and the lumen of the cannula barrel have a depth at least equal to or larger than a diameter of the therapeutic pellet.

14. The tri-partite device of any one of claims 1-13, wherein the pellet chamber comprises a medial opening for loading a therapeutic pellet and wherein the medial opening exposes the interior barrel of the unitary medication loading system.

15. The tri-partite device of claim 14, wherein the pellet chamber is arranged to dispense one or more therapeutic pellets into the lumen of the cannula barrel through the posterior end of the cannula barrel.

16. The tri-partite device of claim 14, wherein the pellet chamber receives:(a) one or more pellets per implantation cycle; or(b) at least two pellets per implantation cycle.

17. A subcutaneous pellet implantation method in a subject in need thereof, the method comprising:-61-4899-7405-1951.1Atty. Dkt. No.: 643355-2000(a) inserting the tri -partite device of any one of claims 1-16 into an exposed soft tissue of a surgical incision within a scar free target tissue at about 90-degree angle until the tip of the open posterior end of the cannula barrel is buried into a subcutaneous fat layer of the exposed soft tissue;(b) positioning the angle of the tri-partite device from the about 90-degree angle to about 30-degree with gentle rotation until the cannula hub / handle abuts a skin;(c) exposing the pellet chamber by pulling the detachable and retractable obturator backward and loading the pellet chamber with two or more therapeutic pellets;(d) holding the cannula hub / handle between an index and a middle finger while pushing the blunt-end stylet of the detachable and retractable obturator with a thumb and pulling the cannula hub / handle back toward the thumb with the index and the middle finger;(e) maintaining a thumb pressure forward to allow the detachable and retractable obturator to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, to push the two or more therapeutic pellets toward the open posterior end of the cannula barrel under the subcutaneous fat layer of the exposed soft tissue ;(f) pulling out the tri-partite device downward and out from the surgical incision while applying pressure to a skin surface area above an insertion site of the tri-partite device with a free hand; and(g) obtaining hemostasis at surgical site by holding pressure on the skin surface area above the insertion site of the tri-partite device.

18. The method of claim 17, wherein exposing the pellet chamber, holding the cannula hub / handle, and maintaining the thumb pressure are repeated at least three times to one or more pre-determined target implantation sites.

19. The method of claim 18, wherein the one or more target implantation sites is changed by wriggling the tri-partite device into a new pre-determined site without removing the tri-partite device from the surgical incision site.-62-4899-7405-1951.1Atty. Dkt. No.: 643355-200020. The method of claim 18, wherein the one or more pellets are implanted in a flank or a hip of the subject.

21. A subcutaneous pellet implantation method in a subject in need thereof, the method comprising:(a) inserting the tri -partite device of any one of claims 1-16 into an exposed soft tissue of a surgical incision toward a first predetermined tract at about 30- degree angle until the tip of the open posterior end of the cannula barrel is buried into a subcutaneous fat layer of the exposed soft tissue;(b) gently rotating the tri-partite device until a cannula hub abuts a skin;(c) exposing the pellet chamber and loading the pellet chamber with two or more therapeutic pellets;(d) holding the cannula hub between an index and a middle finger of a nondominant hand, and pushing the blunt-end stylet of the obturator with a thumb of a dominant hand;(e) maintaining a thumb pressure forward to allow the obturator to slide through the interior barrel of the unitary medication loading system, and the lumen of the cannula barrel, to push the two or more therapeutic pellets toward the open posterior end of the cannula barrel and under the subcutaneous fat layer of the exposed soft tissue;(f) pulling back the tri-partite device with the nondominant hand while the dominant hand holds steady pressure on the blunt-end stylet of the obturator;(g) locking the tri-partite device by threading the obturator and the bi-partite cannula together with the dominant hand in preparation for a second pass;(h) advancing the locked tri-partite device with gently rotation of the tri-partite device toward an adjacent second predetermined tract until the cannula hub abuts the skin; and(i) repeating step (c) to step (f) (e.g., implantation cycle);(j) pulling back the tri-partite device downward and out from the surgical incision while applying pressure to a skin surface area above an insertion site of the tri-partite device with the nondominant hand; and-63-4899-7405-1951.1Atty. Dkt. No.: 643355-2000(k) obtaining hemostasis at the insertion site by applying pressure on the skin surface area above the insertion site; and(l) closing the insertion site.

22. The method of claim 21, further comprising repeating step (c) to step (i) for implanting one or more pellets at an adjacent third predetermined tract (e.g., a third implantation cycle).

23. The method of claim 22, further comprising repeating step (c) to step (i) for implanting one or more pellet at an adjacent fourth predetermined tract (e.g., a fourth implantation cycle).

24. The method of any one of claims 21-23, wherein the first, second, third or fourth predetermined tract is an anesthetic tract.

25. The method of any one of claims 21-24, wherein exposing the pellet chamber comprises the step of:(a) resting the nondominant hand under the cannula hub of the tri-partite device;(b) unthreading the obturator from the tri-partite device with the dominant hand; and(c) pulling the obturator backward.

26. The method of claim 25, wherein resting the nondominant hand under the hub of the tri-partite device comprises holding the cannula hub between the index and the middle finger.

27. The method of any one of claims 21-26, wherein loading the pellet chamber comprises:(a) bringing a pellet container under the bi-partite cannula with the dominant hand;(b) grabbing the pellet container with the thumb of the nondominant hand while resting the nondominant hand under the cannula hub of the bi-partite cannula;(c) loading the one or more pellets from the container into the pellet chamber with the dominant hand; and-64-4899-7405-1951.1Atty. Dkt. No.: 643355-2000(d) returning the pellet container to a sterile field.

28. The method of any one of claims 21-27, wherein the one or more pellets are implanted in a flank or a hip of the subject.

29. The method of any one of claims 21-28, wherein the one or more pellets are hormone pellets.

30. The method of claim 29, wherein the hormone is selected from the group consisting of testosterone, estrogen, estradiol, progesterone, progestin, and gonadotropinreleasing hormone (GnRH).

31. A method of treating a subject suffering from a hormone deficiency or hormone imbalance, the method comprising subcutaneously implanting into the subject a hormone pellet using a method of any one of claims 17-30.

32. The method of claim 31, wherein the hormone is testosterone.

33. The method of any one of claims 17-32, wherein the subject in need thereof has suffered discomfort following a procedure using a commercially available trocar.

34. The method of any one of claims 17-33, wherein the subject in need thereof has a history of pellet extrusion or is at high-risk of pellet extrusion.

35. A kit comprising the tri -partite device of any one of claims 1-16.

36. The kit of claim 35 further comprising:(a) a complete set of procedure tools, and / or(b) instructions for performing a subcutaneous therapeutic pellet implantation method of any one of claims 17-33.4899-7405-1951.1

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