Source: http://www.patentsencyclopedia.com/app/20120221045
Timestamp: 2020-04-08 15:33:26
Document Index: 290403106

Matched Legal Cases: ['art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121', 'art 121']

Patent application number: 20120221045
1. A needle unit, comprising: an outer cannula, wherein the outer cannula has a passageway extending therethrough, and the outer cannula further comprises: an open end connected to the passageway; and a piercing end with a dull tip, wherein the piercing end is for puncturing soft tissue and organs, and an opening is disposed around the dull tip; and an inner wire passing through the passageway and having a threading part at an end thereof near the opening, wherein the inner wire is movable inwardly or outwardly via the opening, and the threading part allows at least a suture thread to pass therethrough.
3. The needle unit according to claim 1, wherein the outer cannula is curved with a curvature along its total longitudinal length, the curvature is a central angle equal to or greater than 0.degree. and smaller than 180.degree. divided by a length of the outer cannula, and the length is 101% to 250% of a human liver thickness.
14. A needle unit, comprising: an outer cannula, wherein the outer cannula is straight or curved, the outer cannula has a passageway extending therethrough, and the outer cannula further comprises: an open end connected to the passageway; and a piercing end with a dull tip, wherein the piercing end punctures soft tissue and organs, and an opening is disposed around the piercing end; and an inner wire for passing through the passageway and having a threading part at an end thereof near the opening, wherein the inner wire is movable inwardly or outwardly via the opening, and the threading part allows at least a suture thread to pass therethrough.
15. The needle unit according to claim 14, wherein the outer cannula is curved with a tangent chord angle equal to or greater than 0.degree. and smaller than 90.degree. from the piercing end to the open end.
[0001] This invention relates generally to a surgical needle, and more particularly, to a needle unit applied in hepatic resections.
[0002] A successful hepatic resection requires a skillful surgical technique, a safe volume of the remnant liver, and the reduction or elimination of unnecessary ischemic and reperfusion injuries. Skillful surgeons must aim to minimize blood loss during parenchyma division, to secure bleeding or bile leakage from the raw surface of the liver, and to keep remnant major vessels and ducts intact. If all of the above are fulfilled, the postoperative course will be uneventful. Otherwise, cumbersome care becomes necessary.
[0003] Hepatic resections always carry a high risk of intraoperative hemorrhage and postoperative hepatic failure. Although mortality rate is decreasing with the refinement of surgical techniques, instruments, and postoperative care, bleeding during parenchyma transection remains a critical hurdle to overcome. In order to reduce blood loss, both inflow and backflow controls are necessary. Several known methods can be applied to block the inflow intermittently or continuously at the level of the hepatoduodenal ligament (e.g. Pringle's maneuver), hilar, or individual segmental branches. Partial blockage of the individual inflow can avoid ischemia and reperfusion injuries on the remnant liver. For the purposes of preventing hepatic failure, the determination of the appropriate ischemic time is critical, especially for a cirrhotic liver. Backflow can be controlled with the inferior vena cava (IVC) exclusion or individual hepatic vein blockage. However, IVC exclusion may compromise the hemodynamic stability; therefore, the use of overloading fluid prior to clamping would add a burden to postoperative recovery.
[0004] Hence, it is necessary to provide a surgical needle, so as to facilitate the control of individual inflow and back flow to reduce intraoperative hemorrhage, and to prevent un-necessary ischemic and reperfusion insult to the unrelated area of the liver in order to minimize the risk of postoperative hepatic failure and so on.
[0005] Accordingly, it is an aspect of the present invention to provide a needle unit, which includes an outer cannula and an inner wire passing through a passageway thereof. The outer cannula is straight or curved, and the outer cannula has a piercing end and an open end connected to the passageway. The piercing end has a dull tip. An opening is disposed around the dull tip of the piercing end or opens at the tip of the cannula. The inner wire has a threading part at an end thereof near an opening of the outer cannula, and the inner wire allows at least a suture thread to pass through the threading part and the inner wire can be moved inwards or outwards via the opening. When the opening is at the top of the cannula, the inner wire may connect with a plug as the piecing end. Therefore, the needle unit can be advantageous to control the desired individual vessels of an organ in partial resection for example, a liver for various kinds of hepatic resections.
