Trocar comprising cannula

Abstract

A trocar sleeve includes a cannula having a distal end and a proximal end; a housing having a distal end and a proximal end, the proximal end of the housing being attached to the distal end of the cannula; and a lumen extending from the distal end of the cannula to the proximal end of the housing, where the cannula and the housing are made of a biocompatible material designed to tolerate a plurality of disinfection cycles.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 409,231 filed on September 23, 2022 and U.S. Provisional Patent Application No. 63 / 409,229 filed on September 23, 2022, the contents of which are incorporated herein by reference in their entirety.

[0003] Technical Field and Background Art

[0004] The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery and, more particularly, but not exclusively, to a trocar assembly.

[0005] Trocars are used during minimally invasive surgical procedures such as laparoscopic surgery. Trocars are placed through the skin of a patient's body into a cavity, such as the abdominal cavity or chest. Trocars provide an entry point into the cavity for tools such as graspers, scissors, staplers, and cameras. Summary of the invention

[0006] According to a first aspect, a trocar sleeve comprises: a cannula having a distal end and a proximal end; a shell having a distal end and a proximal end, the proximal end of the shell being attached to the distal end of the cannula; and an inner cavity extending from the distal end of the cannula to the proximal end of the shell, wherein the cannula and the shell are made of a biocompatible material designed to withstand multiple sterilization cycles.

[0007] In another embodiment of the first aspect, the biocompatible material is selected from the group consisting of polyetheretherketone (PEEK) and polyphenylsulfone (PPSU).

[0008] In another embodiment of the first aspect, the biocompatible material is designed to withstand at least two sterilization cycles.

[0009] In another embodiment of the first aspect, the trocar sleeve has smooth inner and outer surfaces that do not include narrow features to trap debris and are designed for flowing a flow of washing fluid therethrough to remove debris for sterilization.

[0010] In another embodiment of the first aspect, the inner diameter of the lumen ranges from 7.1 mm to 7.3 mm for an occluder or device having an outer diameter of 5 mm and from 14.1 mm to 14.3 mm for an occluder or device having an outer diameter of 12 mm.

[0011] In another embodiment of the first aspect, the inner diameter of the lumen is selected to provide a clearance of about 0.3 mm with an outer diameter of an occluder placed within the lumen.

[0012] In another embodiment of the first aspect, the outer diameter of the cannula ranges from 9.45 mm to 10.6 mm for an obturator or device having an outer diameter of 5 mm, and from 16.75 mm to 17.7 mm for an obturator or device having an outer diameter of 12 mm.

[0013] In another embodiment of the first aspect, the outer diameter of the housing is in the range of 44.8 mm to 47.0 mm.

[0014] In another embodiment of the first aspect, the working length of the trocar sleeve is in the range of about 45 mm to 65 mm for pediatric use.

[0015] In another embodiment of the first aspect, the working length of the trocar sleeve is in the range of 60 mm to 150 mm.

[0016] In another embodiment of the first aspect, further comprising at least one protruding feature configured to secure a thread that is sewn to the skin when the trocar sleeve is in use and positioned through the skin of a subject.

[0017] In another embodiment of the first aspect, the cannula includes a plurality of raised features designed to engage a locking mechanism of the depth limiter, which fixes the position of the cannula relative to the depth limiter.

[0018] In another embodiment of the first aspect, the distal end portion of the cannula does not include a raised feature.

[0019] In another embodiment of the first aspect, the plurality of raised features are spaced apart along the major axis of the cannula to define a degree of resolution for fixing the position of the cannula relative to the depth limiter.

[0020] In another embodiment of the first aspect, the outer diameter of the cannula varies throughout the length of the cannula, the outer diameter decreasing from the proximal end of the cannula to the distal end of the cannula.

[0021] In another embodiment of the first aspect, the outer surface of the cannula includes a first guide element, which is configured to engage a corresponding second guide element of the depth limiter, wherein the cannula can be inserted into the inner cavity of the depth limiter by engaging the first guide element with the second guide element, and when the first guide element does not engage the second guide element, the cannula needle cannula is prevented from being inserted into the inner cavity of the depth limiter.

