Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
  • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
  • B21G1/00—Making needles used for performing operations
  • B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
  • B21F—WORKING OR PROCESSING OF METAL WIRE
  • B21F1/00—Bending wire other than coiling; Straightening wire
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06066—Needles, e.g. needle tip configurations

Definitions

• This application relates to a surgical apparatus, and more particularly, to a curved surgical needle and an apparatus for and method of manufacturing the same.
• Surgical needle manufacture is an extremely precise and time consuming process, particularly where individual needles are formed one at a time.
• Some prior surgical needle manufacturing typically begins with the step of cutting round wire stock to a predetermined length. One end of the stock is then tapered to provide a cutting edge while the opposite end may be manipulated or processed to attain a flattened or other predetermined shape. Later, typically after almost all of the processing is completed, the stock is cut to its final length and then prepared for suture attachment. The needle may then be subjected to further processing, i.e., further refinement such as grinding, polishing and/or hardening.
• Curved needles have advantages over other needle configurations in many surgical procedures for a variety of reasons including, uniformity of entry depth for multiple sutures, and proper "bite" of tissue surrounding the incision or wound.
• a specified curvature i.e., a predetermined radius of curvature.
• the predetermined radius of curvature for the needle may vary with specific applications.
• Configuration of a needle includes curving or forming the needle into predetermined shapes and may be accomplished by using conventional curving methods.
• Such conventional curving methods may include bending a needle around an anvil structure having a desired curving surface to curve a needle to a predetermined radius of curvature.
• a curved needle is to have a bore for receiving a suture
• the anvil structure provides a shaping surface for deforming the needle.
• a needle is positioned for curving by manually placing the needle for engagement with an anvil structure.
• the needle may be held by hand or placed in a retention device which is manipulated manually.
• a needle curving device that is capable of simultaneously curving a multiplicity of needles.
• the needle curving device cooperates with a needle retention structure for positioning one or a multiplicity of needles for curving.
• the needle curving device substantially averts damaging needles and entertains substantially continuous needle curving.
• the needle curving device curves a multiplicity of needles in predetermined configurations.
• the present disclosure relates to a needle curving apparatus in which only one curving member is moved in a path with respect to at least two other curving members to effect curvature of the needles while the barrels of the needles remain substantially elongate.
• the present disclosure relates to a needle curving apparatus in which at least two curving members are moved in a path with respect to at least two other curving members to effect curvature of the needles while the barrels of the needles remain substantially elongate.
• the present disclosure relates to an apparatus for configuring a surgical needle such that the surgical needle has a barrel having a substantially elongate configuration and a point having a substantially curvilinear configuration.
• the apparatus includes: a first curving member having an axis of rotation; a second curving member having an axis of rotation and disposed adjacent to the first curving member and separated by a gap therefrom; and a third curving member having an axis of rotation and movably disposed in a path traversing the first and second curving members.
• the apparatus may further include a fourth curving member having an axis of rotation and that is movably disposed in the path traversing the first and second curving members.
• the fourth curving member moves concurrently with the third curving member in the path traversing the first and second curving members.
• the path of the third curving member may be orthogonal to the axes of rotation of the first and second curving members. Additionally, the path of the fourth curving member also may be orthogonal to the axes of rotation of the first and second curving members.
• the curving members may be configured such that when a surgical needle having a barrel and a point each of a substantially linear configuration is inserted into the gap between the first and second curving members, the second curving member can be moved toward the first curving member to impose a holding force on the barrel of the needle.
• the curving members may be configured such that the third curving member can be moved and, when applicable, the fourth curving member can be moved concurrently, in the path to cause curvature of the point of the needle by at least one of the first and second curving members.
• the curving members may be configured such that the curving members can be rotated around the respective axis of rotation to cause additional curvature of the point of the needle substantially without causing curvature of the barrel of the needle.
• the present disclosure relates also to the apparatus for configuring a surgical needle further including a curving belt disposed on the apparatus with respect to the curving members, the curving belt having an interior surface and an exterior surface and wherein the second and third curving members are disposed and movably positionable to contact the interior surface of the curving belt.
• the second curving member is disposed and movably positionable to enable the one or more needles to be contacted by the exterior surface of the curving belt.
• the second, third and fourth curving members are disposed and movably positionable to contact the interior surface of the curving belt. Additionally, in a similar manner, when the one or more surgical needles is inserted into the gap between the first and second curving members and the second curving member is imposing a holding force on the barrel of the one or more needles, the first curving member is disposed and movably positionable to enable the one or more needles to be contacted by the exterior surface of the curving belt.
• the present disclosure relates also to a method of manufacturing a surgical needle having a point with a substantially curvilinear configuration, wherein the method includes the steps of providing a needle curver apparatus, with the needle curver apparatus including a first curving member having an axis of rotation; a second curving member having an axis of rotation and disposed adjacent to the first curving member and separated by a gap therefrom; and a third curving member having an axis of rotation and movably disposed in a path traversing the first and second curving members.
