Composite suture needle having elastically deformable section

Abstract

A composite suture needle configured for passing through a smaller cannula used in minimally invasive surgery includes a curved elongated body made of stainless steel. The curved elongated body has a proximal end and a distal end with a pointed tip. The composite suture needle includes a sheath covering the curved elongated body. The sheath is curved so as to conform to the shape of the curved elongated body. The sheath is made of a more flexible material than the curved elongated body. The pointed tip of the curved elongated body extends distally beyond a distal end of the sheath. The curved elongated body is made of stainless steel and the sheath is made of a more flexible material such as nitinol than the elongated body.

Description

BACKGROUND TECHNICAL FIELD

[0002] The present patent application relates generally to surgical procedures and surgical tools, and more particularly to systems, devices, and methods of preparing and using a flexible suture needle that passes through a lumen, such as a lumen associated with a trocar and a cannula (hereinafter, a cannula).

[0003] Description of Related Art

[0004] Surgical tools, such as suture needles, are positioned at a surgical site by a surgeon using a lumen, such as a cannula. The size of a suture needle that can pass through a cannula is limited by the size of the opening in the cannula. In many cases, a surgeon desires to use a larger curved suture needle (i.e., a suture needle having a curvature greater than can be accommodated by the cannula opening) to close a surgical wound and repair an anatomical feature, however, it is difficult to pass a larger curved suture needle through a smaller cannula.

[0005] A 5 mm cannula is commonly used during a minimally invasive surgical procedure (MIS), however, a surgeon cannot pass a larger suture needle through the 5 mm cannula, thus forcing it to use only smaller suture needles. Smaller suture needles are less desirable, especially because they often require the surgeon to pass the suture needle and suture thread more through the tissue, which lengthens the surgical procedure and can frustrate the surgeon. The use of smaller needles can also create a bite distance that puts the wound or anatomical feature at risk of dehiscence.

[0006] Another disadvantage of using smaller suture needles is that larger size suture thread cannot be easily attached to the smaller suture needle. This often forces the surgeon to use a suture thread that is smaller in size than is needed for the suture operation. As a result, when a fine or smaller size suture thread is passed through the tissue with a smaller bite size, a cheese wire effect can occur whereby the suture thread cuts through the tissue that it is intended to hold.

[0007] To address one or more of the problems described above, progress has been made to provide a suture needle made from a super-elastic alloy having shape memory properties that enable a curved suture needle to be straightened for passage through a cannula. When the super-elastic suture needle is removed from the other end of the cannula for use at the surgical site, the shape memory properties of the needle cause it to return to the initial curved shape.

[0008] Alloys commonly known as Nitinol are often used to manufacture super-elastic suture needles. However, suture needles made from Nitinol can be very difficult to machine, which results in high production costs that are often passed on to the customer, and this can substantially limit the adoption of Nitinol suture needles for minimally invasive surgical procedures.

[0009] Further, there are a number of challenges associated with securing a suture to a suture attachment barrel of a nitinol suture needle. These challenges include the tendency of the suture attachment barrel of the nitinol needle to spring back after the swaging step, which results in a weak attachment between the suture and the nitinol suture needle.

[0010] Accordingly, there remains a need for improved suture needles that exhibit elasticity such that larger suture needles can be passed through relatively smaller cannulas (e.g., 5 mm cannulas) for use in surgical procedures. There is also a need for suture needles that can be passed through smaller cannulas and that do not plastically deform. Further, there is a need for systems, devices, and methods of manufacturing larger suture needles made primarily of stainless steel that can elastically deform to pass through relatively smaller cannulas for use in minimally invasive surgical procedures. SUMMARY

[0011] Introducing a curved suture needle into the field of minimally invasive surgery is challenging. When a curved suture needle is introduced through a device having a lumen, such as a cannula, the size of the curved suture needle is typically limited to a profile that is smaller than the inner diameter of the cannula. One way to introduce a larger needle through a smaller cannula is to flex or bend the needle into a profile that will fit within the inner diameter of the cannula. However, this often results in the curved suture needle experiencing some degree of plastic deformation, which requires the suture needle to be reshaped after it enters the surgical site and before it can be used for suturing.

[0012] Another approach is to manufacture a suture needle entirely from a superelastic material such as nitinol (i.e., a metal alloy made of nickel and titanium). However, in doing so, the resulting suture needle is not as strong as a suture needle made from more commonly used materials (e.g., 455, 420, 300 series alloys or custom alloys such as tungsten rhenium alloys) and, as a result, the suture needle is not optimal for subsequent suturing procedures. Further, there are a number of challenges in the processing of nitinol alloy suture needles, including point grinding, curve setting, drilling, electro-polishing, and suture attachment. Attempts to overcome the aforementioned challenges often result in suture needles that are of poor quality and / or are costly to produce.

[0013] Most materials can withstand a modest strain before becoming plastically deformed. High-elasticity materials (i.e., those alloys that exhibit a high yield strain) will withstand a greater strain before becoming plastically deformed compared to less-elastic materials. In one embodiment, the composite suture needle comprises a high-elasticity material at the maximum distance from the neutral axis that will be able to withstand a greater flexure before becoming plastically deformed compared to a suture needle made from a single less-elastic material with uniform elastic properties. This is because the outer diameter of the core material is less than the actual outer diameter of the composite suture needle.

[0014] In one embodiment of the present patent application, the suture needle can be at least partially manufactured from a core wire stock that includes a core segment made from a strong alloy (e.g., stainless steel, including maraging alloys, such as ETHALLOY® needle alloys, or 455, 420, 300, or other custom alloys) and a second material having high elastic properties (e.g., nitinol).

[0015] In one embodiment, the suture needle disclosed herein preferably has greater strength than a suture needle made entirely from a high elastic material (e.g., nitinol), and the suture needle has a strength that is entirely suitable for suturing tissue.

[0016] When a curved suture needle having a curved elongated body is flexed (e.g., flattened) to pass through a cannula, the maximum bending occurs at an intermediate segment of the curved elongated body that is located between the tissue-penetrating end and the suture-attachment end. When flexed, the maximum strain occurs along the inner and outer radial surfaces of the curved elongated body. The curved elongated body has a neutral axis that is proximate to the center of the elongated body cross-section. No significant shear strain occurs along the neutral axis, however, the degree of shear strain increases as the distance from the neutral axis increases.

[0017] In one embodiment, a composite suture needle having a large size and a regular curvature (e.g., having a semi-circular shape) can pass through a lumen, such as a cannula. The composite suture needle is elastically straightened as it passes through the cannula, and springs back to its initial curvature when removed from the end of the cannula for use in a surgical procedure.

[0018] In one embodiment, the composite suture needle preferably includes an elongated body having a proximal end and a distal end with a pointed tip; and a sheath covering the elongated body.

[0019] In one embodiment, the sheath comprises a material that is more elastic than the elongated body.

[0020] In one embodiment, the elongated body and the sheath are curved.

[0021] In one embodiment, the pointed tip extends distally beyond a distal end of the sheath.

[0022] In one embodiment, the elongated body is made from a strong alloy, such as stainless steel, and the sheath is made from a high elastic material, such as nitinol.

[0023] In one embodiment, the stainless steel used to manufacture the elongated body can include austenitic stainless steel and maraging (mar age) stainless steel.

[0024] In one embodiment, the elongated body preferably has a diameter-reduced segment defining a first outer diameter, and the distal end of the elongated body defines a second outer diameter that is larger than the first outer diameter of the diameter-reduced segment.

[0025] In one embodiment, the distal end of the elongated body includes a tapered segment having a proximal end that includes a shoulder defining a second outer diameter. In one embodiment, the tapered segment preferably has a distal end that includes a pointed tip.

[0026] In one embodiment, the sheath has a proximal end, a distal end, and a lumen extending from the proximal end to the distal end of the sheath. In one embodiment, the diameter-reduced segment of the elongated body is disposed within the lumen of the sheath. In one embodiment, the inner diameter of the lumen of the sheath is greater than or equal to the first outer diameter of the diameter-reduced segment of the elongated body.

[0027] In one embodiment, the sheath has an outer surface defining a third outer diameter that approximates the second outer diameter of the shoulder of the tapered segment of the elongated body.

[0028] In one embodiment, the composite suture needle preferably includes an elongated body having a curved proximal body segment, a curved distal body segment, and a curved intermediate segment extending between the curved proximal body segment and the curved distal body segment. In one embodiment, the composite suture needle advantageously includes a sheath covering the curved intermediate segment of the elongated body. The curved intermediate segment of the elongated body is advantageously made of a first material, and the sheath is made of a second material that is more elastic than the first material of the curved intermediate segment.

[0029] In one embodiment, the curved proximal segment, the curved distal segment, and the curved intermediate segment of the elongated body form a unitary structure. In one embodiment, the curved proximal segment, the curved distal segment, and the curved intermediate segment of the elongated body are made of the same material, such as stainless steel.

[0030] In one embodiment, the curved intermediate segment of the elongated body and the sheath covering the curved intermediate segment preferably define a flexible region of the composite suture needle that is more elastic than the curved proximal body segment and the curved distal body segment of the elongated body of the composite suture needle.

[0031] In one embodiment, the curved intermediate segment of the elongated body is made of stainless steel, and the sheath covering the curved intermediate segment is made of a high-elasticity material, such as Nitinol.

