Suturing device

Abstract

A device is disclosed comprising a handle; a rotatable shaft; a sleeve comprising a first curved hollow stainless steel (magnetized) tube and a second curved hollow stainless steel (magnetized) tube, wherein the first tube is on a first side of the shaft and the second tube is on a second side of the shaft, wherein the first tube comprises a sharp front end and the second tube comprises a sharp front end; a reciprocating shuttle; and an arcuate needle positioned in the sleeve, wherein the inner diameter of the sleeve is large enough to accommodate the needle and the shuttle, and wherein the shuttle is positioned between the sleeve and the needle. Rotation of the shaft moves the shuttle, which in turn moves the needle through the sleeve.

Description

[0001] Cross-reference to related applications

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 104,503, filed October 22, 2020, which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to suturing devices and methods. Background Technology

[0004] Suturing procedures used to close wounds or incisions consume a significant amount of time during surgical procedures. Typically, the instruments used in suturing include suture material, suture needles, and suture actuators. Efforts have been made to reduce time and improve surgical safety.

[0005] Typically, direct contact between the roller or other drive mechanism and the needle is sought. While intuitive, this approach presents numerous challenges in achieving the desired tissue depth, needle size, and the necessary complexity in moving the needle.

[0006] Therefore, a novel suturing device design that indirectly actuates the suture needle is desired and is also the objective of this disclosure. Summary of the Invention

[0007] All references, including any patents or patent applications cited in this specification, are incorporated herein by reference. No reference is acknowledged to constitute prior art. The discussion of references reflects the claims of their authors, and the applicant reserves the right to challenge the accuracy and relevance of any cited references. It will be clearly understood that although this document references multiple prior art publications, such references do not constitute an acknowledgment that any of these publications constitutes part of common common sense in the art.

[0008] It is hereby acknowledged that the term "comprising" may be given an exclusive or inclusive meaning in different jurisdictions. For the purposes of this specification and unless otherwise stated, the term "comprising" shall be interpreted inclusively—that is, it shall be considered to include not only the listed components directly referenced therein, but also other unspecified components or elements. This principle shall also be used when the terms "included" or "contains" are used in connection with one or more steps of a method or process.

[0009] This disclosure provides an apparatus in one embodiment, comprising: a) a housing having a top end and a bottom end, and a first side and a second side, wherein the bottom end of the housing defines an opening; b) a first rotatable shaft having a first end and a second end, the first rotatable shaft being coupled to a first roller gear near the second end of the first rotatable shaft, the first roller gear and the second end of the first rotatable shaft being positioned within the housing; c) a second rotatable shaft having a first end and a second end, the second rotatable shaft being coupled to a second roller gear near the second end of the second rotatable shaft, the second roller gear and the second end of the second rotatable shaft being positioned within the housing, wherein the first roller gear engages the second roller gear; d) a sleeve comprising a first curved hollow stainless steel magnetized tube having a first end and a second end, the first end of the first tube having a first sharp tip, wherein the second end of the first tube is abutting on a first side of the housing; and a second curved hollow stainless steel magnetized tube having a first end and a second end, the first end of the second tube having a second sharp tip, wherein the second end of the second tube is positioned on a second side of the housing; e) f) a reciprocating shuttle positioned in a sleeve; and f) a bent stainless steel magnetized needle positioned in a sleeve, wherein the inner diameter of the sleeve is large enough to accommodate the needle and the shuttle, and wherein the shuttle is positioned between the sleeve and the needle, wherein the shuttle engages the needle, wherein the shuttle is coupled to first and second rotatable shafts, and wherein rotation of the first and second rotatable shafts causes the shuttle to move through the sleeve, which in turn drives the needle through the sleeve.

[0010] In some embodiments, the needle includes a first end, a second end, and a middle portion, wherein the first end has a sharp tip and the second end is coupled to a suture. In some embodiments, the needle includes a plurality of fins. In other embodiments, the needle includes a first fin near the first end of the needle, a second fin near the middle portion of the needle, and a third fin near the second end of the needle. In still other embodiments, the second fin is at approximately 90 degrees to the first and third fins.

[0011] In additional embodiments, the shuttle has a first end and a second end, and a first window near the first end and a second window near the second end. In some embodiments, the shuttle engages a pin with the interaction of a first, second, or third fin via the first or second window. In some embodiments, the sleeve is semi-circular and extends more than 180 degrees. In other embodiments, the sleeve extends 210 degrees. In a further embodiment, the sleeve guides the pin through the sleeve for a 360-degree rotation. In a particular embodiment, the pin is semi-circular and extends more than 180 degrees. In some embodiments, the pin extends 210 degrees.

[0012] In some embodiments, the device further includes a knob coupled to a first roller gear or a second roller gear. In some embodiments, the device further includes a handle coupled to the knob.