• the method also includes the steps of inserting a substantially elongate surgical needle into the gap between the first and second curving members; and moving the second curving member toward the first curving member to impose a holding force on the barrel of the needle.
• the method may further include the step of moving the third curving member in the path with respect to the first and second curving members to cause curvature of the point of the needle.
• the method may be implemented wherein the needle curver apparatus further includes a fourth curving member having an axis of rotation and that is moveably disposed in the path traversing the first and second curving members. Additionally, the method may further include the step of moving the third and fourth curving members in the path concurrently with respect to the first and second curving members to cause curvature of the point of the needle.
• the method may also include the step of rotating the curving members around the respective axis of rotation to cause additional curvature of the point of the needle substantially without causing curvature of the barrel of the needle.
• the present disclosure relates also to the method of manufacturing a surgical needle that further includes the steps of providing a curving belt disposed on the apparatus with respect to the curving members, the curving belt having an interior surface and an exterior surface, and disposing and movably positioning the second and third curving members to contact the interior surface of the curving belt.
• the first curving member is disposed and movably positionable to enable the one or more needles to be contacted by the exterior surface of the curving belt.
• the method includes the steps of disposing and movably positioning the second, third and fourth curving members to contact the interior surface of the curving belt. Additionally, in a similar manner, when the one or more surgical needles is inserted into the gap between the first and second curving members and the second curving member is imposing a holding force on the barrel of the at least one needle, the first curving member is disposed and movably positionable to enable the one or more needles to be contacted by the exterior surface of the curving belt.
• FIG. 1 is a perspective view of a curved surgical needle in a configuration before being formed by a needle curving apparatus according to the present disclosure
• FIG. 2 is a perspective view of a curved surgical needle in a configuration after being formed by the needle curving apparatus according to the present disclosure
• FIG. 3 is a perspective view of one embodiment of a needle curving apparatus according to the present disclosure showing a curving belt of the apparatus and a bearing region in contact with the belt where the needle curving occurs;
• FIG. 4 is an enlarged perspective view of the needle curving apparatus of FIG. 3 with a cutaway view of the curving belt and the bearing region in contact with the belt where the needle curving occurs;
• FIG. 5 is an enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 4 where the needle curving occurs prior to loading a set of needles to be curved;
• FIG. 6 is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 5 where the needle curving occurs illustrating a set of needles that have been loaded onto a curving tool;
• FIG. 7 A is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 5 where the needle curving occurs illustrating engagement of the set of needles between a handle roller and the curving tool;
• FIG. 7B is a simplified side elevation view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 7 A where the needle curving occurs illustrating engagement of the set of needles between a handle roller and the curving tooi;
• FIG. 8 A is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 5 where the needle curving occurs illustrating partial curving of the needles;
• FIG. 8B is a partial view from an alternate direction of the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 8 A where the needle curving occurs illustrating partial curving of the needles;
• FIG. 9 is the enlarged perspective view of the cutaway view of the bearing region in contact the with belt of the needle curving apparatus of FIG. 5 where the needle curving occurs illustrating complete curving of the needles.
• FIG. 10 is an end view of one embodiment of a needle curving apparatus according to the present disclosure during the step of loading the needles into the needle curving apparatus prior to curving the needles;
• FIG. 11 is a side elevation view of the needle curving apparatus of FIG. 10 during the step of curving the needles;
• FIG. 12 is a plan view of the needle curving apparatus of FIG. 11;
• FIG. 13 is a cross-sectional side elevation view of the needle curving apparatus taken along section line 13-13 of FIG. 12;
• FIG. 14 is a cross-sectional front elevation view of the needle curving apparatus taken along section line 14-14 of FIG. 13;
• FIG. 15 is a perspective view of the lower portion of the needle curving apparatus as viewed from a side during the step of loading the needles;
• FIG. 16 is a simplified side elevation view of the primary mobile members of the needle curving apparatus during the step of loading a curving tool on the needles;
• FIG. 17 is a perspective view of the lower portion of the needle curving apparatus as viewed from the front during the step of lowering the curving tool on the needles;
• FIG. 18 is a simplified side elevation view of the primary mobile members of the needle curving apparatus during the step of lowering the curving tool on the needles;
• FIG. 19 is a perspective view of the lower portion of the needle curving apparatus as viewed from a side during a step of lowering the curving tool on the needles;
• FIG. 20 is a perspective view of the lower portion of the needle curving apparatus during an initial portion of a step of lowering the curving tool on the needles to begin the curvature process;
• FIG. 21 is a perspective view of the lower portion of the needle curving apparatus during the step of lowering the curving tool on the needles to begin the curvature process;
• FIG. 22 is a perspective view of the lower portion of the needle curving apparatus as viewed from the rear during the initial portion of the step of curving the needles;
• FIG. 23 is a simplified end view of the primary mobile members of the needle curving apparatus during the initial portion of the step of curving the needles;
