Trocar assembly

Abstract

There is provided a kit for use in minimally invasive surgery, the kit comprising: a trocar cannula; and a depth limiter component, the depth limiter component comprising: a lumen sized and shaped to receive a trocar cannula wherein an outer diameter of the trocar cannula is sized to correspond to an inner diameter of the lumen; a locking mechanism that sets the trocar cannula in a fixed position within the lumen; the shell comprises the inner cavity and the locking mechanism; and at least one aperture of the housing, the at least one aperture forming fluid communication between the interior cavity of the housing and an external environment external to the housing.

Description

[0001] Related Applications

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

[0003] Technical Field and Background Art

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

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

[0006] According to a first aspect, a kit for minimally invasive surgery includes: a trocar cannula; and a depth limiter component, the depth limiter component including: an inner cavity, the size and shape of which are set to accommodate the trocar cannula, wherein the outer diameter of the trocar cannula is sized to correspond to the inner diameter of the inner cavity; a locking mechanism, which sets the trocar cannula in a fixed position within the inner cavity; a shell, the shell including the inner cavity and the locking mechanism; and at least one orifice of the shell, the at least one orifice forming a fluid connection between the internal cavity of the shell and the external environment outside the shell.

[0007] In another embodiment of the first aspect, the locking mechanism comprises a pressure element designed to exert a mechanical pressure for setting the trocar cannula in the fixed position by friction.

[0008] In another embodiment of the first aspect, the locking mechanism includes a lever connected to a C-shaped pin designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to pressure applied to the lever.

[0009] In another embodiment of the first aspect, the locking mechanism comprises a movable protruding element designed to engage a recessed portion of the trocar cannula.

[0010] In another embodiment of the first aspect, the depth limiter further comprises a substantially flat and smooth distal surface for contacting the skin of a subject surrounding the entry point of the trocar cannula.

[0011] In another embodiment of the first aspect, the depth limiter further comprises a substantially smooth tapered outer surface that tapers outwardly from an edge of the distal surface.

[0012] In another embodiment of the first aspect, the depth limiter further comprises a smooth rounded surface for connecting the edge of the distal surface and the tapered outer surface.

[0013] In another embodiment of the first aspect, the cavity of the housing is located in the thickness between the inner cavity and the outer side surface.

[0014] In another embodiment of the first aspect, the at least one aperture of the housing includes at least one first aperture located on a distal surface of the housing and at least one second aperture located on a proximal surface of the housing.

[0015] In another embodiment of the first aspect, at least one of the first aperture and the second aperture is arcuate.

[0016] In another embodiment of the first aspect, the housing includes at least one third aperture positioned along a surface of the housing forming the inner cavity, the at least one third aperture being in fluid communication with the at least one aperture of the housing.

[0017] In another embodiment of the first aspect, the moving component of the locking mechanism is disposed within the interior cavity of the housing and is in fluid communication with the external environment.

[0018] In another embodiment of the first aspect, the locking mechanism is reversible for releasing 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.

[0019] In another embodiment of the first aspect, the dimensions of the depth limiter are selected to maintain the trocar cannula in a substantially upright position generally perpendicular to the subject's skin when the trocar cannula is secured in place in the depth limiter and when the trocar cannula is not supported by an external entity.

[0020] In another embodiment of the first aspect, the dimension of the limited depth is selected to maintain the instrument in a substantially upright position approximately perpendicular to the skin of the subject 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.

[0021] In another embodiment of the first aspect, the depth limiter component is made of an autoclavable biocompatible material designed for multi-use.

[0022] In another embodiment of the first aspect, the inner cavity includes a first guide element, which is configured to engage a corresponding second guide element of the trocar cannula, wherein the trocar cannula can be inserted into the inner cavity by engaging the first guide element with the second guide element, and when the first guide element does not engage the second guide element, the trocar cannula is prevented from being inserted into the inner cavity.

[0023] In another embodiment of the first aspect, the first guide element engages the second guide element to prevent the trocar cannula from rotating within the depth limiter.

[0024] In another embodiment of the first aspect, a plurality of depth limiters are further included, each having an inner cavity with a plurality of different diameters for accommodating trocar cannulas with different diameters.

[0025] In another embodiment of the first aspect, further comprising a trocar sleeve comprising a trocar housing and a trocar cannula.

[0026] In another embodiment of the first aspect, further comprising a sealing element configured to engage the trocar housing.

[0027] According to a second aspect, a method of performing a minimally invasive surgical procedure comprises delivering a trocar cannula into a subject's body via a lumen of a depth limiter, and activating a locking mechanism of the depth limiter for setting the trocar cannula at a selected fixed position, wherein an instrument for treating tissue in the patient's body is delivered via the trocar cannula secured at the selected fixed position by the locking mechanism of the depth limiter.

