Claims:What is claimed is:

1. A suture-needle apparatus, comprising:

a suture material, a suture needle, a heat shrink tube, a polymer tube, an underlying layer disposed adjacent to said polymer tube, and a custom soldering block,
wherein said suture material and said suture needle configured to swage to a ratio of an outer diameter of said suture needle and an outer diameter of said suture material by said heat shrink tube and said underlying layer disposed adjacent to said polymer tube to provide a swaged suture needle, wherein said ratio is the ratio of said outer diameter of said suture needle is equal to said outer diameter of said suture material, wherein said heat shrink tube comprising an inner diameter and an outer diameter, wherein said outer diameter of said heat shrink tube similar to an outer diameter of said underlying layer disposed adjacent to said polymer tube and said inner diameter of said heat shrink tube similar to an inner diameter of said underlying layer disposed adjacent to said polymer tube to enable said custom soldering block to provide a uniform attachment of said suture material with said suture needle, wherein said custom soldering block is in a horseshoe shape and further configured to provide a uniform searing of said heat shrink tube with said suture needle, said suture material positioned at one end of said suture needle and said suture material rotated in one of a clockwise direction and a counterclockwise direction from said outer diameter of said suture needle to enable said uniform attachment of said suture material with said suture needle.

2. The suture-needle apparatus of claim 1, wherein said ratio in a preferred ratio of a 1:1 ratio.

3. The suture-needle apparatus of claim 1, wherein said suture material is processed to form a plug to ensure said swaged suture needle and said suture material are closer to said ratio.

4. The suture-needle apparatus of claim 1, wherein said suture needle is passed through said heat shrink tube till said suture needle reaches a co-polymeric resin attachment.

5. The suture-needle apparatus of claim 4, wherein said co-polymeric resin attachment is a combination of said heat shrink tube with said underlying layer disposed adjacent to said polymer tube.

6. The suture-needle apparatus of claim 4, wherein said heat shrink tube is passed through a dye block comprising a passage, wherein the diameter of said first passage is varied with the size of said heat shrink tube.

7. The suture-needle apparatus of claim 1, wherein said suture needle is smeared using said custom soldering block for providing said uniform searing of said heat shrink tube.

8. The suture-needle apparatus of claim 1, wherein said outer diameter of heat shrink tube, said inner diameter of said heat shrink tube, said outer diameter of said underlying layer, and said inner diameter of said underlying layer are chosen dependent to an outer diameter of said polymer tube.

9. A method of attaching a suture material to a suture needle, comprising:

passing a suture needle through a heat shrink tube till said suture needle reaches a co-polymeric resin attachment, wherein said co-polymeric resin attachment is a combination of said heat shrink tube with an underlying layer disposed adjacent to a polymer tube;

smearing said suture needle using a custom soldering block, wherein said custom soldering block is in a horseshoe shape and further configured to provide a uniform attachment of said suture material with said suture needle and a uniform searing of said heat shrink tube with said suture needle;

adjusting a temperature of said custom soldering block according to melting point of said suture material, wherein said suture material and said suture needle configured to swage to a ratio of an outer diameter of said suture needle and an outer diameter of said suture material by said heat shrink tube and said underlying layer adjacent to said polymer tube, wherein said ratio is the ratio of said outer diameter of said suture needle is equal to said outer diameter of said suture material;

positioning said suture material at said suture needle end and said suture material rotated in one of a clockwise direction and a counterclockwise direction from said outer diameter of said suture needle for enabling said uniform attachment of said suture material with said suture needle;
cooling said suture needle at room temperature; and

peeling said heat shrink tube from said position of said co-polymeric resin attachment after said suture material is uniformly attached to said suture needle to provide a swaged suture needle.

10. The method of claim 9, further comprising a step of processing said suture needle to form a plug.

11. The method of claim 9, further comprising a step of cutting said heat shrink tube along said underlying layer disposed adjacent to said polymer tube.

