Venous drainage catheter and method of use

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S104000, C604S164030, C604S105000, C606S191000, C606S194000, C606S198000

Reexamination Certificate

active

06270490

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a venous drainage catheter for drainage of blood from the right atrium, inferior vena cava, or superior vena cava during cardiopulmonary bypass. More particularly, the invention relates to a venous drainage catheter comprising a cannula and expanding members disposed circumferentially about drainage ports for maintaining fluid access to the drainage ports.
BACKGROUND OF THE INVENTION
Cardiopulmonary bypass is commonly used to maintain oxygen delivery to peripheral organs during cardiopulmonary arrest in a variety of cardiothoracic surgeries, septal defect repairs, heart valve repairs and replacement, aneurysm repairs, and corrections of congenital defects. Before cardiopulmonary bypass can be initiated, the heart and coronary blood vessels must be isolated from the peripheral vascular system. This is usually accomplished by arterial cannulation of the aorta and venous cannulation of the right atrium, inferior vena cava, or superior vena cava. Venous drainage catheters are commonly used to withdraw the deoxygenated blood from the right atrium, inferior vena cava, or superior vena cava, pass it to a bypass oxygenator machine, and the blood is thereafter returned to the patient's aorta.
Venous drainage catheters typically include at least one drainage port at the distal end. However, the walls of the organ or vessel within which the drainage ports are disposed will often close down around the drainage ports and thereby obstruct the flow of blood into the cannula. This difficulty will often prevent adequate drainage of blood to the bypass oxygenator machine. Thus, a need exists for an improved venous drainage catheter to prevent obstruction of drainage ports by adjacent tissues during operation.
SUMMARY OF THE INVENTION
The present invention solves these and other problems by providing a venous drainage catheter comprising a cannula having drainage ports at its distal end, and expanding members disposed about the drainage ports. The expanding members serve to keep the organ walls from closing down around the cannula drainage ports. This result is accomplished by providing a larger surface area in the target vessel or organ than is obtainable from conventional catheters or cannulae. This feature promotes flow into the targeted site. This feature of providing a larger surface area also helps to create a venturi effect to facilitate drainage. The expanding members may comprise ribs, fins, mesh, or arms, and generally are embodied as bellows. By use of the present invention, the incision site or the access into the organ is substantially smaller than the expanded diameter of the expanding members.
The present invention relates to a venous drainage catheter comprising a cannula, expanding members, and an actuating mechanism for operating the expanding members. The cannula will generally have a proximal end, a distal end, and a lumen therebetween, the proximal end being shaped for attachment to a bypass oxygenator machine. The distal end will typically include at least one drainage port, or more preferably, a plurality of drainage ports comprising two drainage ports, more preferably three drainage ports, more preferably four drainage ports, more preferably five drainage ports, or more. The drainage ports are in fluid communication with the lumen of the cannula.
The expanding members can be any of ribs, fins, mesh, arms, or bellows. The expanding members are disposed circumferentially about the drainage ports, and may be mounted on the cannula or carried by some other member. The expanding members are capable of expanding from a collapsed condition to a radially expanded condition.
The actuating mechanism for operating the expanding members may include any mechanism that allows deployment of the expanding members by operation from a location proximal the expanding members on the cannula. As but one example of an actuating mechanism, the invention provides a cylindrical sheath disposed circumferentially about the expanding members to maintain the expanding members in a collapsed condition. The sheath is slidable proximally to release the expanding members, where upon the expanding members expand radially outwardly. In certain embodiments of the invention, the sheath will further include a rib mounted at its proximal edge, the rib shaped to engage an incision during use. The rib provides an anchor to stabilize the sheath during advancement of the cannula distally, and may also provide a hemostatic seal to prevent blood loss during use of the venous drainage catheter.
The invention also provides a tubular housing for use in a venous drainage catheter system. The tubular housing includes a proximal end, a distal end, and a lumen therebetween. The lumen is shaped to receive the blood cannula. At a proximal end of the housing, a side opening is provided which communicates with the lumen of the housing and is shaped to allow passage of the cannula through the side opening. The distal end of the housing may have an opening positioned to align longitudinally with the drainage port of the cannula. The expanding members may be disposed circumferentially about the one or more distal openings on the housing, and the expanding members may be mounted on the tubular housing.
The invention also provides methods for draining venous blood from the right atrium of a patient. The surgeon provides a venous drainage catheter as described herein. The surgeon makes an incision in the patient to provide access to the atrial appendage. The cannula, or housing, is inserted through the incision and into the right atrium. The expanding members are activated to the expanded condition to hold tissue away from the drainage port. When a housing is used, the drainage cannula is inserted through the proximal opening of the housing and advanced distally into the atrium. The drainage ports are aligned with a distal opening on the housing. In both methods, the proximal end of the cannula is then attached to a bypass oxygenator machine. Venous blood is then withdrawn from the right atrium and is oxygenated before return to the patient's arterial circulation.
According to the invention, the atrial appendage may be sealed circumferentially about the venous drainage catheter by use of a purse-string suture. In another method, the venous drainage catheter includes the cylindrical sheath disposed about and covering the expanding members to maintain them in a collapsed condition. During use, the cylindrical sheath engages the incision, and is held stable while the cannula is advanced distally, thereby sliding beyond the sheath. By sliding the cannula distally, the expanding members are released inside the right atrium and thereby expand to an expanded condition.


REFERENCES:
patent: 3938530 (1976-02-01), Santomieri
patent: 4808163 (1989-02-01), Laub
patent: 5112310 (1992-05-01), Grobe
patent: 5415630 (1995-05-01), Gory et al.
patent: 5456667 (1995-10-01), Ham et al.
patent: 5618270 (1997-04-01), Orejola
patent: 5637097 (1997-06-01), Yoon
patent: 5707362 (1998-01-01), Yoon
patent: 5954745 (1999-09-01), Gertler et al.
patent: 5984908 (1999-11-01), Davis et al.
Laub, Glenn W. et al., “Novel System for Percutaneous Cardiopulmonary Bypass,”Journal of Investigative Surgery, vol. 4, No. 2, pp. 217-230, 1991.
Laub et al., “Novel System for Percutaneous Cardiopulmonary Bypass,”Journal of Investigative Surgery, 4:217-230 (1991).
Takana et al., “Clinical Evaluation of a High-Flow Venous Cannula with Umbrella-Type Basket Tip,” Abstract, ASAIO, 44thAnnual Conference, New York, NY (Apr. 1998).

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