[0022] In another embodiment of the first aspect, the first guide element engages the second guide element to prevent the cannula from rotating within the depth limiter.

[0023] Unless otherwise defined, all technical and / or scientific terms used herein have the same meanings as those generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar to or equivalent to those described herein can be used for the operation or test of embodiments of the present invention, exemplary methods and materials are described below. If a conflict occurs, the patent specification and its definition shall prevail. In addition, materials, methods and examples are exemplary only and are not intended to be necessary restrictions. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Some embodiments of the present invention are described herein in conjunction with the accompanying drawings by way of example. With specific reference now to the accompanying drawings, it should be emphasized that the details shown are shown by way of example and for the purpose of illustrative discussion of the embodiments of the present invention. In this regard, the description in conjunction with the accompanying drawings enables those skilled in the art to understand how to practice the embodiments of the present invention.

[0025] In the attached picture:

[0026] Figure 1 is a schematic diagram of a trocar assembly including a trocar sleeve designed for multiple uses according to some embodiments of the present invention;

[0027] Figure 2 is a schematic diagram of an exemplary trocar sleeve designed for multiple uses according to some embodiments of the present invention;

[0028] Figure 3 is a schematic diagram of an exemplary trocar sleeve designed for multiple uses and designed to engage a depth limiter according to some embodiments of the present invention;

[0029] Figure 4 is a schematic diagram of a bottom view (ie, from the distal end to the proximal end) of a trocar sleeve designed for multiple uses according to some embodiments of the present invention;

[0030] Figure 5 is a schematic diagram of a top view (ie, from the proximal end to the distal end) of a trocar sleeve designed for multiple uses according to some embodiments of the present invention;

[0031] Figure 6 is a schematic diagram of an exemplary depth limiter according to some embodiments of the present invention;

[0032] Figure 7 is a schematic diagram of an exemplary sealing element engaged with a trocar sleeve according to some embodiments of the present invention;

[0033] Figure 8 is a schematic diagram of an exemplary obturator engaged with a trocar sleeve according to some embodiments of the present invention; and

[0034] Fig. 9 is a schematic diagram of an exploded view of a trocar assembly according to some embodiments of the present invention. DETAILED DESCRIPTION

[0035] The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery and, more particularly, but not exclusively, to a trocar assembly.

[0036] As used herein, the terms proximal and distal are used with reference to a user using a trocar assembly on a subject. Proximal refers to the portion of the trocar assembly that is closer to the user during use. Distal refers to the portion of the trocar assembly that is farther from the user during use.

[0037] One aspect of some embodiments of the present invention relates to a trocar sleeve for performing minimally invasive surgery, such as laparoscopic surgery of the abdomen, chest, joints, etc. The trocar sleeve includes a cannula having a distal end and a proximal end, and a housing having a distal end and a proximal end. The proximal end of the housing is attached to the distal end of the cannula, for example, assembled, or formed as a single piece such as by injection molding. The lumen extends from the distal end of the cannula to the proximal end of the housing. The lumen is designed to engage with an obturator. The cannula and the housing are made of biocompatible materials designed to withstand multiple sterilization cycles, such as polyetheretherketone (PEEK) and polyphenylsulfone (PPSU). The biocompatible material is designed to withstand 2 or more sterilization cycles, for example, about 50, or 100, or 250, or 500, or 1000, or any other number of sterilization cycles. The biocompatible material is designed to withstand sterilization cycles performed, for example, by an autoclave apparatus. The trocar sleeve has smooth inner and outer surfaces that are designed to prevent the capture of debris. The trocar sleeve excludes narrow features (e.g., narrow passages, small cavities) that may capture debris. The trocar sleeve is designed to flow a wash fluid stream through to remove debris. One or more dimensions of the trocar sleeve may be different than a trocar sleeve designed for single use.

[0038] At least some embodiments of the trocar sleeves described herein solve the technical problem of reducing biological waste from medical procedures. Standard trocars are designed to be used once and discarded. Multiple trocars used for each surgical procedure multiplied by the number of procedures performed per day can generate a large amount of biological waste. This waste is a biohazard and cannot be recycled, so it is difficult to dispose of. At least some embodiments of the trocar sleeves described herein improve the technical field of medical devices by reducing the waste of medical devices.

