Trocar containing a cannula

Abstract

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 a lumen extending from the distal end of the cannula to the proximal end of the housing, the cannula and the housing being made of a biocompatible material designed to withstand multiple sterilization cycles.

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 409,231, filed September 23, 2022, and U.S. Provisional Patent Application No. 63 / 409,229, filed September 23, 2022, the contents of which are incorporated herein by reference in their entireties.

[0002] FIELD OF THE INVENTION The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery, and more particularly, but not exclusively, to trocar assemblies. [Background technology]

[0003] Trocars are used during minimally invasive surgery, such as laparoscopic surgery. Trocars are placed through the skin of a patient's body into a cavity, such as the abdomen or chest. The trocar provides an access point into the cavity for tools such as graspers, scissors, staplers, and cameras. Summary of the Invention [Means for solving the problem]

[0004] According to a first aspect, a trocar sleeve comprises 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, the cannula and housing being made of a biocompatible material designed to withstand multiple sterilization cycles.

[0005] In a further implementation of the first aspect, the biocompatible material is selected from the group including polyetheretherketone (PEEK) and polyphenylsulfone (PPSU).

[0006] In a further implementation of the first aspect, the biocompatible material is designed to withstand at least two sterilization cycles.

[0007] In a further implementation of the first aspect, the trocar sleeve excludes narrow features that trap debris and has smooth inner and outer surfaces designed to allow the flow of irrigation fluid to remove debris for sterilization.

[0008] In a further implementation of the first aspect, the range of inner lumen diameter is 7.1-7.3 mm for an obturator or device with an outer diameter of 5 mm, and 14.1-14.3 mm for an obturator or device with an outer diameter of 12 mm.

[0009] In a further implementation of the first aspect, the inner diameter of the lumen is selected to provide a clearance of about 0.3 mm from the outer diameter of an obturator placed within the lumen.

[0010] In a further implementation of the first aspect, the range of outer diameter of the cannula is 9.45 to 10.6 mm for an obturator or instrument with an outer diameter of 5 mm, and 16.75 to 17.7 mm for an obturator or instrument with an outer diameter of 12 mm.

[0011] In a further implementation of the first aspect, the outer diameter of the housing is in the range of 44.8 to 47.0 mm.

[0012] In a further implementation of the first aspect, the working length of the trocar sleeve ranges from about 45 mm to 65 mm for pediatric use.

[0013] In a further implementation of the first aspect, the working length of the trocar sleeve is in the range of 60 to 150 mm.

[0014] In a further implementation of the first aspect, the trocar sleeve further comprises at least one protruding feature designed to secure a suture to the subject's skin when in use and positioned through the subject's skin.

[0015] In a further implementation of the first aspect, the cannula includes a plurality of raised features designed to engage a locking mechanism of the depth limiter that secures the location of the cannula relative to the depth limiter.

[0016] In a further implementation of the first aspect, the distal end portion of the cannula excludes the raised feature.

[0017] In a further implementation of the first aspect, the plurality of raised features are spaced along the longitudinal axis of the cannula and define a resolution for fixing the location of the cannula relative to the depth limiter.

[0018] In a further implementation of the first aspect, the outer diameter of the cannula varies over the length of the cannula, the outer diameter decreasing from the proximal end of the cannula towards the distal end of the cannula.

[0019] In a further implementation of the first aspect, the outer surface of the cannula includes a first set of guide elements for engaging with corresponding second guide elements of the depth limiter, the cannula is insertable into the lumen of the depth limiter by engaging the first guide elements with the second guide elements, and the trocar cannula is prevented from being inserted into the lumen of the depth limiter when the first guide elements do not engage the second guide elements.

[0020] In a further implementation of the first aspect, the first guide element engaging the second guide element prevents rotation of the cannula within the depth limiter.

[0021] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, governs. It should be noted that the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. [Brief explanation of the drawings]

[0022] Certain embodiments of the present invention will now be described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are exemplary and are for the purpose of illustrating embodiments of the invention. In this regard, the description using the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced.

