Universal size multi-walled elastomer cannula depth limiter

Abstract

The present invention provides a depth limiter configured to engage with the cannula of a trocar having a lateral cannula dimension. The depth limiter includes an outer frame portion and an inner gripping portion housed within the outer frame portion. The inner gripping portion includes a plurality of petal-shaped protrusions that are flexible relative to each other between a relaxed configuration and at least a first flexural configuration. In the relaxed configuration, the plurality of petal-shaped protrusions collectively form a first effective lateral dimension, which is configured to be smaller than the lateral cannula dimension. In the first flexural configuration, the plurality of petal-shaped protrusions collectively form a second effective lateral dimension, which is larger than the first effective lateral dimension and configured to be equal to the lateral cannula dimension, such that the size of the second effective lateral dimension is set to limit axial movement of the depth limiter relative to the cannula of the trocar.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Patent Application 202011018668, entitled “Universal Size Multi-Walled Elastomer Cannula Depth Limiter” and filed on May 1, 2020, the disclosure of which is incorporated by reference herein. BACKGROUND

[0003] Some surgical procedures can require a clinician to access a surgical site via a patient’s abdominal cavity. To gain such access, an opening is first formed through the abdominal wall tissue that overlies the abdominal cavity. In some surgical procedures, referred to as “laparoscopic” or “endoscopic” surgical procedures, a relatively small opening is formed through the abdominal wall tissue, and then an elongated instrument is used to access the surgical site, the elongated instrument being inserted through an access device, commonly referred to as a “trocar,” that is positioned within the opening. A conventional trocar generally includes a cannula assembly and an obturator that is removably received within a working channel of the cannula assembly. In use, the obturator cooperates with the cannula assembly, and the combined structure (i.e., the trocar) is directed downward by the clinician through the patient’s abdominal wall so that the distal end of the obturator and cannula assembly extends into the abdominal cavity. The clinician then withdraws the obturator from the cannula assembly so that a surgical instrument can be directed downward through the working channel of the cannula assembly to access the surgical site.

[0004] The following patents disclose cannulas, their components, and other types of surgical interventional devices only as exemplary models: U.S. Patent 7,981,092, entitled "Vibratory Trocar," published July 19, 2011; U.S. Patent 8,226,553, entitled "Access Device with Insert," published July 24, 2012; U.S. Patent 8,251,900, entitled "Surgical Access Devices and Methods Providing Seal Movement in Predefined Paths," published August 28, 2012; U.S. Patent 8,579,807, entitled "Absorbing Fluids in a Surgical Access Device," published November 12, 2013; U.S. Patent 8,568,362, entitled "Surgical Access Device with Sorbents," published October 29, 2013; and U.S. Patent 8,568,362, entitled "Surgical Access Device with Sorbents," published January 28, 2014. U.S. Patent 8,636,686, entitled “Device”; U.S. Patent 8,690,831, entitled “Gas Jet Fluid Removal in a Trocar”, published April 8, 2014; and U.S. Patent 2019 / 0000496, entitled “Method of Suturing a Trocar Path Incision”, published January 3, 2019. The disclosure of each of the above-cited U.S. patents and publications is incorporated herein by reference.

[0005] Although various surgical instruments, including surgical intervention devices and end effectors, and other associated components have been manufactured and used, it is believed that no one has manufactured or used the invention described in the appended claims prior to one or more inventors. Attached Figure Description

[0006] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0007] Figure 1 A perspective view of an exemplary cannula needle having a cannula assembly and a tampon shown in an assembled state is shown;

[0008] Figure 2 It is shown in the disassembled state. Figure 1Side front view of the cannulation assembly and tampon;

[0009] Figure 3A It shows that the clinician is manipulating Figure 1 A lateral cross-sectional view of the trocar penetrating the tissue layer of the abdominal wall;

[0010] Figure 3B It shows Figure 1 An enlarged side sectional view of the cannula, showing its reception in... Figure 3A The distal end of the trocar inserted into the abdominal cavity;

[0011] Figure 3C It shows Figure 1 A side sectional view of the cannulation assembly, showing how it remains positioned after the tampon is disassembled and removed. Figure 3A The cannulation assembly inside the abdominal wall;

[0012] Figure 3D It shows that Figure 1 The cannulation assembly from Figure 3A A lateral sectional view of the abdominal wall pulled out proximally;

[0013] Figure 4 A perspective view of another exemplary cannula with a cannula assembly and a tampon shown in an assembled state is shown;

[0014] Figure 5 It is shown in the disassembled state. Figure 4 A perspective view of the cannula assembly and tampon, showing the reusable cannula and disposable sealing assembly of the cannula assembly separated from each other, and showing the tampon in a disassembled state;

[0015] Figure 6 It shows Figure 4 A perspective view of the cannula needle, showing an exemplary depth limiter of the cannula selectively coupled to the cannulation assembly;

[0016] Figure 7 It shows Figure 6 A perspective view of the depth limiter;

[0017] Figure 8A It shows Figure 6 The top front view of the depth limiter shows the lobe-shaped protrusion of the depth limiter in a relaxed configuration;

[0018] Figure 8B It shows something similar to Figure 8A The top front view shows Figure 6 A depth limiter that surrounds a depth limiter with a depth ratio of Figure 4The smaller lateral dimension of the cannula needle positions the cannula, causing the lobe-shaped protrusion of the depth limiter to be pushed radially outward from the cannula to a first flexural configuration, so as to selectively engage the depth limiter with the cannula.

[0019] Figure 8C It shows something similar to Figure 8B The top front view shows Figure 6 The depth limiter, which surrounds Figure 4 The cannula is positioned such that the petal-shaped protrusion of the depth limiter is pushed radially outward from the cannula to a second flexural configuration to selectively engage the depth limiter with the cannula.

[0020] Figure 9 A perspective view of another exemplary depth limiter with multiple stability tabs is shown;

[0021] Figure 10A It shows Figure 9 A perspective view of a depth limiter that is selectively coupled to the trocar during the clinician's manipulation of the cannula through layers of abdominal wall tissue. Figure 4 The cannula of the trocar is inserted and pressed against the cannula. Figure 3A placement on the abdominal wall;

[0022] Figure 10B It shows something similar to Figure 10A A perspective view showing Figure 9 The depth limiter is selectively attached to the abdominal wall via a stabilizing tab;

[0023] Figure 11 A perspective view of another exemplary depth limiter including four legs is shown;

[0024] Figure 12A It shows the relationship with Figure 1 The cannulation assembly of the trocar and the cannulation tubing connection. Figure 11 A partial side sectional view of the depth limiter, wherein the legs of the depth limiter are in a non-deployed configuration when the distal end of the cannula is received in the abdominal cavity;

[0025] Figure 12B The following is shown after the packer is separated and removed. Figure 1 The cannula connection of the cannula assembly. Figure 11 A partial side sectional view of the depth limiter, wherein the legs of the depth limiter are in an extended configuration when the distal end of the cannula is received in the abdominal cavity;

[0026] Figure 13 A perspective view of another exemplary depth limiter including two legs is shown;

[0027] Figure 14A perspective view of another exemplary depth limiter including three legs is shown;

[0028] Figure 15 A perspective view of another exemplary depth limiter including a hub with a notch is shown;

[0029] Figure 16A It shows the relationship with Figure 5 The cannula connection of the cannula assembly. Figure 15 Top plan view of the depth limiter, wherein the hub of the depth limiter is in a movable configuration;

[0030] Figure 16B The following is shown after the packer is separated and removed. Figure 5 The cannula connection of the cannula assembly. Figure 15 A partial side sectional view of the depth limiter, wherein the legs of the depth limiter are in a fixed configuration;

[0031] Figure 17A It shows the relationship with Figure 5 The cannula connection of the cannula assembly. Figure 15 A partial side sectional view of the depth limiter, in which the legs of the depth limiter are in an unfolded configuration;

[0032] Figure 17B The following is shown after the packer is separated and removed. Figure 5 The cannula connection of the cannula assembly. Figure 15 A partial side sectional view of the depth limiter, wherein the legs of the depth limiter are in an extended configuration; and

[0033] Figure 18 A top cross-sectional view of another exemplary depth limiter, including a fluid chamber and four legs, is shown.

[0034] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the invention can be conceived to be implemented in many other ways, including those not necessarily shown in the drawings. The drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the explicit arrangements shown. Detailed Implementation

[0035] The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a preferred mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different and obvious aspects, all of which are not departing from the invention. Therefore, the drawings and descriptions should be regarded as substantially illustrative and not restrictive.