[0006] According to an embodiment of the present invention, the needle unit may include an outer cannula and an inner wire. The outer cannula has a passageway extending therethrough, an open end with or without a dull tip-piercing end. The outer cannula may be straight or curved. The piercing end is for puncturing soft tissue and organs, and an opening is disposed around the piercing end or at the top of the cannula. The inner wire passes through the passageway and it has a threading part at or near the end of the opening, in which the inner wire is movable inwardly or outwardly via the opening, and the threading part allows at least a suture thread to pass therethrough. When the opening is at the top of the cannula, the inner wire may connect with a plug as the piecing end.
[0007] In an example, the outer cannula may be straight or curved with a continuous curvature along its total longitudinal length, in which the curvature is a central angle equal to or greater than 0° and smaller than 180° divided by a length of the outer cannula, and the length is 101% to 250% of a human liver thickness. In another example, the outer cannula may be straight or curved with a tangent chord angle equal to or greater than 0° and smaller than 90° from the open end to the piercing end.
[0008] In an example, the opening may be disposed on a side of the outer cannula and adjacently to the dull tip. In another example, the opening may be directly disposed on an end of the dull tip. In the latter example, threading part may be an oval loop, a circle loop, a diamond loop, a U-shaped part or a hook. Alternatively, the threading part may be added with or without a linear protrusion at tops of the oval loop, the circle loop or the diamond loop near the opening of the outer cannula. The piercing end may be a plug disposed on a tip of the linear protrusion for being the dull tip and covering the opening while the needle unit punctures the soft tissue and the organs.
[0013] FIGS. 1A and 1B depict cross-sectional diagrams of the needle unit according to embodiments of the present invention.
[0014] FIGS. 1C and 1D depict exploded perspective views of the needle units according to embodiments of the present invention.
[0015] FIG. 2 depicts a cross-sectional diagram of the needle unit according to another embodiment of the present invention.
[0016] FIG. 3 depicts a diagram of the inner wire according to embodiments of the present invention.
[0018] FIGS. 5A and 5B depict sagital sections of the left hepatic lobe according to an embodiment of the present invention.
[0020] FIG. 6B depicts a sagital section of the right hepatic lobe according to another embodiment of the present invention.
[0022] Refer to FIG. 1A. FIG. 1A depicts a cross-sectional diagram of the needle unit according to an embodiment of the present invention. In brief, the needle unit 100 may include an outer cannula (straight outer cannula 110a or curved outer cannula 110b) and an inner wire 120. The outer cannula 110a or 110b has a passageway 111 extending therethrough, an open end 113 connected to the passageway, and a piercing end 115 with a dull tip. In general, the piercing end 115 may be a dull tip for puncturing soft tissue or an organ (for example, liver), and an opening 117 is disposed around the dull tip of the piercing end 115. The inner wire 120 passes through the passageway 111 and it has a threading part 121 (for example, a loop) at an end thereof near the opening 117, in which the inner wire 120 is movable inwardly or outwardly via the opening 117, and the threading part 121 allows at least a suture thread 130 to pass therethrough.
[0023] In an example, the opening 117 is disposed on a side of the outer cannula 110a or 110b and adjacent to the dull tip of the piercing end 115, as shown in FIG. 1A. However, in another example, the opening 117 is disposed directly on an end of the outer cannula 110a' or 110b', and the outer cannula 110a' or 110b' has no dull tip in this example, as shown in FIG. 1B. In this example, threading part 121 may be a loop or a hook. In a case of a loop being the threading part 121, the threading part 121 may have a linear protrusion 123 at its top near the opening 117 of the outer cannula 110a' or 110b'. The piercing end may be a plug 150 disposed on a tip of the linear protrusion 123 for being the dull tip of FIG. 1A and covering the opening 117 while the needle unit 100' punctures the soft tissue and the organs. The plug 150 may have a dull tip for puncturing the soft tissue and the organs, and a capping end for covering the opening while the needle unit punctures the soft tissue and the organs. The plug 150 may be made by metal, plastic or other materials appropriately applied in the surgical devices.
[0025] In an embodiment, the outer cannula 110b can be defined by a tangent chord angle α from the piercing end 115 (above the opening 117) to the open end 113, as shown in FIG. 1A. Alternatively, the outer cannula 110b' can be also defined by a tangent chord angle α from the opening 117 to the open end 113, as shown in FIG. 1B. The tangent chord angle α is equal to or greater than 0° and smaller than 90° from the opening 117 to the open end 113.
