Surgery – Instruments – Sutureless closure
Reexamination Certificate
2001-09-07
2003-12-30
Truong, Kevin T. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S108000, C227S175100
Reexamination Certificate
active
06669714
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for locating a puncture hole in a liquid-carrying vessel in a human or animal body. In particular it relates to device for locating puncture holes in blood vessels. Such devices can be used to accurately position a stapling mechanism at the puncture site in a blood vessel after a catheterisation procedure.
BACKGROUND TO THE INVENTION
When performing catheterisation procedures, such as angiography or angioplasty, a catheter is generally introduced into the vascular system by first penetrating the skin, underlying tissues and blood vessel with a sharpened hollow needle. Next, a guidewire is commonly inserted through the lumen of the hollow needle and is caused to enter the selected blood vessel. Subsequently the needle is typically stripped off the guidewire and a combination of a dilator and/or introducer (or an introducer alone) are fed over the guidewire and pushed through the skin to enter the blood vessel. The guidewire can then be removed and a desired catheter to carry out the procedure is fed through the lumen of the introducer and advanced through the vascular system until the working end of the catheter is appropriately positioned. Following the conclusion of the catheterisation procedure the working catheter will be withdrawn and subsequently the dilator and/or introducer will also be removed from the wound. Following this procedure the vessel puncture must be closed in order to prevent loss of blood through the puncture hole.
Typically the wound is closed by maintaining external pressure over the vessel until the puncture naturally seals. This procedure can take approximately 30 minutes with the length of time usually being greater if the patient is hypertensive or anticoagulated. The procedure can also be uncomfortable for the patient and involves costly professional time on the part of the hospital staff. Other pressure techniques such as pressure bandages, sandbags or clamps have been employed but these also involve ensuring the patient remains motionless for an extended period of time and is monitored to ensure the effectiveness of the procedure.
WO 98/17179 discloses a surgical stapler having a blood locator tube adjacent the stapling head. A guidewire passes through an opening at the end of the tube and up through a hollow bore in the tube, so that the stapler can be fed onto the guidewire and down onto the puncture site. When the device reaches the puncture site, the tip of the tube enters the blood flow within the artery and blood passes through the tube and out of the distal end at a point visible to the clinician. The clinician can then actuate the stapling mechanism in the knowledge that the stapling head is at the puncture site in the arterial wall.
The invention aims to provide an improved form of device for locating a puncture site in a liquid-carrying vessel such as a blood vessel.
SUMMARY OF THE INVENTION
According to the present invention there is provided a device for locating a puncture hole in a liquid-carrying vessel in a human or animal body, the device comprising a hollow tube having front and rear openings respectively at opposite front and rear ends of the tube to allow the tube to slide along a guidewire passing through the tube, wherein the front opening comprises a first portion for slidably accommodating the guidewire and at least one second portion to allow liquid from the vessel to flow back through the tube, the device being configured such that a guidewire at least above a certain diameter in the first portion of the front opening is restrained against moving into the second portion.
In a further aspect the invention also provides a surgical stapler comprising a stapling mechanism located on an end of a shaft and a device adjacent the stapling mechanism for locating the end of the shaft at a puncture site in a liquid-carrying vessel in a human or animal body, wherein the device comprises a hollow tube having front and rear openings respectively at opposite front and rear ends of the tube to allow the tube to slide along a guidewire passing through the tube, wherein the front opening comprises a first portion for slidably accommodating the guidewire and at least one second portion to allow liquid from the vessel to flow back through the tube, the device being configured such that a guidewire at least above a certain diameter in the first portion of the front opening is restrained against moving into the second portion.
In a still further aspect the invention provides a method of stapling closed a puncture site in a liquid-carrying vessel in a human or animal body, comprising the steps of:
introducing a stapling mechanism to the location of the vessel;
positioning the stapling mechanism at the puncture site by means of a locator device associated with the stapling mechanism, the locator device sensing the position of the puncture site by entering the vessel at the site; and
delivering a staple to, and deforming the staple to close, the puncture site;
wherein the locator device comprises a hollow tube having front and rear openings respectively at opposite front and rear ends of the tube to allow the tube to slide along a guidewire passing through the tube, wherein the front opening comprises a first portion for slidably accommodating the guidewire and at least one second portion to allow liquid from the vessel to flow back through the tube, the device being configured such that a guidewire at least above a certain diameter in the first portion of the front opening is restrained against moving into the second portion.
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Anthony Thomas
Coleman James
Cummins Christy
Martin Chris
Morris Sean
Nutter & McClennen & Fish LLP
Pantuck Bradford C
Truong Kevin T.
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