Device for laparoscopic access and wound closure

Abstract

The present invention provides devices and methods for laparoscopic access and wound closure. The devices are in the form of a single needle device that can perform several tasks, including piercing or puncturing fascial layers, insufflating a body cavity, and placing sutures for wound closure. In particular, the devices feature a blunt-tipped stylet having a hook or notch at the proximal end that can be used to capture sutures.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 101,958, filed on May 26, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to devices, methods, systems, and kits for safe laparoscopic access and wound closure within a patient in need thereof. The devices, methods, and systems can be used to safely penetrate a patient's body wall for laparoscopic surgery, inject gas into the body cavity, and place sutures for wound closure. With the present invention, these important operations, which typically require the use of multiple specialized devices, can be performed. In particular, the device is a single - needle device having a hook for suture capture.

Background Art

[0003] In laparoscopic surgery, access to the patient's peritoneal cavity and the creation of pneumoperitoneum are generally performed by using a Veress needle. The cannula of the Veress needle is a sharp and beveled stainless - steel needle tip for cutting through the tissue of the abdominal wall. Inside the cannula, there is a spring - loaded hollow stylet having a rounded and non - sharp tip to protect any organ from damage by the sharp and piercing cannula. In the rest position, the rounded and non - sharp tip protrudes slightly beyond the sharp tip of the cannula. The stylet is made of a hollow tube used to transfer gas (e.g., carbon dioxide gas) to create a pneumoperitoneum for laparoscopic surgery. The tip of the cannula, the hollow stylet, and the assembled cannula / stylet are shown in FIG. 1.

[0004] When the Veress needle penetrates the peritoneal wall, the direct contact pressure exerted by the tissue on the tip region pushes the stylet into the inner bore of the cannula, exposing the sharp cannula and penetrating the tissue wall. After the needle tip penetrates the skin / fascia and enters the peritoneal cavity, the blunt-tipped non-sharp stylet pops out rapidly forward, protecting the sharp cutting tip and protecting the internal organs from damage by the sharp cannula. The entry of the Veress needle into the peritoneal cavity provides the surgeon with unique acoustic-vibratory feedback (Figure 2).

[0005] After the Veress needle enters its cavity, gas (e.g., carbon dioxide gas) can be transferred through the hollow bore of the stylet to expand the peritoneal space and form pneumoperitoneum to facilitate laparoscopic surgery.

[0006] During laparoscopic surgery, trocars and probes can also be inserted into the peritoneal cavity. At the end of laparoscopic surgery, the Veress needle, trocars, and probes are withdrawn, and the open wounds are closed with sutures. The process of suturing various peritoneal layers, including the skin and fascial layers, is cumbersome and is thus omitted for small incisions. Such potential risks include infection and the subsequent development of incisional hernias. Methods of peritoneal fascia closure typically require the use of separate devices to mechanically access the edges of internal wounds or incisions with sutures. The sutures are inserted through the wound location across the peritoneal space by a separate device from the inside and brought out. The two ends of the sutures are then pulled up from the outside, tightened, and tied off to complete the closure of the wound left by a device such as a trocar. There are many commercially available wound closure devices for laparoscopic surgery. Most of these devices are expensive and complex mechanical devices. A particular device can enter the peritoneal cavity following the same technique as the Veress needle, with a stylet made of a solid rod through which CO2 gas for forming pneumoperitoneum cannot pass. Further, the device is designed to capture only the suture and pass it internally or externally through the abdominal wall. As an example, the Covidien Endo Close™ or Auto Suture™ devices have a spring-loaded push button to advance the stylet forward to facilitate suture capture within the peritoneal cavity.

[0007] There is still a need for devices, methods, and systems for safe and efficient laparoscopic access and wound closure within a patient that requires it. In particular, a single or unitary device for laparoscopic access, capable of insufflating the body cavity and closing within a patient that requires it is needed.

[0008] The description herein of the particular advantages and disadvantages of known devices, methods, and systems is not intended to limit the scope of the embodiments. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0009] In some embodiments, an object of the present invention is to provide an apparatus (a needle and stylet assembly) for entering a body cavity through a body wall to form an opening and then pulling a suture thread through the opening to close a proximal wound (i.e., a wound near the device entry position formed by another device such as a laparoscopic surgical device (e.g., a trocar)). A further object of the present invention is to provide an apparatus for injecting gas into a body cavity.

[0010] Another object of the present invention is to provide a method for entering a body cavity through a body wall to form an opening and then pulling a suture thread through the opening to close a proximal wound. In certain embodiments, the method may further include injecting gas into the body cavity.

[0011] In some embodiments, another object of the present invention is to provide a kit including an apparatus, which can include, among other things, a needle and stylet assembly, for use in a procedure including entering a body cavity through a body wall to form an opening and then pulling a suture thread through the opening to close a proximal wound. A further object of the present invention is to provide a kit including an apparatus for injecting gas into a body cavity.

[0012] One aspect of the present invention is to provide an apparatus 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 bore. In certain aspects, the cannula includes a housing unit at the cannula distal end. In some embodiments, the housing unit also includes an internal hollow bore. Further, in certain embodiments, the cannula includes an angled needle tip at the cannula proximal end.

[0013] Another aspect of the present invention is to provide an apparatus or assembly comprising a stylet having a proximal end of the stylet and a distal end of the stylet, for example, a stylet with a non-sharp tip, wherein the stylet is configured to be inserted (i.e., inserted internally) into an internal bore and supported by a cannula. In certain embodiments, the stylet includes a hook at the proximal end of the stylet. In other embodiments, the stylet includes a notch at the proximal end of the stylet.

[0014] Another aspect of the present invention is to provide an apparatus or assembly comprising a gas valve for introducing gas into the proximal end of a cannula. In certain embodiments, the gas valve is disposed distally of a housing unit.

[0015] A further aspect of the present invention is to provide an apparatus or assembly comprising a front compression spring. In certain embodiments, the front compression spring surrounds the distal end of the stylet. For example, the front compression spring is wound or wrapped around an outer wall of a portion of the stylet near the distal end of the stylet.

[0016] Another aspect of the present invention is to provide an apparatus or assembly comprising a spring cassette. In certain embodiments, the spring cassette includes a rear compression spring, a protective ring having at least two pins that are distal to the rear compression spring and project outwardly, a distal cassette end cap distal to the protective ring, and a tubular support positioned inside the rear compression spring, the protective ring, and the distal cassette end cap and adjacent to the proximal cassette end cap and the gas valve at the distal end.