• FIG. 24 is a perspective view of the lower front portion of the needle curving apparatus just before the needles are completely curved;
• FIG. 25 is a perspective view of the lower front portion of the needle curving apparatus after the needles have been completely curved;
• FIG. 26 is a simplified end view of the primary mobile members of the needle curving apparatus after the needles have been completely curved;
• FIG. 27 is an enlarged perspective view of an alternate embodiment of the needle curving apparatus of FIG. 3 with a cutaway view of the curving belt and the bearing region in contact with the belt where the needle curving occurs;
• FIG. 28 is an enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 27 where the needle curving occurs prior to loading a set of needles to be curved;
• FIG. 29 is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 28 where the needle curving occurs illustrating a set of needles that have been loaded onto a curving tool;
• FIG. 3OA is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 28 where the needle curving occurs illustrating engagement of the set of needles between a handle roller and the curving tool;
• FIG. 3OB is a simplified side elevation view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 30A where the needle curving occurs illustrating engagement of the set of needles between a handle roller and the curving tool
• FIG. 3 IA is the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 28 where the needle curving occurs illustrating partial curving of the needles due to partial translational movement of the curving rollers;
• FIG. 3 IB is a partial view from an alternate direction of the enlarged perspective view of the cutaway view of the bearing region in contact with the belt of the needle curving apparatus of FIG. 31 A where the needle curving occurs illustrating partial curving of the needles due to partial translational movement of the curving rollers;
• FIG. 32 is a simplified end view of the primary mobile members of the needle curving apparatus of FIG. 27 illustrating complete translational movement of the curving rollers before final curving of the needles;
• FIG. 33 is a simplified end view of the primary mobile members of the needle curving apparatus of FIG. 27 illustrating complete curving of the needles due to rotational movement of the primary mobile members.
• proximal as is traditional, will refer to the end of the apparatus which is closest to the operator, while the term distal will refer to the end of the apparatus which is furthest from the operator.
• FIG. 1 illustrates a surgical needle 10 in a configuration prior to being formed by a needle curving apparatus configured to implement the manufacturing method of the present disclosure. More particularly, surgical needle 10 has a proximal end portion 12a and a distal end portion 12b. A substantially elongate barrel 14 is disposed at the proximal end portion 12a. The barrel 14 has an end forming a proximal end 12a' of the needle 10. A point 16 is disposed at the distal end portion 12b. The point 16 has a tip forming a distal end 12b' of the distal end portion 12b of the needle 10. The point 16 extends from the barrel 14 initially to form a substantially elongate configuration extending from the barrel 14.
• FIG. 2 illustrates the surgical needle 10 in a curved configuration, now designated as surgical needle 10', after being formed by the needle curving apparatus according to the present disclosure. More particularly, the point 16' now has a substantially curvilinear configuration such that a transition point 12c is formed where the curved needle point 16' extends from the substantially elongate barrel 14. The surgical needle 10' is now configured such that a setting of the point 16' is independent of a setting of the barrel 14.
• needle curving apparatus 100 for configuring a surgical needle according to the present disclosure. More particularly, needle curving apparatus 100 is configured to convert the substantially elongate surgical needle 10 into the surgical needle 10' having the barrel 14 with a substantially linear configuration and point 16' having a substantially curvilinear configuration, as illustrated in FIGS. 1-2.
• the needle curving apparatus 100 includes a base or platform member 102, illustrated by way of example as a bottom plate, and an upper adjustment assembly 104.
• the upper adjustment assembly 104 includes an upper bearing region 152 and a rear bearing region 156.
• the base or platform member 102 supports or interfaces with secondary motive components and mechanisms 110 that are configured in such a manner to effect motion of primary motive components 120 by operatively communicating via a flexible, closed loop continuous or ribbon curving belt 125 of the needle curving apparatus 100, to result in the needles 10 being formed in the curved configuration designated as surgical needles 10' after being manipulated or processed by the primary motive components 120 in a bearing region 152 having bearing members in contact with the curving belt 125 where the needle curving occurs.
• the curving belt 125 includes an interior surface 125' and an opposing exterior surface 125" that are separated by the thickness g of the curving belt 125. More particularly, referring to FIG.
• the needle curving apparatus 100 is configured such that the upper bearing region 154, the rear bearing region 156, and the bearing region 152, each including bearing members in contact with the interior surface 125' of the curving belt 125, are positioned on the upper adjustment assembly 104 to provide to the curving belt 125 a generally vertical, triangular configuration with a first portion 150a of the curving belt 125 extending from the upper bearing region 154 to the region 152 where the needle curving occurs; a second portion 150b extending from the region 152 to the rear bearing region 156; and a third portion 150c extending from the rear bearing region 156 to the upper bearing region 154.
• the upper bearing region 154 may include a curving belt tensioning member 154a that in one embodiment is a cylindrically shaped roller bearing.
• the curving belt tensioning member 154a is in contact with the interior surface 125' of the curving belt 125 and is movable with respect to the needle curving apparatus 100 via a motive means, e.g., a pneumatic jack 155, that is operably connected to the belt tensioning member 154.