[0036] For clarity of disclosure, the terms "proximal" and "distal" are defined herein in relation to the surgeon or other operator who grasps the surgical device. The term "proximal" refers to a position where the element is positioned closer to the surgeon, and the term "distal" refers to a position where the element is positioned further away from the surgeon. Furthermore, the extent to which spatial terms such as "top," "bottom," "upper," "lower," "vertical," and "horizontal" are used herein with reference to the accompanying drawings should be understood to be for illustrative purposes only and not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions, not limited to those shown and described herein.

[0037] Furthermore, the terms “about” and “approximately” used herein in connection with any numerical value or range are intended to cover the exact value referenced, as well as the appropriate tolerance that enables the referenced feature or combination of features to be used for the intended purpose described herein.

[0038] I. Exemplary Single Use Trocars and Reusable Trocars

[0039] Figures 1-5 Exemplary surgical interventional devices are shown in the form of a single-use first cannula (10) and a reusable second cannula (110), each cannula configured to provide surgical site access in laparoscopic surgical procedures. Each cannula (10, 110) includes a cannula assembly (12, 112) having a working channel (14, 114) and a tampon (16, 116) configured to be removably and coaxially inserted into the working channel (14, 114) such that the assembled cannula (10, 110) can be guided distally through the patient's abdominal wall and approach the abdominal cavity, for example, as described below. Figures 3A-3D As stated above.

[0040] A. Exemplary Single Use Trocar

[0041] like Figures 1-2As shown, the cannulation assembly (12) of a single-use trocar (10) includes a cannula (20) and a sealing housing (30). The cannula (20) and the sealing housing (30) cooperate to define a working channel (14) that extends longitudinally along the central axis (A) of the trocar (10). Specifically, the working channel (14) is defined by the lumen of the cannula (20) communicating with the hollow interior of the sealing housing (30). The cannulation assembly (12) is configured to receive elongated surgical instruments distally through the working channel (14) to provide access to surgical sites within the patient's abdominal cavity. As described in more detail below, the sealing housing (30) houses a pair of sealing structures that define a sealing assembly configured to retain airflow into the patient's abdominal cavity while allowing surgical instruments and tissue debris to pass through the working channel (14).

[0042] The cannula (20) of this type may include: a bell-shaped hub (not shown) located at the proximal end of the cannula; and an elongated cylindrical tube (22) extending distally from the hub and terminating at an angled cannula tip (24). The outer surface of the cannula (22) includes a plurality of tissue gripping features in the form of annular ribs (26) axially arranged along the middle portion of the cannula (22). The ribs (26) are configured to grip the abdominal wall tissue layers through which the cannula (20) is inserted, thereby aiding in stabilizing the cannula (20) in both the axial and radial directions when it is positioned within an opening formed in the patient's abdominal wall.

[0043] More specifically, in this example, the tissue-holding ribs (26) are formed in an annular fan shape in the sidewall of the cannula (22), such that each rib (26) tapers radially inward from its outermost radial edge in a distal direction. Thus, the outermost radial edge of the ribs (26) is approximately flush with the unribbed proximal and distal portions of the cannula (22). The configuration of the resulting ribs (26) facilitates the distal advancement of the cannula (22) through the tissue layer and prevents its retraction through the tissue layer in the opposite proximal direction. Advantageously, this configuration prevents accidental withdrawal of the cannula (22) from the patient's abdominal wall during surgical procedures. However, it should be understood that in other types of cannulas (10), the cannula (22) may be provided with various other types of tissue-holding features. For example, the cannula (22) may include tissue gripping features in the form of one or more spiral ribs that extend around at least a middle portion of the cannula (22) and may be fan-shaped similar to ribs (26).

[0044] The sealing housing (30) of the cannula assembly (12) includes a proximal housing portion (32) and a distal housing portion (34), the proximal housing portion (32) being removably attached to the distal housing portion. The proximal housing portion (32) includes a proximal head (36) and a distal base (38) fixed together. The distal housing portion (34) includes: a distal shield (40) surrounding a proximal hub (not shown) of the cannula (20); a cover plate (42) fixed to the proximal end of the distal shield (40); and a latching ring (44) rotatably disposed between the distal shield and the cover plate and having a radially outwardly projecting tab (46). The latching ring (44) is selectively rotatable between a locked position and an unlocked position about the central axis (A) of the cannula needle (10) via the tab (46). In the locked position, the latch ring (44) locks the proximal housing portion (32) to the distal housing portion (34). In the unlocked position, the latch ring (44) allows the proximal housing portion (32) to separate from the distal housing portion (34), for example, to directly access the distal sealing structure (not shown) housed within the distal housing portion (34). In some configurations, the distal shield (40) may be integrally formed with the proximal end of the cannula (22), such that the distal shield (40) is a component of the cannula (20).

[0045] Although not shown, the proximal housing portion (32) houses a proximal (or "outer") sealing structure, and the distal housing portion (34) houses a distal (or "inner") sealing structure, both arranged along the central axis (A) of the cannula (10). The proximal and distal sealing structures cooperate to define a sealing assembly that retains airflow into the patient's abdominal cavity during surgical procedures while allowing surgical instruments and tissue debris to pass through the working channel (14). For example, the proximal sealing structure may include an annular sealing member configured to sealably engage the axis of a laparoscopic surgical instrument guided through the working channel (14). The distal end sealing structure may include a duckbill-shaped sealing member configured to maintain the working channel (14) in a sealed state even without the surgical instrument axis.

[0046] The cannulation assembly (12) also includes a blow-in port (50) operably coupled to the proximal end of the cannula (20) and having an adjustable valve in the form of a stopcock valve (52). The blow-in port (50) is configured to guide a blow-in fluid, such as carbon dioxide, from a fluid source (not shown) distally through the working channel (14) and toward the patient's abdominal cavity, thereby expanding (or "blowing in") the cavity with fluid. This expansion of the abdominal cavity creates additional space for easier execution of laparoscopic surgical procedures.

[0047] like Figure 1 and Figure 2As shown, the tampon (16) of the cannula (10) includes a proximal head (60), an elongated cylindrical shaft (62) extending distally from the head (60), and a tapered distal tip (64). The tampon shaft (62) is configured to be received within the working channel (14) of the cannula assembly (12) such that the tampon tip (64) extends distally through the cannula tip (24). The tampon head (60) includes a dome-shaped upper body (66), a base plate (68), and an actuable latching member (70) including a pair of latching arms (72) and a corresponding pair of latching buttons (74). The latching arms (72) are configured to be engaged in corresponding slots (not shown) formed in the top surface of the sealing housing head (36) to connect the tampon (16) to the cannula assembly (12). A latch button (74) is actuable to release the locking arm (72) from the slot, thereby allowing the tampon (16) to separate from the cannulation assembly (12). The tampon (16) also includes a central channel (76) extending longitudinally through the tampon head (60) and the tampon shaft (62), and is configured to receive an endoscope (not shown) therein to provide visualization during insertion of the cannula (10) through the patient's abdominal wall. A clamping rod (78) of the tampon head (60) is pivotable to selectively secure the endoscope within the central channel (76). The central channel (76) and the clamping rod (78) are merely optional features and may be omitted from the tampon (16) in other configurations.

[0048] The cannulation assembly (12) and the tampon (16) may be configured to be disposed of after a single use on a patient. In other configurations, one or more components of the cannula (10) may be suitably configured to withstand sterilization and multiple reuses, for example, as described below. Figures 4-5 The cannula (110) is described in more detail.

[0049] B. Exemplary Deployment of a Trocar to Access a Patient's Abdominal Cavity

[0050] Figures 3A-3D An exemplary method is shown for using the aforementioned cannula (10) to pass through the patient's abdominal wall (2) to access the patient's abdominal cavity (1). It should be understood that the abdominal wall (2) comprises a superficial layer extending outwards and a deep layer extending inwards. The superficial layer typically comprises an outer layer of skin (3) and an inner layer of fat (4); while the deeper layers comprise alternating layers of muscle (5) and fascia (6), which are fibrous and flexible and have relatively higher tensile strength than the superficial layers.