[0032] In one embodiment, the sheath preferably has a proximal end, a distal end, and a lumen extending from the proximal end to the distal end of the sheath. In one embodiment, the curved intermediate segment of the elongated body is disposed within the lumen of the sheath.

[0033] In one embodiment, the curved intermediate section of the elongated body has a first outer diameter and the lumen of the sheath has a first inner diameter that is greater than or equal to the first outer diameter of the curved intermediate section of the elongated body.

[0034] In one embodiment, the distal end of the curved proximal section of the elongated body and the proximal end of the curved distal section define a second outer diameter. In one embodiment, the sheath has an outer surface that defines a third outer diameter that approximates the second outer diameter.

[0035] In one embodiment, the proximal body section of the elongated body preferably includes a proximal end face and the suture receiving aperture is formed in the proximal end face.

[0036] In one embodiment, the curved distal body section of the elongated body includes a tissue puncture point at its distal end.

[0037] In one embodiment, the sheath can be glued or welded to the curved intermediate section of the elongated body.

[0038] In one embodiment, the composite suture needle preferably includes a curved proximal body section made of stainless steel, a curved distal body section made of stainless steel, and a connector interconnecting the curved proximal body section and the curved distal body section.

[0039] In one embodiment, the connector is preferably made of a material that is more elastic than the stainless steel used to manufacture the curved proximal body section and the curved distal body section.

[0040] In one embodiment, the connector interconnects a distal end of the curved proximal body section with a proximal end of the curved distal body section.

[0041] In one embodiment, the connector can include a dovetail structure for connecting with the distal end of the curved proximal body section and the proximal end of the curved distal body section.

[0042] In one embodiment, the connector preferably has an outer diameter that approximates an outer diameter of the distal end of the curved proximal body section and an outer diameter of the proximal end of the curved distal body section of the composite suture needle.

[0043] In one embodiment, the connector is made of Nitinol and the stainless steel used to manufacture the proximal body section and the distal body section can be austenitic stainless steel and martensitic aged (maraging) stainless steel.

[0044] In one embodiment, the elongated body of the composite suture needle is curved along its length, with one surface of the elongated body defining a concave side of the curve and another surface of the elongated body defining a convex side of the curve.

[0045] In one embodiment, the surgical method preferably includes passing the composite suture needle through the lumen of the cannula from the proximal end to the distal end of the cannula, whereby during the passing step, the composite suture needle flattens to transition to a height that is less than or equal to the height of the lumen.

[0046] In one embodiment, after the passing step, the composite suture needle is preferably removed from the distal end of the cannula, whereby the composite suture needle transitions back to a curved shape having a height that is greater than the height of the lumen of the cannula.

[0047] In one embodiment, the composite suture needle is elastically deformable to reduce the height and / or profile of the suture needle to pass the suture needle through a cannula, such as a cannula having a diameter of 5 mm or less.

[0048] In one embodiment, a needle driver can be used to secure the distal end of the composite suture needle with the suture attachment barrel trailing behind the tip of the composite suture needle. In one embodiment, the tip is preferably surrounded by a clamping jaw located at the distal end of the needle driver to protect the tip as the composite suture needle is passed through the cannula. The clamping jaw preferably surrounds and protects the tip to prevent the tip from contacting the interior of the cannula as it passes through the cannula, thereby avoiding damage to the tip during its passage through the cannula.

[0049] In one embodiment, the tip of the composite suture needle does not extend to or protrude beyond the outer surface of the needle holder when the composite suture needle is held by the suture needle driver.

[0050] In the case of a suture needle made of 420 alloy, forming the hole by mechanical drilling can be successfully accomplished using conventional methods, as the core wire is the same as the needle wire that is currently being drilled.

[0051] In one embodiment, the core alloy can be chemically leached or electropolished to a specific depth at the proximal end of the needle to create a hole for suture needle attachment while leaving the Nitinol outer shell intact, which is more chemically inert, especially when using high-strength maraging alloys or the like as the core material.

[0052] In one embodiment, because the tip is made of core wire material rather than super-elastic material (e.g., not Nitinol), it can be easier to grind the tip and / or form a cutting edge.

[0053] In one embodiment, because the core alloy will enable the needle to be bent with conventional bending equipment used in the suture needle manufacturing field, curve setting can be facilitated. By allowing the core alloy to plastically deform during the bending process, it provides resistance to the Nitinol that has a tendency to straighten back to its original form after conventional bending methods are applied.

[0054] In one embodiment, suture needles can be gathered in batches and efficiently heat set through a shape setting heat cycle, eliminating the need for heat setting jigs and additional handling required for shape setting monolithic nitinol alloy needles.

[0055] In one embodiment, when the needle needs to flex to pass through a cannula, the maximum bend occurs between the tissue penetrating end and the suture attachment end (i.e., the intermediate section). When flexed, the maximum strain occurs along the inner radius surface and the opposing outer radius surface.

[0056] In one embodiment, a method of manufacturing a composite suture needle preferably includes obtaining a length of core wire made of a suitable material for manufacturing a suture needle. The core wire preferably includes an outer diameter, a first end, and a second distal end.

[0057] In one embodiment, the method preferably includes obtaining an outer sheath (e.g., a sleeve, tubing) of a length similar to or shorter than the length of the core wire. The sheath preferably has a proximal end and a distal end.

[0058] In one embodiment, the sheath preferably has an inner diameter that is slightly larger than the outer diameter of the core wire, and an outer diameter that approximates the desired finished outer diameter of the composite suture needle.

[0059] In one embodiment, the length of the core wire is placed within the sheath for aligning the proximal end of the core wire with the proximal end of the sleeve.

[0060] In one embodiment, the sheath can be secured to the core wire using a heat shrink fitting process. In one embodiment, the sheath can be heated to thermally expand the diameter of the sheath, enabling the sheath to slide over the core wire (e.g., an elongated body made of stainless steel). After the sheath is positioned over the core wire, the sheath can be cooled to thermally shrink the diameter of the sheath, thereby hugging or tightly fitting over the core wire, thereby forming a composite suture needle having a flexible region covered by the sheath.

[0061] In one embodiment, the sheath can be secured to the core wire by applying an adhesive in the space between the outer diameter of the core wire and the inner diameter of the sheath.

[0062] In one embodiment, the sheath can be secured to the core wire by using a connecting material between the outer diameter of the core wire and the inner diameter of the sheath, whereby the connecting material can be welded to both the core wire material and the sheath material.

[0063] In one embodiment, a hole for receiving a suture can be formed in the composite suture needle by drilling the core material at the proximal end of the composite suture needle, or, particularly for high strength maraging alloys, electrochemically etching / leaching the core wire to a specified depth to produce a symmetrical suture receiving hole.

[0064] In one embodiment, the distal end of the core wire can be ground (or material removed) from the distal end of the composite structure to form a point at the distal end of the composite suture needle.

[0065] In one embodiment, the composite suture needle can have a stainless steel core and a connector component made of a high-elasticity material that exists only along the inner radius surface and the opposite outer radius surface of the suture needle. The high-elasticity connector component can be implemented in a similar manner as a sheath or sleeve configuration (e.g., fixed, glued, or welded) in cooperation with the conventional suture needle material of the core. However, in one embodiment, the high-elasticity connector component can include a mechanical attachment structure, such as a dovetail connector component.

[0066] In one embodiment, the composite suture needle can be bent with equipment and methods known in the art to produce a free-standing composite suture needle having a steel core and a Nitinol sheath that can be subsequently heat treated to set the outer Nitinol sleeve component without the need for jigs or complex additional processes.

[0067] In one embodiment, where the core material of the composite suture needle is a maraging alloy, the setting and precipitation strengthening heat treatment steps can be performed simultaneously (e.g., at 480 degrees Celsius or higher for two minutes or more).

[0068] In one embodiment, the method of manufacturing a composite suture needle preferably includes obtaining a length of core wire made of a suitable material for manufacturing a suture needle, the core wire having an outer diameter, a proximal end, and a distal end; and forming a thin strip of Nitinol around the steel core wire by simultaneously drawing the steel core wire and the Nitinol strip through a series of constricting dies adapted to manufacture a round tube.

[0069] In one embodiment, the seams of the Nitinol tube can be welded via laser or micro-TIG welding techniques as a result of the Nitinol tube being formed around the steel core through the drawing step of the dies.

[0070] In one embodiment, the elastic sheath can be shorter than the core wire.

[0071] In one embodiment, the composite suture needle can be mechanically drilled and / or laser drilled to form the suture thread-receiving hole.

[0072] In one embodiment, the suture thread-receiving hole can be chemically or electrochemically formed by etching away the core material.

[0073] In one embodiment, the composite suture needle can be bent into a specified free-standing shape and then batch heat treated to complete the setting process.

[0074] These and other preferred embodiments of the present patent application will be described in greater detail hereinbelow. BRIEF DESCRIPTION OF DRAWINGS

[0075] FIG. 1A is a perspective view of a suture needle.

[0076] FIG. 1B is FIG. 1A is a side elevational view of the suture needle shown in

[0077] FIG. 1C is FIG. 1A and FIG. 1B is a schematic view of the suture needle shown in

[0078] FIG. 1C-1 is FIG. 1C is an enlarged sectional view of a middle section of the suture needle shown in

[0079] FIG. 2A is a side view of an elongated body of a composite suture needle according to one embodiment of the present patent application.

[0080] FIG. 2B is FIG. 2A is an enlarged view of a distal end of the elongated body shown in

[0081] FIG. 3A is a side view of a sheath of a composite suture needle according to one embodiment of the present patent application.