[0039] At least some of the specific implementations described herein solve the aforementioned technical problems and / or improve the aforementioned technical field by providing a trocar sleeve that can be used repeatedly, which greatly reduces the biological waste generated by the trocar sleeve used once. Compared with the trocar sleeve used once, the multiple use of the trocar sleeve is realized by material selection and / or surface design. The trocar sleeve designed for multiple use is made of a biocompatible material designed to withstand multiple sterilization cycles, which is different from the biocompatible material designed for single use. The biocompatible material designed for single use does not need to undergo any sterilization cycle, or undergoes a single sterilization cycle for initial sterilization after manufacturing but not used, and the single sterilization cycle may be different from the sterilization after use. The inner surface and / or outer surface of the trocar sleeve can be designed to be sterilized by preventing debris from being stuck and / or enabling debris to be washed away by a washing fluid. Residual debris will hinder sterilization. The inner surface and / or outer surface are smooth. The inner and / or outer surfaces do not include narrow features that capture debris, which enables a washing fluid to flow through to remove the debris. In contrast, single-use trocar sleeves have such narrow features that capture debris even after washing. Debris captured in the narrow features can hinder disinfection. One or more dimensions of the trocar sleeve may be larger than a trocar sleeve designed for single use. The larger dimensions enable a washing fluid to wash away the debris, which enables safe and effective disinfection. In contrast, single-use trocar sleeves with smaller dimensions may capture debris that cannot be completely removed by the washing fluid. The captured debris can hinder disinfection.

[0040] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or shown in the drawings and / or examples. The present invention is capable of other embodiments or can be practiced or implemented in various ways.

[0041] Reference now Figure 1 , which is a schematic diagram of a trocar assembly 102 including a trocar sleeve 104 designed for multiple uses, according to some embodiments of the present invention. Referring now to Figure 2 , which is a schematic diagram of an exemplary trocar sleeve 104 designed for multiple uses according to some embodiments of the present invention. Figure 3 , which is a schematic diagram of an exemplary trocar sleeve 104 designed for multiple uses and designed to engage a depth limiter 150, according to some embodiments of the present invention. Figure 4 , which is a schematic diagram of a bottom view (ie, from the distal end to the proximal end) of a trocar sleeve 104 designed for multiple uses according to some embodiments of the present invention. Figure 5 , which is a schematic diagram of a top view (ie, from the proximal end to the distal end) of a trocar sleeve 104 designed for multiple uses according to some embodiments of the present invention. Figure 6 , which is a schematic diagram of an exemplary depth limiter 150 according to some embodiments of the present invention. Figure 7 , which is a schematic diagram of an exemplary sealing element 108 engaged with a trocar sleeve 104 according to some embodiments of the present invention. Figure 8 , which is a schematic diagram of an exemplary obturator 120 engaged with a trocar sleeve 104, according to some embodiments of the present invention. Fig. 9 , which is a schematic diagram of an exploded view of a trocar assembly 102 according to some embodiments of the present invention.

[0042] Now return to reference Figure 1 The trocar assembly 102 includes a trocar sleeve 104. The trocar sleeve 104 includes a trocar housing 106 and a trocar cannula 110. The trocar sleeve 104 includes an inner lumen designed to engage with an obturator 120.

[0043] The trocar assembly 102 may include a depth limiter component 150 disposed along the axis of the trocar cannula 110. The depth limiter 150 includes an inner lumen sized and shaped to receive the trocar cannula 110 and a locking mechanism 152 that sets the trocar cannula 110 in a fixed position within the inner lumen and / or sets the depth limiter 150 at a fixed position along the trocar cannula 110. The inner diameter of the inner lumen of the depth limiter 150 is slightly larger than the outer diameter of the trocar cannula 110 so that the depth limiter 150 can slide along the length of the trocar cannula 110. An exemplary depth limiter component 150 is described, for example, with reference to U.S. Provisional Patent Application No. 94013, entitled “TROCAR ASSEMBLY,” the contents of which are incorporated herein by reference in their entirety.