• a motive means e.g., a pneumatic jack 155
• Increased pressure on the interior surface 125' effected by movement (e.g., upward movement) of the curving belt tensioning member 154a, via the jack 155, causes an increase in tension of the curving belt 125.
• the rear bearing region 156 may include a bearing member 156a that in one embodiment is also a cylindrically shaped roller bearing.
• the bearing member 156a is also in contact with the interior surface 125' of the curving belt 125 and is rotatably driven by a drive motor 140.
• the bearing member 156a is also generally maintained in a fixed position with respect to the needle curving apparatus 100.
• bearing member 152a that in one embodiment is also a cylindrically shaped roller bearing.
• the rotatable bearing member 152a also is in contact with the interior surface 125' of the curving belt 125 and is generally maintained in a fixed position with respect to the needle curving apparatus 100.
• the bearing region 152 also includes a rotatable curving member or curving roller 186 in proximity to and flanked by the fixed rotatable bearing member 152a.
• the rotatable curving member or curving roller 186 has an external rolling surface 186a that is in contact with the interior surface 125' of the curving belt 125.
• the bearing region 152 also includes another rotatable curving member or handle roller 192 flanking the rotatable curving roller 186 generally on an opposite side of the curving roller 186 with respect to the fixed bearing member 152a.
• the handle roller 192 has an external rolling smface 192a that is in contact with the interior surface 125' of the curving belt 125.
• the curving roller 186 and the handle roller 192 are configured on the upper adjustment assembly 104 so that the curving roller 186 may be moved or slid independently in the vertical direction in a path P past the handle roller 192.
• the base or platform member 102 may include a drive motor 170 that is configured and positioned to rotatably drive and adjust the position of a curving member or rotatable curving tool 190.
• the curving tool 190 may be in the form of a roller having an external rolling surface 190a that is in vertical registration with the handle roller 192.
• the curving tool 190 is maintained in a fixed position with respect to the base or platform member 102.
• the external rolling surface 190a of the curving tool 190 may include a plurality of grooves or channels 188 circumferentially formed around the external surface 190a. As explained in more detail below, the plurality of grooves or channels 188 are configured to receive the surgical needles 10 in the configuration prior to the curving process.
• first and second guide rollers 158 and 160 that are also positioned on the upper adjustment assembly 104 to guide the curving belt 125.
• first and second guide rollers 158 and 160 may also be cylindrically shaped roller bearings having external surfaces 158a and 160a, respectively.
• the external surface 158a of the first guide roller 158 is in contact with the interior surface 125' of the curving belt 125 while the external surface 160a of the second guide roller 160 is in contact with the exterior surface 125" of the curving belt 125.
• the rotation of the bearing member 156a by the drive motor 140 drives the curving belt 125 around the first and second guide rollers 158 and 160, respectively, around the curving belt tensioning member 154 and around the fixed bearing member 152a, the curving roller 186 and the handle roller 192.
• the handle roller 192 and the curving tool 190 are in vertical registration with respect to each other. As best illustrated in FIG. 7B, the curving tool 190 has a diameter d while the handle roller 192 has a diameter d'.
• the magnitude of diameter d' is dependent upon the length and size of the surgical needle 10 in the configuration prior to the curving process and/or the length and size of the surgical needle 10' in the configuration after the curving process.
• the curving roller 186 has a diameter D that is greater than the diameter d of the curving tool 190 and that may be greater than the diameter d' of the handle roller 192.
• the diameters d and d' are illustrated as being equal by way of illustration only but the diameters d and d ' may differ.
• the upper adjustment assembly 104 enables vertical movement of both the handle roller 192 and the curving roller 186 such that the curving tool or first curving member 190 and the handle roller or second curving member 192 may be separated by a gap that is determined by the thickness g of the curving belt 125.
• the curving roller or third curving member 186 can be slid in path P so as to be slidably disposed in the path P traversing the curving tool or first curving member 190 and the handle roller or second curving member 192.
• the centerline axis of rotation of the curving roller 186 and the centerline axis of rotation of the curving tool 190 are thus laterally separated by a distance X that can be adjusted to be substantially equal to the radius d/2 of the curving tool 190 plus the thickness g of the curving belt 125 plus the radius D/2 of the curving roller 186 or X substantially equals d/2 + g + D/2.
• the gap between the handle roller or second curving member 192 and the curving roller or third curving member 186 is greater than the thickness g of the curving belt 125.
• the operation of the needle curving apparatus 100 and a corresponding method of manufacturing the surgical needle 100 are herein described. More particularly, in the first step of operation, the lateral distance AT between the centerline axis of rotation of the curving roller 186 and the centerline axis of rotation of the handle roller 192 is adjusted according to the diameter d of the curving tool 190. As explained above with respect to FIG. 7B, the distance X may be adjusted such that the distance X equals d/2 + g + D/2. In the initial configuration of the needle curving apparatus 100, the external surface 192a of the handle roller 192 and the external surface 190a of the curving tool 190 are separated at their closest point therebetween by a vertical gap or distance Y (see FIG. 5).
