Medical instrument system for piercing through tissue

Surgery – Instruments – Obstetric or gynecological instruments

Reexamination Certificate

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Details

C604S164010

Reexamination Certificate

active

06293952

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to medical instruments and, in particular, a system and method for placing a cannula through tissue.
2. Prior Art
Culdoscopy is a well known medical procedure for visualization of the pelvic organs by means of an optical instrument through the vaginal route. In the past a relatively large trocar was used to pierce through the peritoneum wall. However, because of the close proximity of the colon and the uterus and because of the relatively large size of the trocar, a surgeon could inadvertently penetrate into or damage the uterus or colon. Precise positioning of the trocar was not always consistent. The present invention is intended to overcome these problems and provide an easier to use and more consistently precise system.
Culdoscopy was abandoned in the 1970s as laparoscopy provided a panoramic view of the pelvis and was shown to be superior for tubal sterilization. Difficulties and complications of culdoscopic sterilization were, however, associated with visualization and exteriorisation of the tube. The advantages of culdoscopy in infertility were stressed in the French and English literature. While the technology of laparoscopy was continuously improved the technique of culdoscopy did not advance after the 1960s.
Diagnostic laparoscopy as a standard procedure in the investigation of infertility is frequently performed in healthy women without obvious pelvic pathology resulting in normal findings or pathology of doubtful clinical significance. Unfortunately, laparoscopy is not innocuous and should be considered as a major surgical procedure. For these reasons the procedure is frequently postponed in asymptomatic patients until a later stage in the investigation process, and repeat procedures to evaluate the evolution of disease or to check the effect of treatment are not considered routine clinical practice. Minilaparoscopy is likely to be more acceptable by avoiding general anesthesia. However, the access from the umbilicus used in laparoscopy does not give the ideal angle for inspecting the tubo-ovarian structures. To expose the full ovarian surface and fossa ovarica several steps are required such as Trendelenburg position, distension by CO
2
pneumoperitoneum, insertion of a second trocar and manipulation of bowel and adnexa. The CO
2
pneumoperitoneum provokes patient's discomfort and the acidosis is potentially harmful to the patient and, where intrafallopian transfer procedures are involved, to gametes and embryos. Concern has also been expressed that growth and spread of tumor cells may be accelerated by laparoscopy with air or CO
2
. Finally, structures such as fimbriae and avascular adhesions are easier to inspect by hydroflotation than with a pneumoperitoneum. The use of saline as the distension medium in diagnostic laparoscopy is attractive but impracticable with the patient in the Trendelenburg position.
SUMMARY OF THE INVENTION
Unlike culdoscopy used in the past, a patient undergoing minihydroculdoscopy in accordance with the present invention can be positioned in a lithotomy position on her back; not in a knee-chest position as in the old style culdoscopy. This has the advantage of less risk of the patient falling off of the examining table. Unlike culdoscopy used in the past which required relatively large patient sedation because of the pain from use of a large trocar, minihydroculdoscopy in accordance with the present invention can be used with only local anesthesia because only a small puncture hole is pierced and then expanded in a less painful manner than merely puncturing a large size hole. Puncturing a relatively large size hole used in culdoscopy in the past required larger force than with puncturing the relatively small size hole with the present invention. Thus, the present invention provides less risk that the needle will travel too far past the peritoneum wall after puncture occurs. In addition, unlike culdoscopy used in the past with the patient in the knee-chest position, minihydroculdoscopy in accordance with the present invention allows the doctor to view the patient's body behind the peritoneum wall in a more readily recognizable position. Thus, less orientation confusion occurs to the doctor.
In accordance with one embodiment of the present invention, a medical instrument guide is provided comprising a leading end, a shaft and a rear end. The leading end has a general ball shape and a guide channel therethrough. The leading end is sized and shaped to seat in a vagina against a peritoneum wall of a patient. The shaft extends from the leading end. The rear end is connected to the shaft and is sized and shaped to be held and manipulated by a user. The guide can be inserted into the patient's vagina and positioned against the peritoneum wall such that a medical instrument can be inserted through the guide channel to a position against the peritoneum wall below the patient's uterus.
In accordance with another embodiment of the present invention, a Veress needle assembly is provided comprising a tubular needle shaft, and a tubular obturator. The tubular needle shaft has a needle tip. The tubular obturator is slidably located inside the needle shaft and has an open front end. The obturator has an extended position with its front end in front of the needle tip of the needle shaft and a retracted position with its front end located behind the needle tip. The obturator forms a channel therethrough to pass an article out the open front end.
In accordance with another embodiment of the present invention, a medical instrument system is provided comprising a cannula, a dilating obturator, a first Veress needle assembly and a second Veress needle assembly. The dilating obturator is located inside the cannula. The first Veress needle assembly has a first tubular needle shaft and a first needle tip obturator slidably located in the first needle shaft with a closed blunt front end. The second Veress needle assembly has a second tubular needle shaft and a second needle tip obturator slidably located in the second needle shaft with a tubular shape having an open front end. The first and second Veress needle assemblies are alternatively slidably located in the dilating obturator.
In accordance with another embodiment of the present invention, a medical instrument is provided for piercing through tissue. The instrument comprises a Veress needle and a positioner. The positioner has a locator section sized and shaped to be inserted in a vagina of a patient and located against a peritoneum wall of the patient. The positioner has the Veress needle movably mounted thereto. The positioner further comprises means for moving the Veress needle forward on the positioner a predetermined limited longitudinal distance from a home position on the positioner.
In accordance with another embodiment of the present invention, a medical instrument is provided for piercing through tissue. The instrument comprises a Veress needle assembly and a dilating obturator. The dilating obturator has the Veress needle assembly slidably connected thereto. The dilating obturator has retractable laterally extending cutting blades at a front end thereof.
In accordance with another embodiment of the present invention, a medical instrument for access through tissue is provided comprising a cannula and a combined Veress needle and dilator assembly. The combined Veress needle and dilator assembly has a one-piece tube shaped frame piece with a needle tip section and a dilating outwardly expanding section behind the needle tip section. The combined Veress needle and dilator assembly further comprises a spring loaded safety obturator located at the needle tip section. The one-piece frame piece of the combined Veress needle and dilator assembly is adapted to both pierce a small hole through tissue and expand the hole in the tissue to about the same size as the cannula.
In accordance with another embodiment of the present invention, a Veress needle assembly is provided comprising a frame and a pressure

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