12. The method of claim 9, further comprising a step of passing said heat shrink tube through a dye block for peeling said heat shrink tube from said co-polymeric resin attachment. , Description:TECHNICAL FIELD
[001] The disclosed subject matter relates generally to a combined surgical needle-suture attachment, and more particularly to a suture-needle apparatus and method of attaching a suture material to the suture needle using the underlying polymeric resin and the heat shrinkable tube which can be readily peeled.
BACKGROUND
[002] In order to suture a wound, the suture needle has to penetrate the tissues, while doing so tissues are traumatized. It is in the interest of the patient to ensure that it is minimal. The suture needles are typically manufactured from biocompatible metals. The biocompatible metals include stainless steel. The choice of material used to manufacture the suture needle depends on various factors such as manufacturability, biocompatibility, mechanical properties, and so forth. The conventional suture needle requires the needle to have a borehole to accommodate the suture material which needs to be swaged. Therefore, the suture needle under the conventional approach is larger than the suture intended for use. The construct of the suture needle is driven by the bore diameter and not the size of the suture. The suture needle which has the same (or nearly same) outer diameter as that of the suture intended for use cannot be achieved under the conventional approach, the suture needle will always remain considerably larger than the suture material intended for use.

[003] Therefore, when the surgeon performs a wound closure/ tissue approximation procedure using a surgical suture, it leaves a larger tear/ causing more trauma than necessary. The penetration is repeated for the number of times by the surgeon during the process of wound closure/ tissue approximation. Each penetration or bite leads to greater tissue tear/ causing more trauma. The conventional suture needle causes greater cumulative damage than what would be desired by the operating surgeon.
[004] In the light of aforementioned discussion, there exists a need for a surgical needle-suture attachment, where the diameter of the suture needle is the same or nearly the same as that of the suture material intended for use.
BRIEF SUMMARY
[005] The following presents a simplified summary of the disclosure in order to provide a basic understanding to the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.

[006] An objective of the present disclosure is directed towards making secure swaging to get consistent results.

[007] Yet another objective of the present disclosure is directed towards helping to reduce tissue trauma.

[008] Yet another objective of the present disclosure is directed towards attaching the surgical needle to the suture material with a copolymeric resin.

[009] Yet another objective of the present disclosure is directed towards improving the diameter of the suture needle such that the outer diameter of the suture needle is equal or nearly equal to the outer diameter of the suture material, with a preferred ratio of 1:1 or near 1:1.

[0010] Yet another objective of the present disclosure is directed towards reducing the diameter of the suture needle.

[0011] Yet another objective of the present disclosure is directed towards maintaining the suture needle with the same or nearly same outer diameter as that of the suture material intended to be swaged/ used for surgery.

[0012] Yet another objective of the present disclosure is directed towards attaching suture material to the suture needle using an underlying polymeric resin and a heat shrink tube which can be readily peeled.

[0013] According to an exemplary embodiment of the present disclosure, a suture-needle apparatus comprising a suture material and a suture needle configured to swage to a ratio of an outer diameter of said suture needle and an outer diameter of said suture material by a heat shrink tube and an underlying layer disposed adjacent to a polymer tube to provide a swaged suture needle, wherein said ratio is the ratio of said outer diameter of said suture needle is equal or nearly equal to said outer diameter of said suture material.

[0014] According to another exemplary embodiment of the present disclosure, said heat shrink tube comprising an inner diameter and an outer diameter, said outer diameter of said heat shrink tube similar to an outer diameter of said underlying layer disposed adjacent to said polymer tube and said inner diameter of said heat shrink tube similar to an inner diameter of said underlying layer disposed adjacent to said polymer tube to enable a custom soldering block to provide a uniform attachment of said suture material with said suture needle.

[0015] According to another exemplary embodiment of the present disclosure, said custom soldering block is in a horseshoe shape and further configured to provide a uniform searing of said heat shrink tube with said suture needle, said suture material positioned at one end of said suture needle and said suture material rotated in one of a clockwise direction and a counterclockwise direction from said outer diameter of said suture needle to enable said uniform attachment of said suture material with said suture needle.

BRIEF DESCRIPTION OF DRAWINGS
[0016] Other objects and advantages of the present invention will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments, in conjunction with the accompanying drawings, wherein like reference numerals have been used to designate like elements, and wherein:

[0017] FIG. 1A is a diagram depicting a suture-needle apparatus, in accordance with one or more exemplary embodiments.

[0018] FIG. 1B is a diagram depicting an enhanced cross-section of suture-needle apparatus, in accordance with one or more exemplary embodiments.

[0019] FIG. 1C is a diagram depicting a dye block, in accordance with one or more exemplary embodiments.

[0020] FIG. 2 is an example diagram depicting the suture-needle apparatus, in accordance with one or more exemplary embodiments.