• the barrels 14 of set 18 of the surgical needles 10 prior to the curving process are inserted into the grooves or channels 188 circumferentially formed around the external surface 190a of the curving tool 190.
• a set 18 of surgical needles 10 are illustrated in FIG. 6 as being loaded or inserted into the grooves or channels 188, only one needle 10 may be so loaded or inserted to be subjected to the curving process.
• the set 18 of needles 10 may be inserted into the grooves or channels 188 at a position on the external surface 190a that is closest to the external surface 192a of the handle roller 192.
• an arm that clamps or retains a set of needles together uniformly at the barrels inserts the barrels 14 into the channels 188 and then releases the barrels 14 after the insertion.
• the needles 10 are individually inserted into the individual grooves or channels 188 so as to minimize any undesired deformation of the needle 10.
• the curving tool 190, the handle roller 192, and the curving roller 186, as well as the fixed rotatable bearing member 152a remain in the position adjusted to during the first step described above.
• the upper adjustment assembly 114 is adjusted in the vertical direction such that the handle roller 192 and the curving roller 186 are moved down vertically towards the curving tool 190 to cause the exterior surface 125" of the curving belt 125 to contact the set 18 of needles 10 that have been inserted into the grooves or channels 188 of the curving tool 190.
• the gap or distance Y between the handle roller 192 and the curving tool 190 becomes substantially equal to the thickness g of the curving belt 125 now disposed therebetween, and a retention force is imposed by the handle roller 192, the curving belt 125, and the curving tool 190 on the barrels 14 of the needles 10.
• the first curving member or curving tool 190 is now disposed adjacent to the second curving member or handle roller 192.
• the path P of the third curving member 186 is orthogonal to the axes of rotation of the first and second curving members 190 and 192, respectively. It can be seen that the retention force is sufficient to hold the needles 10 in place without causing undesired deformation.
• the curving tool or third curving member 186 is further slid in the path P traversing the first and second curving members, i.e., the curving tool 190 and the handle roller 192, thereby forcing a portion of the curving belt 125 in contact with at least one needle of the set 18 of needles 10, or the entire set 18, into a vertical position to cause, in turn, a 90 degree arc of curvature between the proximal ends 12a' and the distal ends 12b' of the needles 10.
• the position of the handle roller 192 remains in the same position as in the third step of operation, i.e., the second curving member or handle roller 192 remains disposed adjacent to the first curving member or curving tool 190 in vertical registration therewith.
• the curving belt 125 is disposed on the needle curving apparatus 100 with respect to the curving members 190, 192 and 186 in such a manner that the interior surface 125' and the exterior surface 125 "of the curving belt 125 and the second and third curving members 192 and 186 are disposed and movably positionable to contact the interior surface 125' and the first curving member 190 is disposed and movably positionable to enable at least one needle 10 of the set 18 to be contacted by the exterior surface 125" of the curving belt 125.
• the first curving member 190 is rotated in the direction of arrow A, to jointly rotate the third curving member 186, in the direction of the arrow C, and the second curving member 192 in the direction of the arrow B, to initiate and complete the process of curving the needle 10 into the needle 10' having a point with a curvilinear configuration (see FIGS. 1 and 2).
• the fixed rotatable bearing member 152a is also rotated in the direction of arrow D by the curving belt 125.
• the second curving member or handle roller 192 and the third curving member or curving roller 186 are also rotated in the direction of arrows C and B, respectively so that the needle curving process is completed such that the surgical needles 10 are converted into the surgical needles 10' having a curvilinear point 16' and an elongate barrel 14. Operation of the drive motors 140 and 170 is synchronized with respect to each other.
• the needle 10' or set 18 of converted needles 10' is removed from the grooves or channels 188 of the curving tool 190.
• needle curving apparatus 200 is configured also to convert the substantially elongate surgical needle 10 into the surgical needle 10' having the barrel 14 with a substantially linear configuration and point 16' having a substantially curvilinear configuration, as illustrated in FIGS. 1-2.
• the needle curving apparatus 200 includes a base member 202, illustrated by way of example as a bottom plate, and an upper member 204.
• the upper member 204 is supported on the base member 202 by a front adjustment assembly 210 and a rear adjustment assembly 230.
• the front adjustment assembly 210 includes a support shaft 212 that extends through a lower front support member 214 mounted on the base member 202 and an upper front support member 216 through an aperture 218 in the upper member 204.
• the support shaft 212 is enclosed within an outer column 220 that extends from an upper surface 217 of the upper front support member 216 to a lower surface 204a of the upper member 204.
• the outer column 220 includes a flared end 222 configured in a pedestal-type arrangement resting on the upper surface 217 of the upper front support member 216.
• FIG. 220 Another end of the column 220 includes a first tightening member 224, e.g., an adjustable nut having a substantially flat surface interfacing with the lower surface 204a of the upper member 204.
