Apparatus and method for laparoscopic access and wound closure

Abstract

The present invention provides apparatus and methods for laparoscopic access and wound closure. The apparatus is in the form of an integrated needle apparatus that is capable of performing several tasks, including penetrating or piercing the fascia layer, injecting gas into the body cavity, and placing a suture for wound closure. In particular, the apparatus features a blunt-tipped stylet having a hook or notch at the proximal end that can be used to capture a suture.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 101,958, filed May 26, 2020, which is incorporated herein in its entirety. Technical Field

[0003] The present invention relates to devices, methods, systems, and kits for safe laparoscopic access and wound closure of patients in need thereof. The devices, methods, and systems can be used to safely penetrate a patient's body wall for laparoscopic surgery, insufflate gas into the body cavity, and place sutures for wound closure. The present invention enables these important tasks, which typically require the use of extensive specialized equipment. Specifically, the device is a unitary needle device that includes a hook for suture capture.

[0004] background

[0005] In laparoscopic surgery, entering the patient's peritoneal cavity and creating pneumoperitoneum are typically performed using a Veress needle. The cannula of the Veress needle is a sharp, beveled, stainless steel needle end that is used to cut through the abdominal wall tissue. Inside the cannula, there is a spring-loaded hollow stylet with a rounded blunt end to protect any internal organs from being hurt by the sharp, puncturing cannula. In the resting position, the rounded blunt end protrudes slightly beyond the sharp end of the cannula. The stylet is made of a hollow tube for transmitting gas (e.g., carbon dioxide gas) to create pneumoperitoneum for laparoscopic surgery. Figure 1 The cannula, hollow stylet, and distal end of the assembled cannula / stylet are shown in FIG.

[0006] When the Veress needle penetrates the peritoneal wall, the direct contact pressure exerted by the tissue on the tip area pushes the stylet into the inner lumen of the cannula, exposing the sharp cannula to penetrate the tissue wall. After the needle tip pierces the skin / fascia and enters the peritoneal cavity, the blunt stylet with a rounded end quickly springs forward to block the sharp cutting tip and protect the internal viscera from being injured by the sharp cannula. The penetration of the Veress needle into the peritoneal cavity provides the surgeon with unique audible vibration feedback ( Figure 2 ).

[0007] After the Veress needle enters the cavity, gas (eg, carbon dioxide gas) can then be transferred through the hollow lumen of the stylet to insufflate the peritoneal space, thereby creating pneumoperitoneum to facilitate laparoscopic surgery.

[0008] During laparoscopic surgery, a trocar and a scope can also be inserted into the peritoneal cavity. At the end of laparoscopic surgery, the Veress needle, trocar, and scope are retracted, leaving an open wound closed by sutures. The process of suturing various peritoneal layers, including the skin and fascial layers, is laborious and can be omitted for small wounds. Potential risks in this case include infection and subsequent development of an incisional hernia. Methods of peritoneal fascial closure typically require the use of a separate device to mechanically access the internal wound or incision edges with sutures. The sutures are introduced and externalized from inside the peritoneal space through the wound site by a separate device. Then, the two ends of the sutures are pulled up, tightened, and knotted from the outside to complete the closure of the wound left by the device such as a trocar. There are many wound closure devices for laparoscopic surgery on the market. These devices are mostly expensive and complex mechanical instruments. Certain devices can enter the peritoneal cavity in the same technique as the Veress needle, but the stylet is made of a solid rod and the stylet cannot pass CO2 gas for creating pneumoperitoneum. In addition, the device is designed to only capture sutures and deliver them in or out through the abdominal wall. For example, Covidien Endo Close TM or Auto Suture TM devices are equipped with spring-loaded buttons to advance the stylet forward, facilitating the capture of sutures inside the peritoneal cavity.

[0009] There remains a need for devices, methods, and systems for safe and effective laparoscopic access and wound closure in a patient in need thereof. In particular, there is a need for a single or unitary device capable of laparoscopic access, body cavity insufflation, and wound closure in a patient in need thereof.

[0010] The description herein of certain advantages and disadvantages of known devices, methods, and systems is not intended to limit the scope of embodiments.

[0011] SUMMARY

[0012] It is an object of the present invention to provide a device, in some embodiments a needle and stylet assembly, for penetrating a body cavity through a body wall to form an opening, and subsequently pulling a suture through the opening to close a proximal wound (i.e., a wound formed by another device, such as a laparoscopic surgical device (e.g., a trocar), near the device access location). It is another object of the present invention to provide a device for insufflating a body cavity with gas.

[0013] It is another object of the present invention to provide a method for penetrating a body cavity through a body wall to form an opening, and subsequently pulling a suture through the opening to close a proximal wound. In certain embodiments, the method can further comprise insufflating a body cavity with gas.

[0014] It is another object of the present invention to provide a kit comprising the device, which in some embodiments can include, among other things, a needle and stylet assembly, for use in a process that includes penetrating a body lumen through a body wall to form an opening and subsequently pulling a suture through the opening to close a proximal wound. It is another object of the present invention to provide a kit comprising a device for injecting gas into a body lumen.

[0015] One aspect of the present invention is to provide a device or assembly comprising a cannula having a cannula distal end and a cannula proximal end. In preferred embodiments, the cannula is hollow and thus has an internal lumen. In certain embodiments, the cannula comprises a housing unit at the cannula distal end. In some embodiments, the housing unit further comprises an internal hollow lumen. Furthermore, in certain embodiments, the cannula comprises a beveled needle tip at the cannula proximal end.

[0016] Another aspect of the present invention is to provide a device or assembly comprising a stylet, e.g., a blunt-tipped stylet, having a stylet proximal end and a stylet distal end, wherein the stylet is configured to be inserted into the internal lumen of the cannula (i.e., inside the cannula) and supported by the cannula. In certain embodiments, the stylet comprises a hook at the stylet proximal end. In other embodiments, the stylet comprises a notch at the stylet proximal end.

[0017] Another aspect of the present invention is to provide a device or assembly comprising a gas valve for introducing gas at the proximal end of the cannula. In certain embodiments, the gas valve is located at the distal end of the housing unit.

[0018] Another aspect of the present invention is to provide a device or assembly comprising a front compression spring. In certain embodiments, the front compression spring surrounds the stylet distal end. For example, the front compression spring is wrapped or wound around the outer wall of a portion of the stylet proximal to the stylet distal end.

[0019] Another aspect of the present invention is to provide a device or assembly comprising a spring box. In certain embodiments, the spring box comprises: a rear compression spring; a blocking ring having at least two outwardly projecting pins, the blocking ring being distal to the rear compression spring; a distal box end cap, the distal box end cap being distal to the blocking ring; a tubular support, the tubular support being inside the rear compression spring, the blocking ring, and the distal box end cap, the tubular support having a proximal box end cap on one side and a gas valve at the distal end on the other side.

[0020] In certain embodiments of the present invention, the device or assembly can be assembled by passing the stylet, the front compression spring, and the spring box through the distal end of the housing unit (i.e., through the internal lumen of the housing unit) and into the cannula (i.e., through the internal lumen of the cannula) such that the stylet proximal end protrudes beyond the needle tip at the cannula proximal end.

[0021] In some embodiments of the present application, the housing unit further comprises at least one, but preferably at least two (i.e., a plurality) of side slots. In certain embodiments, the side slots are configured to receive at least two pins that protrude outwardly from the blocking ring of the spring box.

[0022] In certain aspects of the present application, the stylet is retractable into the inner lumen of the cannula. In certain embodiments, the stylet is retracted into the cannula when the device or assembly is pressed into the body wall of a patient.

[0023] In other aspects of the present application, the stylet is configured to pop forward beyond the cannula tip after the cannula tip has penetrated the body wall and entered the body cavity. In certain embodiments, the action of the stylet popping forward is controlled by the spring box. For example, in certain embodiments, the stylet can automatically pop forward once the cannula tip has penetrated the body wall.