[0023] In the drawings: [Figure 1] 1 is a schematic diagram of a trocar assembly including a trocar sleeve designed for multiple use, according to some embodiments of the present invention. [Figure 2] 1A-1C are schematic diagrams of exemplary trocar sleeves designed for multiple use, according to some embodiments of the present invention. [Figure 3] 1A-1C are schematic diagrams of exemplary trocar sleeves designed for multiple use and designed to engage a depth limiter, according to some embodiments of the present invention. [Figure 4] 1A-1C are schematic diagrams of bottom views (i.e., distal to proximal) of trocar sleeves designed for multiple use, according to some embodiments of the present invention. [Figure 5] 1 is a schematic diagram of a top view (i.e., proximal to distal) of a trocar sleeve designed for multiple use, according to some embodiments of the present invention. [Figure 6] 1 is a schematic diagram of an exemplary depth limiter, according to some embodiments of the present invention. [Figure 7] 1A-1C are schematic diagrams of exemplary sealing elements engaging with a trocar sleeve, according to some embodiments of the present invention. [Figure 8] 1A-1C are schematic diagrams of an exemplary obturator engaging a trocar sleeve, according to some embodiments of the present invention. [Figure 9]FIG. 1 is a schematic diagram of an exploded view of a trocar assembly, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery, and more particularly, but not exclusively, to trocar assemblies.

[0025] As used herein, the terms proximal and distal are used in reference to a user applying a trocar assembly to 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 further away from the user during use.

[0026] One aspect of some embodiments of the present invention relates to a trocar sleeve for performing minimally invasive surgery, such as laparoscopic surgery on 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, e.g., assembled or formed as a single piece by injection molding, etc. A 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 housing are made from a biocompatible material designed to withstand multiple sterilization cycles, e.g., polyetheretherketone (PEEK) and polyphenylsulfone (PPSU). The biocompatible material is designed to withstand two or more sterilization cycles, e.g., about 50, 100, 250, 500, 1000, or any other number of sterilization cycles. The biocompatible material is designed to withstand sterilization cycles, such as those performed by an autoclave device. The trocar sleeve has smooth inner and outer surfaces designed to prevent debris entrapment. The trocar sleeve excludes narrow features (e.g., narrow passages, small cavities) that could entrap debris. The trocar sleeve is designed to allow for the flow of irrigation fluid to remove debris. One or more dimensions of the trocar sleeve may be different compared to a trocar sleeve designed for single use.

[0027] At least some implementations of the trocar sleeves described herein address the technical problem of reducing biological waste from medical procedures. Standard trocars are designed to be disposed of after a single use. The use of multiple trocars per surgical procedure, when multiplied by the number of procedures performed each day, generates a large amount of biological waste. Such waste is biologically hazardous, cannot be recycled, and is difficult to dispose of. At least some implementations of the trocar sleeves described herein improve the field of medical device technology by reducing medical device waste.

[0028] At least some implementations described herein address the aforementioned technical problems and / or improve upon the aforementioned technical field by providing a trocar sleeve that can be used multiple times, which significantly reduces biological waste generated from single-use trocar sleeves. The multiple use of a trocar sleeve is enabled by material selection and / or surface design compared to single-use trocar sleeves. Trocar sleeves designed for multiple use are made of biocompatible materials designed to withstand multiple sterilization cycles, which may differ from biocompatible materials designed for single use that do not need to undergo sterilization cycles or that undergo a single sterilization cycle for initial sterilization after manufacture but before use, which may differ from sterilization after use. The inner and / or outer surfaces of the trocar sleeve may be designed to enable sterilization by preventing debris from adhering and / or by allowing debris to be washed away with irrigation fluid. Remaining debris hinders sterilization. The inner and / or outer surfaces are smooth. The inner and / or outer surfaces exclude narrow features that trap debris, allowing irrigation fluid to flow for debris removal. In contrast, single-use trocar sleeves have narrow features that trap debris even after irrigation. The debris trapped in the narrow features interferes with sterilization. One or more dimensions of the trocar sleeve may be larger than a trocar sleeve designed for single use. The larger dimension(s) allow irrigation fluid to wash away the debris, which allows for safe and efficient sterilization. In contrast, single-use trocar sleeves with smaller dimensions may trap debris that cannot be completely removed by irrigation fluid. The trapped debris interferes with sterilization.