[0021] FIG. 3 is a flow chart depicting a method of attaching the suture material to the suture needle using the underlying polymeric resin and the heat shrinkable tube which are readily peeled, in accordance with one or more exemplary embodiments.
DETAILED DESCRIPTION
[0022] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0023] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[0024] Referring to FIG. 1A, FIG. 1A is a diagram 100a depicting a suture-needle apparatus, in accordance with one or more exemplary embodiments. The suture-needle apparatus 100 includes a suture material 102, a suture needle 104, a plug 106, a polymer tube 108, a heat shrink tube 110, and a split 112. The suture material 102 and the suture needle 104 may be intended to be swaged/used. Subsequently, the suture needle 104 may be is processed to form the plug 106. The suture material may include, but not limited to, bioabsorbable polymer, copolymeric resin, and so forth. The plug may include, but not limited to, a step, and so forth. For example, a synthetic suture of USP size 2-0 (metric 3 (Ph. Eur)) may have a suture needle of outer diameter 0.300mm- 0.339mm. The plug 106 may be configured to ensure the swaged suture needle 104 and the suture material 102 are closer to the ratio. The ratio in a preferred embodiment is equal or nearly equal to a 1:1 ratio. For example, the ratio may be represented as needle diameter: suture diameter. The appropriate inner and the outer diameter of the heat shrink tube 110 may be chosen. The heat shrink tube 110 may be similar to a copolymeric resin tube. The choice of diameter of the heat shrink tube 110 and the diameter of the underlying layer disposed adjacent to the polymer tube 108 may be dependent to a desired final outer diameter of the polymer tube 108. The outer diameter of heat shrink tube 110, the inner diameter of said heat shrink tube 110, the outer diameter of the underlying layer, and the inner diameter of the underlying layer are chosen dependent to an outer diameter of the polymer tube 108.

[0025] The heat shrink tube 110 along with the underlying layer disposed adjacent to the polymer tube 108 may be cut into appropriate size. The size of the heat shrink tube 110 along with the underlying layer disposed adjacent to the polymer tube 108 may be optimal. The length of the underlying layer disposed adjacent to the polymer tube 108 may be at a range of 2-3 times the length of the plug 106 and the length of the heat shrink tube 110 may be at a range of 6-9 times the length to ensure the secure attachment. The heat shrink tube 110 may be passed through a dye block 100c (as shown in FIG. 1C) to ensure the tip of the peeling surface is split to peel the heat shrink tube 110. The suture needle 104 may be passed through the heat shrink tube 110 till the suture needle 104 reaches a co-polymeric resin attachment. The suture material 102 and the suture needle 104 may be smeared using a custom soldering block 212 (As shown in Fig. 2) for the process of attachment. The proper placement of the suture needle 104 may improve the integrity of the suture material 102. The split 112 may be located in the heat shrink tube 110. The suture material 102 is inserted in the dye block 100c based on the diameter of the dye block 100c.

[0026] Referring to FIG. 1B, FIG. 1B is a diagram 100b depicting an enhanced cross -section of suture-needle apparatus, in accordance with one or more exemplary embodiments. The enhanced cross section of suture-needle apparatus 100b includes the suture material 102, the polymer tube 108, the heat shrink tube 110, and the split 112.
[0027] Referring to FIG. 1C, FIG. 1C is a diagram 100c depicting a dye block, in accordance with one or more exemplary embodiments. The dye block 100c includes a first passage 114a, a second passage 114b, a first sharp edge 116a, and a second sharp edge 116b. The first passage 114a, a second passage 114b may be configured to pass the heat shrink tube 110 through it. The diameter of the first passage 114a and the second passage 114b may be varied with the size of the heat shrink tube. The first sharp edge 116a, and a second sharp edge 116b may be configured to peel the heat shrink tube 110.

