Surgical instrument and method for occlusion of uterine blood vessels

Abstract

A surgical instrument for at least partial occlusion of uterine blood vessels during a cesarean section and method is provided. Tire instrument comprises a first and a second leg pivotally connected to one another at a pivot point. Each leg is defined by an angled upper portion extending above the pivot point and an angled lower portion extending below the pivot point and comprises a first and second opposing jaw, in some embodiments kidney-shaped, disposed on an end on each of the first and second leg proximate to the angled lower portion. Such jaws are configured to compressibly maintain a padding around the lower uterine segment. A latching means disposed along the angled upper portion is operative to releasably maintain the jaws at a selected distance from one another and may be engaged to secure the jaws in position against the lower uterine segment during use.

Description

SURGICAL INSTRUMENT AND METHOD FOROCCLUSION OF UTERINE BLOOD VESSELSINTHE UNITED STATES PATENTAND TRADEMARK OFFICEANINTERNATIONAL PATENT APPLICATIONFORDR. MIRIAM MACKO VIC-BASICGOVERNMENT CONTRACT

[0001] Not applicable.CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to co-pending U.S. patent application number 18 / 545,578 filed on December 19, 2023 titled “Surgical Instrument and Method for Occlusion for Uterine Blood Vessels,” the disclosure of which is hereby incorporated by reference in its entirety.STATEMENT RE. FEDERALLY SPONSORED RESEARCH / DEVELOPMENT

[0003] Not applicable.COPYRIGHT & TRADEMARK NOTICES

[0004] A portion of the disclosure of this patent document may contain material which is subject to copyright protection. This patent document may show and / or describe matter which is or may become trade dress of the owner. The copyright and trade dress owner has no objection to the facsimile reproduction by any one of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyrights and trade dress rights whatsoever.TECHNICAL FIELD

[0005] The disclosed subject matter relates generally to surgical instruments and more particularly to a surgical instruments for at least partial occlusion of uterine blood vessels used in performing cesarean sections and other surgical procedures.BACKGROUND

[0006] The United Nations estimates that about 385,000 babies are bom each day around the world. Despite how common childbirth is, childbirth carries many risks, such as infection, mutilation, and even death. Indeed, one in five women will experience a lifethreatening condition called post-partum hemorrhaging as a result of delivery. This condition is characterized by substantial blood loss. A committee opinion published by Tire American College of Obstetricians and Gynecologists noted that postpartum hemorrhage causes approximately 11% of maternal deaths in the United States and that between 54-93% of these may be preventable. The World Health Organization reports that post-partum hemorrhage results in about 70,000 maternal deaths globally each year. While post-partum hemorrhaging can occur during vaginal delivery, it is more common in women who deliver through cesarean section (“C-section”). which is an increasingly common surgical method for delivery.

[0007] One of tire reasons that C-sections are more likely to result in post-partum hemorrhages is due to the length of time between making the initial incision in the patient’s abdomen and the closing of the incisions. While delivering the baby is the primary concern following incision, this takes only about five minutes while the majority of the approximately hour-long operation is spent suturing the incisions to close the patient. One reason that this suturing takes so long is that blood in the field needs to be cleared in order to suture the patient, which causes even more blood to be lost. Thus, there is a need to reduce blood flow to the surgical field during C-sections, which reduces the blood in the field that needs to be cleared, reduces the length of time it takes to conduct C-sections, and overall reduces the risk of postpartum hemorrhaging. All of this, in turn, makes recovery easier for the mother.

[0008] Despite the fact that C-sections rank among the most common surgical procedures, equipment designed for the complex uterine anatomy is rare. Instead, manyphysicians utilize generic surgical instruments during C-sections, such as the hemostatic clamp proposed in U.S. Patent No. 3,326,217 to Sydney. However, general surgical instruments are designed for use with larger, often less crowded, areas of the body, and, when used during a C- section, risk contact with unintended structures.

[0009] Uterine anatomy is not only complex, but it is also cramped, with many important and delicate anatomical structures in close proximity to one another. As a result, using general surgical instrument in this area carries the risk of causing damage and potential fertility issues due to their ill-fitting nature. For example, the intricacy of uterine anatomymakes it disadvantageous to rely on the usual handles and arms characterizing general surgical instruments for placement. These handles or arms risk contacting unintended structures, make direct placement to a targeted structure challenging, and crowd the surgical field. As a result, while general surgical instruments may be utilized at times, many physicians are reluctant to utilize these tools given their increased risk of complications.

[0010] One childbirth specific instrument proposed to reduce blood loss during delivery- is provided in U.S. Patent No. 9,445,839 to DiBenedetto, which provides a uterine clamp comprising two plates that apply pressure to the uterus in an attempt to get the uterus to contract and reduce the blood flow following delivery. However, DiBenedetto’s proposal is a reactionary measure used in instances where hemorrhaging has already begun to occur and is placed over the entirety of tire uterus, including at tire location of the C-section incision. As a result, DiBcncdctto’s clamp prevents the suturing of a uterine incision while placed and is therefore not suitable to reduce blood loss that occurs during the C-section procedure. That is, while DiBenedetto’s proposal may reduce the severity of post-partum hemorrhaging, it is not effective in preventing the same.