[0051] like Figure 3AAs shown, with the packer (16) received within the cannulation assembly (12) and connected to the sealing housing (30), the clinician manipulates the cannula (10) via the packer head (60) and the sealing housing (30) to push the packer tip (64) against the skin (3) and medially toward the abdominal cavity (1) while rotating the cannula (10) back and forth. Continued medial pushing of the cannula (10) further guides the packer tip (64) and the cannula tip (24) distally through the layers of fat (4) and fascia (5) and toward the cavity (1), as... Figure 3B As shown. As discussed above, this step is facilitated by visualization provided by an endoscope (not shown) mounted within the tampon (16). Once the cannula (20) has reached the desired depth in the insertion cavity (1), the clinician releases the tampon head (60) from the sealed housing (30) by pressing the latch button (74), and then withdraws the tampon (16) proximally from the cannula assembly (12), as... Figure 3C As shown. This allows the working channel (14) of the cannulation assembly (12) to freely receive surgical instruments passing distally through it for performing laparoscopic surgical procedures. As described above, the tissue engagement ribs (26) located on the cannulation channel (22) grip the tissue layers (3,4,5) of the abdominal wall (2), thereby providing the cannulation assembly (12) with at least a minimum degree of stability relative to the abdominal wall (2). After completing the laparoscopic surgical procedure, the clinician grasps the sealing housing (30) and withdraws the cannulation assembly (12) proximally from the abdominal wall (2), as... Figure 3D As shown.

[0052] C. Exemplary Reusable Trocar with Disposable Seal Assembly

[0053] In some cases, it may be desirable to construct the cannula so that one or more of its components can be sterilized and reused for multiple surgical procedures, while one or more other components can be easily and economically disposed of and replaced after each procedure. Figures 4-5 Another exemplary trocar (110) constructed in this manner is shown, which has a similar structure and function to the trocar (10) described above, unless otherwise described below.

[0054] Similar to the cannula (10), the cannula (110) includes a cannula assembly (112) having a working channel (114) and a tampon (116) configured to be coaxially inserted into the cannula assembly (112) along the working channel (114). The cannula assembly (112) includes a cannula (120) having: a bell-shaped hub (122) located at the proximal end of the cannula; and an elongated cylindrical tube (124) extending distally from the hub (122) and terminating at an angled cannula tip (126). The outer surface of the cannula (124) includes a plurality of tissue gripping features in the form of annular ribs (128) arranged axially along the middle portion of the cannula (124) and similar to the ribs (26) described above.

[0055] The cannulation assembly (112) also includes a sealing assembly (130). Unlike the sealing assembly defined by the sealing housing (30) of the cannula (10), the sealing assembly (130) is constructed as a modular, replaceable unit, designed to releasably engage with the proximal hub (122) of the cannula (120). Figure 5 As best shown, the sealing assembly (130) of this example typically includes an upper frame member (132), an intermediate frame member (134), and a lower frame member (136) arranged coaxially and fixed relative to each other. Although not shown, the proximal (or "outer") sealing structure is supported within the upper frame member (132), while the distal (or "inner") sealing structure is supported within the lower frame member (136). Such sealing structures may be structurally and functionally similar to the proximal and distal sealing structures of the cannula needle (10) described above. The sealing assembly (130) also includes a blow-in port (140) having an adjustable valve in the form of a stopcock valve (142).

[0056] The lower portion of the sealing assembly (130) distal to the inlet port (140) is configured to be housed within the proximal hub (122) of the cannula (120), such that an annular sealing member (144) arranged circumferentially around the lower portion seals against the inner surface of the cannula hub (122). In this manner, the interior of the sealing assembly (130) is in fluid communication with the lumen of the cannula (120) to define a working channel (114) for the cannula assembly (112), through which inlet fluid, surgical instruments, and tissue fragments can be guided, in a manner generally described above in conjunction with the cannula (10). The sealing assembly (130) may be further constructed in accordance with the teachings of one or more of the following patents: U.S. Patent Publication 2019 / 0090905 entitled “Trocar Seal Assemblies”, published March 28, 2019, the disclosure of which is incorporated herein by reference; and / or U.S. Patent Publication 2019 / 0380742 entitled “Asymmetric Shaft Seal”, published December 19, 2019, the disclosure of which is incorporated herein by reference.

[0057] like Figure 5 As best shown, the tampon (116) of the cannula (110) includes a proximal head (150), an elongated cylindrical shaft (152) extending distally from the head (150), and a tapered tip (154) located at the distal end of the shaft (152). The tampon head (150) includes a dome-shaped upper body (156), a base plate (158), and an actuable latching member (160) including a pair of downwardly extending latching arms (162) and a corresponding pair of latching buttons (164). The latching arms (162) are configured to be captured within corresponding slots (138) formed in the top surface of the upper frame member (132) of the sealing assembly (130) to engage the tampon (116) with the cannula assembly (112). The latch button (164) is actuable to release the locking arm (162) from the slot (138), thereby allowing the tampon (116) to separate from the cannulation assembly (112).

[0058] The cannula (120) and tampon (116) in this example are suitably constructed of robust materials such as surgical steel, allowing them to be sterilized and reused for multiple surgical procedures. In contrast, as described above, the sealing assembly (130) is constructed as a single-use unit, intended to be separate from the cannula (120) and replaced after each procedure. For example, the sealing assembly (130) may be constructed of a variety of polymeric materials, including plastics and rubber, making it easy to manufacture and sell at a price that allows the sealing assembly (130) to be disposed of after a single use, similar to the cannula (10) described above.

[0059] II. Exemplary Universal Size Multi-Wall Elastomeric Depth Limiter

[0060] In some cases, clinicians may wish to limit the depth to which a single-use or reusable cannula (10, 110) may travel within the abdominal wall (2) (e.g., after inserting the cannula (10, 110) to the desired location). Limiting the depth to which the cannula (10, 110) may travel within the abdominal wall (2) helps prevent the distal tips (64, 154) of the packer (16, 116) and / or the cannula tips (24, 126) of the cannulation assembly (12, 112) from inadvertently approaching deeper into the abdominal cavity (1) than desired. Preventing over-insertion of the cannula (10, 110) reduces undesirable contact between the distal tips (64, 154) and / or the cannula tips (24, 126) and the anatomical structures contained within the abdominal cavity (1). Preventing over-insertion of the cannula (10, 110) also avoids inadvertently reducing the available surgical working space within the abdominal cavity (1).

[0061] Alternatively, or in addition to limiting the depth to which a single-use or reusable cannula (10, 110) may travel in the abdominal wall (2), the clinician may wish to stabilize the cannula (10, 110) relative to the abdominal wall (2) (e.g., after inserting the cannula (10, 110) to the desired location in the abdominal cavity (1)). The clinician can stabilize the cannula (10, 110) relative to the abdominal wall (2) by avoiding under-insertion of the cannula (10, 110). Stabilizing the cannula (10, 110) relative to the abdominal wall (2) after insertion into the abdominal wall (2) helps prevent the cannula (10, 110) from inadvertently pivoting around the insertion point in the abdominal wall (2) after the clinician releases the cannula (10, 110). The cannula (10, 110) stabilizes the insertion tip (24, 126) and thus keeps the surgical instruments close to the entry point of the abdominal cavity (1) in the desired position and / or orientation relative to the abdominal cavity (1), so that the surgical instruments can be easily guided distally through the cannula (10, 110) at a working angle convenient for the clinician.

[0062] A. Exemplary Universal Size Multi-Wall Elastomeric Depth Limiter

[0063] Figure 6 A first exemplary depth limiter (200) is shown for an insertion conduit (124) selectively coupled to a second trocar (110). As described in more detail below, the depth limiter (200) can selectively limit the depth to which the trocar (110) can travel distally into the abdominal wall (2).

[0064] like Figures 7-8CAs best shown, the depth limiter (200) includes a relatively rigid outer frame portion (202) that accommodates a relatively flexible inner gripping portion (204), such that the inner gripping portion (204) is in at least one relaxed configuration (e.g., Figure 8A ) and at least one flexural configuration (e.g., Figure 8B and Figure 8C The inner gripping portion (204) is flexible relative to the outer frame portion (202). For example, the outer frame portion (202) may be made of a relatively rigid polymer material (such as a plastic material (e.g., polycarbonate)) and the inner gripping portion (204) may be made of a relatively flexible elastic material (e.g., rubber). In one example, the outer frame portion (202) and the inner gripping portion (204) are integrally formed together as a single piece. For example, the depth limiter (200) may be constructed via a secondary molding process (also known as "overmolding"), such that the outer frame portion (202) and the inner gripping portion (204) are each injection molded, one injection molded onto the other. In another example, the outer frame portion (202) and the inner gripping portion (204) are separately formed into different parts, and the inner gripping portion (204) is assembled onto the outer frame portion (202) after forming. This type of construction allows the depth restrictor (200) to be considered a single-use unit, designed to be separate from the cannula (120) and replaced after each procedure. For example, this construction allows the depth restrictor (200) to be easily manufactured and sold at a certain price point, making the depth restrictor (200) suitable for disposal after single use, similar to the cannula (10) and sealing assembly (130) described above. In other forms, one or more portions of the depth restrictor (200) may be formed from surgical steel or other materials suitable for making the depth restrictor sterilizable and reusable for multiple surgical procedures.