[0027] In the equation (I), the curvature of the outer cannula is directly defined by a reciprocal of its radius (r). The length (l) of the outer cannula 110b (or curved outer cannula 110b') is defined by multiplying its radius (r) and its central angle (A). In other words, the curvature of the outer cannula 110b is also the central angle (A) divided by the length (l). In an embodiment, the central angle (A) of the outer cannula 110b (or curved outer cannula 110b') is twice of the tangent chord angle α, or 2α, being equal to or greater than 0 radian and smaller than 3.14 radians.
[0028] The length (l) of the outer cannula 110a (or outer cannula 110a') or the outer cannula 110b (or outer cannula 110b') may be 101% to 250% (for example, 10 cm to 30 cm) of a human liver thickness. The outer cannula 110a (or outer cannula 110a') or the outer cannula 110b (or outer cannula 110b') can be made by metal (for example, metals, metal alloys, stainless steel, or the like) or plastic as known in the prior art, and the outer cannula 110a (or outer cannula 110a') or the outer cannula 110b (or outer cannula 110b') has a width w of 14- to 24-gauge (i.e. 2.108 mm to 0.559 mm). Similarly, the outer cannula 110b' of FIG. 1B can be also alternatively with a continuous curvature along its total longitudinal length (l), and the curvature is also defined by the aformentioned equation (I).
[0029] Refer to FIGS. 1C and 1D. FIGS. 1C and 1D depict exploded perspective views of the needle units according to an embodiment of the present invention. The needle unit 100 may include an outer cannula 110 and an inner wire 120, and needle unit 100' may include an outer cannula 110' and an inner wire 120 with a plug 150. The outer cannula 110 has a passageway (unshown) extending therethrough, an open end 113 connected to the passageway, and a piercing end 115. The piercing end 115 has a dull tip for puncturing soft tissue or an organ (for example, liver). An opening 117 is disposed around the piercing end 115, being disposed on a side of the outer cannula and closely to the piercing end 115 (the needle unit 100), or directly on an end of the outer cannula 110' (the needle unit 100'). A threading part 121 at an end of the inner wire 120 is movable inwardly or outwardly from the passageway via the opening 117, and the threading part 121 captures at least a suture thread 130 while it extends outwardly from the opening 117. However, the needle unit of FIGS. 1C and 1D are merely exemplified herein, and it is readily understood that a straight outer cannula may be applied in the needle unit of other embodiments, rather than intending to provide further explanation of the invention as claimed.
[0030] In other examples, the threading part 121 of the needle unit 100' in FIGS. 1C and 1D may have no linear protrusion at tops of the oval loop, the circle loop or the diamond loop near the opening 117 of the outer cannula 110' (unshown). In the aforementioned examples, those loops 121 of the needle unit 100' are made by the metal material and a little wider than the opening 117, so as to keep the threading part 121 outside the opening for being the piercing end during puncturing the soft tissue and the organs (unshown).
[0031] In an embodiment, a handle, for example, a handle 130b shown in FIG. 1C or a handle 130c shown in FIG. 1D, may be optionally disposed on the open end 113 of the outer cannula 110 or the outer cannula 110', in which the handle 130b is extended vertically, obliquely on the open end 113 of the outer cannula 110 or the outer cannula 110', or the handle 130c is extended in the same direction as the outer cannula 110 or the outer cannula 110'. Moreover, the handle 130b shown in FIG. 1C or the handle 130c shown in FIG. 1D respectively has a channel (unshown) in the holding portion 131b or a holding portion 131c to connect an opening 133b or an opening 133c with the passageway 111 of the outer cannula 110 or the outer cannula 110', so as to allow the inner wire 120 passing from the opening 133b or the opening 133c through the channel and the passageway 111 to the opening 117.
[0032] In another embodiment, the outer cannula may be disposed in a hollow tube of a laparoscopic surgical instrument. Refer to FIG. 2. FIG. 2 depicts a cross-sectional diagram of the needle unit according to another embodiment of the present invention. A laparoscopic surgical instrument 140, for example, a trocar instrument commonly available in the prior art, has a hollow tube 141 for accommodating the outer cannula 110 or the outer cannula 110' to move inwardly or outwardly via the open end 145. In this example, a laparoscopic camera commonly available in the prior art may be disposed separately in another trocar instrument.