[0044] The obturator 120 may be bladed or bladeless. The obturator 120 may include a piercing tip 122 for piercing the skin of a subject until entering a cavity, such as an abdominal cavity. After completing the penetration into the abdominal cavity, the obturator portion 120 may be removed from the trocar cannula 110. After removing the obturator portion, any number of surgical instruments, such as, for example, tissue fastening instruments, may be inserted through the cannula 110 of the trocar assembly 102 to perform a surgical procedure.

[0045] The trocar assembly 102 may include a sealing element 108 that is designed to engage the trocar housing 106. The sealing element 108 may be located within the obturator 120, and / or within the housing 106, and / or other designs may be implemented. The sealing element 108 may be designed to prevent or reduce the escape of fluids and / or gases during endoscopic procedures. In endoscopic surgical procedures, the internal gas pressure in a body cavity (e.g., the abdominal cavity) will be maintained above ambient pressure in order to successfully complete the procedure. The sealing element 108 is designed to maintain the gas pressure in the body cavity (e.g., the abdominal cavity) despite multiple insertions and withdrawals of surgical instruments through the trocar cannula.

[0046] One or more components of the trocar assembly 102 can be designed to be reusable in multiple surgical procedures by having a surface (e.g., a smooth surface) designed to allow a washing fluid to wash debris to avoid debris from being retained between washing cycles and / or a narrow passage and / or a narrow cavity where no debris can be retained. The components of the trocar assembly 102 are made of a material designed to be reusable and are designed to withstand two or more washing and / or sterilization cycles, for example, at least about 100, or 250, or 500, or 1000, or other values. For example, PEEK and PPSU. The components of the trocar assembly 102 designed to be reusable include one or more of the following: cannula 110, trocar housing 106, trocar sleeve 104, depth limiter 150 and / or obturator 120. It should be noted that the sealing element 108 can be disposable, because the design of the sealing element 108 is prone to retaining debris and therefore cannot be reliably washed and sterilized multiple times.

[0047] The trocar assembly 102 may include a valve 160 (e.g., a rotary valve design). The valve may be integrated into the sealing element 108, for example, as described in reference Figure 7 As shown. Valve 160 can be integrated into sealing element 108 for positioning at the proximal end of trocar housing 106. When trocar assembly 102 is assembled, valve 160 can be positioned in communication with trocar housing 106 for selectively allowing and / or preventing insufflation fluid (e.g., carbon dioxide) from entering the annular space formed between the inner diameter of trocar housing 106 and obturator 120 and / or another instrument placed within the lumen of trocar housing 106.

[0048] Now return to reference Figure 2 , the trocar sleeve 104 includes a cannula 110 attached to a housing 106. The cannula 110 has a distal end and a proximal end. The housing 106 has a distal end and a proximal end. The proximal end of the housing 106 is attached to the distal end of the cannula 110, for example, as a single piece (e.g., manufactured by injection molding), by screwing one component into another, by gluing, crimping, etc.

[0049] The lumen 202 within the trocar sleeve 104 extends from the distal end of the cannula 110 to the proximal end of the housing 106. The lumen 202 is designed to accommodate the obturator 120. The inner diameter of the lumen 202 is selected to provide a clearance of about 0.2 millimeters (mm), or about 0.3 mm, or about 0.5 mm, or about 0.2 mm to 0.5 mm, or other values ​​with the outer diameter of the obturator 120 located within the lumen 202.