[0028] In another embodiment of the second aspect, further comprising releasing the locking mechanism, and performing at least one of: adjusting the position of the trocar cannula relative to the depth limiter and resetting the locking mechanism, and removing the trocar cannula from the inner cavity of the depth limiter.

[0029] Unless otherwise defined, all technical and / or scientific terms used herein have the same meanings as those generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar to or equivalent to those described herein can be used for the operation or test of embodiments of the present invention, exemplary methods and materials are described below. If a conflict occurs, the patent specification and its definition shall prevail. In addition, materials, methods and examples are exemplary only and are not intended to be necessary restrictions. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Some embodiments of the present invention are described herein in conjunction with the accompanying drawings by way of example. With specific reference now to the accompanying drawings, it should be emphasized that the details shown are shown by way of example and for the purpose of illustrative discussion of the embodiments of the present invention. In this regard, the description in conjunction with the accompanying drawings enables those skilled in the art to understand how to practice the embodiments of the present invention.

[0031] In the attached picture:

[0032] Figure 1 is a schematic diagram of a trocar assembly including a depth limiter according to some embodiments of the present invention;

[0033] Figure 2 is a perspective view of a depth limiter according to some embodiments of the present invention;

[0034] Figure 3 is a side view of a depth limiter according to some embodiments of the present invention;

[0035] Figure 4 is a top view of a depth limiter according to some embodiments of the present invention;

[0036] Figure 5 is a bottom view of a depth limiter according to some embodiments of the present invention;

[0037] Figure 6 is a cross-sectional view of a depth limiter according to some embodiments of the present invention;

[0038] Figure 7 is an exploded view of a depth limiter according to some embodiments of the present invention;

[0039] Figure 8 is a schematic diagram of an exemplary sealing element of a trocar assembly according to some embodiments of the present invention;

[0040] Fig. 9 is a schematic diagram of an exemplary obturator of a trocar assembly according to some embodiments of the present invention; and

[0041] Fig.10 is a flow chart of an exemplary method of treating a subject using a depth limiter according to some embodiments of the present invention. DETAILED DESCRIPTION

[0042] The present invention, in some embodiments thereof, relates to medical devices for minimally invasive surgery and, more particularly, but not exclusively, to a trocar assembly.

[0043] As used herein, the terms proximal and distal are used with reference to a user using a trocar assembly on a subject. Proximal refers to the portion of the trocar assembly that is closer to the user during use. Distal refers to the portion of the trocar assembly that is farther from the user during use.

[0044] One aspect of some embodiments of the present invention relates to a depth limiter component designed to engage with a trocar cannula for performing minimally invasive surgical procedures, such as laparoscopic surgical procedures on the abdomen, chest, joints, etc. The depth limiter component includes an inner cavity sized and shaped to accommodate a trocar cannula. The trocar cannula can be pushed through the inner cavity to a desired depth through the skin of a subject and / or into the body of a subject, the desired depth corresponding to a selected length of the trocar cannula passing through the inner cavity. The depth limiter includes a locking mechanism that sets the trocar cannula at a selected length. The locking mechanism fixes the position of the trocar cannula at a fixed position relative to the inner cavity of the depth limiter.

[0045] The housing of the depth limiter includes an inner cavity and a locking mechanism. Optionally, the housing includes one or more apertures that provide fluid communication between the inner cavity of the housing and the external environment outside the housing. The apertures enable a washing fluid to enter the inner cavity for washing debris out of the inner cavity to the external environment. The apertures enable the inner cavity to be sterilized, which allows the depth limiter to undergo multiple washing and sterilization cycles for reuse in multiple surgical procedures.

[0046] An aspect of some embodiments of the invention relates to a kit comprising a depth limiter and at least one additional component, such as another depth limiter having the same inner cavity diameter, another depth limiter having another inner cavity diameter, and a trocar cannula having an outer diameter corresponding to the inner diameter of the inner cavity of the depth limiter.

[0047] An aspect of some embodiments of the present invention relates to a method of performing minimally invasive surgery (e.g., laparoscopic surgery) on the abdominal cavity of a subject. A trocar cannula is delivered into the body of the subject via the lumen of a depth limiter. A locking mechanism of the depth limiter is configured to set the trocar cannula at a selected fixed position relative to the lumen of the depth limiter. An instrument for treating tissue in the patient's body is delivered via the trocar cannula fixed at a selected fixed position by the locking mechanism of the depth limiter.

[0048] The depth limiter, treatment method and / or other components of the kit that are designed to engage with the depth limiter (e.g., trocar cannula) described herein solve the technical problem that the trocar cannula penetrates too deep into the body of the object. The trocar cannula may come into undesirable contact with internal tissues. Such undesirable contact may have dangerous consequences, such as perforation of the intestine (e.g., large colon, stomach). Even if the trocar cannula does not come into undesirable contact with internal tissues, the trocar cannula may also inadvertently adjust its position proximally (e.g., deeper into the body of the object) or distally (e.g., withdrawn away from the body of the object), which may make it more difficult to perform operations using instruments passing through the cannula.