[0082] FIG. 3B is FIG. 3A is a sectional view of the sheath shown in

[0083] FIG. 4A is a side view of a composite suture needle comprising an elongated body assembled with FIG. 2A and FIG. 2B a sheath of FIG. 3A and FIG. 3B according to one embodiment of the present patent application.

[0084] FIG. 4B is FIG. 4A is a sectional view of the composite suture needle shown in

[0085] FIG. 4C is FIG. 4A another sectional view of the composite suture needle.

[0086] FIG. 4D is FIG. 4A still another sectional view of the composite suture needle shown in

[0087] FIG. 5A is a perspective view of a distal section of a needle driver having a clamping assembly at its distal end according to one embodiment of the present patent application.

[0088] FIG. 5B It is located in FIG. 5A A perspective view of the clamping assembly at the distal end of the needle driver shown.

[0089] FIG. 6A The illustration shows a stage of a method for advancing a composite suture needle with a highly elastic segment toward the distal end of an insertion cannula using a needle actuator according to one embodiment of this patent application.

[0090] FIG. 6B The composite suture needle shown in one embodiment of this patent application has been advanced beyond the distal end of the cannula to be positioned behind the surgical site. FIG. 6A Needle driver and composite suture needle.

[0091] FIG. 6C The illustration shows a stage of a method for retracting a composite suture needle from the surgical site and toward the proximal end of the cannula using a needle driver according to one embodiment of this patent application.

[0092] FIG. 6D This illustrates a later stage of a method for retracting a composite suture needle toward the proximal end of an insertion cannula according to one embodiment of this patent application.

[0093] FIG. 7A This is a side view of the elongated body of a composite suture needle according to one embodiment of this patent application.

[0094] FIG. 7B yes FIG. 7A An enlarged view of the distal end of the slender body shown.

[0095] FIG. 7C yes FIG. 7A An enlarged view of the proximal end of the slender body shown.

[0096] FIG. 8A This is a side view of the sheath of a composite suture needle according to one embodiment of this patent application.

[0097] FIG. 8B yes FIG. 8A The cut view of the sheath shown.

[0098] FIG. 9A According to one embodiment of this patent application, it includes and FIG. 7A to FIG. 7C The slender main body assembly FIG. 8A and FIG. 8B Side view of the composite suture needle with sheath.

[0099] FIG. 9B yes FIG. 9A The cross-sectional view of the composite suture needle shown.

[0100] FIG. 10is a side view of an elongated body of a composite suture needle according to an embodiment of the present patent application.

[0101] FIG. 11A is a side view of a sheath of a composite suture needle according to an embodiment of the present patent application.

[0102] FIG. 11B is FIG. 11A is a cross-sectional view of the sheath shown in

[0103] FIG. 12A is a composite suture needle according to an embodiment of the present patent application including an elongated body assembled with FIG. 10 FIG. 11A and FIG. 11B is a side view of a composite suture needle including a sheath of

[0104] FIG. 12B is FIG. 12A is a cross-sectional view of the composite suture needle shown in

[0105] FIG. 13A is a side view of a composite suture needle according to an embodiment of the present patent application having an elongated body with a curved configuration and a high-elasticity member interconnecting a proximal segment and a distal segment of the elongated body.

[0106] FIG. 13B is FIG. 13A is a cross-sectional view of the high-elasticity member of the composite suture needle shown in

[0107] FIG. 14A is a side view of a composite suture needle according to an embodiment of the present patent application having a high-elasticity segment located between a proximal end and a distal end of the composite suture needle.

[0108] FIG. 14B is FIG. 14A is a cross-sectional view of the composite suture needle shown in

[0109] FIG. 15A is a composite suture needle according to an embodiment of the present patent application FIG. 14A is a perspective view of the composite suture needle in

[0110] FIG. 15B is FIG. 15A is a side view of the composite suture needle shown in

[0111] FIG. 16 shows a composite suture needle in a curved configuration according to an embodiment of the present patent application. FIG. 15A and FIG. 15B of the composite suture needle for enabling the composite suture needle to pass through a cannula. ​

[0112] FIG. 17A A perspective view of a composite suture needle is shown having a high-elasticity intermediate section for enabling the composite suture needle to be moved into a curved configuration for passing through a cannula, according to one embodiment of the present patent application.

[0113] FIG. 17B A perspective view of a composite suture needle is shown having a high-elasticity intermediate section for enabling the composite suture needle to be moved into a curved configuration for passing through a cannula, according to one embodiment of the present patent application. FIG. 17A An end view of the composite suture needle is shown.

[0114] FIG. 17C A perspective view of a composite suture needle is shown having a high-elasticity intermediate section for enabling the composite suture needle to be moved into a curved configuration for passing through a cannula, according to one embodiment of the present patent application. FIG. 17A and FIG. 17B A side view of the composite suture needle is shown. DETAILED DESCRIPTION

[0115] FIG. 1A to FIG. 1C A conventional suture needle 50 is shown having an elongated body 52 with a proximal end 54 and a distal end 56. The elongated body 52 of the suture needle 50 is curved and has a semi-circular or semi-circular shape.

[0116] The suture needle 50 includes a suture attachment barrel 58 proximate the proximal end 54 of the elongated body 52, and a suture attachment opening 60 formed in a proximal face of the suture attachment barrel. An end of a surgical suture (e.g., a filamentary element) is inserted into the suture attachment opening 60, and the suture attachment barrel 58 is swaged to secure the end of the surgical suture to the suture attachment barrel 58 of the elongated body 52 of the suture needle 50.

[0117] The suture needle 50 includes a tip 62, such as a sharp or pointed tip, that is integral with the distal end 56 of the elongated body 52 and defines a forward or distal-most end of the suture needle 50. The tip 62 is sharpened for piercing tissue to facilitate passing the distal end 56 of the elongated body 52 of the suture needle 50 through tissue during a suturing operation.

[0118] Referring to FIG. 1B and FIG. 1C The elongated body 52 of the suture needle 50 includes an inner radial surface 64 (i.e., a concave curved surface) that extends along an interior of the curve of the curved elongated body 52, and an outer radial surface 66 (i.e., a convex curved surface) that extends along an exterior of the curve of the curved elongated body 52. The inner radial surface 64 and the outer radial surface 66 of the elongated body 52 define a thickness T of the elongated body 52 of the suture needle 50, whereby an axis for measuring the thickness T of the elongated body is perpendicular to a neutral axis A of the elongated body 52 of the suture needle 50.

[0119] When the suture needle 50 is in its initial semi-circular configuration, the elongated body 52 of the suture needle 50 defines a height H. When an external force is applied to the outer surface of the elongated body 52 of the suture needle 50 (e.g., when the suture needle is passed through a lumen of a cannula), the elongated body will flex, bend, straighten, and / or flatten to transform into an elongated body having a height or profile that is lower than the initial height H.

[0120] Referring to FIG. 1C and FIG. 1C-1 , the elongated body 52 of the suture needle 50 has a length L N extending along a neutral axis A of the elongated body 52 N extending between the proximal end 54 and the distal end 56 of the elongated body 52, which is also referred to as the neutral length of the suture needle 50. The elongated body 52 of the suture needle 50 has a top length L T extending along the inner radial surface 64 of the elongated body 52 between the proximal end 54 and the distal end 56 of the elongated body, and a bottom length L B extending along the outer radial surface 66 of the elongated body 52 between the proximal end 54 and the distal end 56 of the elongated body 52.

[0121] Referring to FIG. 1C-1 , when the intermediate section 68 of the elongated body 52 of the suture needle 50 is straightened to pass through a cannula, tension and compression forces are applied at the respective inner surface 64 and outer surface 66 of the elongated body 52 of the suture needle 50. When the intermediate section 68 of the elongated body 52 is straightened, the inner radial surface 64 of the elongated body 52 is under tension and the outer radial surface 66 of the elongated body 52 is under compression. The portion of the elongated body 52 extending along the neutral axis A defining the neutral length L N of the elongated body 52 is neither under tension nor under compression. The elastic strain calculations associated with transforming a semi-circular suture needle (shown in FIG. 1A to FIG. 1C and FIG. 1C-1 ) into a straightened configuration can be calculated using the equation ε = ΔL / L N , where ΔL is the change in the top length L T of the suture needle at the inner radial surface 64 of the elongated body 52 or the change in the bottom length L B of the suture needle at the outer radial surface 66 of the elongated body 52, and L N is the neutral length of the elongated body of the suture needle, which is intermediate the inner radial surface 64 and the outer radial surface 66 of the elongated body.

[0122] When the suture needle 50 is flexed to pass through a lumen of a cannula, the maximum bending occurs at the intermediate section 68 of the elongated body 52. When flexed, the maximum strain occurs along the inner radial surface 64 and the outer radial surface 66 of the elongated body 52. Along the neutral length LN The extended neutral axis A is proximate to the center of the cross-section of the elongated body. During flexing (e.g., straightening) of the elongated body, there is no shear strain occurring along the neutral axis A along the neutral length L N of the elongated body 52 N However, as the distance from the neutral axis L N increases, the degree of strain increases. Thus, during flexing of the suture needle 50, the shear strain is greater at the inner radial inner surface 64 and the outer radial surface 66, and is smaller or negligible along the neutral length L

[0123] In one embodiment, the composite suture needle preferably includes a core member made of a first material and a second member made of a second material that is more elastic than the first material. In one embodiment, the first member can include a core member made of stainless steel and the second member can include an outer sheath made of a high-elasticity material (e.g., Nitinol) that covers a segment of the core member.