[0050] The trocar sleeve 104 (i.e., cannula 110 and housing 106) is made of biocompatible materials designed to withstand multiple sterilization cycles, such as PEEK and PPSU. The biocompatible material is designed to withstand two or more sterilization cycles, for example, at least about 50, or 100, or 250, or 500, or 1000, or any other number of sterilization cycles. The biocompatible material is designed to withstand sterilization cycles performed, for example, by an autoclave device. The trocar sleeve 104 has a smooth inner and outer surface, including the inner surface of the lumen 202, which does not include narrow features that capture debris, such as small cavities and / or narrow recesses. The trocar sleeve 104 is designed to allow a washing fluid stream to flow through to remove debris, for example, a washing fluid can flow into one end of the lumen 202 and flow out from the other end of the lumen 202, and / or flow across the outer surface of the sleeve 104. One or more dimensions of the trocar sleeve may be larger than a trocar sleeve designed for single use. For example, the inner diameter of lumen 202 may be larger than a trocar sleeve designed for single use to allow a washing fluid to flow through lumen 202 to prevent debris from being retained inside. Preventing debris from getting stuck in the trocar sleeve enables the trocar sleeve 104 to be sterilized for multiple uses. Residual debris can interfere with sterilization.

[0051] Exemplary dimensions for trocar sleeve 104 include:

[0052] *The inner diameter of the lumen 202 of the trocar sleeve 104 is set according to the outer diameter of the obturator and / or device that is expected to pass through the lumen 202. For an obturator and / or device with an outer diameter of 5 mm, the inner diameter of the lumen 202 is 7.1 mm to 7.3 mm. For an obturator and / or device with an outer diameter of 12 mm, the inner diameter of the lumen 202 is 14.1 mm to 14.3 mm.

[0053] The lumen 202 may have a constant diameter within the trocar sleeve 104 (including the cannula 110 and / or the housing 106). Alternatively, the lumen 202 may have a constant diameter within the cannula 110. When the sealing element 108 is placed within the housing 106, the diameter of the lumen 202 within the cannula may match the inner diameter of the sealing element for maintaining an overall constant diameter of the inner diameter when the cannula assembly 102 is assembled.

[0054] The inner diameter of the lumen 202 can be designed to increase the cross-sectional area of ​​the annular space formed between the inner diameter of the lumen 202 of the trocar sleeve 104 and the outer diameter of the obturator 120 and / or another device passing through the lumen 202. The cross-sectional area of ​​the annular space can be increased compared to other known trocar cannulas to increase the insufflation rate (e.g., gas flow, optionally carbon dioxide gas) into a body cavity (e.g., the abdominal cavity).

[0055] * The outer diameter of the cannula 110 is set according to the outer diameter of the obturator and / or device that is expected to pass through the inner cavity 202. For an obturator and / or device with an outer diameter of 5 mm, the outer diameter of the cannula 110 is 9.45 mm to 10.6 mm. For an obturator and / or device with an outer diameter of 12 mm, the outer diameter of the cannula 110 is 16.75 mm to 17.7 mm.

[0056] * The outer diameter of the housing 106 is in the range of 44.8 mm to 47.0 mm.

[0057] * The working length of the trocar sleeve 104 can be in the range of about 60 mm to 150 mm, for example, 60 mm, 75 mm, 100 mm, and 150 mm. Other exemplary ranges include 50 mm to 160 mm and 45 mm to 155 mm. In some embodiments, the working length of the trocar sleeve 104 is shorter than other known trocar lengths. The short working length is designed for pediatric use, for example, 45 mm to 70 mm, or 50 mm to 60 mm, or about 45 mm, 75 mm, 100 mm, and 150 mm. Other exemplary ranges include 50 mm to 160 mm and 45 mm to 155 mm.

[0058] 50mm, 55mm, 60mm, 65mm. The short working length reduces the risk of injury to pediatric subjects due to the distal end of the trocar contacting internal tissue. It should be noted that the standard (non-pediatric) length can be used with the depth limiter described herein to prevent injury. The pediatric length can be used with the depth limiter as a multi-layer safety net to prevent injury.

[0059] The trocar sleeve 104 may include one or more protruding features 204 designed to secure a line that is sewn to the skin when the trocar sleeve 104 is in use and positioned through the skin of a subject. The protruding features 204 are designed to allow the passage of washing fluids, and / or include smooth surfaces, and / or do not include narrow recesses for preventing the retention of debris to allow disinfection. The protruding features 204 may include, for example, a loop and a handle. Optionally, the protruding features 204 include one or more handles attached to the proximal region of the cannula 110 and the distal region of the housing 106.