[0017] In certain embodiments of the present invention, the apparatus or assembly may be assembled by inserting the stylet, the front compression spring, and the spring cassette through the distal end of a housing unit (i.e., through the internal bore of the housing unit) and into a cannula (i.e., through the internal bore of the cannula) such that the proximal end of the stylet projects beyond the needle tip portion disposed at the proximal end of the cannula.

[0018] In some embodiments of the present invention, the housing unit further comprises at least one, 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 outward from the protective ring of the spring cassette.

[0019] In a particular aspect of the present invention, the stylet may retract into the inner bore of the cannula. In certain embodiments, the stylet retracts into the cannula when the device or assembly is pushed into the patient's body wall.

[0020] In another aspect of the present invention, the stylet is configured to project forward beyond the cannula tip after the cannula tip has entered the body cavity through the body wall. In certain embodiments, the operation of the stylet projecting forward is controlled by a spring cassette. For example, in certain embodiments, when the cannula tip penetrates the body wall, the stylet may automatically project forward.

[0021] Aspects of the present invention also include components configured to facilitate the flow of insufflation gas, such as a gas valve or a stopcock. In certain embodiments, the gas valve is disposed distally of the housing unit. In some embodiments, the gas valve or stopcock is attached to the housing unit. Embodiments of the present invention also include introducing insufflation gas into the body cavity through the gas valve or stopcock and through the stylet.

[0022] In a particular aspect of the present invention, the stylet includes features such as hooks or notches for capturing and manipulating suture threads. In some embodiments, the feature (i.e., the hook or notch) may be retracted rearward to lock in or capture the suture thread. Generally, during suture capture, the hook or notch does not fully retract into the bore of the cannula.

[0023] The use of devices and assemblies in laparoscopic access and wound closure within a patient requiring the same is also disclosed herein.

Brief Description of the Drawings

[0024] The subject matter regarded as the present invention is particularly pointed out and distinctly claimed at the end of this specification. However, the present invention, together with its objects, features, and advantages, may be best understood by reference to the following detailed description when read in conjunction with the accompanying drawings, both as to its construction and method of operation.

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[0045] It should be understood that, for the sake of simplicity and clarity of explanation, the elements shown in the figures are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Furthermore, many features of any one embodiment shown in the figures should not be considered to be independent and separate from the features of the embodiments shown in other figures, and it is contemplated that the features of any one embodiment may be combined with other embodiments. Additionally, reference numerals may be repeated between the drawings to indicate corresponding or similar elements where appropriate. Further, the arrows and brackets used to indicate different locations and portions of the embodiments shown in the figures are only approximate and should in no way be considered limiting. DETAILED DESCRIPTION OF THE INVENTION

[0046] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be understood by those skilled in the art, however, that the present invention may 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 obscure the present invention. Further, one or more aspects of the invention disclosed herein may be embodied in any one of a number of specific embodiments, including, but not limited to, all or part of the specifically described embodiments, or a mixture of components of several of the specifically described embodiments, and it will be understood by those skilled in the art that different embodiments may be contemplated.

[0047] Furthermore, the present invention is described in the context of exemplary embodiments. However, the scope of the present invention is not limited to the specific examples and embodiments described herein. Rather, this specification merely reflects specific embodiments and serves to explain the principles and features of the present invention. Those skilled in the art will recognize that various modifications and improvements can be made without departing from the spirit and scope of the present invention.

[0048] The present invention provides devices and methods for safe laparoscopic access and wound closure within a patient in need thereof. For laparoscopic surgery, devices according to certain embodiments can be used to provide safe access to a patient's body cavity, such as the peritoneal wall. The devices of the present invention also enable the formation of pneumoperitoneum by gas insufflation and efficient wound closure using sutures.

[0049] The escalating cost of healthcare is a major concern, and reducing hospital costs is of utmost importance. Surgical instruments that provide multiple functions are an effective way to reduce such costs. Associated reductions in surgical device procurement, inventory costs, and sterilization expenses are part of the direct benefits. Reducing the surgical time, improving the efficiency in the operating room, enhancing patient safety, and improving the reliability of the device can reduce the overall cost of surgery. The present invention, in particular, serves to reduce costs by combining the functions of a Veress needle and a trocar site closure device into a single, unitary surgical instrument.

[0050] As used herein, "proximal" means close to the point of attachment or insertion into the body, and "distal" means positioned away from the point of attachment or insertion into the body.

[0051] Device

[0052] According to certain embodiments, the present invention includes a device 10 that enters a body cavity through a body wall, forms an opening in a patient, injects gas into the body cavity through the opening, draws a suture through the opening, and closes a proximal wound, such as a wound formed by a surgical device, such as a trocar device, passing therethrough. After the trocar device is withdrawn, 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.

[0053] In certain embodiments, the device 10 comprises a cannula 11. In a preferred embodiment, the cannula 11 is an elongated sleeve having a hollow bore extending along its length.

[0054] In some embodiments, the cannula includes a housing unit 12 disposed at the distal end of the cannula 11 and an angled needle tip 110 disposed at the proximal end of the cannula. In some embodiments, the housing unit 12 is integrally formed with the cannula 11, while in other embodiments, the housing unit 12 and the cannula 11 may be separate components connected (i.e., affixed or attached) to each other via means known in the art, such as screws, screw connections, or adhesives.

[0055] In certain embodiments, the device 10 of the present invention comprises a stylet 13 with a non-sharp tip. The non-sharp tip portion 130 of the stylet 13 may be flat or rounded and is not sharp enough to damage body tissue with a weak force. In certain embodiments, the stylet 13 is an elongated sleeve having a hollow bore extending along its length. In other preferred embodiments, the stylet 13 includes a suture capture function, such as a hook or notch 131, disposed at the proximal end of the stylet 13. According to a particular aspect of the present invention, the stylet 13 with a non-sharp tip may be inserted into the hollow bore of the cannula 11 and may be supported within the cannula 11.

[0056] In certain embodiments, the device 10 of the present invention further comprises a gas valve 16. In some embodiments, the gas valve 16 is disposed distally of the housing unit 12. In a preferred embodiment, the gas valve 16 is configured to introduce gas into the proximal end of the cannula 11. The gas can be used for injecting into a patient's body cavity.

[0057] In certain embodiments, the device 10 of the present invention also comprises a front compression spring 14. In a preferred embodiment, the front compression spring 14 surrounds (i.e., winds around or is wound around) the distal end of the stylet 13.

