Trocar Assembly

Abstract

A minimally invasive surgical kit is provided that includes a depth limiter component that includes a trocar cannula, a lumen sized and shaped to accommodate the trocar cannula, where the outer diameter of the trocar cannula corresponds to the inner diameter of the lumen, a locking mechanism that sets the trocar cannula in a fixed position within the lumen, a housing that includes the lumen and the locking mechanism, and at least one opening in the housing that provides fluid communication between an internal cavity of the housing and an external environment outside the housing.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO 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.

[0003] Trocars are used during minimally invasive surgery, such as laparoscopic surgery. Trocars are placed through the skin of a subject'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 kit for minimally invasive surgery includes a trocar cannula; a lumen sized and shaped to accommodate the trocar cannula, wherein an outer diameter of the trocar cannula corresponds to an inner diameter of the lumen; a locking mechanism for setting the trocar cannula in a fixed position within the lumen; a housing including the lumen and the locking mechanism; and at least one opening in the housing providing fluid communication between an internal cavity of the housing and an external environment outside the housing.

[0005] In a further implementation of the first aspect, the locking mechanism comprises a pressure element designed to apply mechanical pressure to set the trocar cannula in a fixed position by friction.

[0006] In a further implementation of the first aspect, the locking mechanism includes a lever connected to a C-shaped pin that is designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to pressure applied to the lever.

[0007] In a further implementation of the first aspect, the locking mechanism comprises a movable protruding element designed to engage a recess in the trocar cannula.

[0008] In a further implementation of the first aspect, the depth limiter further includes a substantially flat and smooth distal surface for contacting the subject's skin surrounding the entry point of the trocar cannula.

[0009] In a further implementation of the first aspect, the depth limiter further includes a substantially smooth tapered outer surface that tapers outward from an edge of the distal face.

[0010] In a further implementation of the first aspect, the depth limiter further comprises a smooth rounded surface for connecting between the edge of the distal surface and the tapered outer surface.

[0011] In a further implementation of the first aspect, the cavity of the housing is located within the thickness between the lumen and the outer surface.

[0012] In a further implementation of the first aspect, the at least one opening in the housing comprises at least one first opening located on a distal surface of the housing and at least one second opening located on a proximal surface of the housing.

[0013] In a further implementation of the first aspect, at least one of the first opening and the second opening is arc-shaped.

[0014] In a further implementation of the first aspect, the housing comprises at least one third opening located along a surface of the housing that forms the lumen, the at least one third opening being in fluid communication with the at least one opening of the housing.

[0015] In a further implementation of the first aspect, the movable component of the locking mechanism is disposed within an internal cavity of the housing and in fluid communication with the external environment.

[0016] In a further implementation of the first aspect, the locking mechanism is reversible to release the trocar cannula from the secured position for at least one of removal of the trocar cannula from the lumen and further insertion of the trocar cannula into the lumen.

[0017] In a further implementation of the first aspect, the dimensions of the depth limiter are selected to maintain the trocar cannula in a substantially upright position that is approximately perpendicular to the subject's skin while the trocar cannula is fixed in place within the depth limiter and when the trocar cannula is not supported by an external entity.

[0018] In a further implementation of the first aspect, the limited depth dimension is selected to maintain the instrument in a substantially upright position that is approximately perpendicular to the subject's skin when the instrument is inserted into the subject's body through a trocar cannula that pierces the skin and when the instrument is not supported by an external entity.

[0019] In a further implementation of the first aspect, the depth limiter component is made from a biocompatible material that is designed for multiple use and is resistant to autoclaving.

[0020] In a further implementation of the first aspect, the lumen includes a first set of guide elements for engaging corresponding second guide elements of the trocar cannula, the trocar cannula being insertable into the lumen by engaging the first guide elements with the second elements, and the trocar cannula being prevented from being inserted into the lumen when the first guide elements do not engage the second guide elements.

[0021] In a further implementation of the first aspect, the first guide element engaging the second guide element prevents rotation of the trocar cannula within the depth limiter.

[0022] A further implementation of the first aspect further comprises a plurality of depth limiters having lumens with a plurality of different diameters for accommodating trocar cannulas with different diameters.

[0023] A further implementation of the first aspect further comprises a trocar sleeve including a trocar housing and a trocar cannula.

[0024] A further implementation of the first aspect further comprises a sealing element designed to engage the trocar housing.

[0025] According to a second aspect, a method of performing minimally invasive surgery includes passing a trocar cannula into a subject's body through a lumen of a depth limiter and actuating a locking mechanism of the depth limiter to set the trocar cannula to a selected fixed position, wherein an instrument for treating tissue within the patient's body is passed through the trocar cannula secured in the selected fixed position by the locking mechanism of the depth limiter.

[0026] A further implementation of the second aspect further includes at least one of releasing the locking mechanism, adjusting the position of the trocar cannula relative to the depth limiter, resetting the locking mechanism, and removing the trocar cannula from the lumen of the depth limiter.