[0124] Referring to FIG. 2A and FIG. 2B , in one embodiment, the composite suture needle 100 preferably includes an elongated body 102 (i.e., a core member) having a proximal end 104 and a distal end 106. In one embodiment, the distal end 106 of the elongated body 102 preferably includes a tapered segment 108 having a proximal end 110 that defines a shoulder 112 and a distal end 114 that includes a sharp or pointed tip 116. The tapered segment 108 preferably tapers inwardly between its proximal end 110 and distal end 114. In one embodiment, the pointed tip 116 at the distal end 114 of the tapered segment 108 preferably defines a leading end of the elongated body 102 that is designed for piercing tissue to facilitate passing the distal end 106 of the elongated body 102 through the tissue during a suturing operation.

[0125] In one embodiment, the elongated body 102 of the composite suture needle 100 preferably includes a reduced diameter segment 118 that extends between the proximal end 104 of the elongated body and the larger diameter shoulder 112 of the tapered segment 108. In one embodiment, the reduced diameter segment 118 has a cross-section with a circular shape that is configured to receive a sheath made of a high-elasticity material, as will be described in greater detail herein.

[0126] Referring to FIG. 2B , in one embodiment, the reduced diameter segment 118 of the elongated body 102 preferably defines a first outer diameter OD1 and the shoulder 112 of the tapered segment 108 preferably defines a second outer diameter OD2 that is greater than the first outer diameter OD1 of the reduced diameter segment 118 of the elongated body 102.

[0127] Referring to FIG. 2A and 2B In one embodiment, the elongated body 102 can be curved and / or can have a semi-circular or semi-circular shape. In one embodiment, the diameter-reducing section 118 of the elongated body 102 is curved and preferably includes a concave surface 120 extending internally along the curve of the diameter-reducing section and a convex curved outer surface 122 extending externally along the curve of the diameter-reducing section 118. The elongated body 102 preferably defines a first height H1.

[0128] In one embodiment, the elongated body 102 can be made of a strong alloy such as stainless steel. In one embodiment, the stainless steel can include an austenitic stainless steel (302SS) and a maraging (mar age) stainless steel (455SS).

[0129] Austenitic stainless steel (302SS) can have austenite as its primary crystal structure. The austenitic crystal structure is achieved by the sufficient addition of austenite stabilizing elements nickel, manganese, and nitrogen. Due to its crystal structure, austenitic steel cannot be hardened by heat treatment. However, exceptionally high strength can be achieved by work hardening, especially in the wire drawing process used to produce the raw material for needle manufacturing.

[0130] Maraging (mar age) stainless steel (455SS) is preferably a steel known for its excellent strength and toughness without loss of ductility. The "age" part of the term mar age refers to an extended heat treatment process. These steels are a special class of low carbon ultra-high strength steels whose strength is not generated by carbon but by precipitates of intermetallic compounds. Typically, the primary alloying element is 7 to 25 weight percent nickel. Secondary alloying elements including titanium and copper are added to produce intermetallic precipitates. One type of mar age alloy that was specifically developed for suture needles and provides a strength level far exceeding that of prior alloys used to make suture needles is available on the market. ETHALLOY needle alloys are strengthened by a combination of work hardening and heat treatment (precipitation strengthening).

[0131] Referring to FIG. 3A and FIG. 3B In one embodiment, the composite suture needle 100 preferably includes a sheath 124 made of an elastic level that is less than the elastic level of the elongated body 102 used to manufacture the composite suture needle (e.g., 302SS and 455SS) and that is preferably made of a material that is less elastic than the material used to manufacture the elongated body 102 (e.g., 302SS and 455SS). FIG. 2A and FIG. 2B) is made of a material that is relatively more elastic than the material used to make the elongated body 102. In one embodiment, the sheath 124 can be made of a highly elastic material such as Nitinol. In one embodiment, the sheath 124 can have a sleeve, tubular, or cylindrical shape. In one embodiment, the size, shape, and / or configuration of the sheath 124 is preferably designed to fit over the reduced diameter section 118 of the elongated body 102 to form the composite suture needle 100, which includes an elongated body that is relatively less elastic and a sheath 124 that is relatively more elastic than the material used to make the elongated body. FIG. 2A and FIG. 2B ) is made of a material that is relatively more elastic than the material used to make the elongated body 102. In one embodiment, the sheath 124 can be made of a highly elastic material such as Nitinol. In one embodiment, the sheath 124 can have a sleeve, tubular, or cylindrical shape. In one embodiment, the size, shape, and / or configuration of the sheath 124 is preferably designed to fit over the reduced diameter section 118 of the elongated body 102 to form the composite suture needle 100, which includes an elongated body that is relatively less elastic and a sheath 124 that is relatively more elastic than the material used to make the elongated body.

[0132] In one embodiment, the sheath 124 preferably has a proximal end 126, a distal end 128, and a lumen 130 extending from the proximal end 132 to the distal end 134. With reference to FIG. 2B and FIG. 3B , in one embodiment, the lumen 136 of the sheath 124 advantageously defines an inner diameter ID1 that is slightly larger than the outer diameter OD1 of the reduced diameter section 118 of the elongated body 102. In one embodiment, the sheath 124 has an outer surface 132 that preferably defines an outer diameter OD3 that is approximately the outer diameter OD2 of the shoulder 112 of the tapered section 108 of the elongated body 102. In one embodiment, when the sheath 124 is assembled over the reduced diameter section 118 of the elongated body to form the composite needle 100, the distal end 128 of the sheath 124 preferably abuts the shoulder 112 of the tapered section 108 of the elongated body 102. In one embodiment, the outer surface 132 of the sheath 124 is approximately the outer surface at the proximal end 110 of the tapered section 108 of the elongated body to provide a smooth transition between the tapered section 108 of the composite suture needle and the sheath 124.

[0133] In one embodiment, the sheath advantageously covers a majority of the length of the elongated body. In one embodiment, the proximal end of the sheath preferably extends proximally beyond the proximal end of the elongated body to provide a suture receiving aperture. In one embodiment, the sheath can be slid over the elongated body to form a thermal and / or compression fit between the sheath and the elongated body.

[0134] With reference to FIG. 4A and FIG. 4B , in one embodiment, the composite suture needle 100 can be formed by assembling the sheath 124 over the reduced diameter section 118 of the elongated body 102. In one embodiment, the distal end 128 of the sheath 124 preferably abuts the shoulder 112 of the tapered section 108 of the elongated body 102 ( FIG. 2B ). The inner diameter ID1 of the sheath 124 is preferably slightly larger than the outer diameter OD1 of the reduced diameter section 118 of the elongated body 102 ( FIG. 2BThe outer surface 132 of the sheath 124 preferably defines an outer diameter OD3. FIG. 3B The outer diameter is approximately the outer diameter at the proximal end 110 of the tapered section 108 of the slender body 102.

[0135] In one embodiment, after the sheath 124 has been assembled onto the diameter-reducing section 118 of the elongated body 102, the proximal end 126 of the sheath 124 preferably extends proximally beyond the proximal end 104 of the elongated body 102 to define a suture attachment opening 134 located at the proximal end of the composite suture needle 100. The suture attachment opening 134 is preferably surrounded by a forged area 136 of the sheath 124, which can be forged or coiled to secure the end of the suture to the proximal end of the composite suture needle 100. In one embodiment, the end of a suture (not shown) may be inserted into the suture attachment opening 134 of the sheath 124, and the forged area 136 of the sheath 124 may be forged to secure the end of the suture to the proximal end of the composite suture needle 100.

[0136] refer to FIG. 4B to FIG. 4D In one embodiment, the sheath 124 can be secured to the diameter-reducing section 118 of the elongated body 102 by applying heat to the sheath to cause the inner diameter ID1 of the sheath to shrink dimensionally, thereby tightly gripping or closely fitting the outer surface of the diameter-reducing section 118, thus forming a composite suture needle 100 with a more elastic section. In one embodiment, the more elastic section of the composite suture needle is preferably the section of the composite suture needle in which the sheath 124 extends above the diameter-reducing section 118.

[0137] In one embodiment, the sheath 124 can be secured to the diameter reduction section 118 of the elongated body 102 by applying an adhesive within a space 138 located between the outer surface of the diameter reduction section 118 and the inner surface of the sheath 124.

[0138] In one embodiment, the sheath 124 can be secured to the diameter-reducing section 118 of the elongated body 102 by using a connecting material disposed in a space 138 between the outer surface of the diameter-reducing section 118 and the inner surface of the sheath 124, whereby the connecting material is preferably weldable to both the material used to manufacture the elongated body 102 (e.g., stainless steel) and the material used to manufacture the sheath 124 (e.g., nitinol).

[0139] In one embodiment, the composite suture needle 100 preferably includes a reduced diameter section 118 and a sheath 124 covering the reduced diameter section. The length of the elongated body 118 covered by the sheath 124 preferably defines a more resilient region of the composite suture needle 100 that is designed to flex (e.g., flatten out) without plastically deforming when passed through a smaller cannula. Due to the presence of the more resilient region formed by the combination of the reduced diameter section 118 and the highly elastic sheath 124, the elongated body 102 of the composite suture needle 100 will preferably return (e.g., spring back) to its normal semi-circular configuration after the composite suture needle 100 is removed from the end of the cannula (e.g., at the surgical site) so that the composite suture needle 100 can be used to suture tissue.