[0024] Aspects of the present application also include components that facilitate the flow of insufflation gas, such as a gas valve or stopcock. In certain embodiments, the gas valve is located at the distal end of the housing unit. In some embodiments, the gas valve or stopcock is mounted on the housing unit. Embodiments of the present application also include introducing insufflation gas into the body cavity through the gas valve or stopcock and through the stylet.

[0025] In certain aspects of the present application, the stylet includes a feature for capturing and manipulating a suture, such as a hook or notch. In some embodiments, the feature (i.e., hook or notch) can be retracted backwards to lock or capture the suture. Typically, the hook or notch is not fully retracted into the lumen of the cannula during the process of capturing the suture.

[0026] Also disclosed herein are methods of using the devices and assemblies in performing laparoscopic entry and wound closure in a patient in need thereof. BRIEF DESCRIPTION OF DRAWINGS

[0028] The subject matter of the present application is particularly pointed out and distinctly claimed in the concluding portion of the specification. However, both the organization and method of operation of the present application, together with further objectives and advantages thereof, can best be understood by reference to the following detailed description when read with the accompanying drawings in which: Figure 1 The present application (both as to organization and method of operation) together with its objects, features, and advantages can best be understood by reference to the following detailed description, taken in conjunction with the accompanying drawings in which:

[0029] Figure 1 is a picture of the tip of the cannula, stylet, and assembled cannula / stylet.

[0030] Figure 2 is an illustration of audio vibration feedback of a Veress needle penetrating into a peritoneal cavity according to embodiments of the present application.

[0031] Figure 3A andFigure 3B FIGS. 1-3 (collectively referred to as FIG. 3) are pictures of the top and side of an exemplary device according to certain embodiments of the present application.

[0032] Figure 4A Figure 4B and Figure 4C FIGS. 4-6 (collectively referred to as FIG. 4) are drawings showing an exemplary housing unit according to certain embodiments of the present application.

[0033] Figure 5A Figure 5B and Figure 5C FIGS. 5-7 (collectively referred to as FIG. 5) are drawings showing an exemplary housing unit according to certain embodiments of the present application.

[0034] Figure 6A and Figure 6B FIGS. 6-8 (collectively referred to as FIG. 6) are pictures of the top and side of an exemplary stylet assembly according to certain embodiments of the present application.

[0035] Figure 7 is a picture of an exemplary compression spring installed in a cartridge according to certain embodiments of the present application.

[0036] Figure 8 is a picture showing an anti-rotation pin installed on an exemplary housing unit and a female slot located between a stopcock and a spring cartridge according to certain embodiments of the present application.

[0037] Figure 9A and Figure 9B FIGS. 9-11 (collectively referred to as FIG. 9) are drawings showing an exemplary stylet and hook according to certain embodiments of the present application, the stylet and hook advanced to capture a suture ( Figure 9A ) or in a closed or retracted position to capture a suture ( Figure 9B ).

[0038] Figure 10 is a black and white picture of an exemplary hook in an extended (open) and retracted (closed) position according to certain embodiments of the present application.

[0039] Figure 11 is a drawing of an exemplary hook according to certain embodiments of the present application.

[0040] Figure 12A and Figure 12B FIGS. 12-14 (collectively referred to as FIG. 12) are pictures showing an exemplary device according to certain embodiments of the present application, the device having a stopcock at a right angle to the stylet.

[0041] Figure 13A and Figure 13B FIGS. 13-15 (collectively referred to as FIG. 13) are pictures showing an exemplary device according to certain embodiments of the present application, wherein the stopcock is at a right angle to the stylet and includes a button. Figure 13B ​​Close-up view of the stopcock and push button.

[0042] Figure 14 is a picture showing components of an exemplary device according to certain embodiments of the application prior to assembly.

[0043] Figure 15 is a picture showing an exemplary anti-rotation dowel pin installed in an exemplary housing unit according to certain embodiments of the application.

[0044] Figure 16 is a picture showing an exemplary stylet assembly according to certain embodiments of the application.

[0045] Figure 17 and Figure 18A and Figure 18B (collectively Figure 18) is a diagram showing suture placement for wound closure according to certain embodiments of the application.

[0046] Figure 19A and Figure 19B (collectively Figure 19) is a drawing showing an exemplary gas connector according to certain embodiments of the application.

[0047] Figure 20A and Figure 20B (collectively Figure 20) is a drawing showing an exemplary spring box end cap according to certain embodiments of the application.

[0048] Figure 21A and Figure 21B (collectively Figure 21) is a drawing showing an exemplary blocking ring according to certain embodiments of the application.

[0049] It should be understood that the elements shown in the figures are not necessarily to scale, for clarity of illustration. For example, the dimensions of some of the elements can be exaggerated relative to other elements. Furthermore, the numerous features of the one or more embodiments shown in the figures are not to be considered independent and separate features, and can be combined or integrated in accordance with the specific application. Additionally, reference signs in the figures can be repeated to indicate different, but similar, elements. Furthermore, the arrows and brackets used in the figures to indicate different components and parts of the embodiments shown in the figures are only approximate and should not be considered limiting in any way.

[0050] DETAILED DESCRIPTION

[0051] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, it will be apparent to one ordinarily skilled in the art that the application can be practiced without these specific details. In other instances, well-known methods, procedures and / or components have not been described in detail so as not to unnecessarily obscure the application. Also, it will be appreciated that the application disclosed herein is not limited to any particular embodiment and can contemplate different embodiments including embodiments comprising all or part of the specific embodiments described, or embodiments comprising a mix of components from several of the specific embodiments described herein.

[0052] Furthermore, the application is described in the context of example embodiments. However, the scope of the application is not limited to the specific examples and embodiments described in the specification. Rather, the specification merely reflects certain embodiments and is used to illustrate the principles and features of the application. Those skilled in the art will recognize that various modifications and improvements can be made without departing from the spirit and scope of the application.

[0053] The present application provides apparatuses and methods for safe laparoscopic access and wound closure in a patient in need thereof. Apparatuses according to certain embodiments can be used to achieve safe penetration of a patient's body cavity, such as a peritoneal wall, for laparoscopic surgery. The apparatuses of the present application also allow for the creation of pneumoperitoneum via gas injection and effective wound closure using sutures.

[0054] The skyrocketing cost of healthcare is a well-recognized area of concern, and it is critical to control hospital costs. Providing a surgical instrument with multiple functions is an effective way to reduce such costs. The reduction in surgical instrument procurement, inventory costs, and sterilization costs are some of the direct benefits. Shorter surgical times in the operating room, better operating room efficiency, higher patient safety, and higher equipment reliability can reduce the overall cost of surgical procedures. Furthermore, the present application helps reduce costs by combining the functions of a Veress needle and a trocar site closure apparatus into a single monolithic surgical instrument.

[0055] As described herein, "proximal" refers to closer to the point of attachment or insertion into the body, while "distal" refers to further from the point of attachment or insertion into the body.

[0056] Apparatus

[0057] According to certain embodiments, the present invention comprises a device 10 for penetrating a body cavity through a body wall to form an opening in a patient's body, injecting gas into the body cavity through the opening, and drawing a suture through the opening to close a proximal wound, e.g., a wound resulting from penetration with a surgical device such as a trocar device. The resulting wound can be closed with a suture through a process facilitated by the device 10 according to certain aspects of the present invention after the trocar device is retracted.

[0058] In certain embodiments, the device 10 comprises a trocar 11. In preferred embodiments, the trocar 11 is an elongated sleeve having a hollow lumen extending along its length.