[0027] 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]

[0028] 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.

[0029] In the drawings: [Figure 1] 1 is a schematic diagram of a trocar assembly including a depth limiter, according to some embodiments of the present invention. [Figure 2] 1 is a perspective view of a depth limiter according to some embodiments of the present invention. FIG. [Figure 3] 1A-1C are side views of depth limiters, according to some embodiments of the present invention. [Figure 4] 10A-10C are top views of depth limiters, according to some embodiments of the present invention. [Figure 5] FIG. 10 is a bottom view of a depth limiter, according to some embodiments of the present invention. [Figure 6] 1 is a cross-sectional view of a depth limiter according to some embodiments of the present invention. [Figure 7] FIG. 10 is an exploded view of a depth limiter, according to some embodiments of the present invention. [Figure 8]1A-1C are schematic diagrams of exemplary sealing elements of a trocar assembly, according to some embodiments of the present invention. [Figure 9] 1 is a schematic diagram of an exemplary obturator of a trocar assembly, according to some embodiments of the present invention. [Figure 10] 1 is a flowchart of an exemplary method of treating a subject using a depth limiter, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery, and more particularly, but not exclusively, to trocar assemblies.

[0031] 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.

[0032] One aspect of some embodiments of the present invention relates to a depth limiter component designed to engage a trocar cannula for performing minimally invasive surgery, e.g., laparoscopic surgery on the abdomen, chest, joints, etc. The depth limiter component includes a lumen sized and shaped to accommodate the trocar cannula. The trocar cannula may be pushed through the lumen to a desired depth through the skin and / or into the subject's body corresponding to a selected length of the trocar cannula passed through the lumen. The depth limiter includes a locking mechanism that sets the trocar cannula to the selected length. The locking mechanism secures the position of the trocar cannula in a fixed position relative to the lumen of the depth limiter.

[0033] The housing of the depth limiter includes a lumen and a locking mechanism. Optionally, the housing includes one or more openings that provide fluid communication between the internal cavity of the housing and an external environment outside the housing. The opening(s) allow irrigation fluid to enter the internal cavity to flush debris from the internal cavity to the external environment. The opening(s) allow sterilization of the internal cavity, which allows the depth limiter to undergo multiple cleaning and sterilization cycles for reuse in multiple surgical procedures.

[0034] One aspect of some embodiments of the present invention relates to a kit that includes a depth restrictor and at least one additional component, such as another depth restrictor with the same lumen diameter, another depth restrictor with a different lumen diameter, and a trocar cannula having an outer diameter corresponding to the inner diameter of the lumen of the depth restrictor.

[0035] An aspect of some embodiments of the present invention relates to a method of performing minimally invasive surgery, e.g., laparoscopic surgery on a subject's abdomen, including passing a trocar cannula into the subject's body through a lumen of a depth limiter, a locking mechanism of the depth limiter configured to set the trocar cannula in a selected, fixed position relative to the lumen of the depth limiter, and passing an instrument for treating tissue within the patient's body through the trocar cannula secured in the selected, fixed position by the locking mechanism of the depth limiter.

[0036] The depth limiters, treatment methods, and / or other components of kits designed to engage the depth limiters (e.g., trocar cannulas) described herein address the technical problem of a trocar cannula penetrating too deeply into a subject's body. The trocar cannula may make undesired contact with internal tissue. Such undesired contact may have dangerous consequences, such as perforation of the intestine (e.g., colon, stomach). Even if the trocar cannula does not make undesired contact with internal tissue, the trocar cannula may inadvertently adjust its position proximally (e.g., deeper into the subject's body) or distally (e.g., pulled away from the subject's body), which may make it more difficult to perform surgery using instruments passed through the cannula.

[0037] The depth limiters, treatment methods, and / or other components of the kits described herein improve upon conventional approaches in which a depth limiter is not used, in which control of the trocar cannula depth can be performed manually by the user without the assistance of a depth limiter.

[0038] The depth limiters and / or treatment methods and / or other components of the kits described herein address the above-mentioned technical problems and / or improve upon the above-mentioned conventional approaches. The depth limiters described herein allow for the location of a trocar cannula to be fixed, which prevents inadvertent slippage of the trocar cannula further into the subject's body, which could perforate an organ, and / or out of the subject's body, which could contaminate the tool. A user may select the depth of trocar cannula insertion into the subject's body and secure the trocar cannula at the selected depth via a locking mechanism.

[0039] In at least some embodiments, the locking mechanism of the depth limiter is designed to be activated and / or released with one hand, e.g., one finger, by pressing a lever, allowing a user (e.g., a surgeon) to hold a trocar cannula in one hand while activating the depth limiter with the other hand (the cannula may be pre-loaded into the depth limiter).