[0029] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0030] Referring now to FIG. 1, FIG. 1 is a schematic illustration of a trocar assembly 102 including a trocar sleeve 104 designed for multiple uses, according to some embodiments of the present invention. Referring now also to FIG. 2, FIG. 2 is a schematic illustration of an exemplary trocar sleeve 104 designed for multiple uses, according to some embodiments of the present invention. Referring now also to FIG. 3, FIG. 3 is a schematic illustration 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. Referring now also to FIG. 4, FIG. 4 is a schematic illustration of a bottom view (i.e., from distal to proximal) of a trocar sleeve 104 designed for multiple uses, according to some embodiments of the present invention. Referring now also to FIG. 5, FIG. 5 is a schematic illustration of a top view (i.e., from proximal to distal) of a trocar sleeve 104 designed for multiple uses, according to some embodiments of the present invention. Referring now also to FIG. 6, FIG. 6 is a schematic illustration of an exemplary depth limiter 150, according to some embodiments of the present invention. Referring now also to Figure 7, which is a schematic illustration of an exemplary sealing element 108 engaging with a trocar sleeve 104, according to some embodiments of the present invention. Referring now also to Figure 8, which is a schematic illustration of an exemplary obturator 120 engaging with a trocar sleeve 104, according to some embodiments of the present invention. Referring now also to Figure 9, which is a schematic illustration of an exploded view of a trocar assembly 102, according to some embodiments of the present invention.

[0031] 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 a lumen designed to engage an obturator 120.

[0032] The trocar assembly 102 may include a depth limiter component 150 disposed along the shaft of the trocar cannula 110. The depth limiter 150 includes a lumen sized and shaped to accommodate the trocar cannula 110 and a locking mechanism 152 that sets the trocar cannula 110 in a fixed position within the lumen and / or sets the depth limiter 150 in a fixed position along the trocar cannula 110. The inner diameter of the lumen of the depth limiter 150 is slightly larger than the outer diameter of the trocar cannula 110 to allow the depth limiter 150 to 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 entitled "TROCAR ASSEMBLY" (Attorney Docket No. 94013), the contents of which are incorporated herein by reference in their entirety.

[0033] Obturator 120 may be bladed or non-bladed. Obturator 120 may include a piercing tip 122 that is used to pierce the subject's skin until entering a cavity, such as the abdominal cavity. After penetration into the abdominal cavity is complete, obturator portion 120 may be removed from trocar cannula 110. After the obturator portion is removed, any number of surgical instruments, such as, for example, a tissue fastener, can be inserted through cannula 110 of trocar assembly 102 to perform a surgical procedure.

[0034] The trocar assembly 102 may include a sealing element 108 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 fluid and / or gas leakage during an endoscopic procedure. During an endoscopic surgical procedure, internal gas pressure within a body cavity (e.g., the abdomen) should be maintained above ambient pressure to successfully complete the procedure. The sealing element 108 is designed to maintain gas pressure within the body cavity (e.g., the abdominal cavity) despite multiple insertions and withdrawals of surgical instruments through the trocar cannula.

[0035] One or more components of the trocar assembly 102 may be designed to be reusable across multiple surgical procedures by having surfaces designed to allow cleaning fluids to wash away debris, e.g., smooth surfaces, and / or a lack of narrow passages and / or narrow cavities where debris may become trapped, to avoid debris retention between cleaning cycles. The components of the trocar assembly 102 are made from materials designed to be reusable and designed to withstand two or more cleaning and / or sterilization cycles, e.g., at least about 100, 250, 500, 1000, or other values, such as PEEK and PPSU. Components of the trocar assembly 102 designed to be reusable include one or more of the cannula 110, trocar housing 106, trocar sleeve 104, depth limiter 150, and / or obturator 120. It should be noted that the sealing element 108 may be disposable due to the design of the sealing element 108 which tends to retain debris and therefore cannot be reliably cleaned and sterilized multiple times.

[0036] The trocar assembly 102 may include a valve 160 (e.g., a stopcock design). The valve may be integrated into the sealing element 108, for example, as shown with reference to FIG. 7 . The valve 160 may be integrated into the sealing element 108 for placement at the proximal end of the trocar housing 106. When the trocar assembly 102 is assembled, the valve 160 may be placed in communication with the trocar housing 106 to selectively allow and / or prevent the passage of an insufflation fluid, e.g., carbon dioxide, into the annular space formed between the inner diameter of the trocar housing 106 and the obturator 120 and / or another instrument placed within the lumen of the trocar housing 106.