[0060] Now return to reference Figure 3 Optionally, the cannula 110 includes one or more raised features 330 on its outer surface that are designed to be engaged by a locking mechanism 152 of the depth limiter 150, for example, spaced apart riser rings wherein the lock includes a C-shaped element that falls between the riser rings, or a ratchet wherein the locking mechanism 152 includes a pawl designed to allow easy removal of the cannula but prevent the cannula from being pushed deeper unless the remover is pressed to release the pawl.

[0061] Optionally, the distal end 332 of the cannula does not include a raised feature 330 to prevent a user from securing the depth limiter 150 at a position too low along the cannula 110 where the depth limiter 150 may not properly support and / or engage the cannula 110 .

[0062] In another exemplary implementation, the raised feature 330 can be set to a diameter that varies, for example, increases or decreases sequentially. For example, it is possible to preselect a maximum depth, which can prevent the distal push of the cannula and / or can be removed. Alternatively or in addition thereto, the outer diameter of the cannula 110 changes over the entire length of the cannula 110. The outer diameter can be reduced from the proximal end of the cannula to the distal end of the cannula. For example, the locking mechanism 152 is set at a first diameter of the cannula 110. The diameter increases proximally along the cannula 110, which prevents the cannula 110 from being pushed distally into the body of the object. Before the cannula 110 is inserted into the inner chamber of the depth limiter 150, the locking mechanism 152 can be preset to a first diameter, which enables the user to insert the cannula 110 blindly into the predetermined depth by inserting the cannula 110 into the preset locking mechanism 152 of the depth limiter 150.

[0063] Optionally, raised features 330 are spaced apart along the long axis of cannula 110 to define a degree of resolution for fixing the position of cannula 110 relative to depth limiter 150 .

[0064] Alternatively, the outer surface of the cannula 110 is smooth and does not include the raised features 330, such as in an implementation where the depth limiter 150 is connected to the cannula 110. The smooth outer surface of the cannula 110 reduces damage to tissue during insertion and / or reduces the pressure required to insert the cannula 110 into the body. In prior methods, surface features may be designed to anchor the cannula 110 within the tissue. Using the depth limiter 150 to prevent the cannula 110 from penetrating further into the body may render the surface features of prior methods insignificant.

[0065] Optionally, the outer surface of the cannula 110 includes one or more guide elements 350 configured to engage corresponding guide elements of the depth limiter 150. By engaging the guide elements 350 of the cannula 110 with corresponding guide elements of the depth limiter 150, the cannula 110 can be inserted into the lumen of the depth limiter 150. A mismatch between the guide elements 350 of the cannula 110 and the depth limiter 150 prevents the trocar cannula 110 from being inserted into the lumen of the depth limiter 150. Once the guide elements 350 of the cannula 110 engage the guide elements of the depth limiter 150, the cannula 110 is prevented from rotating within the depth limiter 150.

[0066] The guide element 350 of the cannula 110 and the corresponding guide element of the depth limiter 150 can be implemented as, for example, a guide rail and a corresponding groove matching the size of the guide rail, and / or a non-circular shape of the outer surface of the cannula 110 and a corresponding non-circular shape of the inner surface of the inner cavity of the depth limiter 150, such as a square, an oval and a four-leaf clover.

[0067] Now return to reference Figure 4 , depicts a bottom view (ie, from the distal end to the proximal end) of a trocar sleeve 104 designed for multiple uses.

[0068] Now return to reference Figure 5 , depicts a top view (ie, from the proximal end to the distal end) of a trocar sleeve 104 designed for multiple uses.

[0069] Now return to reference Figure 6 , the depth limiter 150 includes a locking mechanism 152 that secures the cannula 110 within the lumen 602. The locking mechanism 152 prevents the cannula 110 from moving proximally and / or distally within the lumen 602 of the depth limiter 150. In use, when the cannula 110 is located in the body of a patient, the depth limiter 150 sets a maximum depth for the cannula 110, e.g., preventing the cannula 110 from entering deeper into the body and damaging tissue.