[0033] In general, the length of the outer cannula 110 or the outer cannula 110' depends on actual requirements, and it is not intended to limit the scope of the present invention in the length set forth herein. For example, during conventionally open abdomen surgery, the outer cannula 110 or the outer cannula 110' may have a length corresponding to 101% to 250% (for example, 10 cm to 30 cm) of a human liver thickness when the needle unit 100 or the needle unit 100' is manually operated. Alternatively, during the laparoscopic operation, when the needle unit 100 or the needle unit 100' is passed through a trocar port, the outer cannula 110 may have a length longer than the length of the hollow tube 141 shown in FIG. 2, for example, a length of 50 cm approximately.
[0034] Refer to FIG. 3. FIG. 3 depicts a diagram of the inner wire according to embodiments of the present invention. In an embodiment, the inner wire 120 may be a metal wire, a plastic wire, or a metal wire coated with a polymer film, for example, a metal wire coated with PTFE. The threading part 121 of the inner wire 120 may be various shapes, for example, oval loops (such as the loop 121a and 121b), circle loops (such as the loop 121c and 121d) or diamond loops (such as the loop 121e and 121f). In another embodiment, the threading part 121 of the inner wire 120 may be a U-shaped part 121g. In a still another embodiment, the threading part 121 of the inner wire 120 may be a hook 121h.
[0035] Refer to FIG. 3 again. In another embodiment, the threading part 121 may further have a linear protrusion at its top near the opening of the outer cannula (herein referred as the outer cannula 110a or the outer cannula 110b), for example, the protrusion 123b of the loop 121b, the protrusion 123d of the loop 121d, or the protrusion 123f of the loop 121f. The protrusions exemplified as above are facilitated to make the inner wire 120 easier move inwardly or outwardly via the opening. In other examples, the protrusion 123b of the loop 121b, the protrusion 123d of the loop 121d, or the protrusion 123f of the loop 121f may have a plug 150 disposed thereon, respectively, for being the dull tip and covering the opening 117 while the needle unit 100 or the needle unit 100' punctures the soft tissue and the organs. Alternatively, the inner wire 120 may have a hook 121i and a plug 150 disposed on the end near the opening of the outer cannula 110 (herein referred as the outer cannula 110a or the outer cannula 110b), in which the hook 121i is employed as the threading part 121i, and the plug 150 is employed as the dull tip.
[0038] During surgery such as hepatic resections, the needle unit can be applied as follows, when taken in conjunction with FIGS. 1A, and 5A-6B. During the hepatic resections, the intraoperative ultrasonography (unshown) or the laparoscopic camera can be properly employed to evaluate the resectability and to determine an appropriate division line. For clarifying the operation of the needle unit in detail, the left hepatic lobe and right hepatic lobe are resected by using the needle unit 100 as exemplified herein. However, it is to be understood that the following description is merely exemplified herein, without intending to provide further explanation of the invention as claimed.
[0040] Refer to FIGS. 1A, 5A and 5B. FIGS. 5A and 5B depict sagital sections of the left hepatic lobe according to an embodiment of the present invention. After essentially preoperative preparations, the anterior abdominal wall 509 is lifted. The outer cannula 110b of the needle unit 100 penetrates from the bottom surface 501 (above the inferior venal cava 503) to upper surfaces 505 of liver 500 at the one side of the main supplying vessel 507 (for example, left hepatic Glissonian pedicle) along a path 511, a first end of a suture thread 130 passes through and ties on the threading part 121 of the inner wire 120 of the needle unit 100 while the inner wire 120 moves outwardly via the opening 117 of the outer cannula 110b.
[0044] The above procedures can be also applied on right hepatic lobectomy or various resections as well when there is little space between the liver upper surface 505 and the abdominal wall 509 to allow applying a straight needle (for example, a needle unit 100 having the outer cannula 110a and the inner wire 120) from the liver surface difficulty.
[0047] Refer to FIGS. 1A, 6A and 6B. FIG. 6A depicts a side view of the right hepatic lobe below the rib cage 610 and the diaphragm 602 according to another embodiment of the present invention, and FIG. 6B depicts a sagital section of the right hepatic lobe according to another embodiment of the present invention. Similarly, after essentially preoperative preparations, the rib cage 610 is lifted slightly. The outer cannula 110b of the needle unit 100 punctures from the upper surfaces 605 to the bottom surface 601 (apart from the inferior venal cava 503 of FIGS. 5A and 5B) of liver 600 at one side of the main supplying vessel 607 along a path 611, with the outer cannula 110b facing the retroperitoneal abdominal wall 623.
2013-12-19 Needle unit