[0037] 2, trocar sleeve 104 includes a cannula 110 attached to a housing 106. Cannula 110 has a distal end and a proximal end. Housing 106 has a distal end and a proximal end. The proximal end of housing 106 is attached to the distal end of cannula 110, for example, by threading one component onto the other as a single piece (e.g., manufactured by injection molding), by gluing, crimping, etc.

[0038] A lumen 202 within trocar sleeve 104 extends from the distal end of cannula 110 to the proximal end of housing 106. Lumen 202 is designed to accommodate obturator 120. The inner diameter of 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 0.2-0.5 mm, or other value, from the outer diameter of obturator 120 positioned within lumen 202.

[0039] The trocar sleeve 104 (i.e., the cannula 110 and the housing 106) is made from a biocompatible material, such as PEEK and PPSU, designed to withstand multiple sterilization cycles. The biocompatible material is designed to withstand two or more sterilization cycles, for example, at least about 50, 100, 250, 500, 1000, or any other number of sterilization cycles. The biocompatible material is designed to withstand sterilization cycles, such as those performed by an autoclave device. The trocar sleeve 104 has smooth inner and outer surfaces, including the inner surface of the lumen 202, which excludes narrow features such as small cavities and / or narrow recesses that could trap debris. The trocar sleeve 104 is designed to allow a flow of irrigation fluid to flow through it to remove debris; for example, the irrigation fluid can flow into one end of the lumen 202, out the other end of the lumen 202, and / or across the exterior surface of the sleeve 104. One or more dimensions of the trocar sleeve may be larger than those of a trocar sleeve designed for single use. For example, the inner diameter of the lumen 202 may be larger than those of a single-use trocar sleeve to allow irrigation fluid to flow through the lumen 202 and prevent debris from becoming trapped inside. Preventing debris from becoming trapped within the trocar sleeve allows the trocar sleeve 104 to be sterilized for multiple uses. Any remaining debris would interfere with sterilization.

[0040] Exemplary dimensions of the trocar sleeve 104 include: * The inner diameter of the lumen 202 of the trocar sleeve 104 is set according to the outer diameter of the obturator and / or instrument expected to pass through the lumen 202. For an obturator and / or instrument having an outer diameter of 5 mm, the inner diameter of the lumen 202 is 7.1 to 7.3 mm. For an obturator and / or instrument having an outer diameter of 12 mm, the inner diameter of the lumen 202 is 14.1 to 14.3 mm.

[0041] Lumen 202 can have a constant diameter within trocar sleeve 104, including cannula 110 and / or housing 106. Alternatively, lumen 202 has a constant diameter within cannula 110. The diameter of lumen 202 within the cannula may match the inner diameter of sealing element 108 when disposed within housing 106 to maintain a generally constant inner diameter when trocar assembly 102 is assembled.

[0042] The inner diameter of lumen 202 may be designed to increase the cross-sectional area of ​​the annular space formed between the inner diameter of lumen 202 of trocar sleeve 104 and the outer diameter of obturator 120 and / or another instrument passing through lumen 202. The cross-sectional area of ​​the annular space may 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 abdomen).

[0043] * The outer diameter of cannula 110 is set according to the outer diameter of the obturator and / or instrument expected to pass through lumen 202. For an obturator and / or instrument having an outer diameter of 5 mm, the outer diameter of cannula 110 is 9.45 to 10.6 mm. For an obturator and / or instrument having an outer diameter of 12 mm, the outer diameter of cannula 110 is 16.75 to 17.7 mm.

[0044] * The outer diameter of the housing 106 is in the range of 44.8 to 47.0 mm.

[0045] *The working length of the trocar sleeve 104 may be within a range of approximately 60 mm to 150 mm, e.g., 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. Short working lengths are designed for pediatric use, e.g., 45 mm to 70 mm, or 50 mm to 60 mm, or approximately 45 mm, 50 mm, 55 mm, 60 mm, or 65 mm. Short working lengths reduce the risk of injury in pediatric subjects from the distal end of the trocar contacting internal tissue. Note that standard (non-pediatric) lengths may be used with the depth limiters described herein to prevent injury. Pediatric lengths may also be used with the depth limiters as a multi-layer safety net to prevent injury.