[0011] Applicant has also previously proposed U.S. Patent No. 10,010,345 for an improved surgical clamp used for the partial occlusion of uterine ligaments during C-sections, which is operative to reduce the blood flow in the lower uterine segment. However, Applicant has found a need for clamps that are not only capable of accommodating a larger variety of differently-sized uteruses. Further, Applicant has made improvements to ensure better positioning of the clamp and reduction of uterine blood flow during use.

[0012] Thus, there is a need for surgical instruments, such as clamps, that may be utilized pre-emptively to reduce blood loss from c-sections.SUMMARY

[0013] The present disclosure is directed to a surgical instrument for reducing blood loss during abdominal surgeries, such as cesarean sections, and methods thereof. More particularly, the surgical instrument may at least partially occlude blood flow in the lower uterine segment during cesarean sections. One of ordinary skill in the art will recognize that the uterus exhibits a characteristic shape resembling a lightbulb, with a larger upper uterine segment and a narrower lower uterine segment. Tire lower uterine segment receives its blood supply primarily through the uterine artery and vein, collectively tire uterine vessels. Ureters, essential in the urinary system, run alongside the uterus, passing behind the uterine vessels and in front of vaginal arteries and veins. Due to the close proximity of the ureters to the lower uterine segment and the uterine vessels, occlusion of blood flow in the lower uterine segment can have significant implications for the urinary system.

[0014] For purposes of summarizing, certain aspects, advantages, and novel features have been described. It is to be understood that not all such advantages may be achieved in accordance with any one particular embodiment. Thus, the disclosed subject matter may beembodied or carried out in a maimer that achieves or optimizes one advantage or group of advantages without achieving all advantages as may be taught or suggested.

[0015] In accordance with one embodiment, the surgical instrument may be configured as a clamp comprising a first and second leg pivotally connected to one another at a pivot point, a handle disposed on each of the first and second legs, a first and second opposing jaw disposed on an end on each of the first and second leg, and a latching means. Each leg may be defined by an angled upper portion extending above the pivot point and an angled lower portion extending below the pivot point. The angled upper and lower portions may permit the jaws to at least partially occlude blood flow from the lower uterine segment while avoiding the ureters and other surrounding structures. Hie pivot point may be positioned at a point along the legs operative to scale movement between the handle in the angled upper portion and the jaws in the angled lower portion to improve application of the clamp.

[0016] The handle may be disposed on the end of the first and second leg proximate to the angled upper portion, and the jaws may be disposed of on the end of the first and second leg proximate to the angled lower portion. Each jaw may comprise an inner surface and an outer surface, wherein the inner surface may be applied to a desired area, such as the lower uterine segment, to at least partially occlude blood flow. The jaws may comprise a non-uniform shape, such as a renifonn shape, to accommodate the anatomy of the uterus and surrounding structures. Of course, the jaws may be any shape that a person of ordinary skill in the art may desire. In some embodiments, each jaw may comprise a padding, however, in other embodiments, the padding may be distinct from the clamp. Instead, the padding may be applied, if desired directly, and the first and second jaws may be operative to maintain the padding in a desired configuration.

[0017] The angled upper portion may comprise a first and second horizontal segment separated by a vertical segment. The first and second horizontal segments may be angled around the vertical segment to approximately define a z-shape. More particularly, tire first horizontal segment may extend from the pivot point to the vertical segment which may extend at a downwards angle to the second horizontal segment. The second horizontal segment may extend off the vertical segment at an upward angle and may comprise the handle. The upper portion having the first and second horizontal segments and the vertical segment may permit the clamp to be applied to the lower uterine segment without crowding the surgical field.

[0018] The angled lower portion may comprise an adjoining segment extending from the pivot point and a horizontally separated segment terminating in the jaws extending from the adjoining segment. The first and second legs of the horizontally separated segment may be spaced apart from each other along a horizontal plane to facilitate the first and second jaws being separated from each other when the legs of angled upper portion and tire adjoining segment are in contact with each other. It is contemplated that this may reduce over compression of tissue and various structures when in use. Further, the padding may be maintained by the opposing jaws around the lower uterine segment and operative to form to the surface of the lower uterine segment. The padding may be any surgically acceptable, soft, and non-slip padding that a person of ordinary’ skill in the art may desire.

[0019] In some embodiments, the jaws may be disposed of at an angle off the end of the first and second legs proximate to the angled lower portion. Disposing of the jaws at an angle off the first and second legs may permit the clamp to be applied to the lower uterine segment in a manner operative to avoid surrounding structures, such as the ureters.