[0013] This disclosure also provides a method for suturing tissue in one embodiment, comprising the steps of: a) providing an apparatus comprising: i) a handle; ii) a housing having a top end and a bottom end, and a first side and a second side, wherein the bottom end of the housing defines an opening; iii) a first rotatable shaft having a first end and a second end, the rotatable shaft being coupled to a first roller gear adjacent to the second end of the rotatable shaft, the first roller gear and the second end of the rotatable shaft being positioned in the housing, the rotatable shaft being coupled to the handle; iv) a second roller gear being positioned in the housing and engaging with the first roller gear; v) a sleeve comprising a first bent hollow stainless steel magnetized tube and a second bent hollow stainless steel magnetized tube, wherein the first tube is positioned on a first side of the shaft and the second tube is positioned on a second side of the shaft; wherein the first tube includes a first sharp tip and the second tube includes a second sharp tip; vi) a reciprocating shuttle; and vii) A) A bent, magnetized stainless steel needle is positioned in a sleeve, wherein the inner diameter of the sleeve is large enough to accommodate the needle and a shuttle, and wherein the shuttle is positioned between the sleeve and the needle, wherein the shuttle engages the needle, wherein the shuttle is coupled to a shaft, and wherein rotation of the shaft moves the shuttle, which in turn drives the needle through the sleeve; b) piercing the tissue with the sleeve; c) driving the rotatable shaft in a forward direction to advance the shuttle in a first tube of the sleeve, which in turn advances the needle into the tissue; d) driving the rotatable shaft in the opposite direction to retract the shuttle into a second tube of the sleeve; e) repeating steps c) and d) until the needle is positioned in a starting position within the sleeve; and f) repeating steps b) to e) until the suturing process is completed. In some embodiments, the device further includes a knob coupled to a handle and communicating with a first or second roller gear.

[0014] The system described herein, both in its construction and its mode of operation, will be best understood through the following detailed description of the embodiments in conjunction with the accompanying drawings, and its additional objectives and advantages will become apparent.

[0015] When the term "invention" is used in this specification, the term "invention" includes "multiple inventions," that is, the plural of "inventions." By stating "invention," the applicant does not in any way acknowledge that this application does not include more than one patentable and non-obviously different invention, and the applicant maintains that this application may include more than one patentable and non-obviously different invention. The applicant hereby declares that the disclosure of this application may include more than one invention, and where more than one invention exists, these inventions may be patentable and non-obvious relative to each other.

[0016] Furthermore, the purpose of the attached abstract is to enable the U.S. Patent and Trademark Office and the general public, particularly scientists, engineers, and practitioners unfamiliar with patent or legal terminology or wording, to quickly determine the nature and essence of the technical disclosure of this application through a cursory examination. The abstract is not intended to limit the full scope of the application, nor is it intended to restrict the scope of the disclosure in any way. Attached Figure Description

[0017] All figures illustrate preferred embodiments, although other embodiments may be considered, and this disclosure is not limited to the embodiments shown.

[0018] Figure 1 This is an illustration of a front view of a suturing apparatus according to an embodiment of the present disclosure.

[0019] Figure 2 yes Figure 1 The illustration shows a side view of the housing and roller section.

[0020] Figure 3 yes Figure 1 The illustration shows a side view of the tissue puncture needle.

[0021] Figure 4A , Figure 4B and Figure 4C This is a diagram of a suture needle and a reciprocating shuttle according to an embodiment of the present disclosure. Figure 4A The front view of the suture needle is shown, which has a needle tip located at one end of the needle and a suture attached to the other end of the needle, three fins spaced 90 degrees apart from each other, and a reciprocating shuttle having a front window and a rear window for engaging the fins of the suture needle. Figure 4B It is a cross-sectional view of the front of the front window of the reciprocating shuttle, and Figure 4C This is a cross-sectional view of the front window of the reciprocating shuttle.

[0022] Figure 5 This is an illustration of a front view of a suturing apparatus according to an embodiment of the present disclosure as it advances into the tissue to be sutured. The suture needle and the reciprocating shuttle are in their initial positions.

[0023] Figure 6 yes Figure 5 The illustration shows a front view of the suturing device. The thread roller rotates in the forward direction, thereby advancing the reciprocating shuttle by 90 degrees to the second position of the reciprocating shuttle, thus driving the suture needle into the tissue to be sutured.

[0024] Figure 7 yes Figure 6 The illustration shows a front view of the suture device. The thread roller rotates in the rearward direction, thereby moving the reciprocating shuttle 90 degrees backward to its initial position, while the suture needle remains in place.

[0025] Figure 8 yes Figure 7 The illustration shows a front view of the suture device. The thread roller rotates in the forward direction, thereby advancing the reciprocating shuttle 90 degrees to the second position of the reciprocating shuttle, thus driving the tip of the suture needle back into the sleeve.

[0026] Figure 9 yes Figure 8 The illustration shows a front view of the suturing device. The thread roller rotates in the rearward direction, thereby moving the reciprocating shuttle 90 degrees backward to the initial position of the reciprocating shuttle, wherein the tip of the suturing needle remains in its original position in the sleeve.