[0046] The trocar sleeve 104 may include one or more protruding features 204 designed to secure sutures to the subject's skin when the trocar sleeve 104 is in use and positioned through the skin. The protruding features 204 are designed to allow irrigation fluid to flush through and / or include smooth surfaces and / or exclude narrow recesses to prevent debris retention to enable sterilization. The protruding features 204 may include, for example, rings and handles. 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.

[0047] Referring now back to FIG. 3 , optionally, cannula 110 includes one or more raised features 330 on its outer surface designed to be engaged by locking mechanism 152 of depth limiter 150, for example, spaced raised rings including a C-shaped element that locks between the raised rings, or a ratchet including pawls designed to allow easy removal of the cannula but prevent locking mechanism 152 from pushing the cannula deeper unless a lever is pressed to release the pawls.

[0048] Optionally, the distal end 332 of the cannula excludes the raised feature 330 to prevent the user from securing the depth limiter 150 in a position too low along the cannula 110, where the depth limiter 150 may not be able to properly support and / or engage the cannula 110.

[0049] In another exemplary implementation, raised feature 330 may be set to a variety of diameters, e.g., continuously increasing or continuously decreasing. For example, to allow pre-selection of a maximum depth, to prevent distal pushing of the cannula and / or to allow removal. Alternatively or additionally, the outer diameter of cannula 110 varies over the length of cannula 110. The outer diameter may decrease from the proximal end of the cannula to the distal end of the cannula. For example, locking mechanism 152 is set on a first diameter of cannula 110. Proximally along cannula 110, the diameter increases, which prevents distal pushing of cannula 110 into the subject's body. The locking mechanism 152 may be preset to a first diameter before the cannula 110 is inserted into the lumen of the depth limiter 150, which allows the user to blindly insert the cannula 110 to a predetermined depth by inserting the cannula 110 into the preset locking mechanism 152 of the depth limiter 150.

[0050] Optionally, raised features 330 are spaced along the long axis of cannula 110 to define a resolution for fixing the location of cannula 110 relative to depth limiter 150 .

[0051] Alternatively, the outer surface of cannula 110 is smooth, excluding raised features 330, for example, in implementations in which depth limiter 150 is connected to cannula 110. The smooth outer surface of cannula 110 reduces damage to tissue during insertion and / or reduces the pressure required to insert cannula 110 into the body. In traditional approaches, surface features may be designed to anchor cannula 110 within tissue. Using depth limiter 150 prevents cannula 110 from penetrating further into the body, which may make the surface features of traditional approaches irrelevant.

[0052] Optionally, the outer surface of cannula 110 includes one or more guide elements 350 configured to engage corresponding guide element(s) of depth limiter 150. Cannula 110 is insertable into the lumen of depth limiter 150 by engaging guide element(s) 350 of cannula 110 with corresponding guide element(s) of depth limiter 150. A mismatch between guide element(s) 350 of cannula 110 and depth limiter 150 prevents trocar cannula 110 from being inserted into the lumen of depth limiter 150. When guide element(s) 350 of cannula 110 engage with guide element(s) of depth limiter 150, rotation of cannula 110 within depth limiter 150 is prevented.

[0053] The guide element(s) 350 of the cannula 110 and the corresponding guide element(s) of the depth limiter 150 may be implemented, for example, as rails and corresponding grooves sized to fit the rails, and / or non-circular shapes, such as a non-circular shape on the outer surface of the cannula 110 and a corresponding square, oval, and four-leaf clover shape on the inner surface of the lumen of the depth limiter 150.

[0054] Referring again now to FIG. 4, there is shown a bottom view (ie, distal to proximal) of a trocar sleeve 104 designed for multiple use.

[0055] Referring again now to FIG. 5, there is shown a top view (ie, from proximal to distal) of a trocar sleeve 104 designed for multiple use.

[0056] 6, depth limiter 150 includes a locking mechanism 152 that secures cannula 110 within lumen 602. Locking mechanism 152 prevents cannula 110 from moving proximally and / or distally within lumen 602 of depth limiter 150. In use, when cannula 110 is positioned within a patient's body, depth limiter 150 sets a maximum depth for cannula 110, for example, preventing cannula 110 from entering deeper into the body and damaging tissue.