[0065] In the example shown, the depth limiter (200) has a generally hollow, cap-shaped profile. For this purpose, the outer frame portion (202) includes a proximal cylindrical hub (206) and a distal flat annular flange (208) extending radially outward from the proximal cylindrical hub. The cylindrical hub (206) includes a plurality of proximal recesses (210) spaced evenly around it circumferentially and defining a generally cylindrical inner bore (212) extending longitudinally along the central axis (C) of the depth limiter (200). In the example shown, the cylindrical hub (206) includes three generally elongated rectangular recesses (210). As described in more detail below, the recesses (210) and the inner bore (212) are configured to collectively accommodate an internal gripping portion (204).

[0066] In this respect, the internal gripping portion (204) includes a plurality of flexible wall or petal-shaped protrusions (220) interconnected at or near their radially outer ends via corresponding apexes or joints (222). In the example shown, the internal gripping portion (204) includes three petal-shaped protrusions (220) interconnected at three corresponding generally elongated rectangular joints (222), such that the internal gripping portion (204) has a generally triangular profile. While the outer frame portion (202) is shown having three recesses (210) and the internal gripping portion (204) is shown having three corresponding petal-shaped protrusions (220) and joints (222), other forms of the depth limiter (200) may be provided with various other numbers and arrangements of these features.

[0067] In the example shown, each lobe-shaped protrusion (220) is elastically biased radially inward relative to the central axis (C) along its length toward the relaxed configuration, as... Figure 8A As shown. Therefore, at least when the petal-shaped protrusions (220) are in a relaxed configuration, each of the petal-shaped protrusions (220) is radially inwardly bent along an arcuate or flexed path. The connector (222) is securely received within a corresponding recess (210) of the cylindrical hub (206), thereby connecting the inner gripping portion (204) to the outer frame portion (202). The petal-shaped protrusions (220) are flexibly received within the inner bore (212) of the cylindrical hub (206), allowing the petal-shaped protrusions (220) to flex radially outward from the relaxed configuration toward at least one flexural configuration, thereby gripping the outer surface of the insertion channel (124) of the cannula needle (110), as... Figure 8B and Figure 8C As shown. For example, at least when the petal-shaped protrusion (220) is in a relaxed configuration, the inner surface of the inner hole (212) may be spaced apart from the petal-shaped protrusion (220). In this way, the petal-shaped protrusions (220) collectively define an expandable, generally triangular inner hole (224) that extends longitudinally along the central axis (C) of the depth limiter (200) and has an unexpanded configuration when the petal-shaped protrusions (220) are in a relaxed configuration and at least one expanded configuration when the petal-shaped protrusions (220) are in at least one flexed configuration.

[0068] More specifically, and as Figure 8A As shown, when the petal-shaped protrusions (220) are in a relaxed configuration, the petal-shaped protrusions (220) can collectively form a first effective lateral dimension (D1), which extends along the diameter through the central axis C between the radially innermost portions or apexes of the petal-shaped protrusions (220) and is smaller than the lateral dimension of the insertion channel (124) of the cannula (110). Figure 8BAs shown, when the petal-shaped protrusions (220) are in the first flexural configuration, the petal-shaped protrusions (220) can collectively form a second effective lateral dimension (D2), which extends diametrically through the central axis (C) between the radially innermost portions or apexes of the petal-shaped protrusions (220) and is substantially equal to the lateral dimension of the cannula (124') (which is smaller than the lateral dimension of the cannula (124')) to selectively restrict the axial movement of the depth limiter (200) relative to the cannula (124'). In this respect, frictional interference conditions may be generated between the cannula (124') and the petal-shaped protrusions (220). In one example, the second effective lateral dimension (D2) may be approximately 5 mm. And as... Figure 8C As shown, when the petal-shaped protrusions (220) are in the second flexural configuration, the petal-shaped protrusions (220) can collectively define a third effective lateral dimension (D3), which extends diametrically through the central axis (C) between the radially innermost portions or apexes of the petal-shaped protrusions (220) and is substantially equal to the lateral dimension of the cannula (124') to selectively restrict the axial movement of the depth limiter (200) relative to the cannula (124'). In this respect, frictional interference conditions may be generated between the cannula (124) and the petal-shaped protrusions (220). In one example, the third effective lateral dimension (D3) may be approximately 12 mm.

[0069] The illustrated petal-shaped protrusions (220) are configured to directly grip the outer surface (such as ribs (128)) of the cannula (124, 124') when pushed into the corresponding flexural configuration via the cannula (124, 124'), thereby generating frictional interference conditions to limit the axial movement of the depth limiter (200) relative to the cannula (124, 124') via the elasticity of the petal-shaped protrusions (220). In some examples, each petal-shaped protrusion (220) is configured to extend through and grip multiple ribs (128). It should be understood that the lobed protrusion (220) may include one or more tube gripping features (such as a textured radially inner surface or a radially inwardly extending ridge (not shown)) configured to grip the outer surface (such as a rib (128)) of the cannula (124, 124') and thereby help to limit the axial movement of the depth limiter (200) relative to the cannula (124, 124').

[0070] Therefore, the flap protrusion (220) can be configured to receive and frictionally engage cannulas (124, 124') having various lateral dimensions, including, for example, cannulas (124, 124') with lateral dimensions between approximately 5 mm and approximately 12 mm. It should be understood that this frictional engagement between the flap protrusion (220) and the cannulas (124, 124') can be overcome by a threshold thrust (e.g., distally guided) or pull (e.g., proximally guided) applied by the user's hand to the depth limiter (200), sufficient to frictionally disengage the flap protrusion (220) from the cannulas (124, 124') and allow axial movement of the depth limiter (200) relative to the cannulas (124, 124'), such as by sliding the flap protrusion (220) along the cannulas (124, 124').

[0071] During operation and continue to refer to Figures 8A-8C The depth limiter (200) is initially positioned around the cannula (124, 124') of the cannula (110), such that the cannula (124, 124') directs the flap protrusion (220) from... Figure 8A The relaxed configuration shown is pushed radially outward to Figure 8B or Figure 8C The corresponding flexural configuration shown allows the cannula (124, 124') to be received within an expandable inner bore (224) before the cannula (110) is deployed into the patient's abdominal cavity (1). In one example, the central axis (C) of the depth limiter (200) may coincide with the central axis (not shown) of the cannula (110).

[0072] During deployment of the cannula (110) into the abdominal cavity (1), the flap-shaped protrusion (220) can be maintained in a flexural configuration, thereby limiting axial movement of the depth limiter (200) relative to the cannulation channel (124, 124') of the cannula (110). For example, a clinician may wish to position the depth limiter (200) at a predetermined axial location along the cannulation channel (124, 124') corresponding to the desired insertion depth of the cannula (120) within the cavity (1). Therefore, the clinician can manipulate the depth limiter (200) to apply a threshold thrust or pull force sufficient to overcome the frictional engagement between the flap protrusion (220) and the cannula (124, 124'), thereby enabling the depth limiter (200) to move axially along the cannula (124, 124') effectively and ergonomically by sliding the flap protrusion (220) along the cannula (124, 124') to a predetermined axial position. Once the depth limiter (200) is in the predetermined axial position, the clinician can release the depth limiter (200), thereby allowing the frictional engagement between the flap protrusion (220) and the cannula (124, 124') to hold the depth limiter (200) in the predetermined axial position.

[0073] With the depth limiter (200) positioned around the cannulation channel (124, 124'), the clinician can deploy the cannula (110) into the patient's abdominal cavity (1), as described above. Figure 3A and Figure 3B The cannula (120) is positioned at the desired insertion depth within the cavity (1). Contact between the distal flange (208) of the depth limiter (200) and the abdominal wall (2) provides the clinician with a visual and / or tactile indication that the cannula (120) has reached the desired insertion depth within the cavity (1). In this manner, the depth limiter (200) helps prevent the distal tip (154) of the tampon (116) and / or the tip (126) of the cannula assembly (112) from inadvertently approaching a location deeper than desired within the abdominal cavity (1) during deployment.