[0027] Figure 10 yes Figure 9 The illustration shows a front view of the suture device. The thread roller rotates in the forward direction, thereby advancing the reciprocating shuttle by 90 degrees to the second position of the reciprocating shuttle, thus driving the suture needle further back into the sleeve.

[0028] Figure 11 yes Figure 10 The illustration shows a front view of the suturing device. The thread roller rotates in the rearward direction, thereby moving the reciprocating shuttle 90 degrees backward to the initial position of the reciprocating shuttle, wherein the tip of the suturing needle remains in its original position in the sleeve.

[0029] Figure 12 yes Figure 11 The illustration shows a front view of the suture device. The thread roller rotates in the forward direction, thereby advancing the reciprocating shuttle by 90 degrees to the second position of the reciprocating shuttle, thus driving the suture needle back to its original position in the sleeve.

[0030] Figure 13 yes Figure 12 The illustration shows a front view of the suturing device. The thread roller rotates in the rearward direction, thereby moving the reciprocating shuttle 90 degrees backward to the initial position of the reciprocating shuttle, wherein the tip of the suturing needle remains in its initial position in the sleeve. Detailed Implementation

[0031] To provide a general understanding of this disclosure, certain illustrative embodiments and examples will now be described. However, those skilled in the art will understand that the same or equivalent functions and sequences may be accomplished by different embodiments, which are also intended to be included within the spirit and scope of this disclosure. The components, devices, systems, and / or methods described herein may be appropriately adapted and modified depending on the application being addressed, and the components, devices, systems, and / or methods described herein may be used in other suitable applications, and such other additions and modifications do not depart from the scope of this document.

[0032] In this document, the singular forms “a,” “an,” and “the” include plural references unless the context explicitly specifies otherwise. For example, the term “material” may include a variety of materials unless the context explicitly specifies otherwise. In this document, unless the context explicitly specifies otherwise, the singular name or type referenced includes variations within the family of said name.

[0033] The use of certain terms in the following description is for convenience only and not for limitation. The terms "down," "up," "bottom," "top," "front," "back," "left," "right," and "side" specify the direction of reference in the figures, but do not constitute a limitation on the orientation that may be used for the various parts of the needle drive or any component thereof.

[0034] This disclosure describes an apparatus that allows movement of a curved member having a semi-circular structure extending greater than 90 degrees and positioned within, through, and through tissue or other material in a fixed sleeve. The curved member moves through the fixed sleeve, which is semi-circular and extends greater than 180 degrees. The fixed sleeve guides the curved member through the fixed sleeve for 360-degree rotation. The curved member includes a nose (front end) and a tail. The nose is sharp and capable of piercing tissue or material. A suture or cord is attached at or near the tail. In some embodiments, the curved member is a needle.

[0035] The retaining sleeve has a first front end and a second front end. Each of the first and second front ends is sharp or pointed and can pierce tissue or other materials.

[0036] The movement of the bending member is achieved or caused by the rotation of a knob connected to the shaft. This shaft extends from the handle portion of the device (where the knob is located or positioned) to a gear mechanism adjacent to the fixed sleeve. The gear mechanism moves the bending member directly or indirectly, as further described in its appendix.

[0037] In some embodiments, a shaft-driven structure drives a bending member. This is indirect, as the shaft does not drive the needle, but rather an intervention structure. The intervention structure can transmit force to the bending member. In some embodiments, the system uses a reciprocating shuttle (or ferry) that can travel back and forth along a fixed or predetermined path. The shuttle can be made of a non-ferromagnetic metal. It engages features in the bending member, which in some embodiments is a magnetized stainless steel needle. Engagement occurs in a repeatable manner at different points and acts as a ratchet. The needle remains in place as the shuttle moves because it is magnetized and held to the inner surface of a retaining sleeve by magnetic force. The retaining sleeve consists of a bent hollow magnetized stainless steel tube located on either side of the shaft and further includes a sharp tip. The retaining sleeve has a sufficiently large inner diameter to accommodate the needle and shuttle. The bent hollow magnetized stainless steel tube acts as a pitchfork, thus piercing tissue, fabric, or other materials when pushed against it.

[0038] Some suturing devices can be used for medical purposes (such as suturing). For example, some of these devices can be used for catheter-directed suturing, catheter-directed intracardiac (or suturing of another body organ), and other flexible platform applications (such as endoscopic suturing, colonoscopy suturing). Some examples of surgeries in which some of these suturing devices can be used include laparoscopic surgery, robotic surgery, video-assisted or unassisted thoracoscopic surgery, arthroscopic surgery, natural orifice surgery, endoscopic surgery, gynecological surgery, cardiac surgery, colorectal surgery, lung surgery, gastric bypass surgery, hysterectomy, dental surgery, urological surgery, brain surgery, or bariatric surgery, or numerous human (e.g., newborns to 120 years of age, males, females) or animal (e.g., mammals, birds, fish, terrestrial animals) applications.