[0140] In one embodiment, the composite suture needle disclosed herein is designed to exhibit resilience for passing through a smaller cannula (e.g., a 5 mm cannula) without significant plastic deformation. In one embodiment, the elongated body of the composite suture needle (i.e., the elongated body 102 shown in FIG. 1) is made of stainless steel, such as high-strength stainless steel. In one embodiment, knowing the yield strength and Young's modulus of the stainless steel used to manufacture the elongated body of the composite suture needle, the elongated body can be designed to have a reduced diameter section that is sized such that the composite suture needle can elastically deform without plastically deforming. FIG. 2A

[0141] The yield point of a material is the point on the stress-strain curve that indicates the limit of the elastic behavior of the material and the beginning of plastic behavior. The yield strength or yield stress is a material property defined as the stress at which a material begins to deform plastically, whereas the yield point is the point at which non-linear (elastic + plastic) deformation begins. Prior to the yield point, the material will deform elastically and will have the ability to return to its original shape once the applied stress is removed. However, once the yield point is passed, some portion of the deformation will be permanent and non-reversible. The yield point determines the limit of the performance of a mechanical component, as it represents the upper limit of the force that can be applied without permanent deformation.

[0142] The Young's modulus of a material is one way of measuring the modulus of elasticity of a material. The modulus of elasticity is a measure of a material's resistance to elastic (i.e., non-permanent) deformation when a stress is applied to the object. The modulus of elasticity of an object is defined as the slope of its stress-strain curve in the elastic deformation region. A stiffer material will have a higher modulus of elasticity.

[0143] Specifying how to measure stress and strain, including the direction, allows for the definition of many types of elastic moduli. The Young's modulus (E) describes tensile elasticity, or the tendency of a material to deform along an axis when an opposing force is applied along that axis. It is defined as the ratio of tensile stress to tensile strain. It is often simply referred to as the elastic modulus.

[0144] ​In one embodiment, the elongated body of the composite suture needle is preferably elastically deformable from a semi-circular shape to a more flattened shape having a straightened segment without plastically deforming the elongated body of the composite suture needle. Thus, when the elastic suture needle is passed through a smaller cannula and is extracted at the surgical site, the elongated body of the composite suture needle will preferably spring back to its original semi-circular shape.

[0145] As known to those skilled in the art, most materials can withstand a moderate strain before becoming plastically deformed. In one embodiment, the sheath 124 is preferably made of a highly elastic material (e.g., Nitinol) that will withstand a greater strain than a less elastic material (e.g., stainless steel) before becoming plastically deformed. In one embodiment, the composite suture needle 100 contains a highly elastic material at the maximum distance from the neutral axis L N ( FIG. 4D ) that will be able to withstand a greater deflection before becoming plastically deformed than a conventional suture needle made of a single less elastic material (e.g., stainless steel) having uniform elastic properties. This is because the outer diameter OD1 of the diameter-reducing segment 118 of the elongated body 102 is less than the outer diameter OD3 of the composite suture needle 100.

[0146] Referring to FIG. 5A and FIG. 5B , in one embodiment, a clamping element such as a needle driver 150 can be used to secure a composite suture needle such as the composite suture needle 100 described above in FIG. 2A to FIG. 2B , FIG. 3A to FIG. 3B and FIG. 4A to FIG. 4D to remove the composite suture needle from the suture needle pack and / or advance the composite suture needle through a lumen of a cannula to position the composite suture needle at a surgical site for a suturing operation. In one embodiment, the shape of the elongated body of the composite suture needle can change (e.g., flatten) as the needle driver 150 advances the composite suture needle through the cannula. In one embodiment, the composite suture needle can have a semi-circular shape defining a first height H1 FIG. 4A and a more elastic intermediate segment that enables the composite suture needle to flex from the semi-circular shape to a more flattened shape. As the needle driver 150 advances the composite suture needle through a cannula having an inner diameter that is less than the first height H1 of the composite suture needle 100 FIG. 4A , the inner walls of the cannula can exert an external force on the elongated body of the composite suture needle such that the elongated body of the composite suture needle will flatten along the diameter-reducing segment 118 FIG. 4B) to a smaller second height for mating through the smaller inner diameter of the cannula. Upon extraction from the end of the cannula, the inner wall of the cannula no longer exerts an external force on the composite suture needle, such that the elongated body of the composite suture needle will preferably transition back (e.g., spring back) to its original semi-circular shape having the first height H1 FIG. 4A ].

[0147] In one embodiment, the needle driver 150 preferably includes an elongated shaft 152 having a proximal end 154 and a distal end 156 with a clamping assembly 158 movable between an open position and a closed position. In one embodiment, the clamping assembly 158 preferably includes a lower jaw 160 and an opposing upper jaw 162 movable between an open position and a closed position. In one embodiment, with the clamping assembly 158 in the open position, the lower jaw 160 and the upper jaw 162 can be guided into alignment with the tip 116 of the composite suture needle 100 FIG. 2A ). In one embodiment, after the lower and upper jaws are aligned with the tip of the composite suture needle, the jaws can be moved to the closed position to clamp and / or grip the tapered section 108 of the elongated body 102 of the composite suture needle FIG. 2A ), with the tip 116 preferably positioned between and surrounded by the opposing lower and upper jaws.

[0148] Referring to FIG. 5B , in one embodiment, the lower jaw 160 can be stationary, rigidly fixed, and / or integral with the distal end 156 of the elongated shaft 152 of the needle driver 150, such that the lower jaw 160 is fixed and does not move relative to the distal end 158 of the elongated shaft 152 of the needle driver 150. In one embodiment, the lower jaw 160 preferably includes a substantially flat top surface 164 adapted to align with the tip 116 of the composite suture needle FIG. 2A ). In one embodiment, the substantially flat top surface 164 of the lower jaw 160 can include surface roughness, such as knurling, for enhanced gripping of the distal end of the composite suture needle when the clamping assembly 158 is in the closed position.

[0149] In one embodiment, the upper jaw 162 of the clamping assembly 158 is advantageously pivotally secured to the distal end 156 of the elongated shaft 152 of the needle driver 150 via a pivot 166 that pivotally secures a proximal end of the upper jaw 162 to the distal end 156 of the elongated shaft 152. The upper jaw 162 preferably includes a substantially flat bottom surface 168 that opposes the substantially flat top surface 164 of the lower jaw 160. The substantially flat bottom surface 168 of the upper jaw 162 can include surface roughness, such as knurling, for gripping the distal end of a composite suture needle when the clamping assembly 158 is in the closed position.

[0150] Referring to FIG. 5A and FIG. 5B In one embodiment, when the lower jaw 160 and the upper jaw 162 are in the closed position to clamp, grip, and / or secure the tapered section 108 of the elongated body 102 of the composite suture needle 100, the top surface 164 of the lower jaw 160 engages a surface of the tapered section 108 at the distal end 106 of the elongated body 102 of the composite suture needle 100, and the bottom surface 168 of the upper jaw 162 preferably engages another surface of the tapered section 108 of the elongated body 102 of the composite suture needle 100 at the distal end 106, with the tip 116 of the composite suture needle positioned between the opposing jaws. In one embodiment, the top and bottom surfaces 164, 168 of the respective lower and upper jaws 160, 162 can be spaced apart from the tip 116 when the jaws are closed so that the tip is not damaged, bent, broken, or blunted by the jaws of the clamping assembly. In one embodiment, the closed jaws 160, 162 preferably surround the outer periphery of the tip 116 when the composite suture needle 100 is passed through the cannula for preventing the tip from being scratched or damaged by the inner walls of the cannula.

[0151] In one embodiment, the suture needle pack can hold one or more composite suture needles, such as the composite suture needle 100 shown in FIG. 4A to FIG. 4D with the tip 116 of the suture needle 100 pre-positioned at a location that will facilitate aligning the tip 116 between the top and bottom surfaces 164, 168 of the respective lower and upper jaws 160, 162 of the clamping assembly 158 of the needle driver 150.

[0152] Referring to FIG. 6AIn one embodiment, after the clamping assembly 158 of the needle driver 150 has closed to clamp onto the distal end 106 of the elongated body 102 of the composite suture needle 100, the needle driver 150 can be used to advance the suture needle 100 through the cannula 170 to position the suture needle at the surgical site for performing the suturing operation. In one embodiment, the cannula 170 preferably has an elongated conduit 172 having an inner diameter defining a second height H2, which is smaller than the first height H1 of the composite suture needle. FIG. 4A The elongated catheter 172 preferably extends to the opening 174 at the distal end 176 of the cannula 170. The clamping assembly 158 of the needle actuator 150, clamped to the distal end 106 of the elongated body 102 of the composite suture needle 100, can be advanced toward the distal end of the catheter 172 of the cannula 170 to pull the composite suture needle 100 through the cannula. When the composite suture needle 100 is pulled toward the distal end 176 of the cannula 170 by the clamping assembly 158 of the needle actuator 150, the composite suture needle 100 needs to pass through a smaller catheter 172 having a second height H2, which is smaller than the initial first height H1 of the composite suture needle 100. FIG. 4A Because the composite suture needle 100 is capable of elastic deformation at the intermediate section 125, the elongated body 102 of the composite suture needle 100 is preferably elastically deformable (e.g., straightened, becoming flatter), such as FIG. 6A As shown.