[0058] In certain embodiments, the apparatus 10 of the present invention further comprises a spring cassette 15. The spring cassette 15 includes various components that operate by manipulating the non-sharp tip stylet 13 between a retracted configuration and an extended configuration within the cannula 11. For example, according to certain aspects of the present invention, the spring cassette 15 may include a rear compression spring 150, a protective ring 151, a distal cassette end cap 153, a tubular support 154, and a proximal cassette end cap 155. In certain embodiments, the protective ring 151 may be disposed distally of the rear compression spring 150. Further, in some embodiments, the protective ring 151 may include at least two pins 152 that protrude outside (i.e., laterally away from) the protective ring 151. In certain embodiments, the distal cassette end cap 153 of the spring cassette 15 is disposed distally of the protective ring 151. Further, in certain embodiments, the tubular support 154 is adjacent to (i.e., adjacent or abutting) the proximal cassette end cap 155 and, in some embodiments, to the gas valve 16 disposed distally of the housing unit 12. In one embodiment, the tubular support 154 is positioned (i.e., arranged or positioned) inside the rear compression spring 150, the protective ring 151, and the distal end cap 153.

[0059] Further, according to certain aspects of the present invention, the stylet 13, the front compression spring 14, and the spring cassette 15 may be inserted through the distal end of the housing unit 12 into the cannula 11 (i.e., into the hollow bore of the cannula 11). The stylet 13 is typically inserted into the hollow bore of the cannula 11 together with the front compression spring 14 and the spring cassette 15 such that the proximal end of the stylet 13 protrudes beyond the angled needle tip 110 of the cannula 11. Thus, when the proximal end of the stylet 13 (including the stylet tip 130) protrudes beyond the angled needle tip 110 of the cannula 11, the stylet 13 can be said to be in an extended configuration. Further, when in the extended configuration, the stylet 13 operates to protect the needle tip 110 of the cannula 11, preventing the needle tip 110 from damaging an organ or other aspects of the body cavity.

[0060] In certain embodiments, the housing unit 12 includes at least two side slots 120 into which at least two pins 152 protruding outward from the protective ring 151 are fitted.

[0061] Furthermore, according to a particular aspect of the present invention, the stylet 13 has a retracted configuration in which the stylet 13 retracts into the hollow bore of the cannula 11. When in the retracted configuration, the angled needle tip 110 of the cannula 11 is exposed so as to be able to puncture the patient's skin.

[0062] According to certain aspects, the extended configuration in which the stylet 13 extends beyond the needle tip portion 110 of the cannula 11 is a main configuration of the device 10 of the present invention. In other words, the device 10 naturally maintains the extended configuration without user involvement, although other embodiments where the device 10 naturally maintains the retracted configuration are also contemplated. In certain embodiments, to change the device 10 of the present invention from the extended configuration to the retracted configuration, the user must press the non-sharp tip of the stylet 13 against a surface, such as the surface of the patient's skin, to push the stylet 13 into the cannula 11. In other embodiments, to change the device 10 from the retracted configuration to the extended configuration, the force applied to the tip of the stylet 13 must be substantially reduced, such as when the tip of the stylet 13 enters the abdomen, or the user must stop applying forward force, such as when receiving audio and vibration feedback when the tip of the stylet 13 enters the abdomen. For example, in a preferred embodiment, the stylet 13 is spring-biased within the cannula 11 such that the rear spring pushes the tip portion 130 of the stylet 13 out of the cannula 11, i.e., into the extended configuration, whenever no force is applied to push the tip portion 130 of the stylet 13 into the cannula 11. In this way, when the angled needle tip portion 110 of the cannula 11 enters the body cavity through the body wall, the stylet 13 pops forward beyond the angled needle tip portion 110 of the cannula 11. The stylet 13 automatically moves forward to prevent organ damage, but as soon as the tissue resistance at the tip of the stylet 13 weakens, audio and vibration feedback indicates that the device 10 has entered the body cavity through the body wall, so the user will stop pushing the device 10 forward.

[0063] In certain embodiments of the present invention, the gas valve and the stylet 13 are each configured to introduce insufflation gas into the body cavity. That is, the insufflation gas can be introduced through the gas valve, further through the internal hollow bore of the stylet 13, and released into the body cavity.

[0064] According to certain aspects of the present invention, the stylet 13 comprises a suture capturing function such as, for example, a hook or notch 131. In certain embodiments, when the user stops pushing the stylet 13 forward, the hook or notch 131 of the stylet 13 may, for example, automatically retract to a stationary position to capture or hold the suture. For example, in certain embodiments, the hook or notch 131 moves back a short distance to a closed or stationary position (FIGS. 9B and 10) to form a gap for capturing 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 form a gap for capturing the suture. Generally, the hook or notch 131 moves substantially inside the hole of the cannula 11 only when piercing the abdominal wall.

[0065] In certain embodiments, the device 10 further comprises an extension tube 17 and a gas connector 18 that functions as an angled (e.g., right angled) adapter between the extension tube 17 and the gas valve 16 (see FIGS. 12, 13, 14, and 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 invention, the gas connector 18 is a hollow component having an opening for the extension tube 17 and an opening for the gas connector 18 arranged such that the gas valve 16 (or stopcock) is attached to the connector 18 at an angle of approximately ninety degrees (90°) with respect to the extension tube 17 and the stylet 13. In certain embodiments, the extension tube 17 and the gas connector 18 are considered part 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 disposed distally of the housing unit 12.

[0066] In certain embodiments, gas valve 16 is a stopcock. In one embodiment, gas valve 16 is distally attached to housing unit 12 and is in an axial position relative to stylet 13. In another embodiment, gas valve 16 is attached to gas connector 18 and is in an orthogonal position relative to stylet 13. In certain embodiments, push button 19 is attached to gas connector 18 (see FIG. 13). Push button 19 can be formed of any suitable material, such as plastic, for example. Push button 19 can be used to assist in the manipulation of stylet 13, for example, during suture capture. In certain embodiments, when gas valve 16 is attached in an orthogonal position relative to stylet 13, stylet 13 can be easily pushed forward against the side of gas connector 18 without push button 19 because gas valve 16 and the gas tube are no longer in the way (see FIG. 12).

[0067] In certain embodiments, the suture is captured using a hook or notch 131. The present invention clearly contemplates embodiments in which hook 131 is used to capture the suture, as well as embodiments in which notch 131 is used. Hook or notch 131 allows for the passage of the suture to the hook or notch 131 and the curved wall to capture the suture.

[0068] In one embodiment, at least two pins 152 protruding outward from protective ring 151 are screws, such as set screws, for example. In another embodiment, at least two pins 152 protruding outward from protective ring 151 are solid pins, such as non-screw pins, for example.