[0020] The latching means may be disposed along the angled upper portion operative to maintain the jaws at a selected distance from one another. In one embodiment, the latchingmeans may be configured as a first and second ratchet track, wherein the first ratchet track may extend toward the second leg from the first leg, and the second ratchet track may extend toward the first leg from the second leg. The first and second ratchet tracks may be operative to engage with one another to releasably lock the first and second legs in a desired position. For example, the first and second legs may be locked in a position such that the jaws may apply pressure to at least partially occlude blood flow in the lower uterine segment.

[0021] Each of the first and second ratchet tracks may comprise a plurality of teeth on an interior surface operative to releasably lock with each other. In some embodiments, when secured, any of the first ratchet track may be configured to extend over the second leg and any of the second ratchet track may be configured to extend over any of the first leg. It is contemplated, that the first and second ratchet tracks being operative to extend over any of the opposing leg may permit the clamp to accommodate a wide range of uterine sizes.

[0022] It is contemplated that the clamp may be configured to at least partially occlude blood flow in the lower uterine segment. More particularly, the clamp may be configured to at least partially occlude blood flow in the lower uterine segment from the uterine vessels without impacting the surrounding structures, such as the ureters. Indeed, a person of ordinary skill in the art will recognize that the ureters, which come into close proximity with the uterus, are at risk of damage when occluding blood flow in the lower uterine segment. This may result in urinary tract infections, catheters, and even subsequent surgeries to repair damage caused to the ureters during C-scctions. Tirus, it should be clear that minimizing impact to or contact with unintended or otherwise non-targeted structures during C-sections is a crucial object of the disclosed invention.

[0023] It is contemplated that surgical instruments, according to the disclosure and claims provided below, may reduce blood loss during cesarean sections.

[0024] Thus, it is an object of the invention to reduce complications caused by blood loss during childbirth.

[0025] It is a further object of the invention to provide a surgical instrument that may scale the movement between the surgeon and the jaws to pemrit rapid, yet precise, securement to a desired area.

[0026] It is another object of the invention to enable the targeted occlusion of blood flow in the lower uterine segment.

[0027] It is still another object of the invention to reduce damage to the urinary tract during the occlusion of blood flow in the lower uterine segment.

[0028] One or more of the above-disclosed embodiments, in addition to certain alternatives, are provided in further detail below with reference to the attached figures. The disclosed subject matter is not, however, limited to any particular embodiment disclosed.BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 shows a front perspective view of an embodiment of the surgical instrument.FIG. 2 show s a perspective view of an embodiment of tire angled upper portion of the surgical instrument.FIG. 3 shows a perspective view7of an embodiment of the latching means of the surgical instrument.FIG. 4 shows a perspective view of an embodiment of the angled lower portion of the surgical instrument.FIG. 5 shows an inner perspective view of an embodiment of the angled lower portion of the surgical instrument.FIG. 6 shows a front view7of an embodiment of the surgical instrument.FIG. 7 shows an embodiment of the clamp in use.FIG. 8 shows a view of the surgical instrument during use in a C-section.FIG. 9 shows an embodiment of a C-section method utilizing an embodiment of the clamp.

[0029] The disclosed embodiments may be better understood by referring to the figures in the attached drawings, as provided below. The attached figures are provided as non-limiting examples for providing an enabling description of the method and system claimed. Attention is called to the fact, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered as limiting of its scope. One skilled in the art will understand that the invention may be practiced without some of the details included in order to provide a thorough enabling description of such embodiments. Well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of tire embodiments.

[0030] For simplicity and clarity of illustration, the drawing figures illustrate the general manner of construction, and descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the invention. Additionally, elements in the drawing figures are not necessarily drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of embodiments of the present invention. The same reference numerals in different figures denote the same elements.

[0031] The terms “first,” “second,” “third,” “fourth,” and the like in the description and in tire claims, if any, are used for distinguishing betw een similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustratedor otherwise described herein. Furthermore, the tenns “include,” and “have,” and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, device, or apparatus that comprises a list of elements is not necessarily limited to those elements, but may include other elements not expressly listed or inherent to such process, method, system, article, device, or apparatus

[0032] The terms “couple,” “coupled,” “couples,” “coupling,” and the like should be broadly understood and refer to connecting two or more elements or signals, electrically, mechanically or otherwise. Two or more electrical elements may be electrically coupled, but not mechanically or otherwise coupled; two or more mechanical elements may be mechanically- coupled, but not electrically or otherwise coupled; two or more electrical elements may be mechanically coupled, but not electrically or otherwise coupled. Coupling (whether mechanical, electrical, or otherwise) may be for any length of time, e.g., permanent or semipermanent or only for an instant.DETAILED DESCRIPTION

[0033] Having summarized various aspects of the present disclosure, reference will now be made in detail to that which is illustrated in the drawings. While the disclosure will be described in connection with these drawings, there is no intent to limit it to the embodiment or embodiments disclosed herein. Rather, the intent is to cover all alternatives, modifications and equivalents included within the spirit and scope of the disclosure as defined by the appended claims.