[0049] The depth limiters, treatment methods, and / or other components of the kit described herein are improved over prior methods that do not use depth limiters. In such methods, control of the depth of the trocar cannula can be accomplished manually by the user without the assistance of a depth limiter.

[0050] The depth limiter and / or treatment method and / or other components of the kit described herein solve the technical problems discussed above, and / or are improvements to the existing methods discussed above. The depth limiter described herein enables the position of the trocar cannula to be fixed, which prevents the trocar cannula from accidentally sliding further into the subject's body (which may perforate an organ) and / or sliding outside the subject's body (which may contaminate the tool). The user can select the depth of the trocar cannula inserted into the subject's body, and the trocar cannula is fixed at the selected depth via a locking mechanism.

[0051] In at least some embodiments, the locking mechanism of the depth limiter is designed to be activated and / or released one-handedly, for example, by pressing a lever with a single finger. This allows the depth limiter to be activated with one hand while the user (e.g., surgeon) holds the trocar cannula (which may be pre-loaded into the depth limiter) with the other hand.

[0052] The depth limiter, treatment method and / or other parts (e.g., trocar cannula) of the kit described herein that are designed to engage with the depth limiter solve the technical problem that continuous support needs to be provided for the trocar, optionally, the instrument in the body of the object is transmitted to the trocar cannula through the skin of the object. The trocar and / or instrument placed at the distal end of the long rod, such as a camera, scissors, grabber and stapler, need to be maintained as long as they are in the body via the cannula. Loosening the trocar and / or instrument causes the trocar and / or instrument to fall sideways, potentially contaminated and / or potentially injuring internal tissue. The trocar and / or instrument need to be continuously supported by a human user holding the trocar and / or instrument, and / or be attached to a surgical robot arm. When the trocar and / or instrument cannot be supported, the instrument is removed from the body of the object.

[0053] The size of the depth limiter can be selected to maintain the trocar assembly in a substantially upright position, optionally when the body cavity (e.g., the abdominal cavity) has been inflated. The trocar assembly on which the depth limiter is placed is maintained in an upright position while the trocar cannula is piercing the skin of the object and in the body of the object. When the trocar assembly is not supported by an external entity such as an operator and / or a robot arm, the depth limiter maintains the trocar assembly in a substantially upright position. Optionally, the size and / or shape of the depth limiter is set to maintain the trocar assembly in a substantially upright position when the instrument passes through the trocar assembly. The instrument is located at the distal end region of a long rod, which is transmitted to the body of the object via the trocar cannula. In the absence of a depth limiter, releasing the trocar assembly will cause the trocar assembly to fall to the side from the substantially upright position previously maintained. The trocar assembly tilting to the side may damage internal organs, and / or place the instrument located in the trocar assembly outside the sterile field, which may contaminate the instrument. Tilting to the side of the trocar cannula may damage the skin and / or other tissue at the point of entry into the body.

[0054] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or shown in the drawings and / or examples. The present invention is capable of other embodiments or can be practiced or implemented in various ways.

[0055] Reference now Figure 1 , which is a schematic diagram of a trocar assembly 102 including a depth limiter 150 according to some embodiments of the present invention. Referring now to Figure 2 , which is a perspective view of a depth limiter 150 according to some embodiments of the present invention. Referring now to Figure 3 , which is a side view of a depth limiter 150 according to some embodiments of the present invention. Figure 4 , which is a top view of a depth limiter 150 according to some embodiments of the present invention. Figure 5 , which is a bottom view of a depth limiter 150 according to some embodiments of the present invention. Figure 6 , which is a cross-sectional view of a depth limiter 150 according to some embodiments of the present invention. Referring now to Figure 7 , which is an exploded view of a depth limiter 150 according to some embodiments of the present invention. Referring now to Figure 8 , which is a schematic diagram of an exemplary sealing element 108 of a trocar assembly 102 according to some embodiments of the present invention. Fig. 9, which is a schematic diagram of an exemplary obturator 120 of a trocar assembly 120 according to some embodiments of the present invention. Fig.10 , which is a flow chart of an exemplary method of treating a subject using a depth limiter according to some embodiments of the present invention.

[0056] Now return to reference Figure 1 , the trocar assembly 102 includes a depth limiter component 150 positioned along the axis of the trocar cannula 110 .

[0057] An exemplary trocar cannula 110 is described, for example, with reference to US Provisional Patent Application Attorney Docket No. 94012, entitled "TROCAR INCLUDING CANNULA," the contents of which are incorporated herein by reference in their entirety.