[0069] The insufflation gas can be any gas suitable for insufflating a body cavity or forming a pneumoperitoneum. In certain embodiments, the insufflation gas is carbon dioxide (CO2).

[0070] In certain embodiments, the body cavity is the peritoneal cavity.

[0071] In certain embodiments, the device 10 is in the form of a single needle device. Generally, the devices according to the embodiments enable the performance of several operations that require the use of a number of special devices. Such operations include, for example, penetration or puncture of the fascia layer, insufflation of gas into the body cavity, and placement of sutures for wound closure.

[0072] The exemplary devices described herein can be used to safely puncture the peritoneal wall, protect against organ injury with a spring-loaded hollow stylet 13, form a pneumoperitoneum for laparoscopic surgery by passing carbon dioxide gas through the holes of the stylet 13, and insert and place sutures for wound closure without the need for separate devices. Exemplary devices are shown in FIGS. 3, 12, and 13.

[0073] The exemplary device can be inserted into the patient's peritoneal cavity by penetrating the skin and fascia layer with the cannula 11 of the device 10. Direct pressure on the stylet tip 130 pushes the stylet 13 with a non-sharp or rounded end into the shaft of the cannula 11, as when penetrating a strong fascia layer. When the cannula tip 110 of the device 10 enters the peritoneal cavity, the tissue force on the dull stylet tip 130 suddenly weakens, and the stylet 13 pops forward rapidly, thus protecting the tip of the cannula 11 so as not to damage any organ inside the cavity. Thereafter, gas (e.g., CO2 gas) can be introduced into the peritoneal cavity through the device 10 and injected into the cavity. The peritoneal cavity is injected during and in preparation for laparoscopic surgery.

[0074] The device 10 utilizes two compression springs 14 and 150 (see FIG. 6). The rear compression spring 150 installed inside the cassette is used to push out the stylet 13. The direct contact pressure on the stylet tip 130 pushes the stylet 13 into the shaft (or hollow hole) of the cannula 11, such as when penetrating the fascia layer. That is, the device 10 of the present invention adopts a retracted configuration. When the cannula 11 enters the peritoneal cavity, the contact pressure weakens, and the stylet 13 pops forward to protect and block the sharp cutting tip 110 of the cannula 11. That is, the device 10 of the present invention adopts an extended configuration.

[0075] After laparoscopic surgery, the device 10 can be used for suture capture, suture passage, and wound closure. The stylet 13 can be pushed forward via the gas valve 16 (or button 19 attached to the gas valve 16 or gas connector 18). The maximum movement 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).

[0076] To facilitate suture capture, the stylet assembly 20 is pushed forward within the extended configuration. After being pushed forward, the hook or notch 131 at the stylet tip 130 is sufficiently away from the end of the cannula 11 to form an opening for the suture to pass through (see FIG. 9). When the suture is caught or captured by the hook or notch 131, the front compression (or second in another form) spring 14 near the proximal side of the spring cassette 15 is used to retract the stylet 13 to the retracted configuration when the forward pressing stops. With the opening covered by the outer cannula 11 and the suture held in the space between the hook and the cannula 11, the front compression spring 14 pulls on the hook or notch 131. FIG. 10 shows the stylet tip 130 in the retracted position. After the suture is securely held, the suture enters and exits the abdominal wall around the wound that is closed by tying from the outside of the abdomen. The wound is closed by tissue approximation, i.e., by moving the tissue edges to the desired position for suturing.

[0077] In certain embodiments, for suture capture, the stylet 13 is operable via a gas valve 16 (e.g., a stopcock), a gas connector 18, or a button 19 attached to the gas valve 16, and may be pushed forward and outward, for example, toward an extended configuration. Alternatively, in other embodiments, the position of the gas valve 16 is shifted at a right angle (i.e., orthogonal) to the stylet 13, thereby creating a space with the thumb actuation or introduction of the button 19 (FIGS. 12 and 13).

[0078] The above description is intended to illustrate the basic principles and modes of operation of the devices according to exemplary embodiments of the present invention. Accordingly, the device designs and various drawings disclosed herein are not intended to represent or limit commercially available products to be manufactured, although the devices shown can actually be manufactured and marketed. In the practice of standard production engineering, molded plastic parts can be used to replace the machined parts as described above to save labor and cost. The various parts illustrated in the figures can be manufactured by an injection molding process.

[0079] As used herein, a "cannula" is a hollow, elongated, cylindrical sheath that terminates in a sharp blade tip for piercing the patient's external tissue.

[0080] The front portion of the exemplary device 10 comprises a cannula 11 having an angled needle tip 110 that is used to pierce or puncture a body wall, such as the abdominal wall. According to certain embodiments, the cannula 11 is a hollow tube having an angled needle tip 110 at its proximal end. The angled 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. Most of the stylet 13 is received inside the cannula 11. When no force or pressure is applied to the stylet tip 130, the proximal stylet tip 130 projects beyond the angled needle tip 110 of the cannula 11 (i.e., in the extended configuration).

[0081] The cannula 11 according to a particular embodiment can be made of any suitable material, such as metal or plastic, for example. In a particular embodiment, the cannula 11 is stainless steel, such as 304 stainless steel.

[0082] The cannula 11 can be any suitable gauge for laparoscopic use. In a particular embodiment, for example, the cannula 11 is 14 gauge. The cannula 11 can be formed from hypodermic needle stock. In a particular embodiment, the surface of the cannula 11 is citrated.

[0083] In a particular embodiment, the length of the cannula 11 from the end (proximal end) of the angled needle tip 110 to the distal end of the cannula 11 ranges from about 4.5 to about 7.7 inches, from about 4.5 to about 6.5 inches, or from about 4.9 to about 5.2 inches. In a particular embodiment, the cannula 11 is about 5 inches in length. Generally, the length of the cannula 11 within the housing unit 12 ranges from about 0.25 to about 0.35 inches, or about 0.30 inches. In a particular embodiment, such as in an obese patient, the length of the cannula 11 from the end (proximal end) of the angled needle tip 110 to the distal end of the cannula 11 ranges from about 5.7 to about 7.7 inches, or from about 6.1 to about 6.4 inches.

[0084] In a particular embodiment, the outer diameter of the cannula 11 ranges from about 0.07 to about 0.09 inches, from about 0.080 to about 0.086 inches, or from about 0.082 to about 0.084 inches.