[0153] exist FIG. 6A Among them, the high-elasticity sheath 124 of the composite suture needle 100 ( FIG. 4A to FIG. 4D The more elastic middle section 125 of the composite suture needle 100 is preferably straightened or flattened to reduce the total height of the composite suture needle to a third height H3, which is smaller than the second height H2 of the catheter 172 of the cannula 170. At the smaller third height H3, the flattened suture needle 100 can pass through the smaller lumen 172 of the cannula 170. As will be described in more detail herein, the composite suture needle is designed to elastically deform significantly when it passes through the smaller cannula, thereby reducing the total height of the composite suture needle from the first height H1 ( FIG. 4A It is changed to the third height H3.

[0154] See FIG. 6B After the composite suture needle 100 has been removed from the opening 174 at the distal end 176 of the cannula 170, the composite suture needle 100 will preferably spring back to its initial curved configuration (e.g., a semi-circular shape) having a second height H2 greater than that of the catheter 172 of the cannula 170. FIG. 6A The fourth height, H4. Surgical personnel can utilize... FIG. 6B The semi-circular composite suture needle 100 shown is used for suturing at the surgical site.

[0155] In one embodiment, after being removed from the distal end 174 of the cannula 170, the compound suture needle 100 preferably springs back to a fourth height H4 that substantially matches the initial first height H1 of the compound suture needle (H4 = H1). FIG. 4A In one embodiment, the fourth height H4 is about 90% of the initial first height H1. In one embodiment, the fourth height H4 is about 95% of the initial first height H1. In one embodiment, the fourth height H1 substantially matches the initial first height H1.

[0156] Referring to FIG. 6C In one embodiment, at the end of the suturing operation, the curved compound suture needle 100 having the fourth height H4 can be removed from the patient by retracting the compound suture needle through the cannula 170. In one embodiment, the clamping assembly 158 of the needle driver 150 is again closed for securing the tapered section 108 of the elongated body 102 of the curved compound suture needle 100 between the lower jaw 160 and the upper jaw 162 of the needle driver 150.

[0157] Referring to FIG. 6D In one embodiment, at the completion of the suturing operation, the needle driver 150 preferably retracts the compound suture needle 100 through the conduit 172 of the cannula 170. Because the second height H2 of the conduit of the cannula is less than the fourth height H4 of the compound suture needle 100 (H2 < H4) FIG. 6B , the middle section 125 of the compound suture needle 100 preferably straightens or flattens to a third height H3 so that the suture needle can be extracted through the conduit 172 of the cannula 170. As the compound suture needle 100 is withdrawn through the cannula 170, the lower jaw 160 and the upper jaw 162 of the needle driver 150 preferably engage the tapered section 108 of the elongated body 102 of the compound suture needle 100 and surround the tip 116 of the suture needle (H3 = H2) FIG. 4A to protect the tip from damage as the needle is pulled and / or retracted through the cannula 170.

[0158] Referring to FIG. 7A to FIG. 7CIn one embodiment, the composite suture needle 200 preferably includes an elongated body 202 (i.e., a core member) having a proximal end 204 and a distal end 206. In one embodiment, the distal end 206 of the elongated body 202 preferably includes a tapered section 208 having a proximal end 210 defining a distal shoulder 212 and a distal end 214 including a sharp or pointed tip 216. The tapered section 208 preferably tapers inwardly between its proximal end 210 and distal end 214. In one embodiment, the pointed tip 216 at the distal end 214 of the tapered section 208 preferably defines a leading end of the elongated body 202 that is designed for piercing tissue to facilitate passage of the distal end 206 of the elongated body 202 through the tissue during a suturing operation.

[0159] In one embodiment, the proximal end 204 of the elongated body includes a larger diameter section having a proximal end 205 adapted to have a suture attachment hole 207 formed therein and a distal end 209 defining a shoulder 211.

[0160] In one embodiment, the elongated body 202 of the composite suture needle 200 preferably includes a reduced diameter section 218 extending between the shoulder 211 at the proximal end 204 of the elongated body and the shoulder 212 at the distal end of the elongated body. In one embodiment, the reduced diameter section 218 has a cross-section with a circular shape that is configured to receive a sheath made of a high-elasticity material, as will be described in greater detail herein.

[0161] In one embodiment, the reduced diameter section 218 of the elongated body 202 preferably defines an outer diameter OD4, the shoulder 211 at the proximal end of the elongated body defines an outer diameter OD5, and the shoulder 212 at the distal end of the elongated body also defines an outer diameter OD5, whereby the outer diameter OD5 of the respective shoulders 211, 212 is greater than the outer diameter OD4 of the reduced diameter section 218 of the elongated body 202 extending between the shoulders.

[0162] In one embodiment, the elongated body 202 can be curved and / or can have a semi-circular or semi-circular shape. In one embodiment, the reduced diameter section 218 of the elongated body 202 is curved and preferably includes a concave surface 220 extending internally along the curve of the reduced diameter section and a convex curved outer surface 222 extending externally along the curve of the reduced diameter section 218.

[0163] In one embodiment, the elongated body 202 can be made of a strong alloy such as stainless steel. In one embodiment, the stainless steel can include an austenitic stainless steel (302SS) and a martensitic aged (maraging) stainless steel (455SS).

[0164] Referring to FIG. 8A and FIG. 8B In one embodiment, the composite suture needle 200 preferably includes a sheath 224 made of a material having a higher elastic horizontal ratio than the material used to manufacture the elongated body 202. In one embodiment, the sheath 224 can be made of a highly elastic material such as Nitinol. In one embodiment, the sheath 224 can have a sleeve, tubular, or cylindrical shape. In one embodiment, the size, shape, and / or configuration of the sheath 224 is preferably designed to fit over the reduced diameter section 218 of the elongated body 102 to form the composite suture needle 200 including an elongated body having a relatively less elastic and a sheath 224 having a relatively more elastic than the material used to manufacture the elongated body. FIG. 7A to FIG. 7C FIG. 7A to FIG. 7C In one embodiment, the sheath 224 preferably has a proximal end 226, a distal end 228, and a lumen 230 extending from the proximal end 232 to the distal end 234. Referring to

[0165] In one embodiment, the lumen 236 of the sheath 224 advantageously defines an inner diameter ID2 that is slightly larger than the outer diameter OD4 of the reduced diameter section 218 of the elongated body 202. In one embodiment, the sheath 224 has an outer surface 232 that preferably defines an outer diameter OD6 that is approximately the outer diameter OD5 of the corresponding shoulder 211, 212 of the elongated body 202. In one embodiment, when the sheath 224 is assembled over the reduced diameter section 218 of the elongated body to form the composite suture needle 200, the distal end 228 of the sheath 224 preferably abuts against the shoulder 212 at the distal end of the elongated body, and the proximal end 226 of the sheath 224 preferably abuts against the shoulder 211 at the proximal end of the elongated body. In one embodiment, the outer surface 232 at the distal end 228 of the sheath 224 is approximately the outer surface at the proximal end 210 of the tapered section 208 to provide a smooth transition between the tapered section 208 of the composite suture needle and the sheath 224, and the outer surface 232 at the proximal end 226 of the sheath 224 is approximately the outer surface at the distal end 209 of the proximal end 204 of the elongated body to provide a smooth transition between the proximal end of the sheath and the larger diameter section of the elongated body at the proximal end. FIG. 7A to FIG. 7C FIG. 8B In one embodiment, the sheath 224 preferably has a proximal end 226, a distal end 228, and a lumen 230 extending from the proximal end 232 to the distal end 234. Referring to

[0166] In one embodiment, the sheath 224 preferably has a proximal end 226, a distal end 228, and a lumen 230 extending from the proximal end 232 to the distal end 234. Referring to

[0167] In one embodiment, the sheath 224 preferably has a proximal end 226, a distal end 228, and a lumen 230 extending from the proximal end 232 to the distal end 234. Referring to FIG. 9A FIG. 9B ​​​In one embodiment, the composite suture needle 200 can be formed by assembling the sheath 224 over the reduced diameter section 218 of the elongated body 202. In one embodiment, the distal end 228 of the sheath 224 is preferably abutted against the shoulder 212 at the distal end of the elongated body 202 FIG. 8B , and the proximal end 226 of the sheath 224 is abutted against the shoulder 211 at the proximal end of the elongated body 202. The inner diameter ID2 FIG. 8B of the sheath 224 is preferably slightly larger than the outer diameter OD4 FIG. 7B and FIG. 7C of the reduced diameter section 218 of the elongated body 202. The outer surface 232 of the sheath 224 preferably defines an outer diameter OD6 FIG. 8B that is approximately the outer diameter OD5 FIG. 7B at the proximal end 210 of the tapered section 208 of the elongated body 202 and the outer diameter OD5 FIG. 7C at the distal end 209 of the proximal end 204 of the elongated body 202.

[0168] In one embodiment, after the sheath 224 has been assembled over the reduced diameter section 218 of the elongated body 202, the proximal end 226 of the sheath 224 is preferably abutted against the shoulder 211 at the proximal end of the elongated body, and the distal end 228 of the sheath 224 is preferably abutted against the shoulder 212 at the distal end of the elongated body 202. In one embodiment, a suture receiving hole 207 is formed in the proximal end 204 of the elongated body 202 for attaching an end of a suture to the proximal end of the composite suture needle.