[0058] The trocar assembly 102 may also include an obturator 120. The obturator 120 may be bladed or bladeless. The obturator 120 may include a piercing tip 122 for piercing the skin of a subject until entering a cavity, such as an abdominal cavity. After completing the penetration into the abdominal cavity, the obturator portion 120 may be removed from the trocar cannula 110. After removing the obturator portion, any number of surgical instruments, such as, for example, tissue fastening instruments, may be inserted through the cannula 110 of the trocar assembly 102 to perform a surgical procedure.

[0059] The trocar assembly 102 may include a trocar sleeve 104 including a trocar housing 106 and a trocar cannula 110. An obturator 120 may be designed to engage with the housing 106.

[0060] The trocar assembly 102 may include a sealing element 108 that is designed to engage the trocar housing 106. The sealing element 108 may be located within the obturator 120, and / or within the housing 106, and / or other designs may be implemented.

[0061] The depth limiter 150 includes an inner lumen sized and shaped to receive the trocar cannula 110 and a locking mechanism 152 that sets the trocar cannula 110 in a fixed position within the inner lumen and / or sets the depth limiter 150 at a fixed position along the trocar cannula 110. The inner diameter of the inner lumen of the depth limiter 150 is slightly larger than the outer diameter of the trocar cannula 110 to enable the depth limiter 150 to slide along the length of the trocar cannula 110.

[0062] The locking mechanism 152 may be reversible for releasing the trocar cannula 110 from a fixed position. Once the locking mechanism 152 is released, the trocar cannula 110 may be completely removed from the lumen and 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 has been repositioned, the locking mechanism 152 may be reactivated to secure the depth limiter 150 at a new position along the trocar cannula 110.

[0063] Optionally, the depth limiter 150 is made of a biocompatible material that is autoclavable, enables multiple washing and sterilization cycles (e.g., more than 100, or 500, or 1000 or other values), and / or is designed for multiple uses, such as polyetheretherketone (PEEK) and polyphenylsulfone (PPSU). Alternatively or in addition, the depth limiter 150 is made of a biocompatible material designed for disposable and / or single use.

[0064] The depth limiter 150, which secures the cannula 110 in place once the locking mechanism 152 has been activated, prevents the cannula 110 from sliding deeper into the patient's body (which could cause damage by contact with internal tissue) and / or prevents the cannula 110 from sliding out of the patient's body (which could complicate the procedure, cause gas to leak out of the body and / or cause contamination).

[0065] Exemplary dimensions for depth limiter 150 include:

[0066] * The inner diameter of the lumen of the depth limiter. The inner diameter is sized to provide an annular space between the outer diameter of the trocar cannula passing through the lumen. For a trocar cannula with an outer diameter of 5 mm, the inner diameter of the lumen is, for example, 8.5 mm or 9 mm, or 9.3 mm or 9.5 mm, or 10 mm. For a trocar cannula with an outer diameter of 12 mm, the inner diameter of the lumen is, for example, 15.5 mm or 16 mm, or 16.5 mm, or 16.9 mm, or 17.5 mm or 18 mm.

[0067] *For a trocar cannula having an outer diameter of 5 mm, the outer diameter of the depth limiter is in the range of 21.8 mm to 30.0 mm or 20.0 mm to 32.0 mm. For a trocar cannula having an outer diameter of 12 mm, the outer diameter of the depth limiter is in the range of 30 mm to 38 mm or 28 mm to 40 mm.

[0068] *The thickness of the depth limiter, i.e., the dimension measured along the long axis through the inner cavity from the distal end to the proximal end, is 18mm to 22mm, or 18mm, or 20mm, or 22mm, regardless of the intended outer diameter of the cannula needle cannula, for example, for 5mm and 12mm outer diameters of the cannula needle cannula.

[0069] The depth limiter may be sized to maintain a trocar assembly (i.e., a cannula including a trocar sleeve) in a substantially upright position, optionally when a body cavity (e.g., an abdominal cavity) has been inflated. The trocar assembly having the depth limiter placed thereon is maintained in an upright position while the trocar cannula is piercing the skin of a subject and in the subject's body. 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 an 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 when an instrument is passed through the trocar assembly. The instrument is located at a distal end region of a long shaft that is delivered into the subject's body via the trocar cannula. In the absence of a depth limiter, releasing the trocar assembly would cause the trocar assembly to fall to the side from the substantially upright position previously maintained. Tilting the trocar assembly to the side may damage internal organs and / or place instruments located in the trocar assembly outside the sterile field, which may contaminate the instruments. Tilting the trocar cannula to the side may damage the skin and / or other tissue at the entry point into the body.