[0039] Note that some of these suturing devices can be used in medical or non-medical settings, regardless of whether the object is living or non-living. For example, living objects can include tissues, organs, body parts, whether human, animal, or other. For example, the tissue can be muscle tissue, bone tissue, nerve tissue, organ tissue, or others. For example, non-living objects can include medical devices, prostheses, implantable devices, machines, surgical instruments, or others. For example, some non-medical settings can include garment making, fabric sewing, knot application, sewing, shoemaking, or others.

[0040] like Figure 1As shown, the suture device 100 is placed in the conduit 101. The suture device 100 includes a housing 102 with a roller gear 103 and a thread roller 104 extending from the housing 102 and upward along the conduit 101 to a handle (not shown) with a knob (not shown) that allows the thread roller 104 to rotate forward and backward. The suture device 100 also includes a sleeve having a first magnetized tube 106a and a second magnetized tube 106b located on either side of the housing 102. The sleeve contains a reciprocating shuttle 105 and a needle 107 (not visible in this figure). A suture 109 is attached to the rear end of the needle 107 (not visible in this figure) and enters the interior of the conduit (shown as being outside the conduit for simplicity).

[0041] like Figure 2 As shown in the side view, the housing 102 includes two roller gears 103 engaged and controlled by two thread rollers 104, and an opening 108 through which the stitching thread 109 passes. A reciprocating shuttle 105 and a needle 107 with fins 107c are also shown. Although the needle 107 is magnetized, the housing 102, roller gears 103, and thread rollers 104 are non-magnetic and can be made of any non-magnetic or unmagnetized metal or metal alloy. The reciprocating shuttle 105 is made of a non-ferromagnetic metal.

[0042] like Figure 3 As shown, a cross-sectional view of a tissue puncture needle 107 having an outer periphery 107a, an inner periphery 107b, and fins 107c is illustrated. An opening 108 and a suture 109 attached to the needle 107 are also shown.

[0043] Figure 4A A needle 107 is shown, having a needle tip 107d at its front end; a front fin 107c1, a middle fin 107c2, and a rear fin 107c positioned at approximately 90 degrees to each other; and a reciprocating shuttle 105 having a front window 105a and a rear window 105b. A suture 109 (not visible in this figure) attached to the rear end of the needle 107 is also shown. Figure 4B A cross-sectional view of the reciprocating shuttle 105 in front of the front window 105a is shown, thus revealing the needle 107 and the needle fin 107c partially covered by the front window 105a. It can also be seen that the reciprocating shuttle 105 is fully open on its inner circumferential side. Figure 4C A cross-sectional view of the reciprocating shuttle 105 at the front window 105a is shown, thus revealing the needle 107 and the fin 107c. Again, it can be seen that the reciprocating shuttle 105 is fully open on its inner circumferential side.

[0044] The needle tip portion 107d of the curved suture needle 107 can be a tapered tip, wherein the needle tip portion is rounded and smoothly tapers to a point. Alternatively, the needle tip portion 107d can be triangular and may have a sharpened cutting edge inside or outside, or may have a "cannula point" or "rounded tip," so that the needle body is round and tapered, but ends at a small triangular cutting point. Alternatively, the needle tip 107d can be blunt, for example for suturing fragile tissue, or may have a needle tip portion including a "lateral cutting point" or "scalpel point," so that the needle is flat at the top and bottom, with a cutting edge from the front to one side (these are commonly used in ocular surgery).

[0045] The material used to construct the suture needle 107 is not limited and may include any magnetic or magnetizable metal or metal alloy. Other processes in forming or finishing the needle may include siliconization, coating with any number or combination of biocompatible coating materials, or lubrication with any number or combination of biocompatible lubricants, and other processes.

[0046] Figure 5 A cross-section of the suturing device 100 in the catheter 101 is shown as it is inserted into the tissue or fabric 110 to be sutured. A housing 102 comprising a roller gear 103 and a thread roller 104, and a sleeve portion comprising a first magnetized tube 106a and a second magnetized tube 106b are shown. The roller gear 103 transmits force from one roller to the other, thereby allowing the use of only one drive thread along the catheter. The first magnetized tube 106a and the second magnetized tube 106b have sharp tips for penetrating or piercing the tissue or fabric to be sutured. The first magnetized tube 106a has a longitudinal slit (not shown in this figure) extending along its inner circumference for free suturing movement. The reciprocating shuttle 105 is in its initial position, with the front window (105a – not shown in this figure) above the middle fin (107c2 – not shown in this figure) of the needle 107 and the rear window (105b – not shown in this figure) above the rear fin 107c3 of the needle 107 and contained within the first magnetized tube 106a. A suture needle 107 is also shown, having a front fin 107c1 contained within the first magnetized tube 106a and the second magnetized tube 106b and constrained by the reciprocating shuttle 105. The needle 107 has an arc of approximately 210 degrees, and the two magnetized tubes 106a and 106b together also form an arc of approximately 210 degrees. The suture 109 is attached to the rear end of the needle 107 and contained within the guide tube 101 (shown outside the guide tube for simplicity). The device 100 is designed to allow the thread roller 104 to move the reciprocating shuttle in either direction (in the forward or backward stroke) at 90-degree or arc intervals. The device 100 is also designed to allow the sharp ends of the magnetic tubes 106a and 106b to penetrate beyond the equator of the circle, thereby maximizing tissue depth even before the suture needle 107 is deployed.