[0040] The depth limiters, treatment methods, and / or other components of kits designed to engage the depth limiters (e.g., trocar cannulas) described herein address the technical problem of the requirement to provide continuous support to the trocar, optionally with instruments passed into the subject's body via the trocar cannula that penetrates the subject's skin. The trocar and / or instruments, e.g., camera, scissors, graspers, and staplers, located at the distal end of a long rod, need to be retained as long as they remain within the body via the cannula. Releasing the trocar and / or instruments could cause them to fall to the side, potentially becoming contaminated and / or damaging internal tissue. The trocar and / or instruments require continuous support, for example, by a human user holding the trocar and / or instruments, and / or attachment to a surgical robotic arm. If the trocar and / or instruments cannot be supported, they are removed from the subject's body.

[0041] The dimensions of the depth limiter may optionally be selected to maintain the trocar assembly in a substantially upright position when the body cavity (e.g., the abdomen) is inflated. With the depth limiter in place, the trocar assembly is maintained in an upright position while the trocar cannula penetrates the skin and the body of the subject. The depth limiter maintains the trocar assembly in a substantially upright position when the trocar assembly is not supported by an external entity, such as a human operator and / or a robotic arm. Optionally, the depth limiter is sized and / or shaped to maintain the trocar assembly in a substantially upright position while an instrument is passed through the trocar assembly. The instrument is located at the distal end region of a long rod that is passed through the trocar cannula and into the body of the subject. Without the depth limiter, releasing the trocar assembly causes the trocar assembly to collapse laterally from the substantially upright position it was previously held in. Sideways tilting of the trocar assembly can damage internal organs and / or place instruments located within the trocar assembly outside the sterile field, which can contaminate the instruments. Sideways tilting of the trocar cannula can damage the skin and / or other tissue at the access point into the body.

[0042] 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.

[0043] Referring now to FIG. 1 , this figure is a schematic illustration of a trocar assembly 102 including a depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 2 , this figure is a perspective view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 3 , this figure is a side view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 4 , this figure is a top view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 5 , this figure is a bottom view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 6 , this figure is a cross-sectional view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 7 , this figure is an exploded view of the depth limiter 150, according to some embodiments of the present invention. Referring again now to FIG. 8 , this figure is a schematic illustration of an exemplary sealing element 108 of the trocar assembly 102, according to some embodiments of the present invention. Reference is now also made to Figure 9, which is a schematic illustration of an exemplary obturator 120 of a trocar assembly 120, according to some embodiments of the present invention. Reference is now also made to Figure 10, which is a flowchart of an exemplary method of treating a subject using a depth limiter, according to some embodiments of the present invention.

[0044] Referring again to FIG. 1, trocar assembly 102 includes a depth limiter component 150 disposed along the shaft of trocar cannula 110 .

[0045] An exemplary trocar cannula 110 is described, for example, with reference to U.S. Provisional Patent Application entitled "TROCAR INCLUDING CANNULA" (Attorney Docket No. 94012), the contents of which are incorporated herein by reference in their entirety.

[0046] Trocar assembly 102 may further include obturator 120. 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.

[0047] Trocar assembly 102 may include a trocar sleeve 104 that includes a trocar housing 106 and a trocar cannula 110. An obturator 120 may be designed to engage housing 106.

[0048] Trocar assembly 102 may include a sealing element 108 designed to engage trocar housing 106. Sealing element 108 may be located within obturator 120 and / or within housing 106, and / or other designs may be implemented.

[0049] Depth limiter 150 includes a lumen sized and shaped to accommodate trocar cannula 110 and a locking mechanism 152 that sets trocar cannula 110 in a fixed position within the lumen and / or sets depth limiter 150 in a fixed position along trocar cannula 110. The inner diameter of the lumen of depth limiter 150 is slightly larger than the outer diameter of trocar cannula 110 to allow depth limiter 150 to slide along the length of trocar cannula 110.

[0050] The locking mechanism 152 may be reversible to release the trocar cannula 110 from the secured position. Once the locking mechanism 152 is released, the trocar cannula 110 may be completely removed from the lumen and from the depth limiter 150, and / or the trocar cannula 110 may be repositioned within the lumen of the depth limiter 150. For example, the depth limiter 150 may be moved proximally or distally along the trocar cannula 110. Once the depth limiter 150 is repositioned, the locking mechanism 152 may be reactivated to secure the depth limiter 150 in its new position along the trocar cannula 110.

[0051] Optionally, depth limiter 150 is made from a biocompatible material that is autoclavable, allows for multiple cleaning and sterilization cycles (e.g., greater than 100, or 500, or 1000, or other values), and / or is designed for multiple use, such as, for example, polyetheretherketone (PEEK) and polyphenylsulfone (PPSU). Alternatively or additionally, depth limiter 150 is made from a biocompatible material that is disposable and / or designed for single use.

[0052] When locking mechanism 152 is activated, depth limiter 150, which secures cannula 110 in place, prevents cannula 110 from sliding deeper into the patient's body (which could cause damage due to contact with internal tissue) and / or prevents cannula 110 from sliding out of the patient's body (which could complicate the procedure, cause gas to escape from the body, and / or cause contamination).