[0085] In a particular embodiment, the inner diameter of the cannula 11 ranges from about 0.06 to about 0.075 inches, from about 0.065 to about 0.07 inches, or from about 0.066 to about 0.069 inches.

[0086] In certain embodiments, the cannula 11 is slightly tapered such that the diameter narrows from the distal end of the cannula towards the proximal end. In certain embodiments, the outer diameter of the cannula 11 ranges from about 0.07 to about 0.09 inches, from about 0.080 to about 0.086 inches, or from about 0.082 to about 0.084 inches at the distal end, and narrows by about 0.002 inches at the proximal end in front of the angled needle tip.

[0087] According to certain aspects of the present invention, the cannula 11 can be attached to the housing unit 12 by any suitable means. In certain embodiments, the cannula 11 is attached to the housing unit 12 mechanically, for example, via set screws, by an adhesive, or a combination thereof. FIG. 5 shows a mechanical drawing of an exemplary housing unit 12.

[0088] During operation of the device 10, the housing unit 12 can be grasped by a physician to control the position and penetration of the device 10. Sufficient downward pressure is applied to enter the device 10 into the body cavity.

[0089] According to certain aspects of the present invention, the housing unit 12 includes a bore 121 with a circular cross-section extending through the length of the device 10. In some embodiments, as shown in FIG. 5, the diameter of the bore 121 narrows at the distal end. In certain embodiments, the housing unit 12 has a diameter of approximately 0.5 inches at the proximal end and approximately 0.75 inches at the distal end. In some embodiments, the bore 121 passing through the housing has a diameter of at least approximately 0.08 inches at its narrowest part. Further, in some embodiments, the bore 121 passing through the housing unit 12 has a diameter of up to approximately 0.32 inches at its widest part, or is large enough to accommodate the diameter of the spring cassette 15. Additionally, a passage for a narrow bore 122 may be included within the housing unit 12, passing from one outside to the central bore 121 at approximately 0.15 inches from the proximal end of the housing unit 12 and at approximately 3 / 16 inches from the distal end. In some embodiments, the housing unit 12 is substantially cylindrical with a diameter of approximately 0.5 inches, except for the most distal approximately 3 / 8 inches of the housing unit 12, which has a diameter of approximately 0.75 inches and is provided with a handle for gripping the device 10.

[0090] According to certain aspects of the present invention, the housing unit 12 may be formed of any suitable material, such as a polymer material like metal or plastic, for example. In some embodiments, the housing unit 12 is hollow and includes at least two slots 120 extending axially along the housing unit 12. In certain embodiments, the slots are aligned with at least two pins 152 extending from a protective ring 151 that fits inside the housing unit 12 together with the spring cassette 15. In a preferred embodiment, the slots 120 are of a length suitable for the stylet assembly 20 to move within the housing unit 12 by a short distance, such as from about 0.1 to about 0.2 inches, or about 0.15 inches. In certain embodiments, the slots 120 are configured to engage the pins 152 to prevent excessive movement of the stylet assembly 20 in either the proximal or distal direction.

[0091] According to certain aspects of the present invention, the stylet 13 is disposed within the cannula 11. In some embodiments, the stylet 13 is a hollow tube having a proximal rounded end (i.e., a blunt tip) or a non-sharp tip 130 to protect the organ from damage by the (sharp) cannula 11. In certain embodiments, the stylet 13 allows gas to pass through the device 10 and into the patient's body cavity (i.e., insufflation) through the hollow tube or aperture. The proximal end of the stylet 13 also includes a suture capture feature, such as a hook or notch 131, for suture capture (see FIG. 9). In some embodiments, the front compression spring 14 and spring cassette 15 are disposed at the distal end of the stylet 13 (see FIG. 8). The spring cassette 15 can include a rear compression spring 150 that is biased / debiased to push the proximal non-sharp stylet tip 130 into an extended configuration, thereby protecting the angled needle tip 110 of the cannula 11 from damaging the organ, for example, after entering the peritoneal cavity.

[0092] As referred to herein, the "stylet assembly" of the present invention can include a notch or hook 131 for suture capture, a front compression spring 14 surrounding the distal end of the stylet 13, a spring cassette 15, and a gas valve 16, such as a stopcock (see FIG. 6). In certain embodiments, the stylet assembly 20 may further include a gas connector 18. The stylet 13 is disposed inside the cannula 11 and the housing unit 12.

[0093] In one embodiment, the spring cassette 15 (FIG. 7) includes (a) a rear compression spring 150, (b) a protective ring 151 having at least two outwardly projecting pins 152 distal to the rear compression spring 150, a distal cassette end cap 153 distal to the protective ring 151, and (c) a proximal cassette end cap 155 and a tubular support 154 adjacent (i.e., adjacent or abutting) to the proximal cassette end cap 155 and the distal end cap 153.

[0094] In certain embodiments, the proximal cassette end cap 155 and the distal end cap 153 are attached to the tubular support 154 by an adhesive. In certain embodiments, the rear compression spring 150 and the protective ring 151 are free or loosely fitted to the tubular support 154 between the two end caps 153 and 155.

[0095] The movement of the protective ring 151 with the pin 152 installed is restricted to slide back and forth along the two side slots 120 of the housing unit 12. In the stationary position, the protective ring 151 and the pin 152 are disposed at the distal ends of the side slots 120.

[0096] Any portion or part of the outer wall of the stylet 13 is attached to the inner bore of the tubular support 154, for example, by an adhesive. Thus, the spring cassette 15 (FIG. 7) is also attached to the stylet 13 via the tubular support 154. Thus, the stylet 13 is supported by the spring cassette 15 that can slide smoothly within the bore of the housing unit 12. When the device 10 is inserted into the abdomen, tissue resistance pushes the stylet 13 rearward and inward, exposing the sharp cutting tip of the cannula 11. Since the protective ring 151 and the pin 152 are disposed at the distal ends of the side slots 120 and they cannot move further rearward, the inward movement of the stylet 13, together with the same movement of the spring cassette 15, compresses and biases the rear compression spring 150 disposed within the spring cassette 15. Since the tissue resistance on the stylet tip 130 weakens when entering the peritoneal cavity, the rear compression spring 150 within the spring cassette 15 releases the biasing force, thereby pushing the stylet 13 outward and protecting the tip of the sharp cannula 11 to prevent organ damage.

[0097] When the gas valve is disposed at a right angle to the stylet 13, the gas valve 16 can be attached directly to the distal end cap 153 or via the extension tube 17 and the gas connector 18.