[0034] With reference to FIG. 1, one embodiment of a surgical instrument for at least partial occlusion of blood flow in the lower uterine segment is illustrated as a clamp 100. The clamp 100 may comprise a first leg 102a and a second leg 102b pivotally connected to oneanother at a pivot point 104, a handle 112a, 112b disposed on an end of each of the legs 102a, 102b, a first jaw 130a and a second jaw 130b disposed at one end each of the respective first and second legs 102a. 120b opposite the handle 112a, 112b, and a latching means.

[0035] Each leg 102a, 102b may comprise an angled upper portion 110 extending above the pivot point 104 and an angled lower portion 120 extending below the pivot point 104. The pivot point 104 may permit movement at the angled upper or lower portions 110 and 120, respectively, to be reflected in the angled lower or upper portions 120, 110. The pivot point 104 may be defined by the point of the clamp where the first leg 102a and the second leg 102b pivot with respect to one another. As shown, the pivot point 104 is configured as a screw that secures the first and second legs 102a, 102b to each other and pennit them to rotate about the screw. In other embodiments, the pivot point may be configured as a box lock, hinge, or any other configuration that a person of ordinary skill in the art may desire.

[0036] FIG. 2 illustrates the angled upper portion 110 of tire clamp 100. In the embodiment illustrated, the handle may be configured as a first finger ring 112a and a second finger ring 112b, and the latching mechanism may be configured as a first ratchet track 114a and a second ratchet track 114b extending inwards off the first and second legs 102a, 102b toward one another to removably latch with each other. Of course, other handles and latching mechanisms that a person of ordinary skill in the art may desire can be utilized.

[0037] As shown in FIG. 3, the first and second ratchet tracks 114a, 114b may each comprise teeth on an inner surface operative to engage the first and second ratchet tracks 114a, 114b to each other. The teeth may overlap with each other to latch the first and second ratchet tracks 114a, 114b to each other, locking the first and second legs 102a, 102b in a set configuration. This may permit the first and second jaws 130a, 130b to secured at a distanceapart from each other in order to apply pressure to a desired area to at least partially occlude blood flow, discussed in more detail with reference to FIG. 7.

[0038] In the embodiment shown in FIG. 3, teeth defining the first and second ratchet tracks 114a, 114b extend over substantially all of tire inner surface of the first and second ratchet tracks 114a, 114b to permit the clamp 100 to accommodate a wide range of uterine sizes. As shown, any of the first ratchet track 114a may extend over and past the second leg 102b and the second ratchet track 114b may extend over and past the first leg 102a when the teeth are secured. It is contemplated that permitting the first and second ratchet tracks 114a, 114b to extend over the second leg 102b and the first leg 10a, respectively, may be operative to accommodate a wide range of uterine sizes. Of course, the first and second ratchet track need to extend past tire respective legs to secure with one another.

[0039] A person of ordinary skill w ill recognize that ratchet tracks come in many forms, including ratchet tracks wherein the ends are not configured to extend past the opposing leg w hen in a locked position, any form or size of ratchet track may be utilized without departing from the spirit of the current invention.

[0040] FIG. 4 illustrates the angled lower portion 120 of the clamp 100 comprising the first and second leg 102a, 102b, the first and second jaw 130a, 130b each jaw' comprising a padding 160a, 160b on its inner surface. Each leg 102a, 102b may comprise an adjoining segment 124 extending from the pivot point, and a horizontally separated segment 122 extending between the adjoining segment 124 and the first and second jaws 130a, 130b. The horizontally separated segment 122 may be spaced apart from each other on a horizontal plane X when the first and second legs 102a, 102b in the adjoining segment 124 are in contact with each other. Thus, it may be seen that when the first and second legs 102a, 102b are in contact with one another in the angled upper portion of the clamp (not pictured here), the adjoiningsegment 124 of the angled lower portion (collectively 124, 122) will also be in contact with each other. It is contemplated that tire first and second opposing jaws 130a, 130b being maintained at a distance from each other may reduce injuries related to the over compression of the lower uterine segment.

[0041] FIG. 5 shows an exemplary view of an inner surface of the first leg 102a, the first jaw 130a, and the padding 160a. It will be understood that an inner surface of the second leg may appear similarly to the first, and that only one of such inner surfaces is shown for the sake of brevity. The padding 160a may be any surgically acceptable, soft and non-slip padding that a person of ordinary skill in the art may desire. For example, the padding may be surgical foam, moleskin, silicone, gel. felt, or any other padding known in the art. It is contemplated that the padding 160a may permit the inner surface to form to the unique anatomy of each patient, reducing injuries related to the over-compression of tire lower uterine segment. While particular reference is made to the first leg, the second leg may comprise any of the characteristics discussed.