[0053] Exemplary dimensions of the depth limiter 150 include: *The inner diameter of the depth limiter lumen is sized to provide an annular space between the lumen and the outer diameter of the trocar cannula passing through it. For example, for a trocar cannula with an outer diameter of 5 mm, the inner diameter of the lumen is 8.5 mm, 9 mm, 9.3 mm, 9.5 mm, or 10 mm. For a trocar cannula with an outer diameter of 12 mm, the inner diameter of the lumen is 15.5 mm, 16 mm, 16.5 mm, 16.9 mm, 17.5 mm, or 18 mm. * The outer diameter of the depth limiter is within the range of 21.8 to 30.0 mm, or 20.0 to 32.0 mm, for a trocar cannula having an outer diameter of 5 mm. The outer diameter of the depth limiter is within the range of 30 to 38 mm, or 28 to 40 mm, for a trocar cannula having an outer diameter of 12 mm. * The thickness of the depth limiter, i.e., the dimension measured from the distal end to the proximal end along the long axis through the lumen, is regardless of the expected outer diameter of the trocar cannula, e.g., 18-22 mm, or 18 mm, or 20 mm, or 22 mm for 5 mm and 12 mm outer diameter trocar cannulae.

[0054] The dimensions of the depth limiter may optionally be selected to maintain the trocar assembly (i.e., including the cannula of the trocar sleeve) in a substantially upright position when the body cavity (e.g., the abdomen) is inflated. The trocar assembly, with the depth limiter in place, is maintained in an upright position while the trocar cannula penetrates the skin and the body of the subject. The depth limiter maintains the trocar assembly in a substantially upright position when the trocar assembly is not supported by an external entity, such as a human operator and / or a robotic arm. Optionally, the depth limiter is sized and / or shaped to maintain the trocar assembly in a substantially upright position while an instrument is passed through the trocar assembly. The instrument is located at the distal end region of a long rod that is passed through the trocar cannula and into the body of the subject. Without the depth limiter, releasing the trocar assembly causes the trocar assembly to collapse laterally from the substantially upright position it was previously held in. Sideways tilting of the trocar assembly can damage internal organs and / or place instruments located within the trocar assembly outside the sterile field, which can contaminate the instruments. Sideways tilting of the trocar cannula can damage the skin and / or other tissue at the access point into the body.

[0055] The dimensions of the depth limiter may be selected to maintain the position of the trocar sleeve, including the trocar channel, optionally within a range of positions from substantially perpendicular to the subject's skin as the instrument rod passes through the trocar sleeve to greater than about 30 degrees, 45 degrees, 60 degrees, or 74 degrees from the surface of the skin. The angle may be measured at the access point into the body where the trocar cannula is located, formed between the long axis of the trocar cannula and a plane tangent to the skin. Examples of selected dimensions include the thickness of the depth limiter (e.g., the difference between the inner and outer diameters of the lumen) and / or a sufficiently large surface area of ​​the distal surface of the depth limiter that contacts the skin to prevent or reduce tilt. In another example, the height of the depth limiter (e.g., the distance between the distal and proximal surfaces of the depth limiter) is sufficient to support the trocar sleeve and / or trocar assembly, and optionally, to withstand torque exerted by the trocar sleeve and / or trocar assembly and / or instrument rod when an instrument is passed therethrough. In yet another example, the difference between the inner diameter of the depth limiter lumen and the outer diameter of the cannula may be small enough so that the walls of the inner lumen provide sufficient support to the trocar sleeve cannula to withstand torque applied by an instrument passing therethrough.

[0056] The locking mechanism may be designed to apply sufficient pressure to the cannula to withstand the torque applied by the instrument rod to maintain the rod in a substantially upright position.

[0057] Optionally, the lumen of depth limiter 150 includes one or more guides that engage trocar cannula 110 at preselected location(s). For example, the lumen includes one or more rails designed to engage one or more recessed channels on the surface of cannula 110. In another example, the inner surface of the lumen has a non-circular shape designed to engage a corresponding shape on the outer surface of trocar cannula 110, e.g., a square, an oval, and a four-leaf clover. When engaged, the guide(s) prevent rotation of cannula 110 within the lumen of depth limiter 150 and / or help lock cannula 110 within depth limiter 150.

[0058] Optionally, cannula 110 includes one or more raised features 130 on its outer surface designed to be engaged by a locking mechanism, e.g., spaced raised rings including a C-shaped element where the lock fits between the raised rings, or a ratchet including pawls designed to allow easy removal of the cannula but prevent the cannula from being pushed deeper unless a lever is pressed to release the pawls. Optionally, cannula distal end 132 excludes raised features 130 to prevent a user from locking depth limiter 150 in a position too low along cannula 110, where depth limiter 150 may not be able to adequately support and / or engage cannula 110. In another exemplary implementation, raised features 130 may be set to various diameters, e.g., continuously increasing or continuously decreasing. For example, they can prevent the cannula from being pushed distally and / or allow removal, to allow pre-selection of a maximum depth. For example, the locking mechanism 152 is set on a first diameter of the cannula 110. Proximally along the cannula 110, the diameter increases, which prevents the cannula 110 from being pushed distally into the subject's body. The locking mechanism 152 may be preset to the 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.