[0070] Now return to reference Figure 7, an exemplary sealing element 108 may be engaged with the trocar sleeve 104. The trocar sleeve 104 is designed to engage with the sealing element 108. The sealing element 108 may be single-use due to a design that includes narrow features that tend to trap debris that cannot be washed away, which hinders sterilization.

[0071] Now return to reference Figure 8 , an exemplary obturator 120 may be engaged with a trocar sleeve 104. The trocar sleeve 104 is designed to engage with the obturator 120. The obturator 120 may be designed for multiple uses, made of biocompatible materials designed to withstand multiple sterilization cycles, and / or include smoother surfaces and / or do not include narrow features that are prone to trapping debris, thereby achieving sterilization. Optionally, when designed to fit into a trocar cannula and / or sleeve having an inner lumen inner diameter of (e.g., about) 50 mm, the outer diameter of the shaft 802 of the obturator 120 may be, for example, (e.g., about) 46 mm. The head 804 of the obturator 120 may be larger than a standard size. The head 804 may be denser and / or heavier than a standard obturator. Larger size, increased density, and / or higher weight may provide greater mass, thereby providing greater torque to the user (e.g., surgeon).

[0072] Now return to reference Fig. 9 , an exploded view depicts an exemplary method for assembling the cannula assembly 102 from the cannula sleeve 104, the obturator 120, and the sealing element 108. Note that the depth limiter 150 is not shown.

[0073] It is expected that during the life of a patent maturing from the present application, many related trocars will be developed, and the scope of the term trocar is intended a priori to include all such new technologies.

[0074] As used herein, the term "about" refers to ± 10%.

[0075] The terms "comprises," "comprising," "including," "containing," "having," and variations thereof mean "including but not limited to."

[0076] The term "consisting of" means "including and limited to."

[0077] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or components, but only if the additional ingredients, steps and / or components do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0078] As used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds (including mixtures thereof).

[0079] Throughout this application, various embodiments of the present invention can be presented in range format. It should be understood that the description of range format is only for convenience and brevity, and should not be construed as a fixed limitation to the scope of the invention. Therefore, the description of the scope should be considered as having all possible sub-ranges clearly disclosed and each numerical value within the scope. For example, the description of a range such as 1 to 6 should be considered as having sub-ranges clearly disclosed such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and each numerical value within the scope, such as 1, 2, 3, 4, 5 and 6. Regardless of the width of the scope, this applies.

[0080] Whenever a numerical range is indicated herein, it is meant to include any recited numeral (fractional or integer) within the indicated range. The phrases "a range is between" a first indicated numeral and a second indicated numeral and "a range is from" a first indicated numeral "to" a second indicated numeral are used interchangeably herein and are meant to include the first indicated numeral and the second indicated numeral and all fractions and integers therebetween.

[0081] As used herein, the term "method" refers to manners, means, techniques and procedures for accomplishing a given task, including but not limited to those manners, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine or readily developable from known manners, means, techniques and procedures.

[0082] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating clinical or aesthetic symptoms of a disorder, or substantially arresting the appearance of clinical or aesthetic symptoms of a disorder.

[0083] When reference is made to a particular sequence listing, such reference should be understood to also include sequences that substantially correspond to the complementary sequence thereof, including minor sequence variations resulting from, for example, sequencing errors, cloning errors, or other alterations leading to base substitutions, base deletions, or base additions, provided that the frequency of such variations is less than 1 nucleotide in 50 nucleotides, or less than 1 nucleotide in 100 nucleotides, or less than 1 nucleotide in 200 nucleotides, or less than 1 nucleotide in 500 nucleotides, or less than 1 nucleotide in 1000 nucleotides, or less than 1 nucleotide in 5,000 nucleotides, or less than 1 nucleotide in 10,000 nucleotides.

[0084] It should be understood that certain features of the invention described in the context of separate embodiments for the sake of clarity may also be provided in combination in a single embodiment. Conversely, various structures of the invention described in the context of a single embodiment for the sake of simplicity may also be provided individually or in any suitable sub-combination, or as appropriate in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiment does not function without those elements.