[0042] The inner surface of the first and second jaws may be configured in any manner that a person of ordinary' skill in the art may desire. For example, the inner surfaces may comprise the padding itself, sensors, or drug delivery means. In some embodiments, the padding may be independent of the clamp and may be applied directly to the lower uterine segment during use. In such embodiments, the clamp may be applied around the padding and may be operative to secure the padding in place.

[0043] In some embodiments, the clamp may be configured for a single-use and maybe disposed of after each use. In other embodiments, any of the clamp may be configured to permit sterilization and may be reusable. For example, the padding may be disposable and the first and second leg, latching means, and jaws may be formed of a medical -grade material thatmay be sterilized. The clamp may comprise metal, plastic, ceramic, or other medical-grade material. In one embodiment, tire clamp may comprise material selected from a group consisting of steel, titanium, plastic, polypropylene, chromium, nickel, and cobalt. Of course, other materials may be utilized, and the aforementioned are provided as non-limiting examples.

[0044] As shown, the jaws 130a, 130b may be reniform in shape. Of course, other shapes may be utilized to form the jaws, including, without limitation, oval, circular, rectangular, or any other shape, including non-uniform shapes, that a person of ordinary skill in the art may desire. The jaws may be any size operative to at least partially reduce blood flowin the lower uterine segment, for example, from about 5 inches to about half an inch in length and from about 4 inches to about 0.25 inches in total height. In one embodiment, the jaws maybe about 2 inches in length and may have a total height of about 1 inch.

[0045] FIG. 6 shows a side view of the clamp 100 to illustrate the angled upper portion 110, angled lower portion 120, and the first and second jaws 130a, 130b. In the embodiment shown, the angled upper portion 120 may comprise a first horizontal segment 604, a vertical segment 606, and a second horizontal segment 608 extending from each other to form a z- shape. The first horizontal segment 608 may extend from the pivot point towards the vertical segment 113. and the second horizontal segment 608 may extend from the vertical segment and may comprise tire latching means and the handle

[0046] The clamp 100 may have a total length between about 5 inches and 20 inches. The angled lower portion may be from about 3 inches to about 12 inches in total length, and the angled upper portion may be from about 2 inches to about 8 inches in total length. In one embodiment, the clamp may be about 10 inches in length, wherein the angled lower portion is about 6 inches in length and the angled upper portion is about 4 inches in length to accommodate atypical uterine cavity of a woman.

[0047] It is contemplated that the angled upper portion having a smaller length than the angled lower portion may be operative to scale movement applied on the angled upper portion to tire angled lower portion, and more particularly, tire jaws. Movement on the angled upper portion, such as moving the first and second legs medially, may result in a larger medial movement of the first and second jaws. It is contemplated that scaling the movement between the angled upper and lower portions may permit the jaws to be rapidly applied and removed from the lower uterine segment.

[0048] As shown in FIG. 6. the horizontally separated segment 122 may extend off the first and second jaws 130a, 130b at an upward angle 8 from about 5° to about 45°. In one embodiment, the angle 8 may be from about 10° to about 25°.

[0049] Hie length of the horizontally separated segment 122 and the adjoining segment 124 may be from about 2.125 inches to about 8.5 inches along the upward angle 8. For example, the horizontally separated segment 122 may be from about 1.5 inches to about 6 inches, and the adjoining segment 124 may be from about 1.0625 inches to about 2.5 inches in length. In one embodiment, the length of the horizontally separated segment 122 and the adjoining segment 124 may be about 4.25 inches in length, where the horizontally separated segment 122 may be about 3 inches in length and tire adjoining segment 124 may be about 1.25 inches and the upward angle 8 may be about 18°. A person of ordinary skill in the art will recognize that because the horizontally separated segment 122 and the adjoining segment 124 extend upward at tire angle 8, their total length in tire clamp 100 may be less than the length of tire individual components.

[0050] The vertical segment 606 may extend off the first horizontal segment 604 at a downward angle a, and the second horizontal segment 608 may extend off the vertical segment 606 at an angle 0. The angles a, 0 may permit the clamp 100 to secure to the lower uterinesegment while avoiding surrounding structures and minimizing obstruction of the surgical field.

[0051] The angle a may be from about 245° to about 45° and the angle 0 may be from about 180° to about 15°. In some embodiments, the angle a may be from about 145° to about 90° and the angle 0 may be from about 160° to about 100°. For example, angle a may be about 110° and angle 0 may be about 130°.