• the support shaft 212 extends through the aperture 218 in the upper member 204 to an upper surface 204b of the upper member 204, where vertical movement of the support shaft 212 with respect to the aperture 218 is limited by a second tightening member 226, e.g., an adjustable nut having a substantially flat surface interfacing with the upper surface 204b of the upper member 204.
• the front support members 214 and 216 are configured to slidably move along the support shaft 212, as shown by way of example in a vertical direction in FIGS. 10-11
• the upper member 204 is also supported on the base member 202 by the rear adjustment assembly 230.
• the rear adjustment assembly 230 extends from the base member 202.
• the rear adjustment assembly 230 includes, in one embodiment, a first support shaft 232 and a second support shaft 234 that are parallel to each other and mounted perpendicularly to the base member 202 and support a lower rear adjustment support member 236 thereupon.
• the lower rear adjustment support member 236 includes first and second apertures 238 and 240 that are disposed therein to coincide with the positions of the first and second support shafts 232 and 234, respectively.
• the first and second support shafts 232 and 234, respectively, are each configured in a hollow configuration having a hollow interior region.
• the rear adjustment assembly 230 further includes an upper rear support member 242 disposed above the lower support member 236.
• the upper support member 242 includes first and second apertures 244 and 246, respectively, that are disposed therein to coincide with the positions of the first and second apertures 238 and 240, respectively, of the lower support member 236, so as to enable reception of a first and a second adjustment column 248 and 250, respectively, therein.
• the first and second adjustment columns 248 and 250 include first and second lower tightening members 252 and 254, respectively, e.g., adjustable nuts, having a surface interfacing with an upper surface 237 of the lower support member 236 and include first and second upper tightening members 256 and 258, respectively, e.g., adjustable nuts, having a surface interfacing with a lower surface 242a of the upper support member 242.
• the rear adjustment assembly 230 further includes third and fourth support shafts 260 and 262, respectively, having one end 264 and 266, respectively, that extends partially through the hollow interior of the first and second support shafts 232 and 234, respectively, and another end 268 and 270, respectively, that extends through the first and second apertures 244 and 246, respectively, of the upper support member 242.
• the rear support members 236 and 242 are thus configured to slidably move along the third and fourth support shafts 260 and 262, respectively, as shown by way of example in a vertical direction in FIGS. 11-15.
• the first and second lower tightening members 252, 254, and the first and second upper tightening members 256, 258 may be employed to limit the motion of the upper and lower support members 236 and 242, respectively, with respect to each other by tightening on the third and fourth support shafts 260 and 262, respectively, at a desired position thereof.
• the front adjustment assembly 210 and the rear adjustment assembly 230 are further disposed in an interfacing relationship with each other to effect the curving of a plurality of the surgical needles 10'. More particularly, as best shown in FIGS. 11, 13 and 14, in one embodiment, the upper support member 242 of the rear adjustment assembly 230 may include a tensioning member support projection 280 that rotatably supports a rotatable tensioning member 282, e.g., a roller, having an external rolling surface 282a, and that is disposed in interfacing relationship with the front adjustment assembly 210.
• a tensioning member support projection 280 that rotatably supports a rotatable tensioning member 282, e.g., a roller, having an external rolling surface 282a, and that is disposed in interfacing relationship with the front adjustment assembly 210.
• the lower support member 236 of the rear adjustment assembly 230 may include a curving tool support projection 284 that rotatably supports a rotatable curving tool 286, e.g., a roller, having an external rolling surface 286a, and that is also disposed in interfacing relationship with the front adjustment assembly 210.
• a curving tool support projection 284 that rotatably supports a rotatable curving tool 286, e.g., a roller, having an external rolling surface 286a, and that is also disposed in interfacing relationship with the front adjustment assembly 210.
• the lower support member 214 of the front adjustment assembly 210 may include a first rotatable curving member 290, e.g., a roller or bending member, having an external rolling surface 290a, and rotatably supported by the lower support member 214 and disposed in interfacing relationship with the rear adjustment assembly 230.
• the first rotatable curving member 290 includes a rotating drive power receiver 294, e.g., a lug disposed at one end of the roller and configured to engage a drive member (not shown) such as a socket or open-end wrench to enable rotation of the first curving member 290.
• the first rotatable curving member 290 may include a plurality of grooves or channels 288 circumferentially formed around the external surface 290a. As explained in more detail below, the plurality of grooves or channels 288 are configured to receive the surgical needles 10 in the configuration prior to the curving process.
• the upper support member 216 of the front adjustment assembly 210 may include a second rotatable curving member 292, e.g., a roller, having an external rolling surface 292a, and is rotatably supported by the upper support member 216 and disposed in interfacing relationship with the rear adjustment assembly 230.
• a second rotatable curving member 292 e.g., a roller, having an external rolling surface 292a, and is rotatably supported by the upper support member 216 and disposed in interfacing relationship with the rear adjustment assembly 230.
