SCALPEL FOR PERFORMING A CESAREAN SECTION

Abstract

A surgical scalpel including a handle with a proximal end and a distal end and which is hollow defines a notch that encases a blade. The scalpel alternatively may include two blades, wherein the blade which is used to perform the initial is retracted during the remainder of the procedure.

Claims

1. (canceled)

2. (canceled)

3. (canceled)

4. (canceled)

5. (canceled)

6. A device for performing a cesarean section, the device comprising: an elongate body comprising a curved anterior portion, a notch positioned proximal to the curved anterior portion, and a posterior portion, proximal to the curved anterior portion; a retractable blade component encased within the elongate body, the blade component comprising first and second blades, the first blade being encased within the curved anterior portion, the second blade being encased within the body, adjacent to the notch, the second blade being positionable across the notch; wherein the curved anterior portion is movable relative to the first blade to expose the first blade from the curved anterior portion to make an initial puncture in a uterine wall, the curved anterior portion further being moveable relative to the first blade to retract the first blade into the curved anterior portion after the initial puncture of the uterine wall to permit insertion of the curved anterior portion into the puncture, and wherein a bottom surface of the curved anterior portion is spaced apart from the second blade to separate the second blade from underlying tissue to prevent contact between the second blade and the underlying tissue.

7. The device of claim 6, wherein the anterior portion of the body comprises a slot, the first blade extending across the slot when exposed.

8. The device of claim 7, wherein the first blade is movable to different positions within the slot to permit different portions of a cutting edge of the first blade to be exposed across the slot.

9. The device of claim 6, wherein the first blade is located anterior to the second blade and wherein the second blade extends across the notch to expose a cutting edge of the second blade.

10. The device of claim 6, wherein the first blade is exposed before contact between the uterine wall and the device.

11. The device of claim 6, wherein the first blade is exposed only during the initial puncture of the uterine wall is performed.

12. The device of claim 7, wherein the first and second blade are slidable along the slot of the body.

13. The device of claim 6, further comprising a spring means connected between an end of the first blade and a fixed part of the elongate body.

14. The device of claim 6, further comprising a spring means connected between an end of the second blade and a fixed part of the elongate body.

15. The device of claim 6, wherein the first blade and the second blade are separate.

16. The device of claim 6, wherein the first blade and the second blade move relative to each other during use.

17. The device of claim 6, wherein the second blade has a concave portion.

18. The device of claim 6, wherein after the initial puncture, first blade is automatically retracted.

19. The device of claim 6, wherein the retractable blade component is a single, continuous blade in which the first blade is an anterior blade portion and the second blade is a posterior blade portion.

20. The device of claim 19, wherein the anterior blade portion and the posterior blade portion are exposed or sheathed within the elongate body independently of each other.

21. The device of claim 19, wherein the posterior blade portion of the single blade has a concave portion.

22. The device of claim 19, wherein the single blade is rotatable relative to the body to result in the anterior blade portion being sheathed within the curved anterior portion.

23. The device of claim 22, wherein when the anterior blade portion retracts within the curved anterior portion upon rotation of the single blade, the posterior blade portion becomes exposed.

24. A method of performing a caesarean section using a blunt scalpel device for preventing trauma to a fetus and mother, the method comprising: contacting a blunt anterior housing of the blunt scalpel device against a uterine wall; piercing the uterine wall by exerting pressure to expose a first blade component of the device from the blunt anterior housing; after the piercing, retracting the first blade component into the blunt anterior housing; and advancing the device to make a longitudinal incision in the uterine wall using a second blade component.

25. The method of claim 24, wherein the first blade is automatically retracted into the blunt anterior housing.

26. The method of claim 24, wherein the second blade component is sheathed during the piercing, the second blade component being exposed as device is advanced to cut longitudinally through the uterine wall.

27. The method of claim 24, wherein the advancing comprises separating uterine fibers without severing blood vessels or muscle structure. A device for performing a cesarean section, the device comprising:

Description

BRIEF DESCRIPTION OF DRAWINGS

[0024] FIG. 1 is a diagram of a device comprising a first and a second blade according to the present disclosure.

[0025] FIGS. 2A-2B are diagrams of a device comprising a blade having an anterior and posterior portion according to the present disclosure.

DETAILED DESCRIPTION

[0026] Various aspects now will be described more fully hereinafter. Such aspects may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art.

[0027] The first portion of the cesarean section procedure of the present invention is conventional. First, the patient is partially, or fully, anesthetized. Then a transverse incision (cut) is made in the abdomen using a sharp scalpel. For example, the incision may be the so-called bikini cut. In all cases, the incision is through the wall of the abdomen. The vesicouterine fold is opened and the bladder is retracted. Up to this point the surgical operation has followed the conventional and well-established procedure for cesarean sections.

[0028] In addition to the possibility of accidental laceration of the baby, the use of a traditional sharp scalpel also has the risk of the doctor extending the transverse incision too far and cutting blood vessels or muscle structure on the sides of the uterus. The use of the device of the present disclosure avoids that risk. Although it will separate the uterine fibers, when used properly it is unable to to sever blood vessels or muscle structure.

[0029] The baby's body is, at times, directly flush with the inner wall of the uterus. During many cesarean sections the amniotic fluid cushion is absent. That cushion of fluid normally protects the baby from surgical trauma. Such trauma may ensue following the contact if a sharp blade scalpel should penetrate the uterine wall and accidentally come in contact with the baby's body surface, causing a laceration.