[0059] In some embodiments, the trocar comprises a housing unit 12 at the distal end of the trocar 11 and a beveled needle tip 110 at the proximal end of the trocar. In some embodiments, the housing unit 12 is integrally formed with the trocar 11, while in other embodiments, the housing unit 12 and the trocar 11 can be separate components that are connected (i.e., fixed or attached) together by means known in the art, such as, for example, screws, threaded connections, or adhesives.

[0060] In certain embodiments, the device 10 of the present invention comprises a blunt-tipped stylet 13. The blunt tip 130 of the stylet 13 can be flat or rounded, but is not sufficiently sharp to injure body tissue with a gentle force. In certain embodiments, the stylet 13 is an elongated sleeve having a hollow lumen extending along its length. In other preferred embodiments, the stylet 13 comprises a suture capture feature, such as, for example, a hook or notch 131 at the proximal end of the stylet 13. According to certain aspects of the present invention, the blunt-tipped stylet 13 can be inserted into the hollow lumen of the trocar 11 and can be supported within the trocar 11.

[0061] In certain embodiments, the device 10 of the present invention further comprises a gas valve 16. In some embodiments, the gas valve 16 is located distal to the housing unit 12. In preferred embodiments, the gas valve 16 is configured to introduce gas at the proximal end of the trocar 11. The gas can be used to insufflate a body cavity of a patient.

[0062] In certain embodiments, the device 10 of the present invention further comprises a front compression spring 14. In preferred embodiments, the front compression spring 14 surrounds (i.e., winds or wraps around) the distal end of the stylet 13.

[0063] In certain embodiments, the device 10 of the present application also includes a spring box 15. The spring box 15 includes various components that operate to manipulate the blunt-tipped stylet 13 between a retracted configuration and an extended configuration within the cannula 11. For example, in accordance with certain aspects of the present application, the spring box 15 can include a rear compression spring 150, a blocking ring 151, a distal box end cap 153, a tubular support 154, and a proximal box end cap 155. In certain embodiments, the blocking ring 151 can be located distal of the rear compression spring 150. Further, in some embodiments, the blocking ring 151 can include at least two pins 152 that protrude outwardly (i.e., laterally away from the blocking ring 151) from the blocking ring 151. In certain embodiments, the distal box end cap 153 of the spring box 15 is located distal of the blocking ring 151. Additionally, in certain embodiments, the tubular support 154 is flanked (i.e., adjacent to or abutting) the proximal box end cap 155 and, in some embodiments, the air valve 16 that is located distal of the housing unit 12. In one embodiment, the tubular support 154 is located (i.e., positioned or positioned within) the interior of the rear compression spring 150, the blocking ring 151, and the distal end cap 153.

[0064] Further, in accordance with certain aspects of the present application, the stylet 13, the front compression spring 14, and the spring box 15 can be inserted through the distal end of the housing unit 12 into the cannula 11 (i.e., into the cannula's 11 hollow lumen). Typically, the stylet 13 is inserted into the cannula's 11 hollow lumen along with the front compression spring 14 and the spring box 15 such that the proximal end of the stylet 13 protrudes beyond the beveled needle tip 110 of the cannula 11. In this manner, the stylet 13 can be said to be in an extended configuration when the proximal end of the stylet 13 (including the stylet tip 130) protrudes beyond the beveled needle tip 110 of the cannula 11. Further, when in the extended configuration, the stylet 13 operates to block the needle tip 110 of the cannula 11, thereby preventing the needle tip 110 from injuring internal organs or other aspects of the body cavity.

[0065] In certain embodiments, the housing unit 12 includes at least two side slots 120 into which the at least two pins 152 that protrude outwardly from the blocking ring 151 fit.

[0066] Further, in accordance with certain aspects of the present application, the stylet 13 has a retracted configuration in which the stylet 13 is retracted into the hollow lumen of the cannula 11. When in the retracted configuration, the beveled needle tip 110 of the cannula 11 is exposed to allow for penetration of a patient's skin.

[0067] According to certain aspects, the extended configuration, in which the stylet 13 extends beyond the needle tip 110 of the cannula 11, is the initial configuration of the device 10 of the present application. In other words, the device 10 naturally remains in the extended configuration without any participation of the user, although other embodiments in which the device 10 naturally remains in the retracted configuration are also contemplated. In certain embodiments, in order to change the device 10 of the present application from the extended configuration to the retracted configuration, the user must press the blunt-tipped stylet 13 against a surface, such as, for example, the skin surface of a patient, to force the stylet 13 into the cannula 11. In other embodiments, in order to change the device 10 from the retracted configuration to the extended configuration, the force exerted on the tip of the stylet 13 must be significantly reduced, such as when the stylet 13 tip enters the abdomen, or the user must stop exerting the forward force, such as when the stylet 13 tip enters the abdomen and receives the audio and vibration feedback. For example, in a preferred embodiment, the stylet 13 is spring-loaded within the cannula 11, such that whenever no force is applied to push the tip 130 into the cannula 11, the rear spring forces the tip 130 of the stylet 13 to extend out of the cannula 11 - i.e., into the extended configuration. In this manner, as the beveled needle tip 110 of the cannula 11 penetrates the body wall and enters the body cavity, in this case the stylet 13 pops forward beyond the beveled needle tip 110 of the cannula 11. Although the stylet 13 will automatically move forward to prevent internal organ damage, the user should stop pushing the device 10 forward once the tissue resistance on the tip of the stylet 13 is reduced, as the audio and vibration feedback indicates that the device 10 has penetrated the body wall and entered the body cavity.

[0068] In certain embodiments of the present application, the gas valve and the stylet 13 are each configured to introduce insufflation gas into the body cavity. That is, insufflation gas can be introduced through the gas valve and through the internal hollow lumen of the stylet 13 to be released within the body cavity.

[0069] According to certain aspects of the present application, the stylet 13 includes a suture capture feature, such as, for example, a hook or notch 131. In certain embodiments, the hook or notch 131 of the stylet 13 can (e.g., automatically) retract to a resting position to capture or hold the suture when the user stops pushing the stylet 13 forward. For example, in certain embodiments, the hook or notch 131 moves a small distance back to a closed or resting position Figure 9B and Figure 10 ) to create a gap to capture the suture. In certain embodiments, the hook or notch moves a distance of about 0.1 inch to about 0.15 inch or about 0.12 inch to create a gap to capture the suture. Typically, the hook or notch 131 only moves substantially within the cannula 11 lumen when piercing the abdominal wall.

[0070] In certain embodiments, the device 10 further includes an extension tube 17 and a gas connector 18 that functions as an angled (e.g., right angle) adapter between the extension tube 17 and the gas valve 16 (see FIGS. 12, 13, Figure 14 , and Figure 16 ) In some embodiments, the extension tube 17 connects the distal end of the stylet 13 to the gas connector 18. According to certain aspects of the present application, the gas connector 18 is a hollow piece having an opening for the extension tube 17 and an opening for the gas connector 18 that is positioned such that the gas valve 16 (or stopcock) is mounted on the connector 18 in a substantially right angle (90°) to the extension tube 17 and the stylet 13. In certain embodiments, the extension tube 17 and the gas connector 18 are considered to be components of the stylet assembly 20, although other configurations are possible. In some embodiments, when the stylet assembly 20 including the extension tube 17 and the gas connector 18 is inserted into the cannula 11 and the housing unit 12, the gas connector 18 is positioned distally of the housing unit 12.

[0071] In certain embodiments, the gas valve 16 is a stopcock. In one embodiment, the gas valve 16 is mounted distally of the housing unit 12 and in an axial position relative to the stylet 13. In another embodiment, the gas valve 16 is mounted on the gas connector 18 and in an orthogonal position relative to the stylet 13. In certain embodiments, a button 19 is attached to the gas connector 18 (see FIG. 13). The button 19 can be formed of any suitable material, such as, for example, plastic. The button 19 can be used to assist in manipulating the stylet 13 during, for example, suture capture. In certain embodiments, when the gas valve 16 is mounted in an orthogonal position relative to the stylet 13, the stylet 13 can be easily pushed forward against the side of the gas connector 18 without the button 19 because the gas valve 16 and gas tubing are no longer in the way (see FIG. 12).