[0098] In certain embodiments, the spring cassette 15 facilitates the retraction of the hook or notch 131 of the stylet 130. That is, in some embodiments, the spring cassette 15 facilitates the movement of the stylet 13 to a retracted configuration.

[0099] When stationary or not in contact, the non-sharp stylet tip 130 protrudes beyond the end of the sharp cannula 11 in the extended configuration by, for example, about 0.080 inches to about 0.100 inches. When the device 10 contacts the patient's abdominal wall, pressure on the non-sharp tip 130 of the stylet pushes it rearward into the cannula 11 and into the retracted configuration. Depressing the spring-loaded stylet 13 exposes the sharp cannula tip 110, which punctures the skin and fascia layers of the abdominal wall. After the device 10 enters the peritoneal cavity, the tissue contact pressure suddenly drops, and the spring 150 compressed or biased within the spring cassette 15 pushes the stylet 13 forward into the extended configuration, whereby the stylet tip 130 protrudes beyond the cannula tip 110, thereby protecting any organ inside the cavity from damage by the cannula tip 110. Thus, the stylet 13 can be retracted by pressure or moved forward by the spring action.

[0100] According to certain aspects of the present invention, the non-sharp or rounded end of the hollow stylet 13 may be manufactured by standard stainless steel tube end forming techniques. The closed-end tube may be spin-closed and welded using standard tools and well-known tube forming procedures.

[0101] According to certain aspects of the present invention, the device 10 of the present invention comprises at least two springs, such as a front compression spring 14 for retraction of the notch or hook 131 and a rear compression spring 150 disposed within the spring cassette 15.

[0102] In certain embodiments, distal to the rear compression spring 150 within the cassette 15, there is a protective ring 151 (shown in FIG. 7) with at least two fixing pins 152 that project through at least two slots 120 in the side walls of the housing unit 12 (FIGS. 4 and 5). The fixing pins 152 may be, for example, threaded set screws (see FIG. 7), or non-threaded pins. Adjacent to the protective ring 151, there is an end cap 153 with an internal taper for connection to the gas valve 16, such as 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., CO2) supply line. When 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 is then attached to the gas connector 18 to effect, for example, a 90° rotation of the gas valve 16 and the gas supply line (FIG. 12).

[0103] When the device 10 is not in use, the protective ring 151 is held in a fixed position at the rear end of the side slots 120 of the housing unit 12 by at least two fixing pins 152 (FIG. 7). When the stylet 13 is pushed rearward, the protective ring 151 does not move, but the spring cassette 15 moves rearward, compressing the spring 150. The gas valve 16 attached to the spring cassette 15 also moves rearward.

[0104] The stylet 13 is not attached to the protective ring 151 that can slide along a tubular support 154 (e.g., a hollow tube) for the spring 150 (FIG. 7). The proximal tip cap 155 of the spring cassette 15, and the distal attachment for the gas valve 16 (e.g., a stopcock) of the spring cassette 15, are attached to the tubular support 154. The stylet 13 is attached to the tubular support 154 through the inner wall (hole) of the tubular support 154.

[0105] When the sharp cannula tip 110 enters the peritoneal cavity, the tissue pressure at the tip of the stylet 130 suddenly weakens, extending the biased rear compression spring 150 and immediately pushing the stylet 13 back out again. As described above, the returned position of the stylet 13 at the needle tip 110 protects against organ damage and destruction by the sharp cutting edge of the cannula 11 when entering the abdomen. After entering the peritoneal cavity, the gas valve 16 can be opened to introduce gas for insufflation of the body cavity and establish pneumoperitoneum for laparoscopic surgery.

[0106] According to a particular aspect of the present invention, after the suture is placed, the retraction of the hook or notch 131 is automatically performed by spring action as soon as the forward pressing force is released. In some embodiments, the mechanical properties of the front compression spring 14 are selected to rapidly close the gap in order to ensure secure capture of the suture disposed inside the gap.

[0107] According to a particular aspect of the present invention, the device 10 comprises a gas valve 16 (e.g., also referred to herein as a "stopcock") that can be used to start or stop the flow of gas (e.g., CO2) to be injected into the patient. When the device 10 is inserted into the peritoneal cavity, the gas valve 16 can be opened to allow gas to flow and inflate the cavity to form a pneumoperitoneum for laparoscopic surgery.

[0108] At the end of the surgery, at least one surgical device, such as a trocar, is withdrawn from the abdomen, leaving a puncture wound. In certain embodiments, the size of the wound may be on the order of the diameter of the cannula 11, i.e., the shaft of the surgical device. In certain embodiments, the wound (e.g., the proximal wound referred to herein) is greater than about 5 mm and needs to be closed. This wound site can be closed by tissue approximation using percutaneous sutures. Instead of performing time-consuming surgical sutures or using a separate device for wound site closure, the device 10 according to certain aspects of the present invention can be used to facilitate wound closure via suture capture hooks or notches. Since the sutures can be captured, held, brought out externally, and put internally, the two ends of the sutures can be placed across the wound and brought out externally. The suture ends are then tightly pulled and tied to close the wound. In addition to externalization, the sutures can be further internalized by first capturing and exposing the patient outside the patient's body, puncturing through the exposed wound fascia from one side, looping inside around the wound, and bringing out from the opposite side of the wound before tying. In this way, the physician can achieve easy site closure using the present invention.

[0109] In one embodiment, wound closure is processed by the following process,

[0110] (i) Bring out the two ends of the suture externally from both sides of the wound (Figure 17),

[0111] (ii) Insert the exemplary device 10 proximal to the wound,

[0112] (iii) Capture or hold the end of the first suture end from within the body cavity,

[0113] (iv) Bring out the first suture end externally for tying outside the wound, and,

[0114] (v) Repeat steps (iii) and (iv) for the second suture end.

[0115] In certain embodiments, the exemplary device 10 may enter through the fascial layer under the skin of the wound.

[0116] In certain embodiments, a suture (e.g., a suture without a metal cutting needle attached) is inserted into the body through a trocar prior to the wound closure procedure.

[0117] In one embodiment, wound closure is processed by the following process,

[0118] (i) Internalize one suture end + the entire suture from one side of the wound (Figure 18),

[0119] (ii) Using the exemplary device 10, exit the suture end from the opposite side of the wound (e.g., from outside the body, capturing and holding one end of the suture with the exemplary device 10),

[0120] In certain embodiments, wound closure is processed by the following process,

[0121] (i) Insert the suture into the body part adjacent to one side of the wound using the exemplary device 10, i.e., the surgical device, to internalize the suture while leaving one end of the suture outside the body,

[0122] (ii) Insert the exemplary device 10 (empty, without suture) into the body from the opposite side of the wound to capture the internalized suture,

[0123] (iii) Exit the other end of the suture outside for tying.