[0057] 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 its design including narrow features that tend to trap debris that cannot be washed away, preventing sterilization.

[0058] Referring back to FIG. 8 , the 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 use, may be made from a biocompatible material designed to withstand multiple sterilization cycles, and / or may include a smoother surface and / or may exclude narrow features that tend to trap debris to enable sterilization. Optionally, the outer diameter of the shaft 802 of the obturator 120 may be, for example, 46 mm (e.g., approximately) when designed to fit within a trocar cannula and / or sleeve with an internal lumen diameter of 50 mm (e.g., approximately). The head 804 of the obturator 120 may be larger than standard size. The head 804 may be denser and / or heavier than standard obturators. The larger size, increased density, and / or higher weight may provide more mass, which provides a greater moment to the user (e.g., a surgeon).

[0059] 9, an exploded view shows an exemplary approach for assembling the trocar assembly 102 from the trocar sleeve 104, the obturator 120, and the sealing element 108. Note that the depth limiter 150 is not shown.

[0060] It is expected that many related trocars will be developed during the life of the patent that matures from this application, and the scope of the term trocar is intended a priori to include all such new technology.

[0061] As used herein, the term "about" means ±10%.

[0062] The terms "comprises," "comprising," "includes," "including," "having," and combinations thereof, mean "including but not limited to."

[0063] The term "consisting of" means "including and limited to."

[0064] The term "consisting essentially of" means that a composition, method, or composition may include additional ingredients, steps, and / or moieties, provided that the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or composition.

[0065] As used herein, the singular forms "a," "an," and "the" are intended to include plural referents unless the context clearly dictates otherwise. For example, the term "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0066] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the broadness of the range.

[0067] Whenever a numerical range is given herein, it is meant to include any recited number (fractional or integer) within the given range. The terms "ranging / ranges between" a first and second designator number and "ranging / ranges from" a first designator number to a second designator number are used interchangeably herein and are meant to include the first and second designator numbers and all fractional and integer numbers therebetween.

[0068] As used herein, the term "method" means methods, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures that are either known, known, or readily developed by practitioners in the chemical, pharmacological, biological, biochemical, and medical fields.

[0069] As used herein, the term "treating" includes arresting, substantially inhibiting, slowing, or reversing the progression of the condition, substantially ameliorating the clinical or cosmetic symptoms of the condition, or substantially preventing the appearance of the clinical or cosmetic symptoms of the condition.

[0070] When referring to a particular sequence listing, such reference should also be understood to encompass sequences that substantially correspond to the complementary sequence, including minor sequence variations resulting from, for example, sequencing errors, cloning errors, or other changes that result in base substitutions, deletions, or additions, provided that the frequency of such variations is less than 1 in 50 nucleotides, alternatively less than 1 in 100 nucleotides, alternatively less than 1 in 200 nucleotides, alternatively less than 1 in 500 nucleotides, alternatively less than 1 in 1000 nucleotides, alternatively less than 1 in 5000 nucleotides, alternatively less than 1 in 10,000 nucleotides.

[0071] Although certain features of the invention are described, for clarity, in the context of separate embodiments, it is understood that they may also be provided in combination in a single embodiment. Conversely, various features of the invention, while for brevity described in the context of a single embodiment, may also be suitably provided separately or in any suitable subcombination, or in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be construed as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0072] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0073] It is the intention of the applicants (applicants) that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Citation or identification of any reference in this application should not be construed as an admission that such document is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. Additionally, any priority documents of this application are incorporated herein by reference in their entirety.

[0074] [Embodiment] (1) A trocar sleeve, 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 attached to the distal end of the cannula; a lumen extending from the distal end of the cannula to the proximal end of the housing; A trocar sleeve, wherein the cannula and the housing are made of a biocompatible material designed to withstand multiple sterilization cycles. (2) A trocar sleeve according to embodiment 1, wherein the biocompatible material is selected from the group consisting of polyetheretherketone (PEEK) and polyphenylsulfone (PPSU). (3) A trocar sleeve as described in embodiment 1, wherein the biocompatible material is designed to withstand at least two sterilization cycles. (4) A trocar sleeve as described in embodiment 1, wherein the trocar sleeve excludes narrow features that trap debris and has smooth inner and outer surfaces designed to allow the flow of irrigation fluid to remove debris for sterilization. (5) A trocar sleeve as described in embodiment 1, wherein the inner diameter of the lumen ranges from 7.1 to 7.3 mm for an obturator or instrument having an outer diameter of 5 mm, and from 14.1 to 14.3 mm for an obturator or instrument having an outer diameter of 12 mm.