[0059] Optionally, a kit is provided that includes the depth limiter and one or more additional components. Examples of kits include one or a combination of the following: * Multiple depth limiters of the same size. * Multiple depth limiters with different lumen diameters designed to accommodate trocar cannulas with different diameters. For example, one or more depth limiters with a 5 mm internal lumen diameter and one or more depth limiters with a 12 mm internal lumen diameter. * One or more trocar cannulas of the same and / or different dimensions. The trocar cannulas are sized to fit within the depth limiters. Exemplary cannulas are described, for example, with reference to the '94012 application. * One or more trocar sleeves including a trocar housing and a trocar cannula. The trocar sleeve(s) may be of the same and / or different sizes. * For example, one or more sealing elements designed to engage the trocar housing, the sealing elements being the same and / or different sizes according to other corresponding components. * One or more obturators designed to fit within the lumen of the trocar sleeve. The outer dimensions of the obturators are designed to be slightly smaller than the inner dimensions of the lumen of the trocar sleeve, allowing the obturators to slide in and out of the lumen of the trocar sleeve. For example, the gap between the outer diameter of the obturator and the inner diameter of the lumen of the trocar sleeve is about 0.2 millimeters, or about 0.3 millimeters, or about 0.4 millimeters, or about 0.5 millimeters, or other values.

[0060] 2, there is shown an exemplary implementation of the locking mechanism 152 of the depth limiter 150. It should be understood that other locking mechanisms may be used, and the implementation shown is exemplary and not necessarily limiting.

[0061] The depth limiter 150 includes a lumen 204 through which the trocar cannula is inserted and to which the locking mechanism 152 is applied.

[0062] The locking mechanism 152 can be set and / or released by lever 202. The lever 202 is pushed inward.

[0063] Optionally, locking mechanism 152 includes a pressure element designed to apply mechanical pressure to frictionally set the trocar cannula in a fixed position. For example, a push lever 202 pushes the pressure-applying element against the cannula. A release lever 202 releases the element and the pressure. For example, locking mechanism 152 includes lever 202 connected to a C-pin. The C-pin is designed to engage the trocar cannula and apply mechanical pressure to the trocar cannula in response to pressure applied to lever 202.

[0064] Alternatively or additionally, locking mechanism 152 engages the trocar cannula to prevent movement of the trocar cannula, for example, push lever 202 presses a movable protruding element into a recess in the wall of the cannula. When the protruding element engages the recess, the cannula cannot be moved.

[0065] Other exemplary implementations of locking mechanism 152 are described herein, for example, with reference to FIG.

[0066] Proximal opening 610 is described herein, for example, with reference to FIG.

[0067] Referring again to FIG. 3, the depth limiter 150 may include an outer surface 302 designed to reduce or prevent harm to the subject.

[0068] Optionally, the depth limiter 150 may include a tapered outer surface 302, which may include an outer diameter that decreases from the proximal surface 304 of the depth limiter 150 toward the distal surface 306 of the depth limiter 150. The taper of the outer surface 302 may be designed to increase the total surface area that contacts the subject's skin during use. During a procedure, the depth limiter 150 is placed on the subject's skin. When little pressure is applied to the depth limiter 150 (e.g., no external pressure, such as from a user pushing), the distal surface 306 of the depth limiter 150 contacts the subject's skin. When additional pressure is applied to the depth limiter 150 (e.g., a user pushing down on a trocar, passing an instrument, or sewing into the skin), the distal surface 306 is forced down into the skin, and nearby surrounding skin comes into contact with the outer surface 302. Increasing the pressure applied to the depth limiter 150, forcing the depth limiter 150 deeper into the skin surface, brings additional portions of the outer surface 302 of the depth limiter 150 into contact with more of the skin. The total surface area of ​​the depth limiter 150 in contact with the skin increases with increasing pressure and depth, reducing the pressure applied to the skin by the depth limiter 150. The reduction in pressure on the skin due to the greater surface area of ​​the depth limiter 150 may reduce or prevent damage to the skin from pressure, e.g., bedsores, bruises, etc. In contrast, given the non-tapered, substantially parallel (i.e., equal diameter) cross-sectional diameter of the depth limiter, then increased pressure on the depth limiter 150 increases the pressure applied by the restricted distal surface 306 on the skin, which may lead to damage.

[0069] Surfaces 302 and / or 306 may be smooth to prevent or reduce damage to the skin. The smoothness may allow for efficient cleaning and / or autoclaving for repeated use of the depth limiter.

[0070] A smooth rounded surface 308 can provide a transition connecting the edge of the distal surface 306 and the tapered outer surface 302. The rounded surface 308 is designed to distribute pressure and / or avoid pressure points on the skin.