[0074] In some cases, it may be desirable to adjust the axial position of the depth limiter (200) along the cannula (124, 124') after the depth limiter (200) has been attached to the cannula (124, 124'). Therefore, the clinician can manipulate the depth limiter (200) again to apply a threshold thrust or pull sufficient to overcome the frictional engagement between the flap protrusion (220) and the cannula (124, 124') to allow the depth limiter (200) to move effectively and ergonomically along the cannula (124, 124') by sliding the flap protrusion (220) along the cannula (124, 124') to a new axial position. Once the depth restrictor (200) is in its new axial position, the clinician can release the depth restrictor (200), allowing the flap protrusion (220) and the cannula (124, 124') to re-engage frictionally, thus holding the depth restrictor (200) in the new axial position. Therefore, the clinician can adjust the axial position of the depth restrictor (200) along the cannula (124, 124') and subsequently re-secure the depth restrictor (200) to the cannula (124, 124') by simply releasing the depth restrictor (200).

[0075] A depth limiter (200) is securely attached to the cannulation channel (124, 124') during laparoscopic surgical procedures, wherein the distal flange (208) of the depth limiter (200) is positioned against the abdominal wall (2). In this manner, the depth limiter (200) helps prevent the tip (126) of the cannulation assembly (112) from inadvertently approaching a deeper location in the abdominal cavity (1) than desired during laparoscopic surgical procedures, and also helps stabilize the cannulation channel (124, 124') relative to the abdominal wall (2).

[0076] After the laparoscopic surgical procedure is completed, the depth limiter (200) can be withdrawn proximally from the abdominal wall (2) along with the cannulation assembly (112). The depth limiter (200) can be removed from the cannulation channel (124, 124') by overcoming the frictional engagement between the flap protrusion (220) and the cannulation channel (124, 124') as described above. In one example, the depth limiter (200) can be simply disposed of after the completion of a single laparoscopic surgical procedure.

[0077] B. Exemplary Universal Size Multi-Wall Elastomeric Depth Limiter with Stability Tab

[0078] In some cases, it may be desirable to provide a cannulation depth limiter with additional stabilizing features to make the cannula more firmly stable relative to the patient’s abdominal wall (2). Figure 9A second exemplary depth limiter (300) including such features is shown. Similar to the depth limiter (200), the depth limiter (300) can selectively limit the depth to which the cannula (110) can travel distally into the abdominal wall (2). The depth limiter (300) is substantially similar to the depth limiter (200) and includes various similar features. Therefore, only the different features are described below.

[0079] The depth limiter (300) of this type includes an outer frame portion (302) comprising a proximal cylindrical hub (206) and a distal flat annular flange (308) extending radially outward from the proximal cylindrical hub. The flange (308) is generally similar to the flange (208), except that the flange (308) includes a plurality of holes (330) spaced circumferentially around it, and also includes a pair of inwardly facing protrusions (332) positioned on opposite sides of each hole (330). The outer frame portion (302) also includes a plurality of stabilizing tabs (340) pivotally connected to the flange (308) via corresponding hinges (342) adjacent to corresponding holes (330), such that each stabilizing tab (340) is pivotable relative to the flange (308) between a corresponding unfolded configuration in which the stabilizing tab (340) is received within the hole (330) and a corresponding retracted configuration in which the stabilizing tab (340) pivots proximally away from the hole (330) about the hinge (342). Each of the hinges (342) shown includes a thinned portion of the same material as the flange (308) and the stabilizing tab (340), allowing the stabilizing tab (340) to bend relative to the flange (308) about it, such that each hinge can be considered a “movable” hinge.

[0080] Each stabilizing tab (340) includes: a pair of outwardly facing protrusions (344) positioned on opposite sides of the stabilizing tab; and a distal adhesive surface (346). The protrusions (344) are configured to selectively engage peripheral edges (such as protrusions (332)) of corresponding holes (330) when the stabilizing tab (340) is in an unfolded configuration to create frictional interference conditions therewith, thereby helping to hold the stabilizing tab (340) in the unfolded configuration.

[0081] Each distal adhesive surface (346) may each include an adhesive or other adhesive applied to the distal surface of the corresponding stabilizing tab (340). Each distal adhesive surface (346) is configured to selectively adhere the corresponding stabilizing tab (340) to the abdominal wall (2) when the distal flange (308) is positioned against the abdominal wall (2) and the corresponding stabilizing tab (340) is in the deployed configuration. In this way, the stabilizing tab (340) helps to stabilize the depth limiter (300) and the cannula (10, 110) together with respect to the abdominal wall (2). In the example shown, each distal adhesive surface (346) is selectively covered by a corresponding removable adhesive mask (348) to protect the distal adhesive surface (346) from undesirable adhesion to surfaces that the distal adhesive surface (346) may otherwise inadvertently come into contact with.

[0082] During operation, and refer to Figures 10A-10B The depth limiter (300) can initially be positioned around the cannulation channel (124, 124') of the cannula (110) before the cannula (110) is deployed into the patient's abdominal cavity (1), as described above regarding Figures 8A-8C As described above, the clinician can then deploy the cannula (110) into the patient's abdominal cavity (1), as described above. Figure 3A and Figure 3B Once the distal flange (308) contacts and rests against the abdominal wall (2), the clinician can remove the adhesive mask (348) from the distal adhesive surface (346), as described above. Figure 10A As indicated by the first arrow (A1), each stabilizing tab (340) pivots relative to the flange (308) around the corresponding hinge (342) from the corresponding retracted configuration to the corresponding deployed configuration, as shown in the figure. Figure 10B As indicated by the second arrow (A2), each stabilizing tab (340) is received within a corresponding hole (330) to allow the distal adhesive surface (346) to contact the abdominal wall (2). Thus, the distal adhesive surface (346) can adhere the stabilizing tab (340) to the abdominal wall (2).

[0083] C. Third Exemplary Depth Limiter

[0084] Figure 11A perspective view of a third exemplary depth limiter (1010) is shown. The depth limiter (1010) includes a hub (1012) and a plurality of legs (1014). The depth limiter (1010) can be used in conjunction with the depth limiters (200, 300) described above. Although the hub (1012) is shown as generally square, other shapes of hubs (1012) are also conceivable. As shown, the hub (1012) includes a bore (1016) that extends fully through it. The bore (1016) may include a gripping surface (1018). The gripping surface (1018) may extend parallel to a longitudinal axis defined by the cannula conduit (22) of the cannula (20). Although Figures 11-12B refer to Figure 1 The cannula (10) with insertion channel (22) described has a depth limiter (1010), but other cannula channels (e.g., cannula (124)) may also be used. The gripping surface (1018) may be smooth or non-smooth. Figure 11 As shown, the gripping surface (1018) includes a smooth surface that can frictionally engage with a portion of the cannula (20), such as a rib (26) . Alternatively, the gripping surface (1018) may include a non-smooth surface that may include one or more features to lockably engage with the cannula conduit (22). In other words, the depth limiter (1010) may be secured to the cannula (20) using a mating thread (such as a nut) or a suitable amount of interference fit. Such threads of the depth limiter (1010) may be helical or non-helical (e.g., fan-shaped). For example, the gripping surface (1018) may include at least one tooth configured to lockably engage with at least one rib (26) of the cannula (20).

[0085] The legs (1014) may have a generally constant cross-sectional area that moves radially away from the hub (1012); however, the legs (1014) may have a non-uniform cross-section. For example, one or more ends of the legs (1014) may include cup-shaped portions (1020) to distribute downward forces. As shown, the legs (1014) are spaced approximately 90 degrees apart. More or fewer legs (1014) are also conceivable.

[0086] A depth limiter (1010) provides additional stability to the cannula (10) against tilting. The depth limiter (1010) may be configured to use legs (1014) to limit sudden tilting, thereby stabilizing the cannula (20). The depth limiter (1010) is configured to prevent accidental over-insertion while also limiting the displacement and / or velocity of the cannula (10) to stabilize it. This stabilization may be achieved using the mechanical spring effect of each leg (1014). The legs (1014) may have reduced mass, allowing them to flex outward, resulting in a variable spring resistance in each direction in which the cannula (10) attempts to tilt. For example, the legs (1014) may have a reduced mass portion (e.g., a movable hinge portion) and / or may rely on the inherent spring force of the legs (1014). The leg (1014) may contact the patient’s body wall to prevent or at least slow the tilting of the cannula (20).