[0075] (6) A trocar sleeve as described in embodiment 1, wherein the inner diameter of the lumen is selected to provide a clearance of approximately 0.3 mm from the outer diameter of an obturator placed within the lumen. (7) A trocar sleeve as described in embodiment 1, wherein the outer diameter of the cannula ranges from 9.45 to 10.6 mm for an obturator or instrument having an outer diameter of 5 mm, and from 16.75 to 17.7 mm for an obturator or instrument having an outer diameter of 12 mm. (8) A trocar sleeve according to embodiment 1, wherein the outer diameter of the housing is in the range of 44.8 to 47.0 mm. (9) The trocar sleeve of embodiment 1, wherein the working length of the trocar sleeve is in the range of approximately 45 mm to 65 mm for pediatric use. (10) The trocar sleeve according to embodiment 1, wherein the working length of the trocar sleeve is in the range of 60 to 150 mm.

[0076] (11) The trocar sleeve of embodiment 1, further comprising at least one protruding feature designed to secure a thread sewn to the skin when the trocar sleeve is in use and placed through the skin of a subject. (12) A trocar sleeve as described in embodiment 1, wherein the cannula includes a plurality of raised features designed to engage a locking mechanism of the depth limiter to fix the location of the cannula relative to the depth limiter. (13) The trocar sleeve of embodiment 12, wherein the distal end portion of the cannula excludes the raised feature. (14) The trocar sleeve of claim 12, wherein the plurality of raised features are spaced apart along a longitudinal axis of the cannula and define a resolution for fixing the location of the cannula relative to the depth limiter. (15) The trocar sleeve of embodiment 1, wherein the outer diameter of the cannula varies over the length of the cannula, the outer diameter decreasing from the proximal end of the cannula to the distal end of the cannula.

[0077] (16) The trocar sleeve of embodiment 1, wherein an outer surface of the cannula includes a first set of guide elements for engaging with corresponding second guide elements of a depth limiter, the cannula is insertable into the lumen of the depth limiter by engaging the first guide elements with the second guide elements, and the trocar cannula is prevented from being inserted into the lumen of the depth limiter when the first guide elements are not engaged with the second guide elements. (17) The trocar sleeve of embodiment 16, wherein the first guide element engaging the second guide element prevents rotation of the cannula within the depth limiter.

Claims

1. A trocar sleeve, 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 attached to the distal end of the cannula; a lumen extending from the distal end of the cannula to the proximal end of the housing; A trocar sleeve, wherein the cannula and the housing are made of a biocompatible material designed to withstand multiple sterilization cycles.

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

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

4. 10. The trocar sleeve of claim 1, wherein the trocar sleeve excludes narrow features that trap debris and has smooth inner and outer surfaces designed to allow a flow of irrigation fluid to remove debris for sterilization.

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

6. The trocar sleeve of claim 1 , wherein the inner diameter of the lumen is selected to provide a clearance of about 0.3 mm from the outer diameter of an obturator disposed within the lumen.

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

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

9. The trocar sleeve of claim 1 , wherein the working length of the trocar sleeve ranges from about 45 mm to 65 mm for pediatric use.

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

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

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

13. The trocar sleeve of claim 12 , wherein a distal end portion of the cannula excludes the raised feature.

14. The trocar sleeve of claim 12 , wherein the plurality of raised features are spaced along a longitudinal axis of the cannula and define a resolution for fixing the location of the cannula relative to the depth limiter.

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

16. 2. The trocar sleeve of claim 1, wherein an outer surface of the cannula includes a first set of guide elements for engaging with corresponding second guide elements of a depth limiter, the cannula is insertable into the lumen of the depth limiter by engaging the first guide elements with the second guide elements, and the trocar cannula is prevented from being inserted into the lumen of the depth limiter when the first guide elements are not engaged with the second guide elements.

17. The trocar sleeve of claim 16, wherein the first guide element engaging the second guide element prevents rotation of the cannula within the depth limiter.

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