[0070] The dimensions of the depth limiter can be selected to maintain the position of the trocar sleeve including the trocar cannula (optionally with the rod of the instrument passing through the trocar sleeve) within a range from substantially perpendicular to the subject's skin to more than about 30 degrees, or 45 degrees, or 60 degrees, or 74 degrees from the skin surface. The angle can be measured at the entry point into the body where the trocar cannula is located, formed between the major axis of the trocar cannula and a plane tangential to the skin. Examples of selected dimensions include: the thickness of the depth limiter (e.g., the difference between the inner diameter and the outer diameter 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 tilting. As another example, the height of the depth limiter (e.g., the distance between the distal surface and the proximal surface of the depth limiter) is sufficient to support the trocar sleeve and / or the trocar assembly (optionally when the instrument is delivered therein) to withstand the torque applied by the trocar sleeve and / or the trocar assembly and / or the rod of the instrument. As another example, the difference between the inner diameter of the lumen of the depth limiter and the outer diameter of the cannula may be small enough that the walls of the inner lumen provide sufficient support to the trocar sleeve cannula to withstand torque applied by instruments passing therethrough.

[0071] The locking mechanism may be designed to apply sufficient pressure to the cannula to withstand the torque applied by the rod of the instrument to maintain the rod in a substantially upright position.

[0072] Optionally, the inner cavity of the depth limiter 150 includes one or more guides that engage the trocar cannula 110 at a preselected position. For example, the inner cavity includes one or more guides that are designed to engage one or more recessed channels on the surface of the cannula 110. For another example, the inner surface of the inner cavity has a non-circular shape that is designed to engage a corresponding shape of the outer surface of the trocar cannula 110, such as a square, an oval, and a four-leaf clover. The guides, when engaged, prevent the cannula 110 from rotating within the inner cavity of the depth limiter 150 and / or help lock the cannula 110 within the depth limiter 150.

[0073] Optionally, the cannula 110 includes one or more raised features 130 on its outer surface, which are designed to be engaged by a locking mechanism, such as spaced apart raised rings, wherein the lock includes a C-shaped element that falls between the raised rings, or a ratchet, wherein the locking mechanism 152 includes a pawl, which is designed to allow the cannula to be easily removed but prevents the cannula from being pushed deeper unless the leaver is pressed to release the pawl. Optionally, the distal end 132 of the cannula does not include a raised feature 130 to prevent the user from fixing the depth limiter 150 at a position too low along the cannula 110, where the depth limiter 150 may not properly support and / or engage the cannula 110. In another exemplary implementation, the raised feature 130 can be set at a varying diameter, such as increasing or decreasing sequentially. For example, a maximum depth can be preselected, which can prevent the distal push of the cannula and / or can be removed. For example, the locking mechanism is set at a first diameter of the cannula 110. The diameter increases proximally along the cannula 110, which prevents the cannula 110 from being pushed distally into the subject's body. Before the cannula 110 is inserted into the lumen of the depth limiter 150, the locking mechanism 152 can be preset to a first diameter, which enables the user to blindly insert the cannula 110 at a predetermined depth by inserting the cannula 110 into the preset locking mechanism 152 of the depth limiter 150.

[0074] 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:

[0075] *Multiple depth limiters of the same size.

[0076] * Having multiple depth limiters with different diameter lumens. The different diameters are designed to accommodate trocar cannulas with different diameters. For example, one or more depth limiters with an internal lumen diameter of 5 mm, and one or more depth limiters with an internal lumen diameter of 12 mm.

[0077] * One or more trocar cannulas of the same and / or different sizes. The trocar cannulas are sized to fit within the depth limiter. For example, reference 94012 application describes an exemplary cannula.

[0078] * One or more trocar sleeves comprising a trocar housing and a trocar cannula. The trocar sleeves may be of the same and / or different sizes.

[0079] * One or more sealing elements, which are designed, for example, to engage the trocar housing. The sealing elements have the same and / or different sizes depending on the other corresponding components.

[0080] * One or more obturators designed to fit in the lumen of the trocar sleeve. The outer dimensions of the obturator are designed to be slightly smaller than the inner dimensions of the lumen of the trocar sleeve so that the obturator can 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 mm, or about 0.3 mm, or about 0.4 mm, or about 0.5 mm, or other values.

[0081] Now return to reference Figure 2 , illustrates an exemplary implementation of a locking mechanism 152 of a depth limiter 150. It should be appreciated that the depicted implementation is exemplary and not necessarily limiting, as other locking mechanisms may be used.

[0082] The depth limiter 150 includes a lumen 204 into which the trocar cannula is inserted and to which a locking mechanism 152 is applied.

[0083] The locking mechanism 152 can be set and / or released by lever 202. Pressing lever 202 inward

[0084] Optionally, the locking mechanism 152 includes a pressure element designed to apply mechanical pressure for setting the trocar cannula in a fixed position by friction. For example, pressing the lever 202 pushes the element applying pressure against the cannula. Releasing the lever 202 releases the element and the pressure. For example, the locking mechanism 152 includes a lever 202 connected to a C-shaped pin. The C-shaped pin is designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to pressure applied to the lever 202.