[0052] The length of the first horizontal segment 111 may be from about 1.5 inches to about 0.375 inches. For example, the first horizontal segment 111 may be about 0.75 inches in length. The length of the vertical segment 113 may be from about 4 inches to about 1 inch in length, for example, 2 inches in length. The second horizontal segment 115 may have a length from about 1.25 inches to about 5 inches, wherein the finger loops 114b may be from about 0.75 inches to about 3 inches of the second horizontal segment 115. For example, tire finger loops 114b may be about 1.5 inches in length, and the second horizontal segment 115 may be about 1 inch in length. As the first horizontal segment 111, vertical segment 113, and the second horizontal segment 115 extend off each other at angles a, 0 their total length in the clamp 100 may be less than the individual components.

[0053] FIG. 7 shows a placement of clamp 100 on the lower uterine segment to at least partially occlude blood flow during a C-section. As shown, the clamp 100 may be secured to a uterine artery and vein, collectively the uterine vessels 712, in the lower uterine segment 710 to at least partially occlude blood flow. More particularly, the clamp 100 may be secured to the uterine vessels 712 in alignment with the lower uterine segment 710 in a manner that avoids compressing the surrounding structures, such as ureters 720. Notably, a plurality of clamps 100, and, more particularly, two clamps 100 may be deployed in order to at least partiallyocclude blood flow in the uterine vessels 712 attached to respective left and right sides of tire patient's uterus 700.

[0054] Another view of tire clamp 100 in use is shown in FIG. 8. This view illustrates an exterior view of the clamp 100 during use during a C-section. A person of ordinary skill will recognize that FIG. 8 is not drawn to scale, but is instead drawn to best illustrate relevant structures. As shown, an incision is visible through a pregnant patient’s abdomen 802 and subcutaneous tissue 804 to reveal the uterus 700 and a uterine incision 702. Retractors 810 may be utilized to hold back the subcutaneous tissue 804 to expose the uterus 700 and uterine incision 702. The legs 102a. 102b may, in some instances, rest on the retractors 810. The angled upper and lower portions may permit the jaws to accommodate the depth of the incision and rest on the patient’s abdomen 802 and the retractors 804.

[0055] One method for the use of the clamp 100 during a C-section is illustrated in FIG. 9. The method may improve surgical outcomes during C-sections by reducing blood loss, improving the visibility of the surgical field, and reducing damage to surrounding structures. The method may comprise the steps of cutting an incision on a pregnant patient’s abdomen 902, dissecting subcutaneous tissue 904, cutting an incision through the patient’s uterus 906, delivering any baby 908 from the uterus, exposing the lower uterine segment 910. clamping padding to the uterine vessels 912, suturing the incision on the patient’s uterus 914. removing the surgical clamp and any padding from the uterine vessels 916, and closing the patient 918. As noted above, a patient will typically have left side and right side uterine vessels, relative to the uterus, therefore, the steps of clamping padding to the uterine vessels 912 may be performed twice. That is, two clamps and padding may be deployed - one for each set of uterine vessels.

[0056] A person of ordinary skill in the art will recognize that steps 902, 904, 906, and 908 are well-known steps in performing a C-section, and any method of performing such stepsmay be utilized. Once the baby has been delivered (block 908), any of the right or left side uterine vessels may be exposed (block 910), and a clamp may be placed around any of the right or left side uterine vessels (block 912) to at least partially occlude blood flow. In the interest of clarity, the clamp 100 will be described according to the exemplary embodiment of the clamp 100 illustrated in FIG. 1, though, of course, other embodiments of the clamp may be utilized.

[0057] FIG. 7 may be referenced to more clearly understand clamping padding according to block 912 in FIG. 9. Namely, and with reference to FIG. 7, tire clamp 100 may be positioned on either of the left or right side uterine vessels 712 where they enter the uterus 700, as shown by the placement of the clamp in FIG. 7.

[0058] Eachj aw 130a, 130b may be positioned on opposing sides of the uterine vessels 712. More particularly, a concave edge of each jaw 130a, 130b may be positioned to align with a lower end of an upper segment of the uterus. In addition, padding (obscured in the figure) may be maintained around opposing sides of the uterine vessels 712 in alignment with their entry into the lower uterine segment.

[0059] Positioning the clamp 100 on the uterine vessels 712 may occur when the first and second ratchet tracks 114a, 114b are not engaged with each other. An operating physician may move the first and second finger loops medially, creating a medial movement in the first and second jaws 130a, 130b until the clamp is applying pressure to the uterine vessels 712 to reduce blood flow. In some embodiments, the blood flow in the uterine vessels 712 may be at least partially occluded. In another embodiment, the blood flow in the uterine vessels 712 maybe entirely occluded. That is, the pressure applied to the uterine vessels 712 may be moderated by the user.

[0060] It is worth noting that while clamping padding to at least one uterine vessel(block 912) may comprise securing a clamp to each of the uterine veins and arteries, in somecmbodimcnts. the clamp may be placed on only one of the uterine veins or arteries. A person of ordinary skill will recognize that this may be done for a variety of reasons, including, w ithout limitation, time, location of tire incision, and the patient’s unique anatomy.