[0072] In certain embodiments, the suture is captured using a hook or notch 131. Embodiments using a hook 131 to capture the suture are expressly contemplated, as are embodiments using a notch 131. The hook or notch 131 allows the suture to pass through the hook or notch 131 and the curved wall to capture the suture.

[0073] In one embodiment, the at least two pins 152 that protrude outwardly from the blocking ring 151 are screws, e.g., set screws. In another embodiment, the at least two pins 152 that protrude outwardly from the blocking ring 151 are solid pins, e.g., unthreaded pins.

[0074] The insufflation gas can be any suitable gas for performing insufflation of a body cavity or for creating a pneumoperitoneum. In certain embodiments, the insufflation gas is carbon dioxide (C02).

[0075] In certain embodiments, the body cavity is the peritoneal cavity.

[0076] In certain embodiments, the device 10 is in the form of an all-in-one needle device. Generally, the device according to embodiments is capable of performing several tasks that require the use of multiple specialized devices. These tasks include, for example, penetrating or piercing the fascia layer, injecting a body cavity with gas, and placing a suture for wound closure.

[0077] The exemplary device described herein can be used to safely pierce the peritoneal wall, prevent internal organ damage with a spring-loaded hollow stylet 13, and pass carbon dioxide gas through the stylet 13 lumen to create a pneumoperitoneum for laparoscopic surgery, as well as introduce and place a suture for wound closure, without the need for separate devices. FIGS. 3, 12, and 13 show exemplary devices.

[0078] The exemplary device can be inserted into the peritoneal cavity of a patient by penetrating the skin and fascia layer with the sheath 11 of the device 10. When penetrating the tough fascia layer, direct pressure on the stylet tip 130 pushes the blunt or rounded tip stylet 13 into the shaft of the sheath 11. When the sheath tip 110 of the device 10 enters the peritoneal cavity, the tissue force against the blunt stylet tip 130 is suddenly reduced, and the stylet 13 springs forward, thereby protecting the tip of the sheath 11 from damaging any internal organs within the cavity. Subsequently, gas (e.g., C02 gas) can be introduced and enter the peritoneal cavity through the device 10 to insufflate the cavity. The peritoneal cavity is insufflated in preparation for and during laparoscopic surgery.

[0079] The device 10 uses two compression springs 14 and 150 (see FIG. 6). The rear compression spring 150, which is installed within the case, is used to push out the stylet 13. When penetrating the fascia layer, direct contact pressure on the stylet tip 130 pushes the stylet 13 into the shaft (or hollow lumen) of the sheath 11. That is, the device 10 of the present invention assumes a retracted configuration. When the sheath 11 enters the peritoneal cavity, the contact pressure is reduced, and the stylet 13 springs forward, thereby shielding and blocking the sharp cutting tip 110 of the sheath 11. That is, the device 10 of the present invention assumes an extended configuration.

[0080] After laparoscopic surgery, the device 10 can be used for suture capture, suture delivery, and wound closure. The stylet 13 can be pushed forward via the gas valve 16 (or the button 19 or the gas connector 18 fixed to the gas valve 16). The maximum travel distance of the stylet tip 130 is limited by the length of the side slot 120 of the housing unit 12 (FIGS. 4 and 5).

[0081] To facilitate capture of the suture, the stylet assembly 20 is pushed forward to an extended configuration. After being pushed forward, the hook or notch 131 of the stylet tip 130 is far enough from the end of the cannula 11 to create an opening for the suture to pass into (see FIG. 9). When the suture is caught or captured by the hook or notch 131, the front compression (or otherwise second) spring 14, near the proximal side of the spring box 15, is used to retract the stylet 13 into the retracted configuration when forward pushing is stopped. The front compression spring 14 pulls the hook or notch 131 into a position where the opening is covered by the outer cannula 11 and the suture remains in the space between the hook and the cannula 11. Figure 10 The stylet tip 130 is shown in the retracted position. After the suture is securely held, the suture passes in and out of the abdominal wall around the wound, closing the wound by knotting from the outside of the abdomen. The wound is closed by tissue approximation (i.e., bringing the edges of the tissue into the desired position for suturing).

[0082] In certain embodiments, to capture the suture, the stylet 13 can be manipulated (e.g., pushed forward and outward into an extended configuration) via the gas valve 16 (e.g., a stopcock), the gas connector 18, or a button 19 attached to the gas valve 16. Alternatively, in other embodiments, the position of the gas valve 16 is switched to be at a right angle (i.e., orthogonal) to the stylet 13, thereby creating space for a thumb activated button 19 or mounting the button 19 (FIGS. 12 and 13).

[0083] The above description is intended to illustrate the basic principles and modes of operation of the apparatus according to exemplary embodiments of the present application. Thus, the apparatus design and various figures disclosed herein are not intended to represent or limit the commercial products to be manufactured, although the apparatus shown can indeed be produced and commercialized. In standard production engineering practices, molded plastic parts can be used to replace any of the machined parts as shown above, to save labor and cost. The various parts illustrated in the figures can be manufactured by an injection molding process.

[0084] A "cannula" as referred to herein is a hollow, elongated, cylindrical sheath that terminates in a sharp cutting edge for piercing the external body tissue of a patient.

[0085] The front portion of the exemplary apparatus 10 includes a cannula 11 having a beveled needle tip 110 for piercing or penetrating a body wall (e.g., an abdominal wall). According to certain embodiments, the cannula 11 is a hollow tube having a beveled needle tip 110 at the proximal end. The beveled needle tip 110 is sharp. Generally, the cannula 11 includes a tubular passage configured to surround at least a portion of the length of the stylet 13. A substantial portion of the stylet 13 is housed within the cannula 11. The proximal stylet tip 130 protrudes beyond the beveled needle tip 110 of the cannula 11 (i.e., in an extended configuration) when no force or pressure is applied to the stylet tip 130.

[0086] The cannula 11 according to certain embodiments can be made of any suitable material, such as, for example, metal or plastic. In certain embodiments, the cannula 11 is made of stainless steel, for example, 304 stainless steel.

[0087] The cannula 11 can be any suitable gauge for laparoscopic use. In certain embodiments, for example, the cannula 11 is a 14 gauge. The cannula 11 can be formed from a hypodermic needle. In certain embodiments, the surface of the cannula 11 is passivated with citric acid.

[0088] In certain embodiments, the length of the cannula 11 from the end (proximal end) of the bevel tip 110 to the distal end of the cannula 11 is in the range of about 4.5 inches to about 7.7 inches, about 4.5 inches to about 6.5 inches, or about 4.9 inches to about 5.2 inches. In certain embodiments, the cannula 11 is about 5 inches long. Generally, the length of the cannula 11 within the housing unit 12 is in the range of about 0.25 inches to about 0.35 inches, or about 0.30 inches. In certain embodiments, such as for obese patients, the length of the cannula 11 from the end (proximal end) of the bevel tip 110 to the distal end of the cannula 11 is in the range of about 5.7 to about 7.7 inches, or about 6.1 inches to about 6.4 inches.

[0089] In certain embodiments, the outer diameter of the cannula 11 is in the range of about 0.07 inches to about 0.09 inches, about 0.080 inches to about 0.086 inches, or about 0.082 inches to about 0.084 inches.

[0090] In certain embodiments, the inner diameter of the cannula 11 is in the range of about 0.06 inches to about 0.075 inches, about 0.065 inches to about 0.07 inches, or about 0.066 inches to about 0.069 inches.