[0169] Referring to FIG. 9B , in one embodiment, the sheath 224 can be secured to the reduced diameter section 218 of the elongated body 202 by applying heat to the sheath to cause the inner diameter of the sheath to shrink in size to tightly embrace or closely fit the outer surface of the reduced diameter section 218, thereby forming the composite suture needle 200 with a more resilient section. In one embodiment, the sheath 224 can be secured to the reduced diameter section 218 of the elongated body 202 by applying an adhesive within the space 238 between the outer surface of the reduced diameter section 218 and the inner surface of the sheath 224.

[0170] In one embodiment, the sheath 224 can be secured to the reduced diameter section 218 of the elongated body 202 by using a connecting material disposed within the space 238 between the outer surface of the reduced diameter section 218 and the inner surface of the sheath 224, whereby the connecting material is preferably weldable to both the material used to manufacture the elongated body 202 (e.g., stainless steel) and the material used to manufacture the sheath 224 (e.g., nitinol).

[0171] In one embodiment, the composite suture needle 200 preferably includes a reduced diameter section 218 and a sheath 224 covering the reduced diameter section. The length of the elongated body 202 covered by the sheath 224 preferably defines a more flexible region of the composite suture needle 200 that is designed to flex (e.g., flatten out) without plastically deforming when passing through a smaller cannula. As a result of the presence of the more flexible region formed by the combination of the reduced diameter section 218 and the highly elastic sheath 224, the elongated body 202 of the composite suture needle 200 will preferably return (e.g., spring back) to its normal semi-circular configuration after the composite suture needle 200 is removed from the end of the cannula (e.g., at the surgical site) so that the composite suture needle 200 can be used to suture tissue.

[0172] Referring to FIG. 10 In one embodiment, the composite suture needle 300 preferably includes an elongated body 302 (i.e., a core member) having a proximal end 304 and a distal end 306 having a tapered section 308 terminating at a sharp or pointed tip 316. The tapered section 308 preferably tapers inwardly to the sharp tip 316. The sharp tip 316 desirably defines a forward end of the elongated body 302 that is adapted to pierce tissue during a suturing operation.

[0173] In one embodiment, the elongated body 302 preferably defines an outer diameter OD7. In one embodiment, the elongated body 302 can be curved and / or can have a semi-circle or semi-circular shape. In one embodiment, the elongated body 302 is curved and preferably includes a concave surface 320 extending along the interior of the curve of the elongated body and a convex curved outer surface 322 extending along the exterior of the curve of the elongated body.

[0174] In one embodiment, the elongated body 302 can be made of a strong alloy such as stainless steel. In one embodiment, the stainless steel can include austenitic stainless steel (302SS) and martensitic aged (maraging) stainless steel (455SS).

[0175] Referring to FIG. 11A and FIG. 11B In one embodiment, the composite suture needle 300 preferably includes a sheath 324 made of a material having a higher level of elasticity than the material used to manufacture the elongated body 302 (i.e., the core member) of the composite suture needle. FIG. 10 In one embodiment, the sheath 324 can be made of a highly elastic material such as Nitinol. In one embodiment, the sheath 324 can have a sleeve, tubular or cylindrical shape. In one embodiment, the size, shape and / or configuration of the sheath 324 is preferably designed to fit over the elongated body 302 (i.e., the core member) of the composite suture needle. FIG. 10) to form a composite suture needle 300 that includes an elongated body that is relatively less elastic and a sheath 324 that is relatively more elastic than the material used to manufacture the elongated body.

[0176] In one embodiment, the sheath 324 preferably has a proximal end 326, a distal end 328 having a tapered outer surface 335, and a lumen 330 extending from the proximal end 326 to the distal end 328. Referring to FIG. 10 and FIG. 11A to FIG. 11B In one embodiment, the lumen 330 of the sheath 324 advantageously defines an inner diameter ID3 that is slightly larger than an outer diameter OD7 of the elongated body 302 ( FIG. 10 ). In one embodiment, the tapered outer surface 335 at the distal end 328 of the sheath 324 preferably approximates the outer surface of the tapered segment 308 at the distal end 306 of the elongated body 302 when the sheath 324 is assembled over the elongated body 302 to form the composite suture needle 300 to provide a smooth transition between the distal end 328 of the sheath 324 and the tapered segment 308 of the elongated body 302.

[0177] In one embodiment, the sheath preferably covers a majority of the length of the composite suture needle when the sheath is assembled with the elongated body. In one embodiment, the sheath can be formed around the elongated body and provided to a needle manufacturing facility as a pre-fabricated composite wire. The needle manufacturing facility can be used to grind the tip to expose the stainless steel of the elongated body. The proximal end of the elongated body can be drilled, laser drilled, and / or electropolished to create a suture receiving hole.

[0178] Referring to FIG. 12A and FIG. 12B In one embodiment, the composite suture needle 300 can be formed by assembling the sheath 324 over the elongated body 302 ( FIG. 10 ). In one embodiment, the tapered segment 335 at the distal end 328 of the sheath 324 preferably covers the tapered segment 308 at the distal end 306 of the elongated body 302. The inner diameter ID3 of the sheath 324 ( FIG. 11B ) is preferably slightly larger than the outer diameter OD7 of the elongated body 302 ( FIG. 10 ).

[0179] In one embodiment, the sharp tip 316 and the distal portion of the tapered segment 308 of the elongated body 302 preferably protrude beyond the tapered segment 335 at the distal end 328 of the sheath 324 after the sheath 324 has been assembled over the elongated body 302.

[0180] Referring to FIG. 12BIn one embodiment, the sheath 324 can be secured to the elongated body 302 by applying heat to the sheath to cause the inner diameter of the sheath to shrink in size to tightly embrace or closely fit the outer surface of the elongated body 302, thereby forming the composite suture needle 300 having a more elastic section. In one embodiment, the sheath 324 can be secured to the elongated body 302 by applying an adhesive within the space 338 located between the outer surface of the elongated body 302 and the inner surface of the sheath 324.

[0181] In one embodiment, the sheath 324 can be secured to the elongated body 302 by using a connecting material disposed within the space 338 located between the outer surface of the elongated body 302 and the inner surface of the sheath 324, whereby the connecting material is preferably weldable to both the material used to manufacture the elongated body 302 (e.g., stainless steel) and the material used to manufacture the sheath 324 (e.g., Nitinol).

[0182] In one embodiment, the composite suture needle 300 preferably includes the elongated body 302 and the sheath 324 covering the elongated body. The length of the elongated body 302 covered by the sheath 324 preferably defines a more elastic region of the composite suture needle 300 that is designed to flex (e.g., flatten out) without plastically deforming when passing through a smaller cannula. Due to the presence of the more elastic region formed by the combination of the elongated body 302 and the highly elastic sheath 324, the elongated body 302 of the composite suture needle 300 will preferably return (e.g., spring back) to its normal semi-circular configuration after the composite suture needle 300 is removed from the end of the cannula (e.g., at the surgical site) so that the composite suture needle 300 can be used to suture tissue.

[0183] In one embodiment, after the sheath 324 has been assembled over the elongated body 302, the proximal end 326 of the sheath 324 preferably extends proximally beyond the proximal end 304 of the elongated body 302 to define a suture attachment opening 334 at the proximal end of the composite suture needle 300. The suture attachment opening 334 is preferably surrounded by a swage region 336 of the sheath 324 that can be swaged or crimped for securing an end of a suture to the proximal end of the composite suture needle 300. In one embodiment, an end of a suture (not shown) can be inserted into the suture attachment opening 334 of the sheath 324 and the swage region 336 of the sheath 324 can be swaged so as to secure the end of the suture to the proximal end of the composite suture needle 300.

[0184] Reference FIG. 13AIn one embodiment, the composite suture needle 400 having a high-elasticity intermediate section 425 preferably includes an elongated body 402 having a proximal end 404 and a distal end 406. The elongated body 402 of the composite suture needle 400 can be curved and can have a semi-circular or semi-circular shape.

[0185] In one embodiment, the high-elasticity intermediate section 425 is configured as a high-elasticity region of the composite suture needle 400 to enable the composite suture needle to be straightened for passage through a smaller cannula and then return to its initial curved configuration for a suturing operation.

[0186] In one embodiment, the composite suture needle 400 advantageously includes a suture attachment barrel 408 proximate the proximal end 404 of the elongated body 402, and a suture attachment opening 410 formed in a proximal face of the suture attachment barrel 408. An end of a surgical suture (e.g., filamentary element, thread) can be inserted into the suture attachment opening 410, and the suture attachment barrel 408 can be swaged to secure the end of the surgical suture to the proximal end 404 of the elongated body 402 of the composite suture needle 400.

[0187] In one embodiment, the composite suture needle 400 preferably includes a tip 412, such as a sharp or pointed tip, that is integral with the distal end 406 of the elongated body 402 and advantageously defines a leading or distal-most end of the composite suture needle 400. The tip 412 is preferably sharpened for piercing tissue to facilitate passage of the distal end 406 of the elongated body 402 of the composite suture needle 400 through tissue during a suturing operation.

[0188] Reference is made to FIG. 13A and FIG. 13B In one embodiment, the elongated body 402 preferably has a proximal body section 420 having a distal end 422, a distal body section 424 having a proximal end 426, and a high-elasticity connector 428 interconnecting the distal end 422 of the proximal body section 420 and the proximal end 426 of the distal body section 424. The high-elasticity connector 428 can include a mechanical connection structure, such as a dovetail structure, for connecting the high-elasticity connector with the proximal body section 420 and the distal body section 424. In one embodiment, the high-elasticity connector 428 preferably has an outer diameter OD9 that substantially matches an outer diameter OD 10 substantially matches.