[0124] In certain embodiments, the stylet 13 may be manually pushed forward (e.g., beyond the rest position or neutral position) to capture the suture for wound closure. The stylet 13 may include a hook 131 (e.g., a hook similar to a crochet hook) for suture capture. In certain embodiments, the hook 131 is formed as a notch in the stylet 13.

[0125] To capture the suture, the stylet tip 130 can be pushed forward, for example, via the gas valve 16 or via a handle or button 19 that can be attached to the gas valve 16 to capture the suture on a notch or hook 131. In certain embodiments, when the gas valve is orthogonal to the stylet 13 (Figure 12), the gas connector 18 may function as a handle for pushing the stylet tip 130 forward. The notch or hook 131 securely holds the suture after automatically retracting by spring action when the pressing force is released.

[0126] According to certain aspects of the present invention, the forward pushing advances the protection ring 151 together with the tip 130 of the stylet 13, thereby forming a gap that enables the capture of the suture (see FIGS. 9 and 10). The forward displacement of the stylet 13 is limited by the width of the side slot 120 where the fixed pin 152 protrudes (see FIGS. 3, 4, and 5). In addition to the rear compression spring 150 installed in the spring cassette 15, there is a front compression spring 14 disposed adjacent to the proximal spring cassette end cap 155 of the cassette (see FIG. 6). When the gas valve 16 is no longer being pushed, this front compression spring 14 is used to retract the stylet 13 and capture the suture disposed inside the gap of the hook 131. FIGS. 9 and 10 show the hook 131 in the open position (i.e., ready to receive / capture the suture) when the device 10 is pushed forward, and also show the hook 131 in the closed position (retracted position, rest position, or neutral position) that can securely hold the suture disposed within the gap. The captured suture is housed within a small cavity surrounded by the hook 131 and the cutting edge of the cannula tip 110. When the opening through which the suture is grasped is surrounded by the hook 131 and the inclined tip of the cannula 110, the angular position (i.e., rotational position) of the stylet 13 relative to the cannula 11 is maintained by the anti-rotation pin 123 of the housing unit 12 together with the anti-rotation slot 156 formed in the distal end cap 153 as shown in FIG. 8. The anti-rotation pin 123 can be seen at the distal end of the housing unit 12, and the anti-rotation slot 156 can be seen at the distal end cap 153.

[0127] In certain embodiments, the device 10 is used to capture, hold, pass, exteriorize, and interiorize suture. In certain embodiments, the device 10 is used to close remaining wounds with a retractable laparoscope device. Closing the wound according to an embodiment can be achieved by a procedure of tissue access and percutaneous suturing to close the wound or puncture site without using a standard suture needle (using only the suture). The two ends of the suture can be mechanically positioned close to the opposing edges of the wound ready for closure. The exteriorized ends of the suture are used to join both the fascia and subcutaneous tissue, and optionally the skin. In certain embodiments, the abdominal wall is lifted, tightened, and tied by pulling the two ends of the suture upward from both sides of the wound to complete the closure. The suture can be inserted into the abdominal cavity using standard lighting and visualization by an inserted camera. Alternatively, the suture can be captured externally, held by the needle device 10, and then inserted into the abdominal cavity near the wound site.

[0128] The hook 131 can be formed by laser or mechanical cutting.

[0129] In one embodiment, the device 10 (i) at the proximal end, having an angled needle tip 110, and at the distal end, a cannula 11 attached to the housing unit 12, (ii) a stylet 13 with a non-sharp tip, having a hook or notch 131 at the proximal end of the stylet and being supported within the cannula, (iii) a gas valve 16 configured to introduce gas at the proximal end of the cannula and disposed distally of the housing unit 12, (iv) a front compression spring 14 surrounding the distal end of the stylet 13, (v) a spring cassette 15, a rear compression spring 150, a protective ring 151 having two outwardly projecting pins 152 distal to the rear compression spring 150, A distal cassette end cap 155 distal to the protective ring 151, and A tubular support 154 adjacent to the proximal cassette end cap 155 and the distal gas valve 16, the tubular support 154 being positioned inside the rear compression spring 15, the protective ring 151, and the distal end cap 155, the tubular support 154 and A spring cassette 15 comprising Comprising The stylet 13, the front compression spring 14, and the spring cassette 15 are inserted into the cannula 11 through the distal end of the housing unit 12, whereby the proximal end of the stylet 13 projects beyond the cannula tip 110, The housing unit 12 comprises two side slots 120 into which two pins 123 protruding outward from the protective ring 151 fit, When the device 10 is pushed into the patient's body wall, the stylet 13 retracts within the cannula 11, After the cannula tip 110 enters the body cavity through the body wall, the stylet 13 pops forward beyond the cannula tip 110, The insufflation gas is introduced into the body cavity through the gas valve 16 and the stylet 13, The hook or notch 131 can be retracted to capture the suture thread.

[0130] Method of Use

[0131] Generally, the exemplary device 10 can be used as a Veress needle for penetrating a body cavity wall, such as the peritoneal wall. The contact pressure exerted by the body cavity wall on the stylet of the device 10 pushes the stylet 13 into the inner bore of the cannula 11, exposing the angled needle tip 110 of the cannula 11 to penetrate the body cavity wall. After the cannula 11 penetrates the skin / fascia and enters the body (e.g., peritoneal) cavity, the stylet 13 pops forward to protect the cannula tip 110, thereby protecting the internal organs from damage by the sharp cannula 11. The entry of the exemplary device 10 of the present invention into the peritoneal cavity provides the surgeon with intrinsic audio-vibratory feedback (Figure 2).

[0132] After the exemplary device 10 enters the body cavity, gas (e.g., CO2) can be passed through the hollow bore of the stylet and injected into the body cavity. To form a space for laparoscopic surgery, insufflation of the body cavity is performed. In the example of the peritoneal cavity, insufflation of CO2 gas into the peritoneal cavity forms a pneumoperitoneum to facilitate laparoscopic surgery.

[0133] At the end of laparoscopic surgery, the exemplary device 10 of the present invention is retracted in a ready-to-use state to close the open wound left by the trocar, probe, and other large-diameter devices withdrawn after surgery with a suture.