• the rotatable bending member 286 may be considered as an example of a third rotatable curving member.
• the rotatable tensioning member 282, the first rotatable curving or bending member 290, the second rotatable curving member or curving roller 292, and the third rotatable curving member or curving tool 286 are thus configured to enable interconnection therebetween via a flexible closed-loop ribbon drive belt 225.
• the closed-loop drive belt 225 includes an internal surface 225' and an external surface 225" and is configured such that the internal surface 225' contacts the external surface 282a of the tensioning member 282, the external surface 286a of the third rotatable curving member 286, and the external surface 292a of the second rotatable curving member 292, while the external surface 225" contacts the external surface 290a of the first rotatable curving member 290.
• the lower support member 214 and the upper support member 216 of the front adjustment assembly 210 are configured with an opening region 227, in interfacing relationship with the rear adjustment assembly 230, that enables free rotation of the drive belt 225.
• the lower support member 236 and the upper support member 242 of the rear adjustment assembly 230 are also configured with an opening region 229, in interfacing relationship with the front adjustment assembly 210, that enables free rotation of the drive belt 225.
• the upper member 204 includes a large aperture and adjacent small apertures or slots through which bolts 132, 134 extend.
• the upper front support member 216 and the upper rear support member 242 are slidably moved along their respective support shafts. More particularly, the tightening members 224 and 226 are untightened to allow the upper front support member 216 to raise the second rotatable curving member 292 away from the first rotatable curving member 290. Similarly, the tightening members 252, 254, 256 and 258 are untightened to allow the upper rear support member 242 to raise the third rotatable curving member 286 also away from the first rotatable curving member 290.
• the tension on the drive belt 225 is slackened and the needles 10 may be loaded by holding the individual needles 10 at the point 16, and lowering the third curving member 286.
• a gap g* is formed between the first and second curving members 290 and 292, respectively.
• the barrel 14 of the needle 10 is inserted into the gap g' so that the third curving member 286
• the holding force is sufficient to hold the needles 10 in place without causing undesired deformation.
• third curving member 286 can be moved laterally with respect to first rotatable curving member 290 to facilitate setup of the needle curving system.
• the diameter of rotatable curving member 290 may be chosen to achieve a particular finished needle radius and the lateral position of curving member 286 may be laterally adjusted to account for the diameter of curving member 290 to provide close interaction between curving member 286 and curving member 290.
• FIGS. 20-21 it can be seen that the first and second curving members 290 and 292, respectively, and the third curving member 286 are now configured with respect to each other such that the third curving member 286 can be further slid in the path P' with respect to the first and second curving members 290 and
• the needles 10 are individually inserted into the individual grooves or channels 288 circumferentially formed around the external surface 290a of the first curving member 290 so as to minimize any undesired deformation of the needle 10.
• the first curving member 290 is rotated in the direction of arrow A ', to jointly rotate the third curving member 286, in the direction of the arrow C, and the second curving member 292 in the direction of the arrow B ⁇ to initiate and complete the process of curving the needle 10 into the needle 10' having a point with a curvilinear configuration (see FIGS. 23 and 26).
• the surgical needles 10 are converted into the surgical needles 10' having a curvilinear point 16' and an elongate barrel 14.
• FIGS. 27-33 illustrate an alternate embodiment of the needle curving apparatus 100 of FIGS. 4-9. More particularly, needle curving apparatus 300 illustrated in FIGS. 27-33 is identical to the needle curving apparatus 100 except that needle curving apparatus 300 further includes a fourth rotatable curving member or curving roller 186' having an axis of rotation. Needle curving apparatus 300 will not be discussed in detail except to the extent necessary to describe differences or similarities with respect to the needle curving apparatus 100.
• the fourth curving member 186' is also disposed in proximity to and flanked by the fixed bearing member 152a.
• the rotatable curving member or curving roller 186' has an external rolling surface 186a'. As illustrated in FIGS. 28-3 IB, initially, the external rolling surface 186a' does not make contact with the interior surface 125' of the curving belt 125.
• the fourth curving member 186' is movably disposed in the path P traversing the first and second curving members 190 and 192, respectively.
• the fourth curving member 186' is in vertical registration with respect to the third curving member 186, and the third and fourth curving members 186 and 186', respectively, are separated at their closest point of approach by a region 386 therebetween.
• the curving belt 125 i.e., as illustrated in FIG. 33 wherein third curving member 186 rotates in the direction of arrow C and fourth curving member 186' rotates in the direction of arrow E, there is no contact between the third and fourth curving members 186 and 186', respectively, and the gap region 386 is maintained during operation of the needle curving apparatus 300.
• curvature of the needles 18 is initially effected by translational movement in the path P of both the third and fourth curving members 186 and 186', respectively, such that third curving member 186 moves into a position at the same elevation as, and adjacent to, first curving member 190.