[0071] Referring again now to FIG. 4, a top view of depth limiter 150 showing proximal surface 304 is provided.

[0072] Referring again to Figure 5, a bottom view of depth limiter 150 is provided showing distal surface 306. Distal opening 612 is described herein, for example, with reference to Figure 6. Referring again to Figure 6, a cross-sectional view of depth limiter 150 is shown.

[0073] The depth limiter includes a housing 602 that includes the locking mechanism 152. The housing 602 has an inner surface 604 that defines the lumen 204. The housing 602 may further include an outer surface 302 (also referred to as an exterior surface), a proximal surface 304, and a distal surface 306. The housing 602 has a thickness 606 defined between the inner surface 604 and the exterior surface 302.

[0074] Housing 602 includes one or more openings that provide fluid communication between an internal cavity 614 of housing 604 and an external environment 616. Optionally, housing 602 includes one or more distal openings 612 located on distal surface 306 and / or one or more proximal openings 610 located on proximal surface 304. Optionally, at least two different openings are provided. The openings, for example, allow cleaning fluid to enter cavity 614 to flush out debris and / or allow heat from autoclaving to enter cavity 614 for sterilization in implementations in which depth limiter 150 is designed for multiple use. Optionally, housing 602 includes two or more openings that allow cleaning fluid to enter cavity 614 from and exit external environment 616.

[0075] The proximal opening 610 and / or the distal opening 612 may be arc-shaped, extending along an arc having a length of, for example, approximately 10, 15, 30, 45, 60, 90, 180, 10-180, 30-60 degrees, or other values. The arc shape provides a large area for the opening, allowing a sufficient amount of irrigation fluid to enter and / or providing a large exit port for irrigation fluid and / or debris to exit. The arc shape provides a large port for sterilization of the interior cavity 614.

[0076] The housing 602 may include one or more lumen openings 618 located along the inner surface 604 of the housing 602 that defines the lumen 204. The lumen opening(s) 618 are in fluid communication with other opening(s) of the housing 602, e.g., the proximal opening 610 and / or the distal opening 612, which are in fluid communication with the external environment 616. The lumen openings may aid in flushing the surfaces of the lumen and / or provide additional inlet and / or outlet ports for cleaning the internal cavity 614 and / or aid in sterilizing the internal cavity 614.

[0077] Optionally, the movable components of locking mechanism 152 are disposed within an internal cavity 614 of housing 602 and are in fluid communication with an external environment 616. Disposing the movable components within internal cavity 614 allows for the movable components to be cleaned and / or sterilized.

[0078] Referring again now to FIG. 7, an exploded view of the components of depth limiter 150 is shown.

[0079] Referring now back to FIG. 8, the exemplary sealing element 108 may be assembled as part of the trocar assembly 102 and / or may be included in one or more of the kits described herein.

[0080] Referring again now to FIG. 9, exemplary obturator 120 may be assembled as part of trocar assembly 102 and / or may be included in one or more of the kits described herein.

[0081] 10, at 1000, suitable components for assembling a trocar are optionally selected from a kit described herein. For example, the size of the components is selected depending on the size of the subject. The trocar is assembled from the selected components.

[0082] At 1002, a trocar cannula is passed through the lumen of the depth limiter into the subject's body. The trocar cannula may be passed through an incision and / or perforation in the skin. The trocar cannula may be inserted into a body cavity, such as the abdomen, chest, joint, etc.

[0083] The cavity may be inflated with gas to separate the skin from the underlying organs and provide space for viewing and / or manipulating surgical instruments.

[0084] At 1004, the locking mechanism of the depth limiter is actuated to set the trocar cannula in a selected fixed position.

[0085] The locking mechanism may be activated with one hand following trocar insertion, and optionally the cannula is pre-loaded into the depth limiter while the user (e.g., surgeon) holds the cannula with the other hand.

[0086] Alternatively, the order of blocks 1002 and 1004 is reversed. Prior to insertion into the patient's body, the depth-limited locking mechanism can be first activated to set the trocar cannula in a selected fixed position. The trocar cannula, engaged with the depth limiter via the locking mechanism, can then be inserted into the body. Placing the depth limiter on the cannula prior to insertion into the patient's body ensures that the cannula does not enter the patient's body deeper than set by the depth limiter.

[0087] At 1006, the locking mechanism may be released. The position of the trocar cannula may be adjusted relative to the depth limiter. The trocar cannula may be pushed deeper into the body or retracted from the body. The locking mechanism may be reactivated to secure the cannula in the new selected position.

[0088] At 1008, an instrument for treating tissue within the patient's body may be passed through the trocar cannula, which has been secured in a fixed position selected by the locking mechanism of the depth limiter. The subject may be treated using the instrument.

[0089] At 1010, the instrument can be released, for example, by a user who was holding the instrument. The depth limiter can be designed to support the instrument in a substantially upright position and prevent the instrument from tilting to the side, as described herein. Alternatively, the trocar sleeve without the instrument being passed through it is released. The depth limiter can be designed to support the trocar sleeve in a substantially upright position and prevent the trocar sleeve from tilting to the side, as described herein.