[0134] In certain embodiments, the exemplary device 10 of the present invention may be used to insert and deploy a suture without the need for a separate device. The hooks or notches of the exemplary device 10 can be used to insert a suture secured to the hook or notch 131 into the proximal wound in the retracted position. The suture can be applied to the proximal wound by operating the exemplary device 10 and exiting the body cavity from within across the location of the wound (e.g., incision). The two ends of the suture are then pulled up, tightened, and tied from the outside to complete the closure of the wound left by a large-bore device such as a removed trocar. According to certain embodiments, the exemplary device 10 may be used to close the wound by exiting the two ends of the suture out from both sides of the wound. This is done by puncturing the exemplary device 10 through the sides of the wound respectively, grasping and capturing the suture, pulling the ends of the suture out from within the abdomen, and tightly tying the externalized suture ends to close the wound by tissue approximation. For this operation, a suture having two free ends must be pre-inserted into the abdomen through the trocar port. Alternatively, the suture may be internalized from one side of the wound, and then the ends of the suture are externalized from the opposite side before tying. In certain embodiments, the ends of the suture are first captured by the exemplary device 10 from outside the body before passing the entire suture through the abdomen by puncturing through one side of the wound to complete the suture internalization process.

[0135] In certain embodiments, a separate device, such as a trocar, is then used to insert the suture into the body cavity (e.g., peritoneal cavity). Next, the hook or notch 131 of the exemplary device 10 can 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 for receiving and capturing the suture. The front compression spring 14 is used to retract the stylet hook 131 and capture the suture disposed within the gap space (see FIGS. 9 and 10). The suture is exited from the body cavity through the wound (e.g., incision) site by the exemplary device 10. Next, the two ends of the suture are then pulled up, tightened, and tied from the outside by the exemplary device 10 to complete the closure of the proximal wound.

[0136] Certain embodiments of the present invention also provide a method for laparoscopic access and wound closure within a patient in need thereof. In one embodiment, the method comprises (a) entering the body cavity through the body wall with the device 10 to form an opening, wherein the device 10

[0137] (i) at the proximal end, comprises an angled needle tip 110 and, at the distal end, a cannula 11 attached to the housing unit 12;

[0138] (ii) at the proximal end, comprises a hook or notch 131 and a non-sharp-tipped stylet supported within the cannula 11;

[0139] (iii) a gas valve 16 configured to introduce gas into the proximal end of the cannula 11 and disposed distally of the housing unit 12;

[0140] (iv) a front compression spring 14 surrounding the distal end of the stylet 13;

[0141] (v) a spring cassette 15, a rear compression spring 150; A protective ring 151 having two outwardly projecting pins 152 distal to the rear compression spring 150, a distal cassette end cap 153 distal to the protective ring 151, A proximal cassette end cap 155 and a tubular support 154 adjacent to the distal gas valve 16, the tubular support 154 being positioned inside the rear compression spring 150, the protective ring 151 and the distal end cap 153 Comprising a spring cassette 15 Comprising

[0142] The stylet 13, the front compression spring 14 and the spring cassette 15 are inserted into the cannula 11 through the distal end of the housing unit 12, whereby the proximal end of the stylet projects beyond the cannula tip 110.

[0143] The housing unit 12 comprises two side slots 120 into which two pins 152 projecting outwardly from the protective ring 151 fit.

[0144] When the device 10 is pushed into the patient's body wall, the stylet 13 retracts within the cannula 11.

[0145] After the cannula tip 110 has entered the body cavity through the body wall, the stylet 13 pops forward beyond the cannula tip 110.

[0146] The insufflation gas is introduced into the body cavity through the gas valve 16 and the stylet 13.

[0147] The hook or notch 131 can be retracted to capture the suture thread, entering

[0148] (b) Injecting gas into the cavity through the opening

[0149] (c) Operating the stylet 13 of the device 10 to capture the suture thread within the body cavity

[0150] (d) Place the suture across the proximal wound and bring the suture out to close the proximal wound and includes.

[0151] In certain embodiments, the suture is inserted into the body cavity through a separate port device such as a trocar. In certain embodiments, the step of operating the stylet of device 10 to capture the suture for wound closure is performed after inserting the suture (e.g., suture material) into the body cavity through a separate port.

[0152] In certain embodiments, the suture is inserted into the body cavity by the process of suture internalization as described above using exemplary device 10. The suture is held and / or captured outside the body by exemplary device 10 and then punctured through the body wall (e.g., abdominal wall) into the body cavity for use in wound closure.

[0153] In certain embodiments, the step of operating the stylet of device 10 includes pushing the stylet forward.

[0154] It will be apparent to those skilled in the art that many modifications and substitutions can be made to the above embodiments without departing from the spirit and scope of the present invention.

Claims

1. (i)a cannula having an inclined needle tip at its proximal end and being attached to a housing unit at its distal end; (ii)a non-sharp-tipped stylet having a hook or notch at its proximal end and being supported within the cannula; (iii)a gas valve configured to introduce gas into the proximal end of the cannula and disposed distally of the housing unit; (iv)a front compression spring surrounding the distal end of the stylet; (v)a spring cassette comprising: a rear compression spring; a protective ring having two outwardly projecting pins distal to the rear compression spring; a distal cassette end cap distal to the protective ring; a proximal cassette end cap and a tubular support adjacent to the gas valve, the tubular support being positioned inside the rear compression spring, the protective ring, and the distal end cap; An apparatus comprising: the stylet, the front compression spring, and the spring cassette are inserted into the cannula through the distal end of the housing unit, whereby the proximal end of the stylet projects beyond the cannula tip; the housing unit comprises two side slots into which the two pins projecting outwardly from the protective ring fit; when the apparatus is pushed into the patient's body wall, the stylet retracts within the cannula; after the cannula tip enters the body cavity through the body wall, the stylet pops forward beyond the cannula tip; supply gas is introduced into the body cavity through the gas valve and the stylet; the hook or notch can be retracted to capture a suture thread.

2. The apparatus according to claim 1, wherein the non-sharp-tipped stylet comprises a hook.

3. The apparatus according to claim 1, wherein the non-sharp-tipped stylet comprises a notch.

4. The apparatus according to claim 1, wherein the gas valve comprises a stopcock.

5. The apparatus according to claim 1, wherein the gas valve is further axially mounted distally of the housing unit.

6. The apparatus according to claim 1, wherein the gas valve is mounted orthogonally to the housing unit.

7. The apparatus according to claim 1, wherein the two pins protruding outward from the protective ring are provided with screws. **Claim 8** The apparatus according to claim 1, wherein the two pins protruding outward from the protective ring are provided with solid pins. **Claim 9** The apparatus according to claim 1, wherein the body cavity is a peritoneal cavity.

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