[0091] In certain embodiments, the cannula 11 is slightly tapered such that the diameter tapers from the distal end to the proximal end of the cannula. In certain embodiments, the outer diameter of the cannula 11 is in the range of about 0.07 inches to about 0.09 inches, about 0.080 inches to about 0.086 inches, or about 0.082 inches to about 0.084 inches at the distal end and tapers about 0.002 inches at the proximal end before the bevel tip.

[0092] According to certain aspects of the present application, the cannula 11 can be secured to the housing unit 12 by any suitable means. In certain embodiments, the cannula 11 is mechanically secured to the housing unit 12, for example, via set screws, with adhesive, or a combination thereof. FIG. 5 illustrates a mechanical drawing of an exemplary housing unit 12.

[0093] During operation of the device 10, the physician can grasp the housing unit 12 to control the position and penetration of the device 10. A downward pressure is applied sufficient to penetrate the device 10 into the body cavity.

[0094] According to certain aspects of the present application, the housing unit 12 includes a hole 121 of circular cross-section that extends through the length of the device 10. In some embodiments, as shown in FIG. 5, the diameter of the hole 121 is finer at the distal end. In certain embodiments, the housing unit 12 has a diameter of about 0.5 inches at the proximal end and a diameter of about 0.75 inches at the distal end. In some embodiments, the hole 121 through the housing has a diameter of at least about 0.08 inches at its finest portion. Further, in some embodiments, the hole 121 through the housing unit 12 has a diameter of at most about 0.32 inches at its widest portion, or a diameter large enough to accommodate the spring box 15. Additionally, a fine bore 122 channel can be included in the housing unit 12 that extends from one lateral side to the central hole 121, about 0.15 inches from the proximal end of the housing unit 12 and about 3 / 16 inches from the distal end of the housing unit 12. In some embodiments, the housing unit 12 is substantially cylindrical with a diameter of about 0.5 inches, except for a portion of about 3 / 8 inches at the distal-most end of the housing unit 12, which has a diameter of about 0.75 inches and provides a handle for grasping the device 10.

[0095] According to certain aspects of the present application, the housing unit 12 can be formed of any suitable material, such as a metal or a polymeric material, such as, for example, a plastic. In some embodiments, the housing unit 12 is hollow and includes at least two slots 120 that extend axially along the housing unit 12. In certain embodiments, the slots are aligned with at least two pins 152 that extend from a blocking ring 151 that is assembled within the housing unit 12 along with the spring box 15. In preferred embodiments, the length of the slots 120 is adapted to allow the stylet assembly 20 to move a short distance, such as about 0.1 inches to about 0.2 inches, or about 0.15 inches, within the housing unit 12. In certain embodiments, the slots 120 are configured to engage the pins 152, thereby preventing the stylet assembly 20 from moving too far in either the proximal or distal direction.

[0096] According to certain aspects of the present application, stylet 13 is positioned within cannula 11. In some embodiments, stylet 13 is a hollow tube with a proximal rounded end (i.e., a dull tip) or a blunt tip 130 to protect any internal organs from the (sharp) cannula 11. In certain embodiments, stylet 13 allows for gas to pass through device 10 - such as into, through the hollow tube or lumen - and into the patient’s body cavity (i.e., insufflation). The proximal end of stylet 13 also includes a suture capture feature, such as, for example, a hook or notch 131, which is used for suture capture (see FIG. 9). In some embodiments, front compression spring 14 and spring box 15 are located at the distal end of stylet 13 (see FIG. 8). Figure 8 ) Spring box 15 can include a rear compression spring 150 that stores / releases energy to push the proximal blunt stylet tip 130 out into an extended configuration to block the beveled needle tip 110 of cannula 11 to prevent internal organ damage after, for example, entering the peritoneal cavity.

[0097] As described herein, the “stylet assembly” of the present application can include a notch or hook 131 for suture capture; a front compression spring 14 that surrounds the distal end of stylet 13; a spring box 15; and a gas valve 16, for example, a stopcock (see FIG. 6). In certain embodiments, stylet assembly 20 can further include a gas connector 18. Stylet 13 is positioned within cannula 11 and housing unit 12.

[0098] In one embodiment, spring box 15 Figure 7 ) includes: (a) a rear compression spring 150; (b) a blocking ring 151 with at least two outwardly protruding pins 152, blocking ring 151 is located distal to rear compression spring 150; a distal box end cap 153, distal box end cap 153 is located distal to blocking ring 151; (c) a tubular support 154 with proximal box end cap 155 and distal end cap 153 on both sides (i.e., adjacent or abutting).

[0099] In certain embodiments, proximal box end cap 155 and distal end cap 153 are affixed to tubular support 154 by adhesive. In certain embodiments, rear compression spring 150 and blocking ring 151 are freely or loosely fitted on tubular support 154 between the two end caps 153 and 155.

[0100] The movement of blocking ring 151 with pins 152 is restricted to sliding forward and backward along the two side grooves 120 of housing unit 12. In the resting position, blocking ring 151 and pins 152 are located at the distal end of side grooves 120.

[0101] A section or portion of the outer wall of stylet 13 is affixed to the inner lumen of tubular support 154, for example, by adhesive. Thus, spring box 15Figure 7 ) is also secured to the stylet 13 by the tubular support 154. Thus, the stylet 13 is supported by the spring cartridge 15, which can slide smoothly within the lumen of the housing unit 12. As the device 10 is inserted into the abdomen, tissue resistance pushes the stylet 13 back and in to expose the sharp, cutting tip of the cannula 11. Because the blocking ring 151 and pin 152 are located at the distal end of the side slot 120 and cannot move back, the inward movement of the stylet 13 and the same movement of the spring cartridge 15 compresses and stores energy in the rear compression spring 150 located within the spring cartridge 15. When the tissue resistance on the stylet tip 130 is reduced upon entering the peritoneal cavity, the rear compression spring 150 within the spring cartridge 15 releases the energy, thereby pushing the stylet 13 outward and shielding the sharp cannula 11 tip from internal organs.

[0102] The gas valve 16 can be mounted directly on the distal end cap 153 or through an extension tube 17 and gas connector 18 if the gas valve is located at a right angle to the stylet 13.

[0103] In certain embodiments, the spring cartridge 15 facilitates retraction of the hook or notch 131 of the stylet 130. That is, in some embodiments, the spring cartridge 15 facilitates movement of the stylet 13 to a retracted configuration.

[0104] In a resting, or non-contacting, state, the blunt stylet tip 130 protrudes beyond the end of the sharp cannula 11 in an extended configuration, for example, by about 0.080 inches to about 0.100 inches. When the device 10 contacts the patient's abdominal wall, the pressure on the blunt tip 130 of the stylet pushes the stylet back into the cannula 11 and into a retracted configuration. The retraction of the spring-loaded stylet 13 exposes the sharp cannula tip 110 to puncture the skin and fascia layers of the abdominal wall. After the device 10 enters the peritoneal cavity, the tissue contact pressure drops suddenly, and the compression or stored energy spring 150 within the spring cartridge 15 forces the stylet 13 forward into an extended configuration such that the stylet tip 130 protrudes beyond the cannula tip 110, thereby protecting any internal organs within the cavity from the cannula tip 110. Thus, the stylet 13 can be retracted by pressure or moved forward via spring action.

[0105] According to certain aspects of the present application, the blunt or rounded end of the hollow stylet 13 can be manufactured by standard stainless steel tube end forming techniques. Closed end tubes can be rotated closed and welded closed by using standard tools and well-known tube forming procedures.

[0106] According to certain aspects of the present application, the device 10 of the present application includes at least two springs, such as, for example, a front compression spring 14 for retracting the notch or hook 131 and a rear compression spring 150 mounted in the spring cartridge 15.