[0189] In one embodiment, the composite suture needle 400 preferably includes a high-elasticity connector 428 that preferably has a higher level of elasticity than the material used to manufacture the proximal body section 420 and the distal body section 424 of the elongated body 402 of the composite suture needle 400. In one embodiment, the high-elasticity connector 428 can be made of a high-elasticity material, such as Nitinol, and the elongated body 420 including the proximal body section 420 and the distal body section 424 can be made of stainless steel.

[0190] In one embodiment, the high-elasticity connector 428 at the intermediate section 425 of the composite suture needle 400 preferably defines a more elastic region of the elongated body 402 that is designed to flex without plastically deforming when passing through the cannula. As a result of the presence of the more elastic intermediate section 425 formed by the high-elasticity connector 428, the elongated body 402 of the composite suture needle 400 will advantageously return (e.g., spring back) to its normal semi-circular configuration after the composite suture needle 400 is removed from the end of the cannula (e.g., at the surgical site) so that the composite suture needle 400 can be used to suture tissue.

[0191] Reference is made to FIG. 14A In one embodiment, the composite suture needle 500 can have a structure similar to that shown and described above in the embodiments of FIG. 4A to FIG. 4D , FIG. 9A to FIG. 9B and / or FIG. 12A to FIG. 12B In one embodiment, the composite suture needle 500 preferably includes an elongated body that extends from a proximal end 506 having a suture attachment barrel 508 that defines the proximal-most end of the composite suture needle to a distal end 510 having a tapered region 512 with a sharp tip 514 that defines the distal-most end of the composite suture needle 500. In one embodiment, the suture needle 500 preferably includes a bendable or high-elasticity region 525 that preferably extends along a majority of the length of the elongated body.

[0192] Reference is made to FIG. 14B In this embodiment, the high-elasticity region 525 of the composite suture needle 500 preferably includes an elongated body 502 made of a less elastic material, such as stainless steel, and an outer sheath 530 surrounding the elongated body that is made of a more elastic material, such as Nitinol. In one embodiment, the outer surface of the composite suture needle 500 can have the appearance of a normal stainless steel needle.

[0193] In one embodiment, the needle shown and described above in FIG. 14A and FIG. 14B can be transitioned from a semi-circular shape or semi-circular configuration FIG. 14A to a curved configuration having a seagull shape. Reference is made to FIG. 15A andFIG. 15B In one embodiment, the composite suture needle 500 can be bent along the high-elasticity region 525 to provide a needle having a gull-wing configuration. In FIG. 15A and FIG. 15B the gull-wing configuration, the suture needle 500 preferably has a smaller height or lower profile than the suture needle in the unbent configuration shown and described above in FIG. 14A The high-elasticity region 525 is preferably more bendable and less rigid than the proximal end 506 and the distal end 510 of the composite suture needle 500. Thus, the proximal end 506 and the distal end 510 of the composite suture needle preferably maintain their original shape in both the unbent configuration FIG. 14A and the bent configuration FIG. 15A and FIG. 15B .

[0194] Referring to FIG. 16 in one embodiment, where the high-elasticity region 525 of the composite suture needle 500 is bent to place the suture needle 500 into the bent gull-wing configuration, the suture needle 500 can pass through the cannula 570. In FIG. 16 the bent composite suture needle 500 having the gull-wing configuration defines a height H5 that is less than the inner diameter ID4 of the lumen 572 of the cannula 570, such that the bent composite suture needle 500 can easily pass through the length of the cannula to reach the surgical site without damaging the needle or creating an unsafe condition for the patient.

[0195] Referring to FIG. 17A to FIG. 17C in one embodiment, the composite suture needle 600 having a configuration similar to that shown and described above in FIG. 4A to FIG. 4D , FIG. 9A to FIG. 9B and / or FIG. 12A to FIG. 12B may include an elongated body 602 having a proximal end 606 and a distal end 610 with a sharp tip 614. The composite suture needle 600 preferably includes a high-elasticity region 625 having a stainless steel core and a more elastic outer sheath, which enables the elongated body 602 to be bent such that the tip 614 is adjacent to the proximal end 606 of the elongated body.

[0196] In the bent configuration shown in FIG. 17A to FIG. 17C the composite suture needle 600 can pass through the cannula to reach the surgical site. Once the suture needle 600 has reached the surgical site, the surgeon can use a surgical tool to transform the bent suture needle into the unbent semi-circular configuration (e.g., the embodiment of FIG. 14A shown and described herein). Once the suturing operation has been completed at the surgical site, the surgeon can again bend the composite suture needle 600 at the high-elasticity region 625 to reduce the size of the needle for removal from the surgical site via the cannula.

[0197] In one embodiment, the elongate body of the elastic suture needle can have a bendable region disposed thereon that facilitates changing the shape and / or configuration of the suture needle to fit through a cannula (e.g., a 5 mm cannula), as disclosed in commonly-assigned U.S. Patent Application Serial No. 16 / 282,604, filed February 22, 2019, and U.S. Patent Application Serial No. 16 / 282,652, filed February 22, 2019, the disclosures of which are hereby incorporated by reference herein.

[0198] While the foregoing is directed to embodiments of the present application, other and further embodiments of the application can be devised without departing from the basic scope thereof, which is determined solely by the scope of the claims that follow. For example, the present application contemplates that any of the features shown in any embodiment described herein or incorporated by reference herein can be combined with any of the features shown in any other embodiment described herein or incorporated by reference herein, and still fall within the scope of the present application.

Claims

1. A composite suture needle, comprising: An elongated body having a proximal end and a distal end with a pointed tip; A sheath covering the elongated body to form a highly elastic region, wherein the sheath comprises a material more elastic than the elongated body, and wherein the pointed end extends distally beyond the distal end of the sheath. The composite suture needle is flexible along the highly elastic region to provide a gull-shaped configuration, and the proximal and distal ends of the elongated body retain their initial shape in both the unbent and bent configurations of the composite suture needle. The elongated body has a diameter-reducing section defining a first outer diameter, the distal end of the elongated body includes a tapered section having a proximal end, the proximal end includes a shoulder defining a second outer diameter, and the sheath has an outer surface defining a third outer diameter, the third outer diameter being approximately the second outer diameter of the shoulder at the proximal end of the tapered section of the elongated body.

2. The composite suture needle according to claim 1, wherein, The sheath comprises a highly elastic material, and the elongated body comprises stainless steel.

3. The composite suture needle according to claim 2, wherein, The highly elastic material includes nickel-titanium.

4. The composite suture needle according to claim 2, wherein, The stainless steel is selected from the group consisting of the following stainless steels: austenitic stainless steel and martensitic aging stainless steel.

5. The composite suture needle according to claim 1, wherein, The distal end of the elongated body defines a second outer diameter that is larger than the first outer diameter of the diameter-reducing section.

6. The composite suture needle according to claim 5, wherein, The tapered section has a distal end that includes the tip.

7. The composite suture needle according to claim 6, wherein, The sheath has a proximal end, a distal end, and a lumen extending from the proximal end to the distal end of the sheath, wherein the diameter-reducing section of the elongated body is disposed within the lumen of the sheath, and wherein the lumen of the sheath has an inner diameter greater than or equal to the first outer diameter of the diameter-reducing section of the elongated body.

8. The composite suture needle according to claim 1, wherein, The elongated body and the sheath are curved.

9. A composite suture needle, comprising: An elongated body having a curved proximal body section, a curved distal body section, and a curved intermediate section extending between the curved proximal body section and the curved distal body section; A sheath covering the curved intermediate section of the elongated body to form a highly elastic region, wherein the curved intermediate section of the elongated body comprises a first material, and the sheath comprises a second material that is more elastic than the first material of the curved intermediate section. The composite suture needle is capable of bending along the highly elastic region to provide a gull-shaped configuration, and the bent proximal body segment and the bent distal body segment of the elongated body retain their initial shape in both the unbent and bent configurations of the composite suture needle. The elongated body has a curved intermediate section with a first outer diameter, the distal end of the curved proximal body section and the proximal end of the curved distal body section define a second outer diameter, and the sheath has an outer surface defining a third outer diameter that approximates the second outer diameter.

10. The composite suture needle according to claim 9, wherein, The curved intermediate section and the sheath covering the curved intermediate section define a flexible region of the composite suture needle, which is more elastic than the curved proximal body section and the curved distal body section of the elongated body of the composite suture needle.

11. The composite suture needle according to claim 9, wherein, The curved middle section of the elongated body is made of stainless steel, and the sheath covering the curved middle section is made of nitinol.

12. The composite suture needle according to claim 9, wherein, The sheath has a proximal end, a distal end, and a lumen extending from the proximal end of the sheath to the distal end, wherein the curved intermediate section of the elongated body is disposed within the lumen of the sheath.

13. The composite suture needle according to claim 12, wherein, The lumen of the sheath has a first inner diameter that is greater than or equal to the first outer diameter of the curved intermediate section of the elongated body.

14. The composite suture needle according to claim 9, wherein, The proximal body segment of the elongated body includes a proximal end face and a suture receiving hole formed in the proximal end face, and wherein the curved distal body segment of the elongated body includes a tissue puncture point at its distal end.

15. The composite suture needle according to claim 9, wherein, The sheath is attached, glued, or welded to the curved middle section of the elongated body via a heat-shrink fitting process.

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