[0047] Figure 6 The next step of the suturing process is shown. The suturing device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the forward direction, causing the thread roller 104 to rotate forward, thus advancing the reciprocating shuttle 105 90 degrees to a second position, where the front window 105a is still above the intermediate fin 107c2 of the needle 107. This, in turn, drives the needle tip (107d—not visible in this figure) 90 degrees further into the tissue 110 beyond the sharp end of one of the hollow magnetized tubes 106b (shown in cross-section). The suture 109 is attached to the rear end of the needle (107—not visible in this figure), which is contained within the hollow magnetized tube 106a and constrained by the reciprocating shuttle 105.

[0048] Figure 7 The next step of the suturing process is shown. The suturing device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the rearward direction, causing the thread roller 104 to rotate rearward, thereby reversing the reciprocating shuttle 105 by 90 degrees back to its initial position, where the front window 105a is now above the rear fin 107c3 of the needle 107. This movement does not cause the needle 107 or the needle tip (107d—not visible in this figure) to retract 90 degrees because the magnetized needle 107 is held in place by the hollow magnetized tube 106b. The suture 109 is attached to the rear end of the needle (107—not visible in this figure), which is contained within the hollow magnetized tube 106a and constrained by the reciprocating shuttle 105.

[0049] Figure 8 The next step of the suturing process is shown. A suturing device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the forward direction, causing the thread roller 104 to rotate forward, thus advancing the reciprocating shuttle 105 90 degrees to a second position, where the front window 105a is now positioned above the rear fin 107c3 of the needle 107 inside the magnetized hollow tube 106b (shown in cross-section). This, in turn, drives the needle tip 107d 90 degrees to further position the front fin 107c1 and the needle tip 107d within the hollow magnetized tube 106a. A suture 109 is attached to the rear end of the needle (107 – not visible in this figure), which is contained within the hollow magnetized tube 106a and confined by the reciprocating shuttle 105. Because both the suture needle 107 and the sleeve assembly (including the magnetized hollow tubes 106a and 106b) have a 210-degree arc, there is a 30-degree overlap on each side when the suture needle is in its most exposed configuration. The suture needle is always magnetically held against certain points in contact with the hollow magnetized tube 106a or the magnetized hollow tube 106b.

[0050] Figure 9The next step of the stitching process is shown. The stitching device 100, located in the guide tube 101, is shown when the roller gear 103 rotates in the rearward direction. This causes the thread roller 104 to rotate rearward, thereby reversing the reciprocating shuttle 105 90 degrees back to its initial position, where the front window 105a is now empty and the rear window 105b is positioned above the front fin 107c1 of the needle 107, which is constrained by the reciprocating shuttle 105. This movement does not cause the needle 107, the front fin 107c1, or the needle tip (107d—not visible in this figure) to retract 90 degrees because the magnetized needle 107 is held in place by the two hollow magnetized tubes 106b and 106a. The suture 109 is attached to the rear end of the needle 107, which is contained within the hollow magnetized tube 106b.

[0051] Figure 10 The next step of the suturing process is shown. The suturing device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the forward direction, causing the thread roller 104 to rotate forward, thus advancing the reciprocating shuttle 105 90 degrees to a second position, where the front window 105a is now empty and the rear window is positioned above the front fin 107c1 of the needle 107 (not visible in this figure). This, in turn, drives the needle tip 107d 90 degrees to now further penetrate and pass through the hollow magnetized tube 106a, which now contains the intermediate fin 107c2 of the needle 107. The suture 109 is attached to the rear end of the needle (107 – not visible in this figure), which is contained within the tissue 110 to be sutured. The suture needle is magnetically held against the hollow magnetized tube 106a.

[0052] Figure 11 The next step in the stitching process is shown. The stitching device 100, located in the guide tube 101, is shown when the roller gear 103 rotates in the rearward direction. This causes the thread roller 104 to rotate rearward, thereby reversing the reciprocating shuttle 105 90 degrees back to its initial position, where the front window 105a is now above the front fin and the rear window 105b is above the middle fin 107c2 of the needle 107, which is constrained by the reciprocating shuttle 105. This movement does not cause the needle 107 or its tip (107d – not visible in this figure) to retract 90 degrees because the magnetized needle 107 is held in place by the hollow magnetized tube 106a. The suture 109 is attached to the rear end of the needle 107 (not visible in this figure).