[0085] Although the present invention has been described in conjunction with its specific embodiments, it is apparent that many alternatives, modifications and variations are apparent to those skilled in the art. Therefore, this document is intended to cover all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0086] The applicant's intention is that all patent disclosures, patents and patent applications mentioned in this specification are incorporated into this specification by reference in their entirety, just as each individual patent disclosure, patent or patent application is clearly and independently indicated when quoted that each individual patent disclosure, patent or patent application is incorporated into this paper by reference. In addition, the citation or identification of any reference in this patent application should not be construed as admitting that such reference can be used as the prior art of the present invention. In the case of using section headings, they should not be construed as necessary restrictions. In addition, any priority document of the present application is hereby incorporated into this paper by reference in its entirety.

Claims

1. A trocar sleeve, comprising: a cannula having a distal end and a proximal end; a housing having a distal end and a proximal end, the proximal end of the housing being attached to the distal end of the cannula; and an inner lumen extending from the distal end of the cannula to the proximal end of the housing, Wherein, the cannula and housing are made of biocompatible materials designed to withstand multiple sterilization cycles.

2. The trocar sleeve according to claim 1, wherein: The biocompatible material is selected from the group consisting of polyetheretherketone (PEEK) and polyphenylsulfone (PPSU).

3. The trocar sleeve according to claim 1, wherein: The biocompatible material is designed to withstand at least two sterilization cycles.

4. The trocar sleeve according to claim 1, wherein: The trocar sleeve has smooth inner and outer surfaces that do not include narrow features that trap debris and are designed to flow a stream of washing fluid therethrough to remove debris for sterilization.

5. The trocar sleeve according to claim 1, wherein: The inner diameter of the lumen ranges from 7.1 mm to 7.3 mm for an occluder or device having an outer diameter of 5 mm, and from 14.1 mm to 14.3 mm for an occluder or device having an outer diameter of 12 mm.

6. The trocar sleeve according to claim 1, wherein: The inner diameter of the lumen is selected to provide a clearance of approximately 0.3 mm with the outer diameter of an obturator placed within the lumen.

7. The trocar sleeve according to claim 1, wherein: The outer diameter of the cannula ranges from 9.45 mm to 10.6 mm for an obturator or device having an outer diameter of 5 mm, and from 16.75 mm to 17.7 mm for an obturator or device having an outer diameter of 12 mm.

8. The trocar sleeve according to claim 1, wherein: The outer diameter of the housing is in the range of 44.8 mm to 47.0 mm.

9. The trocar sleeve according to claim 1, wherein: The working length of the trocar sleeve is in the range of about 45 mm to 65 mm for pediatric use.

10. The trocar sleeve according to claim 1, wherein: The working length of the trocar sleeve is in the range of 60 mm to 150 mm.

11. The trocar sleeve of claim 1 further comprising at least one protruding feature designed to secure a thread that is sewn to the skin of a subject when the trocar sleeve is in use and positioned through the skin.

12. The trocar sleeve of claim 1, wherein: The cannula includes a plurality of raised features designed to engage a locking mechanism of a depth limiter, which secures the position of the cannula relative to the depth limiter.

13. The trocar sleeve of claim 12, wherein: The distal end portion of the cannula does not include the raised feature.

14. The trocar sleeve of claim 12, wherein: The plurality of raised features are spaced apart along the major axis of the cannula to define a degree of resolution for fixing the position of the cannula relative to the depth limiter.

15. The trocar sleeve of claim 1, wherein: The outer diameter of the cannula varies throughout the length of the cannula, the outer diameter decreasing from the proximal end of the cannula to the distal end of the cannula.

16. The trocar sleeve of claim 1, wherein: The outer surface of the cannula includes a first guide element configured to engage a corresponding second guide element of a depth limiter, wherein the cannula is insertable into the inner cavity of the depth limiter by engaging the first guide element with the second guide element, and the trocar cannula is prevented from being inserted into the inner cavity of the depth limiter when the first guide element does not engage the second guide element.

17. The trocar sleeve of claim 16, wherein: The first guide element engages the second guide element to prevent the cannula from rotating within the depth limiter.

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