[0107] In certain embodiments, distal to the rear compression spring 150, which is located within the cartridge 15, is a blocking ring 151 (as shown in Figure 7 ) which is equipped with at least two anchoring pins 152 which protrude through at least two slots 120 on the housing unit 12 side wall (Figures 4 and 5). The anchoring pins 152 can be, for example, threaded set screws (see Figure 7 ) or non-threaded pins. Immediately adjacent to the blocking ring 151 is an end cap 153 which has an internal taper to connect to the gas valve 16, such as, for example, a male Luer slip of a stopcock. The gas valve 16 or stopcock also has a female Luer lock fitting for connection to an external gas (e.g., C02) supply line. In the case where the gas valve 16 is orthogonal to the stylet 13, an additional short extension tube 17 can be attached to the distal end cap 153 which in turn is attached to a gas connector 18 to effect a turn of, for example, 90° of the gas valve 16 and gas supply line (Figure 12).

[0108] When the device 10 is not in use, the blocking ring 151 is held in a fixed position by the at least two anchoring pins 152 (see Figure 7 ) which are fixed to the rear ends of the side slots 120 on the housing unit 12. When the stylet 13 is pushed back, the blocking ring 151 does not move, but the spring cartridge 15 moves back, forcing the spring 150 to shorten and be compressed. The gas valve 16 which is attached to the spring cartridge 15 also moves back.

[0109] The stylet 13 is not fixed to the blocking ring 151 which can slide along a tubular support 154 (e.g., a hollow tube) for the spring 150 (see Figure 7 ). The proximal end cap 155 of the spring cartridge 15 and the distal attachment of the spring cartridge 15 for the gas valve 16 (e.g., stopcock) are attached to the tubular support 154. The stylet 13 is attached to the tubular support 154 via the inner wall (lumen) of the tubular support 154.

[0110] When the sharp cannula tip 110 enters the peritoneal cavity, the tissue pressure on the tip of the stylet 130 is suddenly reduced, causing the energy-storing rear compression spring 150 to lengthen and immediately push the stylet 13 out again. As previously described, the stylet 13 which is positioned at the needle tip 110 shields the sharp cutting edge of the cannula 11 upon entering the abdomen to avoid internal organ damage and injury. After entering the peritoneal cavity, the gas valve 16 can be opened to introduce gas for insufflation of the body cavity and for establishment of pneumoperitoneum for laparoscopic surgery.

[0111] According to certain aspects of the present application, retraction of the hook or notch 131 is accomplished automatically via spring action once the forward pushing force is released after placement of the suture. In some embodiments, the mechanical properties of the front compression spring 14 are selected so that the gap closes quickly to ensure secure capture of the suture placed within the gap.

[0112] According to certain aspects of the present application, the device 10 includes a gas valve 16 (also referred to herein as a "stopcock") that can be used to start or stop the flow of gas (e.g., C02) into the patient. When the device 10 is inserted into the peritoneal cavity, the flow of gas can be turned on by means of the gas valve 16 to inflate the cavity and create pneumoperitoneum for laparoscopic surgery.

[0113] At the end of the procedure, at least one surgical device (e.g., a trocar) is retracted from the abdomen, leaving a puncture wound. In certain embodiments, the size of the wound can be on the order of the diameter of the shaft of the trocar 11 or surgical device. In certain embodiments, the wound (e.g., the proximal wound referred to herein) is larger than about 5 mm and needs to be closed. The wound site can be closed by tissue approximation for percutaneous suturing. Instead of performing a time-consuming surgical suture or utilizing a separate device for wound site closure, the device 10 according to certain aspects of the present application can be used to facilitate wound closure by suture capture hooks or notches. Because the suture can be captured, held, externalized, and internalized, the two ends of the suture can be positioned and externalized through the wound. The suture ends are then pulled tight and knotted to close the wound. In addition to externalization, the suture can also be internalized by first capturing the suture outside the patient's body, piercing the exposed wound fascia from one side, looping around the wound on the inside, and externalizing from the opposite side of the wound before knotting. In this way, the physician can achieve easy site closure using the present application.

[0114] In one embodiment, wound closure is performed by the following process:

[0115] (i) externalizing the two ends of the suture from opposite sides of the wound Figure 17 );

[0116] (ii) inserting the exemplary device 10 proximal to the wound,

[0117] (iii) capturing or holding the first suture end from inside the body cavity,

[0118] (iv) externalizing the first suture end to knot outside the wound; and

[0119] (v) repeating steps (iii) and (iv) for the second suture end.

[0120] In certain embodiments, the exemplary device 10 can pass through the fascial layer under the skin of the wound to enter.

[0121] In certain embodiments, prior to a wound closure procedure, a suture filament (e.g., without an attached metal cutting needle) is introduced into the body through a trocar.

[0122] In one embodiment, wound closure is performed by the following procedure:

[0123] (i) internalizing one end of a suture from one side of a wound (Fig. 18);

[0124] (ii) externalizing the suture end from the opposite side of the wound using the exemplary device 10 (e.g., from outside the body, using the exemplary device 10 to capture and hold one end of the suture).

[0125] In certain embodiments, wound closure is performed by the following procedure:

[0126] (i) inserting a suture into the body near one side of a wound using the exemplary device 10 or a surgical device to internalize the suture, while leaving one end of the suture outside the body,

[0127] (ii) inserting the exemplary device 10 (empty; without a suture) into the body from the opposite side of the wound to capture the internalized suture;

[0128] (iii) externalizing the other end of the suture to tie a knot.

[0129] In certain embodiments, the stylet 13 can be manually pushed forward (e.g., beyond a rest or neutral position) to capture a suture for wound closure. The stylet 13 can be equipped with a hook 131 for capturing the suture (e.g., similar to a crochet needle hook). In certain embodiments, the hook 131 is shaped as a notch in the stylet 13.

[0130] To capture a suture, the stylet tip 130 can be pushed forward, e.g., via the gas valve 16 or a handle or button 19 that can be attached to the gas valve 16, to capture the suture on the notch or hook 131. In certain embodiments, where the gas valve is orthogonal to the stylet 13 (Fig. 12), the gas connector 18 can also serve as a handle for pushing the stylet tip 130 forward. When the pushing force is released, the notch or hook 131 securely holds the suture after being automatically retracted by spring action.

[0131] According to certain aspects of the present invention, pushing forward causes the blocking ring 151 to advance with the tip 130 of the stylet 13, creating a gap to allow capture of a suture filament (see Figs. 9 and Figure 10). The forward displacement of stylet 13 is limited by the width of side slot 120, where anchor pin 152 protrudes (see FIGS. 3, 4 and 5). In addition to the rear compression spring 150 mounted in spring box 15, there is also a front compression spring 14 (see FIG. 6) located next to the proximal spring box end cap 155 of the box. This front compression spring 14 serves to retract stylet 13 and capture the suture placed within the gap of hook 131 when the air valve 16 is no longer pushed. FIGS. 9 and Figure 10 shows hook 131 in the open position when device 10 is pushed forward (i.e., ready to receive / capture suture) and also shows hook 131 in the closed position (retracted, at rest or neutral position) that is able to securely hold any suture placed within the gap. The captured suture is enclosed within the small cavity defined by the cutting edge of the cannula tip 110 and hook 131. As shown, the angular position (i.e., rotational position) of stylet 13 relative to cannula 11 is held by anti-rotation pin 123 of housing unit 12 and anti-rotation slot 156 formed on distal end cap 153 together. Anti-rotation pin 123 is visible on the distal end of housing unit 12 and anti-rotation slot 156 is visible on distal end cap 153. Figure 8

[0132] In certain embodiments, device 10 is used to capture, hold, deliver, exteriorize and interiorize sutures. In certain embodiments, device 10 is used to close wounds left by retracted laparoscopic devices. The wound closure according to embodiments can be accomplished by a procedure of tissue approximation and percutaneous suturing for closing the wound or puncture site without the use of standard suture needles (using only the suture wire). The two ends of the suture can be positioned to mechanically approximate the opposing edges of the wound ready for closure. The exteriorized ends of the suture are used to incorporate fascia and subcutaneous tissue, and optionally skin. In certain embodiments, the abdominal wall is elevated by pulling the two ends of the suture upward from opposite sides of the wound, tightened and knotted to complete the closure. The suture can be introduced into the abdominal cavity under standard illumination and visualized by an inserted camera. Alternatively, the suture can be captured externally by needle device 10, held and subsequently inserted into the abdominal cavity near the wound site.