[0087] Figures 12A-12B The depth limiter (1010) is shown; however, Figures 12A-12B The teaching content can also be applied to the depth limiters (1110, 1210) described in detail below. Figure 12A It shows the relationship with Figure 1 The cannula needle (10) is connected to the cannula assembly (12) and the cannula tube (22). Figure 11 A partial side sectional view of the depth limiter (1010), wherein the leg (1014) of the depth limiter (1010) is in a non-deployed configuration when the distal end of the cannula (10) is received within the abdominal cavity (1). Figure 12A In the non-deployed configuration (e.g., the stationary configuration), the legs (1014) can bend downwards. As the depth limiter (1010) is pushed against the abdominal wall (2), the legs (1014) bend flatter, providing a reaction force against the abdominal wall (2) and the cannula (20). The degree to which the legs (1014) bend flatter can be controlled by the user. For example, an additional force (e.g., downward hand pressure from the user) may cause the legs (1014) to bend flatter until the depth limiter (1010) is positioned close to the abdominal wall (2). As the flatness of the legs (1014) increases, the amount of reaction force on the cannula (20) may also increase, which increases the locking force. For example, the legs (1014) may have a degree of deployment when the user has pressed the depth limiter (1010) into a partially (but not fully) deployed configuration. Additionally, if the user subsequently applies an off-axis load, one or more of the legs (1014) may press further than the other legs (1014), but when the off-axis load is removed, the legs (1014) can balance and return to their original centered position in a controlled manner.

[0088] Figure 12BThe following is shown after the separation and removal of the packer (16) and... Figure 1 The cannulation assembly (12) is connected to the cannulation tube (22). Figure 11 A partial side cross-sectional view of the depth limiter (1010) is shown, wherein the legs (1014) of the depth limiter (1010) are in an extended configuration with the distal end of the cannula (22) received within the abdominal cavity (1). In the extended configuration, the legs (1014) reduce the amount of rotational displacement / tilting that the cannula (10) can achieve, and also reduce the speed at which the cannula (10) can achieve this tilting (i.e., preventing sudden, accidental movement within the body). To completely disengage the depth limiter (1010) from the cannula (22), the user can retract the cannula (20) outside the abdominal wall (2) to sufficiently reduce the compressive / clamping force of the depth limiter (1010) on the abdominal wall (2), allowing the user to pull the depth limiter (1010) back with their hands. The depth limiter (1010) can be disposable or reusable.

[0089] D. Fourth Exemplary Depth Limiter

[0090] Figure 13 A fourth exemplary depth limiter (1110) similar to the depth limiter (1010) is shown. The depth limiter (1110) includes a hub (1112) similar to a hub (1012), legs (1114) similar to legs (1014), holes (1116) similar to holes (1016), and gripping surfaces (1118) similar to gripping surfaces (1018). The legs (1114) may include cup-shaped portions (1120) similar to cup-shaped portions (1020). Unlike the depth limiter (1010) shown as including four legs (1014), the depth limiter (1110) includes two legs (1114). For example, the legs (1114) can be separated by approximately 180 degrees. The legs (1114) are similar to those in the reference above. Figures 12A-12B The legs (1014) shown are bent as depicted.

[0091] E. Fifth Exemplary Depth Limiter

[0092] Figure 14A fifth exemplary depth limiter (1210) similar to depth limiters (1010, 1110) is shown. The depth limiter (1210) includes a hub (1212) similar to a hub (1012), legs (1214) similar to legs (1014), a hole (1216) similar to a hole (1016), and a gripping surface (1218) similar to a gripping surface (1018). The legs (1114) may include a cup-shaped portion (1220) similar to a cup-shaped portion (1020). Unlike the depth limiter (1010) shown as including four legs (1014), the depth limiter (1210) includes three legs (1214). For example, the legs (1214) may be evenly spaced about 120 degrees circumferentially around the hub (1212). However, the legs (1214) may be unevenly spaced. In some cases, using three or four legs (1014, 1214, 1314, 1414) allows for further stability and ergonomics to allow the user's (U) fingers to grasp. The legs (1214) can be similar to those referenced above. Figures 12A-12B The legs (1014) shown are bent as depicted.

[0093] F. Sixth Exemplary Depth Limiter

[0094] Figures 15-17B A sixth exemplary depth limiter (1310) is shown. Specifically, Figure 15 A perspective view of the depth limiter (1310) is shown. As shown, the depth limiter (1310) includes a hub (1312) and a plurality of legs (1314) extending from the hub (1312). The depth limiter (1310) can be used in conjunction with any or more of the depth limiters (200, 300) described above. Although the hub (1312) is shown as generally cylindrical, other shapes of hubs (1312) are also conceivable. As shown, the hub (1312) includes a bore 1316 and a plurality of recesses 1318. The recesses (1318) allow the depth limiter (1310) to be converted from a movable configuration to a fixed configuration.

[0095] The aperture (1316) includes a gripping surface (1320) configured to engage with the outer surface of the cannula (124) in a fixed configuration. The gripping surface (1320) may extend parallel to the longitudinal axis defined by the cannula (124) of the cannula (120). The gripping surface (1320) may be smooth or non-smooth. Figure 15As shown, the gripping surface (1320) may include a smooth surface that frictionally engages with the ribs (128) of the cannula (120) in a fixed configuration. Alternatively, the gripping surface (1320) may include a non-smooth surface that may include one or more features for locking engagement with the cannula conduit (124). The hub (1312) of the depth limiter (1310) may be secured to the cannula (120) using a mating thread (such as a nut) or an interference fit. The thread may be helical or non-helical (e.g., fan-shaped). For example, the gripping surface (1320) may include at least one tooth configured to lockably engage with at least one rib (128) of the cannula (120). For example, a notch (1318) may be formed in the hub (1312) of the depth limiter (1310) such that when sufficient force is applied to each leg (1314), the leg (1314) may selectively collapse, causing the gripping surface (1320) to clamp more tightly onto the cannula (120). Thus, the depth limiter (1310) can limit the insertion depth of the cannula channel (124) of the cannula (120) and provide stability control of the cannula channel (124) of the cannula (120).

[0096] The legs (1314) may have a generally tapered cross-section that moves radially away from the hub (1312). For example, one or more ends of the legs (1314) may include distal end pads (1322) to distribute downward forces. As shown, the legs (1314) are spaced approximately 90 degrees apart. The legs (1314) may be spaced unevenly. Alternatively, more or fewer legs (1314) are also conceivable (similar to...). Figures 13-14 The legs associated with the depth limiters (1110, 1210) are shown. The depth limiter (1310) provides additional stability to the cannula (110) against tilting. The depth limiter (1310) can be configured to use the legs (1314) to limit sudden tilting, thereby stabilizing the cannula (120). The legs (1314) can contact the body wall to prevent or at least slow down the tilting of the cannula (120). Although Figures 16A-17B The insertion cannula (124) of the reference cannula (110) describes a depth limiter (1310), but other insertion cannulas (e.g., insertion cannula (22)) may also be used.

[0097] Figure 16A and Figure 17A A depth limiter (1310) in a movable configuration is shown. Specifically, Figure 16A It shows the relationship with Figure 5 The cannulation assembly (112) is connected to the cannulation conduit (124). Figure 15Top plan view of the depth limiter (1310), wherein the hub (1312) of the depth limiter (1310) is in a movable configuration. Figure 17A It shows the relationship with Figure 5 The cannulation assembly (112) is connected to the cannulation conduit (124). Figure 15 A partial side sectional view of the depth limiter (1310), wherein the legs (1314) of the depth limiter (1310) are in a movable configuration. Figure 16A and Figure 17A In the movable configuration, the gripping surface (1320) forms a second effective diameter (ED2), which allows axial movement of the depth limiter (1310) relative to the outer diameter of the cannula (124) of the cannula (120). In the movable configuration, which is also considered a stationary configuration, the legs (1314) bend downwards. Once pushed against the abdominal wall (2), the legs (1314) bend more flat and provide reaction forces against the abdominal wall (2) and the cannula (120).

[0098] Figure 16B and Figure 17B A depth limiter (1310) in a fixed configuration is shown. Specifically, Figure 16B The diagram shows the interaction after the tampon (116) is separated and removed. Figure 5 The cannulation assembly (112) is connected to the cannulation conduit (124). Figure 15 A partial side sectional view of the depth limiter (1310), wherein the leg (1314) of the depth limiter (1310) is in a fixed configuration. Figure 17B The diagram shows the interaction after the tampon (116) is separated and removed. Figure 5 The cannulation assembly (112) is connected to the cannulation conduit (124). Figure 15 A partial side cross-sectional view of the depth limiter (1310), wherein the legs (1314) of the depth limiter (1310) are in a fixed configuration. In the fixed configuration, the notch (1318) can be forced closed to narrow the orifice (1316). The legs (1314) reduce the amount of rotational displacement / tilting that the cannula (110) may exhibit, and also reduce the speed at which the cannula (110) may tilt (i.e., prevent sudden movement within the body). In the fixed configuration, the gripping surfaces (1320) together form a first effective diameter (ED1) that limits the axial movement of the depth limiter (1310) relative to the cannula (120) by direct contact with the cannula (120). The depth limiter (1310) can be disposable or reusable.