[0085] Alternatively or in addition, locking mechanism 152 engages with the trocar cannula to prevent movement of the trocar cannula, for example, pressing lever 202 pushes a movable protruding element into a recess in the wall of the cannula. When the protruding element engages in the recess, the cannula cannot move.

[0086] In this article, for example, reference Figure 1 Other exemplary implementations of the locking mechanism 152 are described.

[0087] In this article, for example, reference Figure 6 A proximal aperture 610 is depicted.

[0088] Now return to reference Figure 3 , the depth limiter 150 may include an outer surface 302 designed to reduce or prevent injury to the subject.

[0089] Optionally, the depth limiter 150 may include a tapered outer surface 302 that may include an outer diameter that decreases from a proximal surface 304 of the depth limiter 150 toward a distal surface 306 of the depth limiter 150. The tapering 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 positioned over the subject's skin. With a small amount of pressure applied to the depth limiter 150 (e.g., no external pressure such as by a user pressing), 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., the user presses down, delivers an instrument, sutures a trocar to the skin), the distal surface 306 presses down into the skin, and the surrounding nearby skin contacts the outer surface 302. As the pressure applied to the depth limiter 150 increases (which pushes the depth limiter 150 deeper into the skin surface), additional portions of the outer surface 302 of the depth limiter 150 come into contact with more skin. The total surface area of ​​the depth limiter 150 contacting the skin increases with increasing pressure and depth, which reduces the pressure applied by the depth limiter 150 on the skin. Reducing the pressure on the skin through the larger surface area of ​​the depth limiter 150 can reduce or prevent pressure damage to the skin, such as pressure ulcers, bruises, etc. In contrast, considering a non-tapered, substantially parallel (i.e., equal diameter) cross-sectional diameter of the depth limiter, in this case, the increased pressure on the depth limiter 150 increases the pressure applied by the restricted distal surface 306 on the skin, which can cause damage.

[0090] Surfaces 302 and / or 306 may be smooth to prevent or reduce damage to the skin. The smoothness may allow for effective cleaning and / or autoclaving of the depth limiter for repeated use.

[0091] The smooth rounded surface 308 may provide a transition connecting between 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.

[0092] Now return to reference Figure 4 , presents a top view of the depth limiter 150 , showing the proximal surface 304 .

[0093] Now return to reference Figure 5 , presents a bottom view of the depth limiter 150, showing the distal surface 306. Figure 6 The distal orifice 612 is depicted. Now returning to reference Figure 6 , a cross-sectional view of the depth limiter 150 is presented.

[0094] The depth limiter includes a housing 602 that includes the locking mechanism 152. The housing 602 has an inner surface 604 that defines the inner cavity 204. The housing 602 may also include an outer surface 302 (also referred to as an outer side 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 outer side 302.

[0095] The housing 602 includes one or more orifices that provide fluid communication between the internal cavity 614 of the housing 604 and the external environment 616. Optionally, the housing 602 includes one or more distal orifices 612 located on the distal surface 306 and / or one or more proximal orifices 610 located on the proximal surface 304. Optionally, at least two different orifices are provided. For example, in a specific implementation where the depth limiter 150 is designed for multiple uses, the orifices enable a washing fluid to enter the cavity 614 for washing out debris, and / or enable high pressure sterilization heat to enter the cavity 614 for sterilization. Optionally, the housing 602 includes two or more orifices so that a washing fluid can flow from the external environment 616 into the cavity 614 and out into the external environment 616.

[0096] The proximal orifice 610 and / or the distal orifice 612 can be arc-shaped, for example, extending along an arc having a length of about 10 degrees, or 15 degrees, or 30 degrees, or 45 degrees, or 60 degrees, or 90 degrees, or 180 degrees, or 10 degrees to 180 degrees, or 30 degrees to 60 degrees, or other values. The arc provides a large area of ​​the orifice so that a sufficient amount of washing fluid can enter and / or provide a large outlet to allow washing fluid and / or debris to leave. The arc provides a large port for disinfection of the internal cavity 614.

[0097] The housing 602 may include one or more lumen apertures 618 positioned along an inner surface 604 of the housing 602 defining the lumen 204. The lumen apertures 618 are in fluid communication with other apertures of the housing 602 that are in fluid communication with the external environment 616, such as the proximal aperture 610 and / or the distal aperture 612. The lumen apertures assist in washing the lumen surfaces and / or provide additional inlets and / or outlets for washing the interior cavity 614 and / or assist in disinfecting the interior cavity 614.

[0098] Optionally, the moving components of the locking mechanism 152 are disposed within an interior cavity 614 of the housing 602 and are in fluid communication with an external environment 616. Placing the moving components within the interior cavity 614 enables washing and / or sterilization of the moving components.