[0133] Hook 131 can be formed by laser or mechanical cutting.

[0134] In one embodiment, device 10 comprises:

[0135] (i) a cannula 11 comprising a beveled needle tip 110 at a proximal end and attached to a housing unit 12 at a distal end;

[0136] ​(ii) a blunt tipped stylet 13 comprising a hook or notch 131 at the proximal end of the stylet and supported within the cannula;

[0137] (iii) a gas valve 16 positioned distal to the housing unit 12 configured to introduce gas at the proximal end of the cannula;

[0138] (iv) a front compression spring 14 surrounding the distal end of the stylet 13;

[0139] (v) a spring box 15 comprising:

[0140] a rear compression spring 150;

[0141] a blocking ring 151 having two outwardly projecting pins 152, the blocking ring 151 being distal to the rear compression spring 150;

[0142] a distal box end cap 155 distal to the blocking ring 151;

[0143] a tubular support 154 having proximal and distal box end caps 155 and a distal gas valve 16 on either side, the tubular support 154 being inside the rear compression spring 150, the blocking ring 151 and the distal end cap 155;

[0144] wherein the stylet 13, the front compression spring 14 and the spring box 15 are inserted through the distal end of the housing unit 12 and into the cannula 11 such that the proximal end of the stylet 13 protrudes beyond the cannula tip 110;

[0145] wherein the housing unit 12 comprises two side slots 120, the two outwardly projecting pins 123 of the blocking ring 151 fitting into the two side slots 120,

[0146] wherein the stylet 13 retracts into the cannula 11 when the device 10 is pressed into the body wall of a patient;

[0147] wherein the stylet 13 is ejected forward beyond the cannula tip 110 after the cannula tip 110 has penetrated the body wall and entered the body cavity;

[0148] wherein the injected gas is introduced into the body cavity through the gas valve 16 and the stylet 13; and

[0149] wherein the hook or notch 131 can be retracted to capture a suture.

[0150] Method of use

[0151] Generally, exemplary device 10 can be used as a Veress needle for penetrating a body cavity wall, e.g., a peritoneal wall. Contact pressure exerted by the body cavity wall on the stylet of device 10 pushes the stylet 13 into the internal lumen of the cannula 11, exposing the beveled needle tip 110 of the cannula 11 to penetrate the body cavity wall. After the cannula 11 pierces the skin / fascia and enters the body (e.g., peritoneal) cavity, the stylet 13 is ejected forward to block the cannula tip 110, thereby protecting the internal organs from the sharp cannula 11. The penetration of the exemplary device 10 of the present invention into the peritoneal cavity gives the surgeon a unique audio-vibratory feedback Figure 2

[0152] After the exemplary device 10 enters the body cavity, gas (e.g., C02) can then be passed through the hollow lumen of the stylet to insufflate the body cavity. Insufflation of the body cavity is performed to create a space for laparoscopic surgery. In the example of the peritoneal cavity, insufflation of the peritoneal cavity with C02gas creates pneumoperitoneum, which facilitates laparoscopic surgery.

[0153] At the end of laparoscopic surgery, the exemplary device 10 of the present invention is retracted, ready for use in closing the open wound left by the post-surgery retracted trocar, probe and other large diameter devices (by suturing).

[0154] In certain embodiments, the exemplary device 10 of the present invention can be used to introduce and place sutures without the need for a separate device. The hook or notch of the exemplary device 10 can be used to introduce a suture that is secured in the hook or notch 131 in the retracted position into the proximal wound. The suture can be applied to the proximal wound by manipulating the exemplary device 10 and externalized from the wound (e.g., incision) site from the inside of the body cavity. The two ends of the suture are then pulled up from the outside, tightened and knotted to complete the closure of the wound left by the removed large bore device, such as a trocar. According to certain embodiments, the exemplary device 10 can be used to close the wound by externalizing the two ends of the suture from opposite sides of the wound. This is accomplished by the exemplary device 10 piercing through the sides of the wound, respectively, grabbing and capturing the suture, pulling the suture ends from the abdomen and knotting the externalized suture ends together to close the wound by tissue approximation. For this operation, the suture with two free ends must be pre-introduced into the abdomen via a trocar port. Alternatively, the suture can be internalized from one side of the wound and then the suture ends are externalized from the opposite side before being knotted. In certain embodiments, the suture ends are first captured from outside the body by the exemplary device 10 before the entire suture is pierced through from one side of the wound and carried to the abdomen to complete the suture internalization process.

[0155] ​In certain embodiments, a separate device similar to a trocar is then used to introduce a suture into the body cavity (e.g., peritoneal cavity). The hook or notch 131 of the exemplary device 10 can then be used to capture the suture by pushing the stylet assembly 20 forward. By pushing the stylet assembly 20 forward, the hook or notch 131 opens a gap to receive and capture the suture. The front compression spring 14 is used to retract the stylet hook 131 and capture the suture placed within the gap space (see FIG. 9 and Figure 10 ) The suture is externalized from the body cavity through the exemplary device 10 through the wound (e.g., incision) site. The two ends of the suture are then pulled up, tightened, and knotted from the outside through the exemplary device 10 to complete the closure of the proximal wound.

[0156] Certain embodiments of the present invention also provide a method for laparoscopic access and wound closure in a patient in need thereof. In one embodiment, the method comprises: (a) penetrating a body cavity through a body wall to form an opening with a device 10, the device 10 comprising:

[0157] (i) a trocar 11 comprising a beveled needle tip 110 at a proximal end and attached to a housing unit 12 at a distal end;

[0158] (ii) a blunt-tipped stylet comprising a hook or notch 131 at a proximal end and supported within the trocar 11;

[0159] (iii) a gas valve 16 positioned distal to the housing unit 12, configured to introduce gas at the proximal end of the trocar 11;

[0160] (iv) a front compression spring 14 surrounding the distal end of the stylet 13;

[0161] (v) a spring box 15 comprising a rear compression spring 150; a blocking ring 151 having two outwardly projecting pins 152, the blocking ring 151 being distal to the rear compression spring 150; a distal box end cap 153 distal to the blocking ring 151; a tubular support 154 having a proximal box end cap 155 on both sides and the gas valve 16 at a distal end, the tubular support 154 being inside the rear compression spring 150, the blocking ring 151, and the distal end cap 153;

[0162] wherein the stylet 13, the front compression spring 14, and the spring box 15 are inserted through the distal end of the housing unit 12 and into the trocar 11 such that the proximal end of the stylet protrudes beyond the trocar tip 110;

[0163] wherein the housing unit 12 comprises two side slots 120 into which the two outwardly projecting pins 152 of the blocking ring 151 fit,

[0164] wherein the stylet 13 is retracted into the cannula 11 as the device 10 is pressed into the body wall of the patient;

[0165] wherein the stylet 13 is ejected forward beyond the cannula tip 110 after the cannula tip 110 has penetrated the body wall and entered the body cavity;

[0166] wherein insufflation gas is introduced into the body cavity through the gas valve 16 and the stylet 13; and

[0167] wherein the hook or notch 131 can be retracted to capture the suture;

[0168] (b) insufflating gas through the opening into the cavity;

[0169] (c) manipulating the stylet 13 of the device 10 to capture the suture in the body cavity; and

[0170] (d) positioning the suture to pass through the proximal wound and externalizing the suture to close the proximal wound.