[0099] G. Seventh Exemplary Depth Limiter

[0100] Figure 18A top cross-sectional view of a seventh exemplary depth limiter (1410) is shown. The depth limiter (1410) includes a hub (1412) and a plurality of legs (1414) extending from the hub (1412). The depth limiter (1410) can be used in conjunction with any or more of the depth limiters (200, 300) described above. In some forms, the hub (1412) can be generally cylindrical. As shown, the hub (1412) includes a bore (1416) configured to receive a cannula (120) conduit (124). As shown, the legs (1414) can be separated by approximately 90 degrees. However, the legs (1414) can be separated unevenly. Alternatively, more or fewer legs (1414) are also conceivable, similar to Figures 13-14 The depth limiter (1110, 1210) is shown.

[0101] The depth limiter (1410) includes a fluid chamber (1418) that may be disposed within the hub (1412) and the leg (1414). For example, the fluid chamber (1418) may be completely surrounded by the hub (1412) and the leg (1414). The fluid chamber may include a plurality of fluid channels (1420) including a narrow portion (1422). The narrow portion (1422) may be generally disposed between the hub (1412) and the leg (1414). The narrow portion (1422) regulates the flow between the hub (1412) and the leg (1414). In other words, the fluid chamber (1418) may be integrated into the leg (1414), wherein the narrow portion (1422) forms a restricted flow region at the base of each leg (1414). As shown, one or more ends of the legs (1414) may include extensions (1424) configured to extend from a compression configuration (C) to an extended configuration (E). A depth limiter (1410) provides additional stability to the cannula (110) against tilting. As additional tilting forces act on each individual leg (1414), fluid may be redistributed to the other legs (1414), but the fluid may be restricted by these confined areas (1422), thus creating a damping effect on the tilting of the cannula (110). This damping effect regulates the rate of tilting of the cannula (110). Therefore, the depth limiter (1410) can limit sudden tilting of the cannula (110) via confined fluid flow between the legs (1414), thereby stabilizing the insertion (120).

[0102] The orifice (1416) includes a gripping surface (1426) that can engage with the outer surface of the cannula (124) of the cannula (120). The gripping surface (1426) may extend parallel to the longitudinal axis defined by the cannula (124) of the cannula (120). The gripping surface (1426) may be smooth or non-smooth.Figure 18 As shown, the gripping surface (1426) may include a smooth surface that frictionally engages with the ribs (128) of the cannula (120). Alternatively, the gripping surface (1426) may include a non-smooth surface that may include one or more features for locking engagement with the cannula conduit (124). For example, the hub (1412) of the depth limiter (1410) may be secured to the cannula (120) or to a fan-shaped cannula using a mating thread (such as a nut). The thread may be helical or non-helical (e.g., fan-shaped). For example, the gripping surface (1426) may include at least one tooth configured to lockably engage with at least one rib (128) of the cannula (120). The depth limiter (1410) may be disposable.

[0103] III. Exemplary Combinations

[0104] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0105] Example 1

[0106] A depth limiter configured to engage with a first cannula of a first cannula having a first cannula lateral dimension, the depth limiter comprising: (a) an outer frame portion; and (b) an inner gripping portion housed within the outer frame portion, wherein the inner gripping portion includes a plurality of petal-shaped protrusions that are flexible relative to each other between a relaxed configuration and at least one flexural configuration including a first flexural configuration, wherein in the relaxed configuration, the plurality of petal-shaped protrusions collectively form a first effective lateral dimension, wherein the first effective lateral dimension is configured to be smaller than the first cannula lateral dimension, wherein in the first flexural configuration, the plurality of petal-shaped protrusions collectively form a second effective lateral dimension larger than the first effective lateral dimension, wherein the second effective lateral dimension is configured to be equal to the first cannula lateral dimension, such that the size of the second effective lateral dimension is set to limit axial movement of the depth limiter relative to the first cannula of the first cannula.

[0107] Example 2

[0108] According to the depth limiter of Embodiment 1, the internal gripping portion is more flexible than the external frame portion.

[0109] Example 3

[0110] According to any one of the foregoing embodiments, the depth limiter is configured to connect with a second cannula of a second cannula having a second cannula lateral dimension greater than the first cannula lateral dimension, wherein the at least one flexure configuration includes a second flexure configuration, wherein in the second flexure configuration, the plurality of petal-shaped protrusions collectively form a third effective lateral dimension greater than the second effective lateral dimension, wherein the third effective lateral dimension is configured to be equal to the second cannula lateral dimension, such that the size of the third effective lateral dimension is set to limit axial movement of the depth limiter relative to the second cannula of the second cannula of the second cannula.

[0111] Example 4

[0112] According to any one of the foregoing embodiments, each of the petal-shaped protrusions is radially inwardly offset along its length relative to the central axis of the depth limiter toward the relaxation configuration.

[0113] Example 5

[0114] According to the depth limiter of embodiment 4, each of the petal-shaped protrusions is radially outwardly flexible along its length relative to the central axis of the depth limiter from the relaxation configuration toward the at least one flexural configuration.

[0115] Example 6

[0116] According to any one of the foregoing embodiments, the depth limiter includes three petal-shaped protrusions arranged in a triangle around the central axis of the depth limiter.

[0117] Example 7

[0118] The depth limiter according to any one of the foregoing embodiments, wherein the petal-shaped protrusions are interconnected via corresponding connectors.

[0119] Example 8

[0120] According to the depth limiter of embodiment 7, the outer frame portion includes a plurality of circumferentially arranged recesses, wherein the recesses receive the connector of the inner gripping portion.

[0121] Example 9

[0122] According to any one of the foregoing embodiments, the depth limiter wherein the petal-shaped protrusion is configured to directly grip the outer surface of the first cannula when pushed through the first cannula into the first flexural configuration.

[0123] Example 10

[0124] According to any one of the foregoing embodiments, in the depth limiter, each of the petal-shaped protrusions is spaced apart from the outer frame portion, at least when the petal-shaped protrusion is in the relaxed configuration.

[0125] Example 11

[0126] According to any one of the foregoing embodiments, the depth limiter includes a proximal hub and a distal flange, the distal flange extending radially outward from the proximal hub relative to the central axis of the depth limiter.

[0127] Example 12

[0128] The depth limiter according to any one of the foregoing embodiments, wherein the internal gripping portion comprises an elastomeric material.

[0129] Example 13

[0130] The depth limiter according to any one of the foregoing embodiments, wherein the outer frame portion comprises a polymer material.

[0131] Example 14

[0132] According to any one of the foregoing embodiments, the depth limiter wherein the outer frame portion and the inner gripping portion are integrally formed as a single unit.

[0133] Example 15

[0134] According to any one of the foregoing embodiments, the depth limiter wherein the outer frame portion and the inner gripping portion are separately configured as different parts, and these different parts are configured to be connected together.

[0135] Example 16

[0136] A surgical interventional device assembly includes: (a) a cannula having a cannula cross-section, wherein the cannula includes a working channel configured to guide surgical instruments along a central axis of the cannula; and (b) a depth limiter movably coupled to the cannula and including: (i) an outer frame portion, and (ii) an inner gripping portion housed within the outer frame portion and including a plurality of flap-shaped protrusions flexible relative to each other between a relaxed configuration and at least one flexural configuration, wherein, in the at least one flexural configuration, the plurality of flap-shaped protrusions are configured to deform and resiliently support inward against the cannula to limit axial movement of the depth limiter relative to the cannula.

[0137] Example 17

[0138] According to the surgical interventional device assembly of Embodiment 16, the outer frame portion is rigid, and the inner gripping portion is flexible relative to the outer frame portion.

[0139] Example 18

[0140] According to any one of Embodiments 16 to 17, the surgical intervention device assembly wherein the cannula is configured to push the plurality of flap-shaped protrusions from the relaxed configuration toward the at least one flexural configuration.

[0141] Example 19

[0142] A method of using a depth limiter with a cannula, wherein the depth limiter includes an outer frame portion and an inner gripping portion, the inner gripping portion being housed within the outer frame portion and including a plurality of petal-shaped protrusions that are flexible relative to each other between a relaxed configuration and at least one flexural configuration, the method comprising: (a) positioning the inner gripping portion around a cannula of the cannula such that the cannula pushes the petal-shaped protrusions from the relaxed configuration to the at least one flexural configuration; and (b) frictionally engaging the petal-shaped protrusions with the cannula to restrict axial movement of the depth limiter relative to the cannula of the cannula.