[0053] Figure 12The next step of the suturing process is shown. A suturing device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the forward direction, causing the thread roller 104 to rotate forward, thus advancing the reciprocating shuttle 105 90 degrees to a second position, where the front window 105a is now above the front fin 107c1 of the needle 107 and the rear window is above the middle fin 107c2 of the needle 107 (not visible in this figure). This, in turn, drives the needle tip 107d (not visible in this figure) 90 degrees to now further enter the hollow magnetized tube 106b and moves the rear fin 107c into the hollow magnetized tube 106a. A suture 109 is attached to the rear end of the needle 107, which is contained within the hollow magnetized tube 106a.

[0054] Figure 13 The next step of the stitching process is shown. The stitching device 100 located in the guide tube 101 is shown as the roller gear 103 rotates in the rearward direction, causing the thread roller 104 to rotate rearward, thereby causing the reciprocating shuttle 105 to reverse 90 degrees back to its initial position. The front window 105a is now positioned above the intermediate fin 107c2 (not visible in this figure), and the rear window 105b is positioned above the rear fin 107c3 of the needle 107, which is restrained by the reciprocating shuttle 105. This movement does not cause the needle 107, the needle tip 107d, or the front fin 107c1 to retract 90 degrees because the magnetized needle 107 is held in place by the hollow magnetized tubes 106a and 106b. The suture 109 is attached to the rear end of the needle 107. The needle 107 has now rotated a full 360 degrees, and both the needle 107 and the reciprocating shuttle are in their original starting positions. The suturing device 100 is now ready to retract from the tissue 110 and move to the next part of the tissue to be sutured.

[0055] According to some embodiments, the suture 109 can be secured to the rear end of the needle 107 via a thread attachment portion. That is, the needle 107 is typically an atraumatic needle, i.e., an eyeless needle 107, having suture material or thread 109 attached to its end by a securing attachment, whereby the suture material 109 is inserted into a channel at the blunt end of the needle 107, for example, into the thread attachment portion, and then the channel deforms to its final shape to hold the suture 109 and the needle 107 together. The needle 107 can be permanently secured to the suture material 109 or can be designed to detach from the suture material 109 by a sharp, straight pull. These "moments" are typically used for interrupted sutures, i.e., each suture passes only once and is then knotted.

[0056] The suture material or thread 109 can be monofilamentous, i.e., formed from a single thread, or multifilamentous, i.e., formed from a combination of two or more threads, such as three threads arranged in a braided manner. The suture 109 has a length, which is typically at least 5 inches, or at least 10 inches, or at least 15 inches, or at least 20 inches. The suture 109 typically has two ends, which can be described as an unfolded end and / or a posterior end. In this case, the unfolded end of the suture 109 is the end that first enters the tissue, adjacent to the needle 107, for example, connected to the posterior end of the trunk portion of the needle 107 via a thread attachment portion. Alternatively, the suture material 109 can be looped, such that each of the two free ends is connected to the needle 107 via a thread attachment portion.

[0057] The suture 109 can be a suture thread, which can be of various regular non-absorbable or absorbable materials. The suture 109 can include silk, cotton, fabric, nylon, polyester, silver, copper, Dacromet, rubber, silicone, white or chrome catgut, polyethylene glycol, polydioxanone, monocrystalline, polypropylene, melamine, caprolactone, polymers, ethylene glycol, L-lactone, p-dioxanone, trimethyl carbonate, ε-caprolactone, stainless steel, ceramic, glass, leather, or other natural or artificial materials. The suture 109 can be solid, but it can also be perforated. The suture 109 can be dense internally, but it can also be hollow. The suture 109 can have a closed (e.g., O-shape, D-shape, 0-shape, square, rectangle, triangle, polygon) or open (e.g., U-shape, C-shape, V-shape) cross-section, whether symmetrical or asymmetrical.

[0058] The suture material or suture 109 can be bioabsorbable, meaning that it is broken down and absorbed by the body after being introduced into the tissue. Typically, this degradation process is at least partially mediated by or occurs within a biological system. Therefore, bioabsorbability refers to a chain-breaking process that breaks down polymer chains through various mechanisms, including, for example, chemical reactions (e.g., hydrolysis, oxidation / reduction, enzymatic mechanisms, or combinations thereof) or through thermal or photolytic processes. Bioabsorbable suture materials may include polymers such as copolymers of polyethylene glycol, ethylene glycol, and lactic acid; copolymers of trimethyl carbonate and ethylene glycol with diethylene glycol (e.g., MAXON™, Tyco Healthcare); terpolymers consisting of ethylene glycol, trimethyl carbonate, and dioxane (e.g., BIOSYN™ [ethylene glycol compound (60%), trimethyl carbonate (26%), and dioxane (14%)], Tyco Healthcare); and copolymers of ethylene glycol, caprolactone, trimethyl carbonate, and lactams (e.g., CAPROSYN™, Tyco Healthcare). In some embodiments, the bioabsorbable suture material may contain or include any other polymers that are currently available or may be developed in the future for use in suture applications.