[0099] Now return to reference Figure 7 , which presents an exploded view of the components of the depth limiter 150.

[0100] Now return to reference Figure 8 , the exemplary sealing element 108 may be assembled as part of the trocar assembly 102, and / or included in one or more kits described herein.

[0101] Now return to reference Fig. 9 , the exemplary obturator 120 may be assembled as part of the trocar assembly 102, and / or included in one or more kits described herein.

[0102] Now return to reference Fig.10 At 1000, suitable components for assembling a cannula are optionally selected from a kit described herein. For example, the size of the components is selected according to the size of the subject. The cannula is assembled from the selected components.

[0103] At 1002, a trocar cannula is delivered into a subject's body via a lumen of a depth limiter. The trocar cannula may be delivered via an incision and / or puncture of the skin. The trocar cannula may be inserted into a cavity of the body, such as the abdominal cavity, chest, joint, etc.

[0104] The cavity may be inflated with gas to separate the skin from the underlying organs, thereby providing space for viewing and / or manipulating surgical instruments.

[0105] At 1004, a locking mechanism of the depth limiter is activated to set the trocar cannula at a selected fixed position.

[0106] The locking mechanism may be activated one-handedly after trocar insertion, optionally while the user (eg, surgeon) holds the cannula with the other hand, wherein the cannula is preloaded into the depth limiter.

[0107] Alternatively, the order of blocks 1002 and 1004 is reversed. Prior to insertion into the patient's body, the locking mechanism of the limited depth may first be activated to set the trocar cannula at a selected fixed position. The trocar cannula engaged with the depth limiter via the locking mechanism may 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 the depth limiter setting.

[0108] 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 at the new selected position.

[0109] At 1008, an instrument for treating tissue in the patient's body may be delivered via the trocar cannula secured at a selected fixed position by a locking mechanism of the depth limiter. The instrument may be used to treat a subject.

[0110] At 1010, the instrument may be released, for example, by a user holding the instrument. The depth limiter may be designed to support the instrument in a substantially upright position, thereby preventing the instrument from tipping sideways, as described herein. Alternatively, the trocar sleeve through which no instrument is passed is released. The depth limiter may be designed to support the trocar sleeve in a substantially upright position, thereby preventing the trocar sleeve from tipping sideways, as described herein.

[0111] After the body cavity is inflated, the trocar sleeve may be released.

[0112] At 1012, the locking mechanism is released.

[0113] The locking mechanism may be activated one-handedly after trocar insertion, optionally while the user (eg, surgeon) is holding the cannula with the other hand.

[0114] Remove the trocar cannula from the lumen of the depth limiter.

[0115] At 1014, for example, for different trocars, one or more features described with reference to 1002 to 1012 are iterated, such as for placing multiple trocars at different locations on the subject's body to provide multiple entry points for multiple instruments. These features may be iterated, for example, for adjusting the depth of the trocar cannula.

[0116] It is expected that during the life of a patent maturing from the present application, many related trocars will be developed, and the scope of the term trocar is intended a priori to include all such new technologies.

[0117] As used herein, the term "about" refers to ± 10%.

[0118] The terms "comprises," "comprising," "including," "containing," "having," and variations thereof mean "including but not limited to."

[0119] The term "consisting of" means "including and limited to."

[0120] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or components, but only if the additional ingredients, steps and / or components do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0121] As used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds (including mixtures thereof).

[0122] Throughout this application, various embodiments of the present invention can be presented in range format. It should be understood that the description of range format is only for convenience and brevity, and should not be construed as a fixed limitation to the scope of the invention. Therefore, the description of the scope should be considered as having all possible sub-ranges clearly disclosed and each numerical value within the scope. For example, the description of a range such as 1 to 6 should be considered as having sub-ranges clearly disclosed such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and each numerical value within the scope, such as 1, 2, 3, 4, 5 and 6. Regardless of the width of the scope, this applies.

[0123] Whenever a numerical range is indicated herein, it is meant to include any recited numeral (fractional or integer) within the indicated range. The phrases "a range is between" a first indicated numeral and a second indicated numeral and "a range is from" a first indicated numeral "to" a second indicated numeral are used interchangeably herein and are meant to include the first indicated numeral and the second indicated numeral and all fractions and integers therebetween.

[0124] As used herein, the term "method" refers to manners, means, techniques and procedures for accomplishing a given task, including but not limited to those manners, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine or readily developable from known manners, means, techniques and procedures.

[0125] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating clinical or aesthetic symptoms of a disorder, or substantially arresting the appearance of clinical or aesthetic symptoms of a disorder.