[0143] Example 20

[0144] According to the method of embodiment 19, the method further includes: (a) applying a threshold force to the depth limiter to cause the flap protrusion to frictionally disengage from the cannula; and (b) sliding the flap protrusion axially along the cannula to adjust the axial position of the depth limiter relative to the cannula.

[0145] IV. Miscellaneous

[0146] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the foregoing teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0147] Furthermore, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application No. END9247USNP1, filed on the same date as this application, entitled “Pinch-To-Release Cannula Depth Limiter”; U.S. Patent Application No. END9247USNP2, filed on the same date as this application, entitled “Multi-Diameter Cannula Depth”; U.S. Patent Application No. END9247USNP3, filed on the same date as this application, entitled “Pinch-To-Clamp Cannula Depth Limiter”; U.S. Patent Application No. END9247USNP5, filed on the same date as this application, entitled “Threaded Cannula Depth Limiter”; U.S. Patent Application No. END9247USNP6, filed on the same date as this application, entitled “Tilting Tang Cannula Depth Limiter”; and U.S. Patent Application No. END9247USNP6, filed on the same date as this application, entitled “Two Piece”. The following U.S. patent applications were filed on the same date as this application: “Separable Obturator” [Attorney Reference No. END9247USNP7]; “Latchless Obturator with Interference Fit Feature” [Attorney Reference No. END9247USNP8]; “Balancing Feature for Reusable Trocar” [Attorney Reference No. END9247USNP9]; “Airflow Channels and Patterns in Lumen for Cannula” [Attorney Reference No. END9247USNP10]; and / or “Stabilizer for Surgical Shafts or Cannulas” [Attorney Reference No. END9247USNP11]. The disclosure of each of these patent applications is incorporated herein by reference.

[0148] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0149] The aforementioned devices can be applied to both traditional medical treatments and surgeries performed by medical professionals and robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as the DAVINCI system from Intuitive Surgical, Inc. (Sunnyvale, California). TMSystem. Similarly, those skilled in the art will recognize that the various teachings herein can be readily combined with the teachings of any of the following patents: U.S. Patent 5,792,135, entitled “Articulated Surgical Instrument For Performing Minimally Invasive Surgery With Enhanced Dexterity and Sensitivity,” published August 11, 1998, the disclosure of which is incorporated herein by reference; U.S. Patent 8,783,541, entitled “Robotically-Controlled Surgical End Effector System,” published July 22, 2014, the disclosure of which is incorporated herein by reference; U.S. Patent 8,479,969, entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a Robot,” published July 9, 2013; and U.S. Patent 8,479,969, entitled “Robotically-Controlled Cable-Based Surgical End…”, published August 12, 2014. U.S. Patent 8,800,838, entitled “Effectors”, the disclosures of which are incorporated herein by reference; and / or U.S. Patent 8,573,465, entitled “Robotically-Controlled Surgical End Effector System with Rotary Actuated Closure Systems”, published on November 5, 2013, the disclosures of which are incorporated herein by reference.

[0150] Devices of the types described above may be designed for single-use disposal or they may be designed for multiple uses. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to surgery for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0151] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0152] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A depth limiter configured to couple with a first intubation tube of a first trocar needle having a first tube lateral dimension, the depth limiter comprising: (a) an outer frame portion; and (b) an inner gripping portion housed within the outer frame portion, wherein the outer frame portion and the inner gripping portion are integrally formed together as a unitary piece, wherein the inner gripping portion comprises a plurality of petal-like projections that are flexible relative to one another between a relaxed configuration and at least one flexed configuration including a first flexed configuration, wherein in the relaxed configuration, the plurality of petal-like projections collectively form a first effective lateral dimension, wherein the first effective lateral dimension is configured to be less than the first tube lateral dimension, wherein in the first flexed configuration, the plurality of petal-like projections collectively form a second effective lateral dimension that is greater than the first effective lateral dimension, wherein the second effective lateral dimension is configured to be equal to the first tube lateral dimension, such that the second effective lateral dimension is sized to limit axial movement of the depth limiter relative to the first intubation tube of the first trocar needle, wherein the outer frame portion includes a proximal hub comprising a proximally-facing plurality of recesses uniformly spaced circumferentially thereabout and a cylindrical bore extending longitudinally along a central axis of the depth limiter, the inner gripping portion being received within the cylindrical bore by the plurality of recesses.

2. The depth limiter of claim 1, wherein, The inner gripping portion is more flexible than the outer frame portion.

3. The depth limiter of claim 1, wherein, The depth limiter is configured to couple with a second intubation tube of a second trocar needle having a second tube lateral dimension that is greater than the first tube lateral dimension, wherein the at least one flexed configuration includes a second flexed configuration, wherein in the second flexed configuration, the plurality of petal-like projections collectively form a third effective lateral dimension that is greater than the second effective lateral dimension, wherein the third effective lateral dimension is configured to be equal to the second tube lateral dimension, such that the third effective lateral dimension is sized to limit axial movement of the depth limiter relative to the second intubation tube of the second trocar needle.

4. The depth limiter of claim 1, wherein, Each of the petal-like projections is biased radially inward along its length relative to the central axis of the depth limiter toward the relaxed configuration.

5. The depth limiter of claim 4, wherein, Each of the petal-like projections is radially flexible outward along its length relative to the central axis of the depth limiter from the relaxed configuration toward the at least one flexed configuration.

6. The depth limiter of claim 1, wherein, The plurality of petal-like projections comprises three petal-like projections arranged in a triangle about the central axis of the depth limiter.

7. The depth limiter of claim 1, wherein, The petal-like projections are interconnected via respective joints.

8. The depth limiter of claim 7, wherein, The plurality of recesses receive the joints of the inner gripping portion.

9. The depth limiter of claim 1, wherein, The petal-like projections are configured to directly grip an outer surface of the first intubation tube when urged to the first flexed configuration by the first intubation tube.

10. The depth limiter of claim 1, wherein, Each of the petal-shaped protrusions is spaced apart from the outer frame portion at least when the petal-shaped protrusions are in the relaxed configuration.

11. The depth limiter of claim 1, wherein, The distal flange extends radially outward from the proximal hub relative to a central axis of the depth limiter.

12. The depth limiter of claim 1, wherein, The inner gripping portion comprises an elastomeric material.

13. The depth limiter of claim 1, wherein, The outer frame portion comprises a polymeric material.

14. A surgical intervention device assembly, comprising: (a) a cannula having a cannula lateral dimension, wherein the cannula includes a working channel configured to guide a surgical instrument along a central axis of the cannula; and (b) a depth limiter according to any one of claims 1-13, wherein, in the at least one flexed configuration, the plurality of petal-shaped protrusions are configured to deform and resiliently bear inward against the cannula to limit axial movement of the depth limiter relative to the cannula.

15. The surgical intervention device assembly of claim 14, wherein, The outer frame portion is rigid and the inner gripping portion is flexible relative to the outer frame portion.

16. The surgical intervention device assembly of claim 14, wherein, The cannula is configured to urge the plurality of petal-shaped protrusions from the relaxed configuration toward the at least one flexed configuration.

17. A method of using a depth limiter with a trocar, wherein, The depth limiter comprises an outer frame portion and an inner gripping portion housed within the outer frame portion and comprising a plurality of petal-shaped protrusions that are flexible relative to one another between a relaxed configuration and at least one flexed configuration, wherein the outer frame portion and the inner gripping portion are integrally formed together as a unitary piece, wherein the outer frame portion includes a proximal hub comprising a proximally-facing plurality of recesses spaced evenly circumferentially thereabout and a cylindrical bore extending longitudinally along a central axis of the depth limiter, the inner gripping portion being received within the cylindrical bore through the plurality of recesses, the method comprising: (a) positioning the inner gripping portion about a cannula tubing of a trocar such that the cannula tubing urges the petal-shaped protrusions from the relaxed configuration to the at least one flexed configuration; and (b) frictionally engaging the petal-shaped protrusions with the cannula tubing, thereby limiting axial movement of the depth limiter relative to the cannula tubing of the trocar.

18. The method of claim 17, further comprising: (a) frictionally disengaging the petal-shaped protrusions from the cannula tubing by applying a threshold force to the depth limiter; and (b) axially sliding the petal-shaped protrusions along the cannula tubing to adjust an axial position of the depth limiter relative to the cannula tubing.

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