[0090] The trocar sleeve may be released after distension of the body cavity.

[0091] At 1012, the locking mechanism is released.

[0092] The locking mechanism may be activated following trocar insertion, optionally with one hand, while the user (eg, surgeon) holds the cannula with the other hand.

[0093] The trocar cannula is removed from the lumen of the depth limiter.

[0094] At 1014, one or more features described with reference to 1002-1012 are repeated for different trocars, e.g., to place multiple trocars at different locations on a subject's body to provide multiple access points for multiple instruments. Features may also be repeated, e.g., to adjust the depth of a trocar cannula.

[0095] 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.

[0096] As used herein, the term "about" refers to ±10%.

[0097] The terms "comprises," "comprising," "includes," "including," "having," and combinations thereof, mean "including but not limited to."

[0098] The term "consisting of" means "including and limited to."

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] As used herein, the term "treating" includes arresting, substantially inhibiting, slowing, or reversing the progression of a disease state, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] [Embodiment] (1) A kit for minimally invasive surgery, comprising: a trocar cannula; a depth limiter component, said depth limiter component comprising: a lumen sized and shaped to receive a trocar cannula, the outer diameter of the trocar cannula being sized to correspond to the inner diameter of the lumen; a locking mechanism for setting the trocar cannula in a fixed position within the lumen; a housing containing the lumen and the locking mechanism; and at least one opening in the housing that provides fluid communication between an interior cavity of the housing and an external environment outside the housing. (2) The kit of embodiment 1, wherein the locking mechanism comprises a pressure element designed to apply mechanical pressure to set the trocar cannula in the fixed position by friction. (3) The kit of embodiment 2, wherein the locking mechanism comprises a lever connected to a C-shaped pin, the C-shaped pin configured to engage the trocar cannula and apply mechanical pressure to the trocar cannula in response to pressure applied to the lever. (4) The kit of embodiment 1, wherein the locking mechanism comprises a movable protruding element designed to engage a recess in the trocar cannula. (5) The kit of embodiment 1, wherein the depth limiter further comprises a substantially flat and smooth distal surface for contacting the subject's skin surrounding the entry point of the trocar cannula.

[0110] (6) The kit of embodiment 1, wherein the depth limiter is substantially smooth and further comprises a tapered outer surface tapering outward from an edge of the distal surface. (7) The kit of embodiment 6, wherein the depth limiter further comprises a smooth, rounded surface for connecting between the edge of the distal surface and the tapered outer surface. (8) The kit of embodiment 1, wherein the cavity of the housing is located within a thickness between the lumen and the outer surface. (9) The kit of embodiment 1, wherein the at least one opening in the housing comprises at least one first opening located on a distal surface of the housing and at least one second opening located on a proximal surface of the housing. (10) The kit of embodiment 9, wherein at least one of the first opening and the second opening is arc-shaped.

[0111] (11) The kit of embodiment 1, wherein the housing includes at least one third opening located along a surface of the housing that forms the lumen, and the at least one third opening is in fluid communication with the at least one opening of the housing. (12) The kit of embodiment 1, wherein the movable component of the locking mechanism is disposed within the internal cavity of the housing and is in fluid communication with the external environment. (13) The kit of embodiment 1, wherein the locking mechanism is reversible to release the trocar cannula from the fixed position for at least one of removal of the trocar cannula from the lumen and further insertion of the trocar cannula into the lumen. (14) The kit of embodiment 1, wherein the dimensions of the depth limiter are selected to maintain the trocar cannula in a substantially upright position approximately perpendicular to the subject's skin while the trocar cannula is secured in place within the depth limiter and when the trocar cannula is not supported by an external entity. (15) The kit of claim 14, wherein the dimension of the limited depth is selected to maintain the instrument in the substantially upright position, approximately perpendicular to the subject's skin, when the instrument is inserted into the subject's body through the trocar cannula that pierces the skin and when the instrument is not supported by the external entity.

[0112] (16) The kit of embodiment 1, wherein the depth limiter component is made from a biocompatible material that is designed for multiple use and is resistant to autoclaving. (17) The kit of embodiment 1, wherein the lumen includes a first set of guide elements for engaging corresponding second guide elements of the trocar cannula, the trocar cannula is insertable into the lumen by engaging the first guide elements with the second elements, and the trocar cannula is prevented from being inserted into the lumen when the first guide elements do not engage the second guide elements. (18) The kit of embodiment 17, wherein the first guide element engaging the second guide element prevents rotation of the trocar cannula within the depth limiter. (19) The kit of embodiment 1, further comprising a plurality of depth limiters having lumens with different diameters for accommodating trocar cannulas with different diameters. (20) The kit of embodiment 1, further comprising a trocar sleeve including a trocar housing and the trocar cannula.