[0030] FIGS. 1 and 2 show devices 10 and 110 according to the present disclosure. Each consists of a handle or body (20 or 120, respectively), which can be made of metal or plastic. If device 10 or 110 is made of metallic material, it can be sterilizable and reusable. In an alternative embodiment, handle 10 is disposable and made of, for example, plastic. Handle 20 has a top edge 30 and a bottom edge 40, wherein top edge 30 and bottom edge 40 are curved to provide the scalpel with a body that is easy to grasp. As illustrated at least in FIG. 2A, handle 120 has a top edge 130 and a bottom edge 140, wherein top edge 130 and bottom edge 140 are curved to provide the scalpel with a body that is easy to grasp. The curvature of the edges also can provide the physician with a clear indication of the correct orientation for the scalpel during surgery. Importantly, each device 10 and 110 has a notch (shown as 70 in device 10 and 170 in device 110) located between an anterior portion (80 in device 10 and 180 in device 110) and a ledge portion (90 in device 10 and 195 in device 110). Each notch houses the cutting edge of a blade as described below, providing protection from accidental or unintentional cutting by a practitioner with the device.

[0031] Device 10 comprises a first blade 50 and a second blade 60. First blade 50 is encased in part by the anterior portion 80 of handle 20. Device 10 can be disposable or resusable. When device 10 is disposable, it is generally used only for a single operation, since it may become dull or nicked. Each of first blade 50 and second blade 60 has a razor-sharp edge. That edge is sufficiently sharp so that, with very little pressure, it will cut normal skin. For example, if lightly drawn across a finger, it will cut the skin and the finger will bleed. Generally the blades are available in stainless steel or carbon steel and may be individually wrapped to protect their sterility.

[0032] In one embodiment, first blade 50 has a pointed tip to facilitate an initial incision of the skin. In another embodiment, second blade 60 has a concave portion as depicted, for example, in FIG. 1.

[0033] When device 10 is first contacted with the skin, first blade 50 is exposed to complete an initial cut. Importantly, the sharp cutting edge of first blade 50 is positioned such that it is oriented away from tissues (fetus) present beneath the initial cut. After the initial cut, device 10 is advanced to make a longitudinal incision in the skin. As device 10 is advanced, first blade 50 is automatically retracted. Second blade 60 can be exposed or sheathed during the initial cut by first blade 50. Second blade 60 is exposed as device 10 is advanced to cut longitudinally through the skin and, optionally, underlying tissue.

[0034] A second aspect of the device is illustrated in FIGS. 2A and 2B as device 110. As shown in FIG. 2A, device 110 encases a single blade 150 shaped such that two portions, represented in FIG. 1 as anterior blade portion 160 and posterior blade portion 170, may be exposed or sheathed within a handle 120 either together or independently. Blade 150 comprises an exterior edge which comprises a sharp cutting edge which may run along the partial or full length of the exterior edge of blade 150. As with device 10, handle 120 of device 110 has a top edge 130 and a bottom edge 140.

[0035] In one embodiment, single blade 150 has a pointed tip to facilitate an initial incision of the skin. In another embodiment, posterior blade portion 170 has a concave portion as depicted, for example, in FIG. 2A.

[0036] When device 110 is first contacted with the skin in preparation for puncture or incision, anterior portion 160 of single blade 150 is exposed to complete an initial cut. Importantly, the sharp cutting edge of blade 150 is positioned such that it is oriented away from tissues (fetus) present beneath the initial cut. After the initial cut, device 110 is advanced to make a longitudinal incision in the skin. As device 110 is advanced, single blade 150 rotates slightly to result in anterior portion 160 of single blade 150 being encased within the anterior portion of handle 120. FIG. 2B illustrates this embodiment, showing that the anterior end of single blade 150 has retracted in a posterior direction and thus anterior portion 160 of single blade 150 is now fully encased within anterior portion 180 of device 110. Posterior portion 170 of single blade 150 becomes exposed with the rotation of single blade 150 which resulted in sheathing of anterior portion 160.

[0037] Device 10 or 110 is molded from a plastic or metal material to have a hollow portion which can encase partially or wholly first blade 50 and/or second blade 60 of device 10 or anterior section 160 and/or posterior section 170 of device 110. This hollow portion can be straight, convex or concave.

[0038] Preferably, the body of device 10 or 110 has an overall length of about 3 to 5 inches, and more particularly between 4 to 6 or 4 to 5 inches, because range can accommodate physicians with hands in the range of 6 to 8 inches. The width of the body of device 10 or 110 can range between 0.8 to 1.0 inches and have a thickness of between 0.150 and 0.250 inches. A scalpel having a body of about 4.8 inches in length, a width at point 80 of 0.9 inches and a maximum thickness of about 0.2 inches is particularly advantageous.

[0039] In one aspect is a method for performing a cesarean section procedure using the device as disclosed herein. The patient is partially or fully anesthetized. A transverse incision (cut) is made through the wall of the abdomen using a sharp scalpel. Then, device 10 or device 110 is used to cut through the wall of the uterus. An incision is made using first blade 50 of device 10 or anterior portion 160 of device 110, preferably of less than 1 mm, through the tough outer surface layer of the uterus. Device 10 or 110 is then advanced to make a transverse incision, wherein the incision involves cutting by second blade 60 or posterior portion 170. This separates muscle fiber and opens up the uterus wall, forming a transverse incision. This incision is through the wall of the uterus, e.g., through the myometrium and the endometrium.

[0040] The remainder of the cesarean section operation is conventional. The incision may, if desired, be enlarged by hand pressure. The baby is extracted and the uterus and abdomen repaired.

[0041] In addition to the possibility of accidental laceration of the baby, the use of a sharp scalpel also has the risk of the doctor extending the transverse incision too far and cutting blood vessels or muscle structure on the sides of the uterus. The use of the blunt scalpel of the present invention avoids that risk. Although it will separate the uterine fibers, it is too blunt to sever blood vessels or muscle structure.

[0042] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.