[0126] When reference is made to a particular sequence listing, such reference should be understood to also include sequences that substantially correspond to the complementary sequence thereof, including minor sequence variations resulting from, for example, sequencing errors, cloning errors, or other alterations leading to base substitutions, base deletions, or base additions, provided that the frequency of such variations is less than 1 nucleotide in 50 nucleotides, or less than 1 nucleotide in 100 nucleotides, or less than 1 nucleotide in 200 nucleotides, or less than 1 nucleotide in 500 nucleotides, or less than 1 nucleotide in 1000 nucleotides, or less than 1 nucleotide in 5,000 nucleotides, or less than 1 nucleotide in 10,000 nucleotides.

[0127] It should be understood that certain features of the invention described in the context of separate embodiments for the sake of clarity may also be provided in combination in a single embodiment. Conversely, various structures of the invention described in the context of a single embodiment for the sake of simplicity may also be provided individually or in any suitable sub-combination, or as appropriate in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiment does not function without those elements.

[0128] Although the present invention has been described in conjunction with its specific embodiments, it is apparent that many alternatives, modifications and variations are apparent to those skilled in the art. Therefore, this document is intended to cover all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0129] The applicant's intention is that all patent disclosures, patents and patent applications mentioned in this specification are incorporated into this specification by reference in their entirety, just as each individual patent disclosure, patent or patent application is clearly and independently indicated when quoted that each individual patent disclosure, patent or patent application is incorporated into this paper by reference. In addition, the citation or identification of any reference in this patent application should not be construed as admitting that such reference can be used as the prior art of the present invention. In the case of using section headings, they should not be construed as necessary restrictions. In addition, any priority document of the present application is hereby incorporated into this paper by reference in its entirety.

Claims

1. A kit for minimally invasive surgery, the kit comprising: Trocar intubation; and A depth limiter component, the depth limiter component comprising: an inner lumen sized and shaped to receive a trocar cannula, wherein an outer diameter of the trocar cannula is sized to correspond to an inner diameter of the inner lumen, a locking mechanism that sets the trocar cannula in a fixed position within the lumen, a housing including the inner cavity and the locking mechanism, and The housing includes at least one aperture, the at least one aperture providing fluid communication between an interior cavity of the housing and an external environment outside the housing.

2. The kit according to claim 1, wherein: The locking mechanism comprises a pressure element designed to exert a mechanical pressure for setting the trocar cannula in the fixed position by friction.

3. The kit according to claim 2, wherein: The locking mechanism includes a lever connected to a C-shaped pin designed to engage the trocar cannula and apply a mechanism pressure to the trocar cannula in response to pressure applied to the lever.

4. The kit according to claim 1, wherein: The locking mechanism includes a movable protruding element designed to engage a recessed portion of the trocar cannula.

5. The kit according to claim 1, wherein: The depth limiter also includes a substantially flat and smooth distal surface for contacting the skin of a subject surrounding the entry point of the trocar cannula.

6. The kit according to claim 1, wherein: The depth limiter also includes a substantially smooth tapered outer surface that tapers outwardly from an edge of the distal surface.

7. The kit according to claim 6, wherein: The depth limiter further includes a smooth rounded surface for connecting 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 in the thickness between the interior cavity and the exterior side surface.

9. The kit of claim 1, wherein: The at least one aperture of the housing includes at least one first aperture located on a distal surface of the housing and at least one second aperture located on a proximal surface of the housing.

10. The kit according to claim 9, wherein: At least one of the first aperture and the second aperture is arcuate.

11. The kit of claim 1, wherein: The housing includes at least one third aperture positioned along a surface of the housing forming the interior cavity, the at least one third aperture being in fluid communication with the at least one aperture of the housing.

12. The kit of claim 1, wherein: The moving components of the locking mechanism are disposed within the interior cavity of the housing and are in fluid communication with the external environment.

13. The kit of claim 1, wherein: The locking mechanism is reversible for releasing 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. The kit of claim 1, wherein: The depth limiter is dimensioned to maintain the trocar cannula in a substantially upright position generally perpendicular to the skin of a subject when 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 a substantially upright position approximately perpendicular to the skin when the instrument is inserted into the subject's body through the trocar cannula piercing the subject's skin and when the instrument is not supported by the external entity.

16. The kit of claim 1, wherein: The depth limiter component is made of an autoclavable biocompatible material designed for multi-use.

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

18. The kit of claim 17, wherein: The first guide element engages the second guide element to prevent 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 a plurality of different diameters for accommodating trocar cannulas of different diameters.

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

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

22. A method of performing a minimally invasive surgical procedure, the method comprising: delivering a trocar cannula into the body of the subject through the lumen of the depth limiter; as well as activating a locking mechanism of the depth limiter for setting the trocar cannula at a selected fixed position, Therein, an instrument for treating tissue in a patient's body is delivered via the trocar cannula which is secured at a selected fixed position by the locking mechanism of the depth limiter.

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

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