[0171] In certain embodiments, the suture is introduced into the body cavity through a separate port device, such as a trocar. In certain embodiments, the step of manipulating the stylet of the device 10 to capture the suture for wound closure occurs after the suture (e.g., suture material) is introduced into the body cavity through a separate port.

[0172] In certain embodiments, using the exemplary device 10, the suture is introduced into the body cavity through a suture internalization procedure as previously described. The suture is held and / or captured by the exemplary device 10 extracorporeally and subsequently pierced through the body wall (e.g., abdominal wall) into the body cavity for wound closure.

[0173] In certain embodiments, the step of manipulating the stylet of the device 10 includes pushing the stylet forward.

[0174] It will be apparent to those skilled in the art that numerous modifications and alternatives can be made to the embodiments described above without departing from the spirit and scope of the present invention.

[0175] The present invention also provides the following clauses:

[0176] 1. A device comprising:

[0177] (i) a cannula comprising a beveled needle tip at a proximal end and attached to a housing unit at a distal end;

[0178] (ii) a blunt-tipped stylet comprising a hook or notch at a proximal end of the stylet and supported within the cannula;

[0179] (iii) a gas valve positioned at a distal side of the housing unit and configured to introduce gas at the proximal end of the cannula;

[0180] (iv) a front compression spring surrounding the distal end of the stylet;

[0181] (v) a spring box, the spring box comprising:

[0182] rear compression spring;

[0183] a blocking ring having two pins protruding outward, the blocking ring being located distal to the rear compression spring;

[0184] a distal box end cover, the distal box end cover being located distal to the blocking ring;

[0185] a tubular support having a proximal cartridge end cap and a distal air valve on both sides, the tubular support being located inside the rear compression spring, the blocking ring and the distal cartridge end cap;

[0186] wherein the stylet, the front compression spring, and the spring box are inserted through the distal end of the housing unit and into the cannula such that the proximal end of the stylet protrudes beyond the distal end of the cannula;

[0187] wherein the housing unit comprises two side grooves, into which the two pins protruding outward from the blocking ring are fitted,

[0188] wherein the stylet is retracted into the cannula when the device is pressed into the patient's body wall;

[0189] wherein, after the distal end of the cannula has penetrated the body wall and entered the body cavity, the stylet pops out forward beyond the distal end of the cannula;

[0190] wherein the injection gas is introduced into the body cavity through the gas valve and the stylet; and

[0191] Wherein, the hook or notch can be retracted to capture the suture.

[0192] 2. The device of clause 1 , wherein the blunt-tip stylet comprises a hook.

[0193] 3. The device of clause 1 , wherein the blunt-tip stylet comprises a notch.

[0194] 4. The apparatus of clause 1 , wherein the gas valve comprises a stopcock.

[0195] 5. The apparatus according to clause 1, wherein the gas valve is mounted on the distal side of the housing unit and in an axial position.

[0196] 6. The device of clause 1, wherein the gas valve is mounted on the housing unit and in an orthogonal position.

[0197] 7. The device of clause 1, wherein the two pins protruding outwardly from the blocking ring comprise screws.

[0198] 8. The device of clause 1, wherein the two pins protruding outwardly from the blocking ring comprise solid pins.

[0199] 9. The device of clause 1, wherein the body cavity is the peritoneal cavity.

[0200] 10. A method for laparoscopic access and wound closure in a patient in need thereof, the method comprising:

[0201] penetrating a body cavity through a body wall with a device comprising:

[0202] (i) a cannula comprising a beveled needle tip at a proximal end and attached to a housing unit at a distal end;

[0203] (ii) a blunt tipped stylet comprising a hook or notch at a proximal end and supported within the cannula;

[0204] (iii) a gas valve positioned at a distal end of the housing unit configured to introduce gas at the proximal end of the cannula;

[0205] (iv) a front compression spring surrounding a distal end of the stylet;

[0206] (v) a spring box comprising: a rear compression spring; a blocking ring having two pins protruding outwardly, the blocking ring being distal to the rear compression spring; a distal box end cap distal to the blocking ring; a tubular support having proximal and distal box end caps and a distal gas valve on either side, the tubular support being internal to the rear compression spring, the blocking ring, and the distal box end cap;

[0207] (vi) wherein the stylet, the front compression spring, and the spring box are inserted through a distal end of the housing unit and into the cannula such that the proximal end of the stylet protrudes beyond the tip of the cannula;

[0208] (vii) wherein the housing unit comprises two side slots into which the two pins protruding outwardly from the blocking ring fit,

[0209] (viii) wherein the stylet retracts into the cannula when the device is pressed into the body wall of the patient;

[0210] (ix) wherein the stylet is ejected forward beyond the distal end of the cannula after the distal end of the cannula has penetrated the body wall and entered the body cavity;

[0211] (x) wherein gas is introduced into the body cavity through the gas valve and the stylet; and

[0212] (xi) wherein the hook or notch is capable of retracting into the cannula to capture a suture;

[0213] injecting gas through the opening and into the cavity;

[0214] manipulating the stylet of the device to capture a suture in the body cavity; and

[0215] positioning the suture through the proximal wound and externalizing the suture to close the proximal wound.

[0216] 11. The method of clause 10, wherein the suture is introduced into the body cavity by a separate suture device.

[0217] 12. The method of clause 10, wherein the step of manipulating the stylet of the device to capture a suture for wound closure occurs after a separate suture device has introduced a suture into the body cavity.

[0218] 13. The method of clause 10, the step of manipulating the stylet of the device comprises pushing the stylet forward.

Claims

1. An apparatus for laparoscopic access and wound closure, comprising: (i) a cannula comprising a beveled needle tip at a proximal end and attached to the housing unit at a distal end; (ii) a blunt-tipped stylet comprising a hook or notch at a proximal end of the blunt-tipped stylet and supported within the cannula; (iii) a gas valve positioned at a distal side of the housing unit and configured to introduce gas at the proximal end of the cannula; (iv) a front compression spring surrounding the distal end of the blunt-tip stylet; (v) a spring box, the spring box comprising: rear compression spring; a blocking ring having two pins protruding outward, the blocking ring being located distal to the rear compression spring; a distal box end cover, the distal box end cover being located distal to the blocking ring; a tubular support member, with a proximal box end cover and the air valve on both sides of the tubular support member, the tubular support member being located inside the rear compression spring, the blocking ring and the distal box end cover; wherein the blunt-tip stylet, the front compression spring, and the spring box are inserted through the distal end of the housing unit and into the cannula such that the proximal end of the blunt-tip stylet protrudes beyond the distal end of the cannula; wherein the housing unit comprises two side grooves, into which the two pins protruding outward from the blocking ring are fitted, wherein the blunt-tip stylet is retracted into the cannula when the device is pressed into the patient's body wall; wherein, after the distal end of the cannula has penetrated the body wall and entered the body cavity, the blunt-tip stylet is ejected forward beyond the distal end of the cannula; wherein the insufflation gas is introduced into the body cavity through the gas valve and the blunt-end stylet; and Wherein, the hook or notch can be retracted to capture the suture.

2. The device according to claim 1, wherein The blunt-tip stylet includes a hook.

3. The device according to claim 1, wherein The blunt-tip stylet includes a notch.

4. The device according to claim 1, wherein The gas valve includes a stopcock.

5. The apparatus according to claim 1, wherein The gas valve is installed at the distal side of the housing unit and is in an axial position.

6. The apparatus according to claim 1, wherein The gas valve is mounted on the housing unit and is in an orthogonal position.

7. The apparatus according to claim 1, wherein The two pins protruding outwardly from the blocking ring comprise screws.

8. The apparatus according to claim 1, wherein The two pins protruding outwardly from the blocking ring comprise solid pins.

9. The apparatus according to claim 1, wherein The body cavity is the peritoneal cavity.

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