[0059] Additionally, the suture material or thread 109 may be non-degradable, meaning it will not be degraded by chemical, thermal, or photolytic processes. Non-degradable suture materials include polyamides (also known as nylon, such as nylon 6 and nylon 6.6), polyesters (e.g., polyethylene terephthalate), polytetrafluoroethylene (e.g., expanded polytetrafluoroethylene), polyether esters (e.g., polybutylene terephthalate (a block copolymer of butylene terephthalate and polytetramethylene ether glycol)), polyurethanes, metal alloys, metals (e.g., stainless steel wire), polypropylene, polyethylene, silk, and cotton. Sutures made from non-degradable suture materials are particularly suitable for applications where the suture is to be permanently retained or removed from the body. In some embodiments, the non-degradable suture material may include or contain any other polymers currently existing or potentially developed for suture applications.

[0060] The suture material or suture 109 may include coatings or formulations applied to its surface that may affect healing, such as coating materials, wound healing agents, antibacterial agents, growth factors, adhesives, sealants, blood products, blood components, antiseptics, anti-adhesion agents, proteins, polysaccharides, peptides, genetic material, viral vectors, nucleic acids, nucleotides, plasmids, lymphokines, radioactive agents, metals, alloys, salts, growth factors, growth factor antagonists, cells, hydrophobic agents, hydrophilic agents, immunomodulators, anticolonizing agents, and combinations thereof. The suture material or suture 109 may include coatings or formulations applied to its surface that enhance the surgeon's ability to suture accurately, such as colorants, dyes, ultraviolet absorbers, ultraviolet stabilizers, photochromic agents, diagnostic agents, imaging agents, radiopaque agents, or combinations thereof.

[0061] Suture sizes are based on diameter. The United States Pharmacopeia ("USP") specifies suture sizes ranging from 0 to 7 in a wider range and from 1-0 to 11-0 in a narrower range; within the narrower range, the higher the value preceding the hyphen 0, the smaller the suture diameter. According to the USP nomenclature system, the actual diameter of a suture depends on the suture material, such that, as an example, a suture of size 5-0 made of collagen has a diameter of 0.15 mm, while a suture of the same USP size but made of synthetic absorbable or non-absorbable materials has a diameter of 0.1 mm. Choosing a suture size for a specific purpose depends on various factors, such as the nature of the tissue to be sutured and the importance of the cosmetic problem; while smaller sutures may be easier to maneuver through narrow surgical sites and associated with less scarring, the tensile strength of sutures made of a particular material tends to decrease as the size decreases. It should be understood that suture materials used with the suture needles disclosed herein include, but are not limited to, 7, 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0, and 11-0. It should be understood that various suture lengths can be used with the suture needles described herein.

[0062] Features or functions described with respect to certain exemplary embodiments may be combined and recombinated with various other exemplary embodiments. Furthermore, different features and / or points of the exemplary embodiments disclosed herein may also be combined and recombinated in a similar manner. Additionally, some exemplary embodiments, whether individually and / or collectively, may be components of a larger system, where other procedures may precede and / or otherwise modify their application. Furthermore, as disclosed herein, multiple steps may be required before, after, and / or concurrent with embodiments. Note that any and / or all methods and / or procedures, at least as disclosed herein, may be performed at least partially in any manner by at least one entity or actor.

[0063] As used herein, the terms "approximately" or "substantially" refer to a change from the nominal value / term, for example, a change of up to + / - 10%, or a change of ± 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10%. Such a change is always included in any given value / term provided herein, whether or not it is specifically mentioned.

[0064] Any component described herein may include materials suitable for medical use. These materials may be flexible, elastic, or resilient. They may be suitable for sterilization, disinfection, or sterilization using hot steam, autoclaves, or other methods. For example, the material may include plastics, metals, rubber, shape memory materials, fabrics, foams, or others.

[0065] The apparatuses and systems disclosed herein have been described specifically with reference to certain accompanying drawings and various embodiments, but may be embodied in many different forms and should not be construed as being limited to the embodiments disclosed herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the various concepts of this disclosure to those skilled in the art.

[0066] Please note that the various terms used herein can mean direct or indirect, whole or part, temporary or permanent, action or inaction. For example, when an element is referred to as "located on another element," "connected," or "linked" to another element, then the element may be directly on, connected to, or linked to that other element, or there may be intermediate elements, including indirect or direct variations. Conversely, when an element is referred to as "directly connected" or "directly linked" to another element, there are no intermediate elements.

[0067] Similarly, as used herein, the term "or" means inclusive or "not exclusive" or. That is, unless otherwise specified or clearly apparent from the context, "X adopts A or B" means any naturally inclusive permutation and combination. In other words, "X adopts A or B" is satisfied in any of the above cases if X adopts A; X adopts B; or X adopts both A and B.

[0068] Similarly, as used herein, the various singular forms “a,” “one,” and “the” are intended to include the various plural forms as well, unless the context explicitly indicates otherwise. For example, the terms “a” or “one” should refer to “one or more,” even though the phrase “one or more” is used herein.