[0061] Returning to FIG. 9, the placenta may be delivered before, during, or after the placement of the clamp on the uterine vessels (block 912). It is contemplated that this may occur according to the preference of the operating physician, and the manner of performing these steps will not limit the invention.

[0062] Next, the uterus incision may be sutured (block 914). It is contemplated that clamping padding to the uterine vessel (block 912) to at least partially occlude the blood flowin the uterine vessels 712 may reduce the time needed to suture the uterus incision (block 914) since the risk of hemorrhage from such vessels is reduced. After the uterus incision has been sutured (block 914), any deployed clamps may be removed from the uterine vessels (block 916)., permitting blood flow back to the uterus. Removing the clamp from the uterine vessels (block 916) may comprise moving the first and second finger rings 114a, 114b laterally until the first and second jaws 130a, 130b release from the uterine vessels 712.

[0063] Returning again to FIG. 7, the patient may be closed (block 918). A person of ordinary skill in the art will recognize that steps 914 and 918 are known in the art and any technique may be utilized to accomplish these steps without limiting the invention.

[0064] It should be emphasized that the above-described embodiments are merely examples of possible implementations. Many variations and modifications may be made to the above-described embodiments without departing from the principles of the present disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

[0065] Moreover, embodiments and limitations disclosed herein are not dedicated to the public under tire doctrine of dedication if the embodiments and / or limitations: (1) are not expressly claimed in the claims; and (2) are or are potentially equivalents of express elements and / or limitations in the claims under the doctrine of equivalents.CONCLUSIONS, RAMIFICATIONS, AND SCOPE

[0066] While certain embodiments of the invention have been illustrated and described, various modifications are contemplated and can be made without departing from the spirit and scope of the invention. For example, the surgical instrument may be utilized in a variety of procedures and operations to reduce blood loss. Accordingly, it is intended that the invention not be limited, except as by the appended claim(s).

[0067] The teachings disclosed herein may be applied to other systems, and may not necessarily be limited to any described herein. The elements and acts of the various embodiments described above can be combined to provide further embodiments. All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions and concepts of the various references described above to provide yet further embodiments of the invention.

[0068] Particular tenninology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being refined herein to be restricted to any specific characteristics, features, or aspects of the surgical instrument and method for occlusion of uterine blood vessels with which that terminology is associated. In general, the terms used in the following claims should not be constructed to limit the surgical instrument and method for occlusion of uterine blood vessels to the specific embodimentsdisclosed in the specification unless the above description section explicitly define such terms. Accordingly, the actual scope encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing tire disclosed system, method and apparatus. The above description of embodiments of the surgical instrument and method for occlusion of uterine blood vessels is not intended to be exhaustive or limited to the precise form disclosed above or to a particular field of usage.

[0069] While specific embodiments of, and examples for, the method, system, and apparatus are described above for illustrative purposes, various equivalent modifications are possible for which those skilled in the relevant art will recognize.

[0070] While certain aspects of the method and system disclosed are presented below in particular claim forms, various aspects of the method, system, and apparatus are contemplated in any number of claim forms. Thus, the inventor reserves the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the surgical instrument and method for occlusion of uterine blood vessels.

Claims

CLAIMSWhat is claimed is:

1. A surgical instrument for at least partial occlusion of uterine blood vessels in a lower uterine segment, comprising; a first and a second leg pivotally connected to one another at a pivot point, each leg defined by an angled upper portion extending above the pivot point, and an angled lower portion extending below the pivot point; a handle disposed on an end of each of the first and second leg proximate to the angled upper portion; a first and second opposing jaw disposed on an end on each of the first and second leg proximate to the angled lower portion, each jaw having an inner surface and an outer surface, the inner surface configured to maintain a padding around the lower uterine segment; a latching means disposed along the angled upper portion operative to maintain the jaws at a selected distance from one another; wherein the first and second leg upper portions are angled together to define a first and second horizontal segment separated by a vertical segment to define an approximately z-shaped upper portion, and wherein the first and second leg lower portion are angled apart from one another along a horizontal plane such that when the upper portion are maintained in contact with one another, the first and second opposing jaw inner surfaces arc maintained at a distance from one another.

2. The surgical instrument of claim 1, wherein the locking means comprises a first ratchet track extending toward the second leg from the first leg and a second ratchet track extending toward the first leg from the second leg, each ratchet track operative to engage one another toreleasably lock the first and second legs in a desired position, wherein a terminal end of each of the first ratchet track is configured to extend past second leg and the second ratchet tracks is configured to at extend past the first leg when engaged in at least some positions.

3. The surgical instrument of claim 1 , wherein the spacing of the inner surfaces of the first and second opposing jaws is operative to avoid overcompression of uterine blood vessels when applied to such uterine blood vessels in the lower uterine segment.