[0028] Referring to FIG. 2, FIG. 2 is an example diagram 200 depicting the suture-needle apparatus, in accordance with one or more exemplary embodiments. The surgical needle-suture apparatus 200 includes the suture material 202, the suture needle 204, the plug 206, the polymer tube 208, the heat shrink tube 210 and a custom soldering block 212. The custom soldering block 212 may be configured to provide the uniform attachment of the suture material 202 with the suture needle 204. The design of the custom soldering block 212 may be a horseshoe shaped and is configured to ensure the uniform searing of the heat shrink tube 210. The custom soldering block 212 may be configured to ensure the smooth attachment. The temperature of the soldering block 212 may be mapped to the suture material. The suture materials are known to disintegrate at higher temperatures. For example, Poly glycolic acid (PGA) sutures have a melting point of 230 deg C, Polydioxanone (PD) sutures have a melting point of 110 deg C. The suture material 202 may be positioned at the end of the suture needle 204 and is rotated in one of clockwise direction and a counter clockwise direction at a distance from the outer diameter of the suture needle 204 for the uniform attachment. For example, one complete rotation of the suture needle 204 may provide complete and secure attachment. The cooling of the heat shrink wrapped suture needle may be maintained at room temperature. The heat shrink tube 210 may be peeled after the suture material 202 is securely attached to the suture needle 204.

[0029] Referring to FIG. 3, FIG. 3 is a flow chart 300 depicting a method of attaching the suture material to the suture needle using the underlying polymeric resin and the heat shrinkable tube which are readily peeled, in accordance with one or more exemplary embodiments. As an option, the method 300 is carried out in the context of the details of FIG. 1A, FIG. 1B and FIG. 2. However, the method 300 is carried out in any desired environment. Further, the aforementioned definitions are equally applied to the description below.

[0030] The method commences at step 302, the suture needle may be prepared, which is of the same (or nearly same) size as the suture material intended to be swaged/ used. Thereafter, at step 304, the suture needle is processed to form the plug. Thereafter, at step 306, the heat shrink tube may be chosen with the appropriate inner diameter and outer diameter. Thereafter, at step 308, the heat shrink tube and the underlying layer disposed adjacent to the polymer tube may be chosen dependent to the desired final outer diameter of the shrink polymer tube. Here, the diameter includes the outer diameter of the heat shrink tube, the inner diameter of the heat shrink tube, the outer diameter of the underlying layer, and the inner diameter of the underlying layer are chosen dependent to the outer diameter of the polymer tube. Thereafter, at step 310, the heat shrink tube along with the underlying layer disposed adjacent to polymer tube may be cut into appropriate size. Determine whether the length of the underlying layer disposed adjacent to polymer tube is optimal? At step 312. If the answer at step 312 is YES, the method continues at step 320. If the answer at step 312 is NO, the method continuous at step 314, the easy passage of the suture material may be obstructed during the surgery. Thereafter, at step 316, determine whether the length of the underlying layer disposed adjacent to the polymer tube is very short? If the answer at step 316 is YES, the method continuous at step 318, detachment of the suture material occurs from the suture needle. If the answer at step 316 is NO, the method continuous at step 320, the heat shrink tube may be passed through the dye block for peeling the heat shrink tube from the co-polymeric resin attachment. Thereafter, at step 322, the suture needle may be passed through the heat shrink tube till the suture needle reaches the co-polymeric resin attachment. Thereafter, at step 324, the suture needle may be smeared using the custom soldering block and the custom soldering block provides the uniform attachment of the suture material with the suture needle and the uniform searing of the heat shrink tube with the suture needle. Thereafter, at step 326, the temperature of the soldering block may be adjusted according to the suture material. Thereafter, at step 328, the suture material may be positioned at the suture needle end and rotated in one of the clockwise direction and the counterclockwise direction from the outer diameter of the suture needle for enabling the uniform attachment of the suture material with the suture needle. Thereafter, at step 330, the suture needle may be cooled at room temperature. Thereafter, at step 332, the heat shrink tube may be peeled after the suture material is uniformly attached to the suture needle to provide the swaged suture needle.