[0113] (21) The kit of embodiment 1, further comprising a sealing element designed to engage the trocar housing. (22) A method for performing minimally invasive surgery, comprising: passing a trocar cannula through the lumen of the depth limiter and into the subject's body; and actuating a locking mechanism of the depth limiter to set the trocar cannula in a selected fixed position; The method, wherein an instrument for treating tissue within the patient's body is passed through the trocar cannula, which is secured in the selected fixed position by the locking mechanism of the depth limiter. (23) The method of embodiment 22, further comprising at least one of releasing the locking mechanism, adjusting the position of the trocar cannula relative to the depth limiter, resetting the locking mechanism, and removing the trocar cannula from the lumen of the depth limiter.

Claims

1. 1. A kit for minimally invasive surgery, comprising: a trocar cannula; a depth limiter component, said depth limiter component comprising: a lumen sized and shaped to receive a trocar cannula, the outer diameter of the trocar cannula being sized to correspond to the inner diameter of the lumen; a locking mechanism for setting the trocar cannula in a fixed position within the lumen; a housing containing the lumen and the locking mechanism; and at least one opening in the housing that provides fluid communication between an interior cavity of the housing and an external environment outside the housing.

2. The kit of claim 1 , wherein the locking mechanism comprises a pressure element designed to apply mechanical pressure to set the trocar cannula in the fixed position by friction.

3. 3. The kit of claim 2, wherein the locking mechanism comprises a lever connected to a C-pin configured to engage the trocar cannula and apply mechanical pressure to the trocar cannula in response to pressure applied to the lever.

4. The kit of claim 1 , wherein the locking mechanism comprises a movable protruding element designed to engage a recess in the trocar cannula.

5. The kit of claim 1 , wherein the depth limiter further comprises a substantially flat and smooth distal surface for contacting the subject's skin surrounding the entry point of the trocar cannula.

6. The kit of claim 1 , wherein the depth limiter is substantially smooth and further comprises a tapered outer surface that tapers outward from an edge of a distal face.

7. The kit of claim 6 , wherein the depth limiter further comprises a smooth rounded surface for connecting between an edge of the distal surface and the tapered outer surface.

8. The kit of claim 1 , wherein the cavity of the housing is located within a thickness between the lumen and an exterior surface.

9. 2. The kit of claim 1, wherein the at least one opening in the housing comprises at least one first opening located on a distal surface of the housing and at least one second opening located on a proximal surface of the housing.

10. The kit of claim 9 , wherein at least one of the first opening and the second opening is arcuate.

11. 10. The kit of claim 1, wherein the housing comprises at least one third opening located along a surface of the housing that forms the lumen, the at least one third opening being in fluid communication with the at least one opening in the housing.

12. The kit of claim 1 , wherein a movable component of the locking mechanism is disposed within the interior cavity of the housing and is in fluid communication with the external environment.

13. 2. The kit of claim 1, wherein the locking mechanism is reversible to release the trocar cannula from the secured position for at least one of removal of the trocar cannula from the lumen and further insertion of the trocar cannula into the lumen.

14. 2. The kit of claim 1, wherein the dimensions of the depth limiter are selected to maintain the trocar cannula in a substantially upright position approximately perpendicular to the subject's skin while the trocar cannula is secured in place within the depth limiter and when the trocar cannula is not supported by an external entity.

15. 15. The kit of claim 14, wherein the dimension of the limited depth is selected to maintain the instrument in the substantially upright position, approximately perpendicular to the subject's skin, when the instrument is inserted into the subject's body through the trocar cannula that pierces the skin and when the instrument is not supported by the external entity.

16. 10. The kit of claim 1, wherein the depth limiter component is made from a biocompatible material that is designed for multiple use and is resistant to autoclaving.

17. 2. The kit of claim 1, wherein the lumen includes a first set of guide elements for engaging corresponding second guide elements of the trocar cannula, the trocar cannula is insertable into the lumen by engaging the first guide elements with the second elements, and the trocar cannula is prevented from being inserted into the lumen when the first guide elements do not engage the second guide elements.

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

19. The kit of claim 1 , further comprising a plurality of depth limiters having lumens with different diameters for accommodating trocar cannulas with different diameters.

20. The kit of claim 1 , further comprising a trocar sleeve containing a trocar housing and the trocar cannula.

21. The kit of claim 1 , further comprising a sealing element designed to engage the trocar housing.

22. 1. A method of performing minimally invasive surgery, comprising: passing a trocar cannula through the lumen of the depth limiter and into the subject's body; and actuating a locking mechanism of the depth limiter to set the trocar cannula in a selected fixed position; The method, wherein an instrument for treating tissue within the patient's body is passed through the trocar cannula, which is secured in the selected fixed position by the locking mechanism of the depth limiter.

23. 23. The method of claim 22, further comprising at least one of releasing the locking mechanism, adjusting the position of the trocar cannula relative to the depth limiter, resetting the locking mechanism, and removing the trocar cannula from the lumen of the depth limiter.

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