Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-02-15
2003-08-05
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S034000, C604S167060, C604S164070, C604S165020, C604S171000, C251S004000
Reexamination Certificate
active
06602240
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to medical devices and methods and more particularly to devices and methods for sealing the lumen of a medical device for maintaining hemostasis (control of bleeding) attendant to the use of minimally invasive transluminal, endoluminal and other such devices and procedures wherein devices such as sheaths, through which other catheter devices are passed, are inserted percutaneously or surgically into a blood vessel of a patient, or in cases of laparoscopic procedures where sealing the lumen is to control the leakage of CO
2
gas used to insufflate a body cavity.
Minimally invasive interventions have become increasingly popular for approaching a variety of diseases such as the diagnosis and treatment of coronary heart disease using stent devises, laparoscopic procedures in general surgery, neurovascular disease for implanting coils, stents and other procedures, venous disease for placing vena cava filters or other procedures, as well as treatment of abdominal aortic aneurysms using stent grafts that are placed in the aorta or other vessels. The sizes of the catheter devices used to perform these therapies can range from 3 French to 30 French (0.039″ to 0.393″). Typically the devices that are used are within a 7 to 24 French (0.066″ to 0.315″) diameter.
In procedures such as these, a device known as an access sheath, also known as an introducer sheath, is typically placed through the skin in the upper thigh area of a patient's leg, either through a surgical cutdown or a percutaneous puncture, and down into the lumen of a blood vessel (vein or artery) with a technique known as the Seldinger technique (physician uses the “flashback” or blood spurt to confirm that the center of the lumen has been reached by the device), once a sheath is placed, most procedures employ catheter devices that are then inserted through the sheath and into the blood vessel at some distance away from the intended treatment site, and are then advanced through the vessel lumen until the selected treatment location is reached. In most instances this approach is performed “over the wire”, a technique that requires the physician to first place a guidewire device through the sheath and into the vessel lumen over which the larger catheter device can be tracked to the remote location.
The access sheaths that are employed for initial entry into the vessel typically include an integral hemostasis valve of some kind on the proximal portion of the device. There are numerous designs, including “duck-bill” type valves, valves that stretch and re-coil to accommodate various devices such as “iris” type valves, and various perforated elastomer valves. For example, U.S. Pat. No. 4,436,519 discloses a removable hemostasis valve having a “duck bill” type construction. U.S. Pat. No. 5,685,858 discloses a sliding valve for use with a catheter when no sheath is used. U.S. Pat. No. 4,738,658 discloses a tapered valve for use when a sheath is removed. U.S. Pat. No. 5,423,762 discloses a modular catheter sheath introducer with a replaceable hemostasis valve. During a procedure, however, these valves can fail, leading to leakage around the catheter and the valve, resulting in increased blood loss.
Given the popularity of less invasive techniques and their success, a broad range of devices or varying diameters are being used through sheaths, and the procedures are becoming increasingly complex and time consuming, making hemostasis over the duration of the procedure of paramount importance. A common problem during these procedures is a “leaky valve”, or the inability to maintain hemostasis around the catheter or wire using the integral sheath valve. In many procedures using larger devices such as aortic stent grafting, leaking valves can be quite commonplace. Currently, some surgeons and interventionists (radiologists, cardiologists) resort to tying gauze strips around the leaking section in an attempt to stem the flow of leaking blood. Typically the gauze just absorbs the blood and does not provide a durable solution. Various attempts have been made to come up with an improved integrated valve to deal with these issues with limited success.
There is a need for improved ancillary devices and methods for more effectively maintaining hemostasis, often after the existing valves have degenerated during a procedure, either due to multiple catheter exchanges (a time during the procedure when no catheter is in place and only a guidewire remains in the sheath), or the use of large catheter devices such as during the placement of stent grafts (some up to 32 French). It would be desirable to have an ancillary device that allows a physician to quickly regain hemostasis during the procedure thereby minimizing blood loss, while still being able to pass additional devices through the indwelling sheath once the ancillary device is placed, and complete the procedure as intended.
It would be desirable to have a device that can be applied to an existing sheath device to provide axial compression along the shaft of the sheath device and radial pressure around any devices introduced through the sheath, to block any leakage that may be flowing from the compromised valve at the proximal end of the sheath. Such a device would need to accommodate a guidewire and other catheters to pass through it so that the procedure can be completed. In addition, it would be desirable for such a compression device to be fixedly connected to said sheath during the time when hemostasis is desired, but also be removable from the sheath device in the event that the sheath is removed or changed during the procedure, or is no longer necessary.
Furthermore, it would be desirable to have a system of devices and methods that are easily applied around an indwelling sheath, either by the physician or the assisting staff, and that do not add unacceptable bulk to the catheter body already in place against the patient's skin. It is desirable that such improved devices be cost effective and adaptable to accommodate various sheath sizes, while still allowing the physician to pass additional catheters and instruments through the ancillary devices while continuing to minimize blood loss.
It would be further desirable to apply the compression device of the present invention to achieve hemostasis without requiring the removal of any indwelling instrumentation (such as catheters and guidewires), or having to thread such compression device over the entire length of the indwelling instrumentation to reach the desired point of hemostasis.
SUMMARY OF THE INVENTION
These and further objectives and advantages are met by the design and use of the various embodiments of the present invention. The present invention provides for improved methods and apparatus for providing a seal around a primary treatment device, such as, for example, regaining hemostasis during an intraluminal procedure when the primary means of hemostasis is compromised or fails, or in the case of laproscopic procedures, to control leakage of gas used to insufflate a body cavity. For purposes of this specification, the terms “standard introducer sheath” or “catheter”, or “integral valve”, “laparoscopic trocar or port” or “guidewire” shall all refer to primary treatment devices that have been placed in the patient prior to a medical procedure or during the procedure, usually endoluminally or percutaneously. Usually a standard introducer sheath will have an integral valve or elastic orifice at the proximal end to aid in hemostasis, but still allow the passage of therapeutic or diagnostic devices therethrough. In some instances, a sheath is not used, and therefore the therapeutic device may be a primary treatment device itself, such as a catheter with a valve. It should be noted however, that in the case of a procedure performed without a sheath the device of the present invention may be applied as the primary means of sealing by way of attachment around the proximal portion of the treatment device, such as a laparoscopic trocar or an
Hermann George D.
Hill Bradley
Holmgren Neil
Howell Thomas
Whittemore Joshua
Fogarty Thomas J.
Morrison & Foerster / LLP
Thissell Jeremy
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