[0031] In an embodiment of the present disclosure, the suture-needle apparatus includes the suture material 102/202, the suture needle 104/204, the heat shrink tube 110/210, the polymer tube 108/208, the underlying layer disposed adjacent to the polymer tube 108/208, and the custom soldering block 212. The suture material 102/202 and the suture needle 104/204 may be configured to swage to a ratio of an outer diameter of the suture needle 104/204 and an outer diameter of the suture material 102/202 by the heat shrink tube 110/210 and the underlying layer disposed adjacent to the polymer tube 108/208 to provide a swaged suture needle. The ratio is the ratio of the outer diameter of the suture needle 104/204 is equal or nearly equal to the outer diameter of the suture material 102/202. The heat shrink tube 110/210 comprising an inner diameter and an outer diameter. The outer diameter of the heat shrink tube 110/210 similar to the outer diameter of the underlying layer disposed adjacent to the polymer tube 108/208 and the inner diameter of the heat shrink tube 110/210 similar to the inner diameter of the underlying layer disposed adjacent to the polymer tube 108/208 to enable the custom soldering block 212 to provide a uniform attachment of the suture material 102/202 with the suture needle 104/204. The custom soldering block 212 may be in a horseshoe shape and further configured to provide a uniform searing of the heat shrink tube 110/210 with the suture needle 102/202. The suture material 102/202 may be positioned at one end of the suture needle 104/204 and the suture material 102/202 rotated in one of a clockwise direction and a counterclockwise direction from the outer diameter of the suture needle 104/204 to enable the uniform attachment of the suture material 102/202 with the suture needle 104/204. The suture material 102/202 may be processed to form a plug to ensure the swaged suture needle 104/204 and the suture material 102/202 are closer to the ratio. The suture needle 104/204 may be passed through the heat shrink tube 108/208 till the suture needle 104/204 reaches a co-polymeric resin attachment. The co-polymeric resin attachment may be a combination of the heat shrink tube 108/208 with the underlying layer disposed adjacent to the polymer tube 108/208. The heat shrink tube 108/208 may be passed through the dye block 100c includes the first passage 114a, and the second passage 114b to peel the heat shrink tube 110/210 from the co-polymeric resin attachment using the first sharp edge 116a and the second sharp edge 116b disposed in the dye block 100c. The suture needle 104/204 may be smeared using the custom soldering block 212 for providing the uniform searing of the heat shrink tube 110/210. The diameter (outer and inner diameters) of the heat shrink tube 110/210 and the diameter (outer and inner diameters) of the underlying layer are dependent to an outer diameter of the polymer tube 108/208. The outer diameter of heat shrink tube 110/210, the inner diameter of said heat shrink tube 110/210, the outer diameter of the underlying layer, and the inner diameter of the underlying layer are chosen dependent to an outer diameter of the polymer tube 108/208.

[0032] In another embodiment of the present disclosure, the method of attaching the suture material 102/202 to the suture needle 104/204, comprising: passing the suture needle 104/204 through the heat shrink tube 110/210 till the suture needle 104/204 reaches a co-polymeric resin attachment, the co-polymeric resin attachment is a combination of the heat shrink tube 110/210 with an underlying layer disposed adjacent to a polymer tube 108/208, smearing the suture needle 104/204 using the custom soldering block 212, the custom soldering block 212 is in a horseshoe shape and further configured to provide a uniform attachment of the suture material 102/202 with the suture needle 104/204 and the uniform searing of the heat shrink tube 110/210 with the suture needle 104/204, adjusting a temperature of the custom soldering block 212 according to melting point of the suture material 102/202, the suture material 102/202 and the suture needle 104/204 are configured to swage to the ratio of the outer diameter of the suture needle 104/204 and the outer diameter of the suture material 102/202 by the heat shrink tube 110/210 and the underlying layer adjacent to the polymer tube 108/208, the ratio is the outer diameter of the suture needle 104/204 is equal or nearly equal to the outer diameter of the suture material 102/202, positioning the suture material 102/202 at the suture needle end and the suture material 102/202 rotated in one of the clockwise direction and the counterclockwise direction from the outer diameter of the suture needle 104/204 for enabling the uniform attachment of the suture material 102/202 with the suture needle 104/204, cooling the suture needle 104/204 at room temperature and peeling the heat shrink tube 110/210 from the position of the co-polymeric resin attachment after the suture material 102/202 is uniformly attached to the suture needle 104/204 to provide a swaged suture needle. Processing the suture needle 104/204 to form a plug. Cutting the heat shrink tube 110/210 along the underlying layer disposed adjacent to the polymer tube 108/208. Passing the heat shrink tube 110/210 through the dye block 100c for peeling the heat shrink tube 110/210 from the co-polymeric resin attachment.

[0033] Although the present disclosure has been described in terms of certain preferred embodiments and illustrations thereof, other embodiments and modifications to preferred embodiments may be possible that are within the principles and spirit of the invention. The above descriptions and figures are therefore to be regarded as illustrative and not restrictive.

[0034] Thus the scope of the present disclosure is defined by the appended claims and includes both combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.