4. The surgical instrument of claim 1, wherein the first and second opposing jaws are renifomi in shape.

5. Tire surgical instrument of claim 4, wherein a concave edge of each first and second opposing reniform shaped jaws is configured to align w ith a lower end of an upper segment of the uterus .

6. The surgical instrument of claim 1, configured to enable compression of at least a portion of uterine tissue while avoiding compression of a patient’s ureters.

6. The surgical instrument of claim 1, wherein the padding is a plurality of paddings, at least one each of the plurality of paddings affixed to the inner surface of tire first and second opposing jaws.

7. The surgical instrument of claim 6, wherein the padding is surgical foam.

8. The surgical instrument of claim 6, wherein tire padding is removable from tire inner surface the first and second opposing jaws and is disposable.

9. Tire surgical instrument of claim 1, wherein the angled upper portion of each first and second legs is shorter than the angled lower portion of each first and second legs rendering the surgical clamp operative to scale movement between the legs in the angled upper and lower portions.

10. The surgical instrument of claim 1. wherein each of the handles comprises a finger loop configured to accommodate one or more of a user’s fingers.

11. Tire surgical instrument of claim 1, wherein the first and second opposing jaws are angled relative to the angled lower portion.

12. A method for performing a cesarean section comprising the steps of: cutting an incision on the patient’s abdomen: dissecting through one or more layers of subcutaneous tissue to expose the uterus; cutting an incision through the uterus; delivering the baby; delivering the placenta; exposing the lower uterine segment; placing a first surgical instrument for partial occlusion of uterine vessels, the surgical instrument comprising:a first and a second leg pivotally connected to one another at a pivot point, each leg defined by an angled upper portion extending above the pivot point, and an angled lower portion extending below the pivot point; a handle disposed on an end of each of the first and second leg proximate to the angled upper portion; a first and second opposing jaw disposed on an end on each of the first and second leg proximate to the angled lower portion, each jaw having an inner surface and an outer surface, tire inner surface configured to maintain a padding around the lower uterine segment; a latching means disposed along the angled upper portion operative to maintain the jaws at a selected distance from one another; wherein the first and second leg upper portions are angled together to define a first and second horizontal segment separated by a vertical segment to define an approximately z-shaped upper portion, and wherein the first and second leg lower segments are angled apart from one another along a horizontal plane such that when the upper segments are maintained in contact with one another, the first and second opposing jaw inner surfaces are maintained at a distance from one another, positioning the padding around the lower uterine segment wherein the inner surface of the first jaw is positioned at a posterior side of the lower uterine segment and the inner surface of the second jaw is positioned at the anterior side of the lower uterine segment; moving the first and second legs medially, resulting in medial movement of the first and second jaws;applying pressure on the lower uterine segment through the first and second jaw to at least partially occlude blood flow; securing the latching means; suturing the uterus; releasing the latching means; removing the surgical instrument from the abdominal cavity; and closing the patient.

12. The method of claim 11, wherein the at least one latching means comprises a first ratchet track and a second ratchet track operative to lock the first hand and second legs in place, wherein an end of each of tire first ratchet track is configured to extend past the second leg and the second ratchet tracks is configured to at extend past the first leg when engaged in at least some positions.

13. A surgical instrument for at least partial occlusion of uterine blood vessels, comprising: a first and a second leg pivotally connected to one another at a pivot point, each leg defined by an angled upper portion extending above the pivot point, and an angled lower portion extending below the pivot point; a handle disposed on an end of each of tire first and second leg proximate to the angled upper portion; a first and second opposing jaw disposed on an end on each of the first and second leg proximate to the angled lower portion, each jaw having an inner surface and an outer surface, the inner surface configured to maintain a padding around the lower uterine segment;a first ratchet track disposed along the first leg in the angled upper portion extending towards the second leg; and a second ratchet track disposed along the second leg in the angled upper portion extending towards the first leg.

14. The surgical instrument of claim 13, wherein the first and second leg lower portion are angled apart from one another along a horizontal plane such that when tire upper portion are maintained in contact with one another, the first and second opposing jaw inner surfaces are maintained at a distance from one another.

15. Tire surgical instrument of claim 13, wherein each jaw further comprises a padding.

16. The surgical instrument of claim 15, wherein the padding is surgical foam.

17. The surgical instrument of claim 15, wherein the padding is disposable.

18. The surgical instrument of claim 13, , wherein the angled upper portion of each first and second legs is shorter than the angled lower portion of each first and second legs, operative to scale movement between the legs in tire angled upper and lower portions.

19. The surgical instrument of claim 13, wherein each of the handles comprises a finger loop configured to accommodate one or more of a user’s fingers.

20. The surgical instrument of claim 13, wherein the first and second leg upper portions are angled together to define a first and second horizontal segment separated by a vertical segment to define an approximately z-shaped upper portion.

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