[0069] Furthermore, the terms "comprising," "containing," "including," or "having" as used in this specification specify the presence of the stated feature, integer, step, operation, element, or component, but do not exclude the presence and / or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Additionally, when this disclosure indicates that something is "based on" something else, such a statement means that it may also be based on one or more other things. In other words, unless explicitly stated otherwise, "based on" as used herein includes meaning "at least partially based on" or "at least partially based on."

[0070] Furthermore, although the terms first, second, and others may be used herein to describe various elements, components, regions, layers, or portions, these elements, components, regions, layers, or portions should not necessarily be limited by these terms. Rather, these terms are used to distinguish one element, component, region, layer, or portion from another. Therefore, the first element, component, region, layer, or portion discussed below may be referred to as the second element, component, region, layer, or portion without departing from the scope of this disclosure.

[0071] Furthermore, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Therefore, terms, such as those defined in commonly used dictionaries, should be interpreted as having meanings consistent with their meanings in the relevant technical context and not as idealized or overly formal meanings, unless explicitly defined herein.

[0072] Furthermore, the features described with respect to certain exemplary embodiments may be combined in or with a variety of other exemplary embodiments in any permutation or combination. Certain features or elements of the exemplary embodiments disclosed herein may be combined in a similar manner. The terms "combination," "combinability," or "combination thereof" as used herein refer to all permutations and combinations of the items preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of the following: A, B, C, AB, AC, BC, or ABC, and, if the order is important in a particular case, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, a combination explicitly includes repeated combinations of one or more items or terms, such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, etc. Those skilled in the art will understand that, unless it is clearly apparent from the context, there is generally no limitation on the number of items or terms in any combination.

[0073] Although preferred embodiments have been described in detail herein, those skilled in the art will recognize that various modifications, additions, substitutions, etc., can be made without departing from the spirit of this disclosure. Therefore, these are considered to be within the scope of this disclosure.

Claims

1. An apparatus comprising: a) A housing having a top end and a bottom end, as well as a first side and a second side, wherein the bottom end of the housing defines an opening; b) A first rotatable shaft having a first end and a second end, the first rotatable shaft being coupled to a first roller gear near the second end of the first rotatable shaft, the first roller gear and the second end of the first rotatable shaft being positioned in the housing; c) A second rotatable shaft having a first end and a second end, the second rotatable shaft being coupled to a second roller gear near the second end of the second rotatable shaft, the second roller gear and the second end of the second rotatable shaft being positioned in the housing, wherein the first roller gear engages the second roller gear; d) A sleeve comprising a first curved hollow stainless steel magnetized tube having a first end and a second end, the first end of the first curved hollow stainless steel magnetized tube having a first sharp tip, wherein the second end of the first curved hollow stainless steel magnetized tube is positioned on the first side of the housing; and a second curved hollow stainless steel magnetized tube having a first end and a second end, the first end of the second curved hollow stainless steel magnetized tube having a second sharp tip, wherein the second end of the second curved hollow stainless steel magnetized tube is positioned on the second side of the housing; e) A reciprocating shuttle, positioned within the sleeve; and f) A bent stainless steel magnetized needle is positioned in the sleeve, wherein the sleeve has a sufficiently large inner diameter to accommodate the needle and the shuttle, wherein the shuttle is positioned between the sleeve and the needle, wherein the shuttle engages the needle, wherein the shuttle is coupled to the first and second rotatable shafts, wherein rotation of the first and second rotatable shafts causes the shuttle to pass through the sleeve, which in turn drives the needle through the sleeve.

2. The apparatus according to claim 1, wherein, The needle includes a first end, a second end, and a middle portion, wherein the first end has a sharp tip and the second end is connected to a suture.

3. The apparatus according to claim 2, wherein, The needle includes multiple fins.

4. The apparatus according to claim 3, wherein, The needle includes a first fin near the first end of the needle, a second fin near the middle portion of the needle, and a third fin near the second end of the needle.

5. The apparatus according to claim 4, wherein, The second fin is at approximately 90 degrees to the first fin and the third fin.

6. The apparatus according to claim 4, wherein, The shuttle has a first end and a second end, as well as a first window near the first end and a second window near the second end.

7. The apparatus according to claim 6, wherein, The shuttle engages the needle via the interaction of the first or second window with the first, second or third fin.

8. The apparatus according to claim 1, wherein, The sleeve is semi-circular and extends more than 180 degrees.

9. The apparatus according to claim 8, wherein, The sleeve extends 210 degrees.

10. The apparatus according to claim 1, wherein, The sleeve guides the needle through the sleeve and rotates 360 degrees.

11. The apparatus according to claim 1, wherein, The needle is semi-circular and extends more than 180 degrees.

12. The apparatus according to claim 10, wherein, The needle extends 210 degrees.

13. The apparatus of claim 1, further comprising a knob coupled to the first roller gear or the second roller gear.

14. The device of claim 13, further comprising a handle coupled to the knob.

15. The apparatus according to claim 1, wherein, The device is configured to be placed in a conduit.

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