• such translational movement exerts pressure on the set of needles 18 such that the handle roller 192 and the curving roller 186 are moved down vertically towards the curving tool 190 to cause the exterior surface 125" of the curving belt 125 to contact the set of needles 18 that have been inserted into the grooves or channels 188 of the curving tool 190.
• the gap or distance Y between the handle roller 192 and the curving tool 190 becomes substantially equal to the thickness g of the curving belt 125 now disposed therebetween, and a retention force is imposed by the handle roller 192, the curving belt 125, and the curving tool 190 on the barrels 14 of the needles 10.
• the third and fourth curving members 186 and 186' are further slid down in path P traversing the first and second curving members, i.e., the curving tool 190 and the handle roller 192, thereby forcing a portion of the curving belt 125 in contact with at least one needle of the set 18 of needles 10, or the entire set 18, into a vertical position to cause, in turn, a 90 degree arc of curvature between the proximal ends 12a' and the distal ends 12b' of the needles 10.
• both the third and fourth curving members 186 and 186', respectively, are now slid down further in path P so that the fourth curving member 186' is now at substantially the same elevation as the first curving member 190, to establish the position of the curving members 190, 192, 186 and 186' prior to rotation thereof and subsequent curvature of the point 16 of the needles 10.
• the path P of the fourth curving member 186' is orthogonal to the axes of rotation of the first and second curving members 190 and 192, respectively.
• the first, second, third and fourth curving members 190, 192, 186 and 186' can be moved in the path P to cause curvature of the point 16' of the needle 10'.
• the curving belt 125 is disposed on the needle curving apparatus 100 with respect to the curving members 190, 192, 186 and 186' and has the interior surface 125' and the exterior surface 125" such that the second, third and fourth curving members 192, 186 and 186' are disposed and movably positionable to contact the interior surface 125' and the first curving member 190 is disposed and movably positionable to enable at least one needle 10 of the set 18 to be contacted by the exterior surface 125" of the curving belt 125.
• the present disclosure also relates to a method of manufacturing the surgical needle 10' having the point 16' with a substantially curvilinear configuration.
• the method includes the step of providing the needle curving apparatus 100, 200 or 300, as described above.
• the method includes the step of inserting a substantially elongate surgical needle having a barrel and a point, e.g., needle 10 having barrel 14 and point 16, into the gap g or g ' between the first and second curving members 190, 290 and 192, 292, respectively.
• the method also includes the step of moving or sliding the third curving member 186 or 286 in the path P or P' with respect to the first and second curving members 190, 290 and 192, 292, respectively, to impose a holding force on the barrel 14 of the needle 10 (see FIGS. 7 A and 7B, or 16 and 18, or 30A and 30B, respectively).
• the method includes the step of concurrently moving or sliding both third curving member 186 and the fourth curving member 186' in the path P with respect to the first and second curving members 190, 290 and 192, 292, respectively, to cause curvature of the point 16' of the needle 10' (see FIGS. 30A and 30B).
• the method may include the steps of further sliding or moving the third curving member 186 or 286 in the path P or P' to cause curvature of the point 16 of the needle 10 by at least one the first and second curving members 190, 290 and 192, 292, respectively, and of rotating the first and second curving members 190, 290 and 192, 292, respectively, and the third curving member 186, 286 around the respective axis of rotation, the first curving member 190, 290 rotating in the direction of arrow A or A ', the second curving member 192, 292 rotating in the direction of arrow B or B ', and the third curving member 186, 286 rotating in the direction of arrow Cor C, respectively, to cause additional curvature of the point of the needle substantially without causing curvature of the barrel of the needle (see FIGS.
• the method may include the steps of further moving or sliding concurrently the third curving member 186 and the fourth curving member 186' in the path P to cause curvature of the point 16 of the needle lO by at least one of the first and second curving members 190 and 192, respectively, and of rotating the first and second curving members 190 and 192, respectively, and concurrently the third curving member 186 and the fourth curving member 186' around the respective axis of rotation, the first curving member 190 rotating in the direction of arrow A, the second curving member 192 rotating in the direction of arrow B, the third curving member 186 rotating in the direction of arrow C , and the fourth curving member 186' rotating in the direction of arrow E, and assisted by the rotation of the fixed rotatable bearing member 152a in the direction of arrow D, to cause additional curvature of the point of the needle substantially without causing curvature of the barrel of the needle (
• a surgical needle with the advantage of a curved point in which it is possible to have a setting of the point which is independent of the barrel. Furthermore, the barrel of the needle is protected from being curved with the point of the needle, and thus remains in an elongate configuration.
• the embodiments of the present disclosure provide also a needle curving apparatus in which only one curving member is moved in a path with respect to at least two other curving members to effect curvature of the needles while the barrel of the needles remains elongate.

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• 2008
  • 2008-04-22 US US12/524,066 patent/US20100043515A1/en not_active Abandoned
  • 2008-04-22 WO PCT/US2008/061101 patent/WO2008134295A1/en active Application Filing
  • 2008-04-22 EP EP08746508A patent/EP2152449A1/de not_active Withdrawn

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