The invention relates to medical cannulas; particularly to medical cannulas used in cardiac surgery.
Cannulas and catheters are commonly used throughout numerous medical and surgical procedures to transfer fluids in and out of vessels and cavities of a patient. In open heart surgery, a cardiopulmonary by pass support system is used to temporarily replace the functions of the heart and lungs by supplying oxygenated blood to the patient's circulatory system. While the patient is on the support system, the ascending aorta is clamped off and the heart can be stopped to facilitate its repair. An aortic cardioplegia cannula is initially inserted into the ascending aorta for supplying anterograde cardioplegia solution to the heart. The heart also receives retrograde cardioplegia from a different source to facilitate perfusion of the heart. The heart is stopped and can then be repaired with one or more anastomoses of a vessel graft (typically a saphenous vein) creating a new blood flow path directly from the ascending aorta to the heart. This procedure is known as “coronary bypass” around the blocked coronary arteries.
This surgical procedure typically utilizes a cardioplegia/vent cannula having a proximal “Y” junction whereby cardioplegia solution can be initially supplied to the heart, then when desired, the cardioplegia line can be closed off, and the vent line (connected to a vacuum system) can be opened to evacuate air and blood from the ascending aorta to facilitate the anastomoses surgical procedures. A device typical of such prior art cardioplegia/vent cannulas is described in U.S. Pat. No. 4,596,552 entitled Cardioplegia Cannula by DeVries. This cannula in the patent to DeVries illustrates a typical distal tip, having a fixed length, which extend a relatively short distance into the aorta.
Recent data shows that minimizing the manipulation of the ascending aorta during surgery minimizes the chances of embolization and possible “stroke”. Most surgeons therefore typically only apply the cross clamp once, and perform all proximal and distal anastomoses during the same cross clamp application. When this technique is used, the patient continues to receive retrograde cardioplegia while the proximal anastomoses are being performed. The patient and the ascending aorta are naturally in the supine, horizontal orientation; thus, the aortic root fills up with blood coming from the left main and right main coronary arteries. The operating field is usually flooded with blood, impairing adequate visibility of the field by the surgeon. The aortic cannula is then vented to keep the field as dry and clear as possible. The present aortic cannulas have a fixed length intra-aorta distal tip, which extend a fixed (relatively short) distance into the aorta. The short length is required to allow the cannula to be inserted into the vessel by a trocar (large tubular needle), extended through the distal tip of the cannula, without damage to the opposed wall of the vessel.
The present cannulas typically are able to clear the blood only from the upper region of the aorta. This limited venting may not provide optimum visibility for the proximal anastomoses procedures, and may preclude possible advantageous proximal anastomoses along the mid and lower sides of the aorta. It would be highly desirable to have a vent cannula with a distal tip that could be extended, if necessary, to more effectively clear the surgical field of the aorta during heart surgery.
In view of the foregoing, it is an object of the present invention, to provide a cannula having an extendable distal tip.
It is another object to provide an aortic vent cannula having an extendable distal tip, and which is compatible with current introducer devices, cardioplegia flow and suction features of current cardioplegia cannulas.
The foregoing objects are accomplished by the present invention of an improved vent cannula having an extendable tip for venting and clearing a surgical field. Briefly, the vent cannula comprises a tubular base having a primary passage therein with a distal end and having an interconnected, angled secondary passage therein, and a flexible tube slidably positioned within the secondary passage than is extendable into the primary passage and through the distal end to extend the functional tip of the cannula.
In more detail, the vent cannula includes a tubular base having a primary longitudinal passage therein with a primary distal tip for insertion into a body vessel. The base has a lateral flange for supporting and securing the base to the exterior wall of the vessel, and has a proximal primary tubular portion having a primary proximal end for further connection to a fluid transfer system.
The base further has a tubular junction extending at an acute angle from the proximal primary portion and having a secondary passage therein communicating with the primary passage. The tubular junction further has a proximal secondary portion with a secondary proximal end.
A flexible tube is slidably retained within the secondary passage. The flexible tube has a flexible distal portion with a flexible distal tip thereon, a flexible proximal portion with a side port therein and with a proximal handle. The flexible tube is initially positioned at a “first position” wherein the flexible distal tip is within the secondary passage; and is slideable to a “second position” wherein the side port of the flexible proximal portion is at the junction of the primary and secondary passages, and the flexible distal tip is inserted into the primary passage and extended from the primary distal tip to thereby extend the functional tip of the cannula.
The cannula further comprises means for sealing the flexible tube within the secondary proximal end of the base. Such sealing means are provided in examples described as a first embodiment and a second embodiment of the present invention
A first embodiment of the cannula includes the forgoing base and flexible tube assembly and further includes a sealing means comprising a flexible collapsible sleeve. The sleeve has a proximal end connected and sealed onto the flexible proximal handle of the flexible tube, and has a distal end connected and sealed onto the secondary proximal end of the base. The sleeve provides a positive air tight seal of the cannula at all times, and particularly during any repositioning of the flexible tube within the base.
A second embodiment of the cannula includes the forgoing base and flexible tube assembly and further includes a sealing means wherein the flexible proximal portion of the flexible tube is slidably sealed within sealing washers retained between the secondary passage and an end cap.
In more detail, in the second embodiment the base further includes a secondary tubular member with an annular end flange thereon; and a cylindrical cap having an inner diameter engagable with the end flange and having a central aperture therein with a diameter corresponding to the diameter of the flexible proximal portion of the flexible tube. One or more elastomeric sealing washers are interposed between the end flange and the end cap. The flexible tube is thereby sealed and slideable within the secondary proximal end of the base.
The cannulas of the present invention are fully compatible with other standard components (used with conventional vent cannulas). The primary tubular proximal end of the base further includes an end fitting thereon for initially attaching a trocar within the primary passage for inserting the primary distal tip of the base into the vessel. After insertion, the trocar is removed and the end fitting is further used for attaching a standard “Y” junction thereto for use during surgical procedures. The “Y” junction has a first tubular branch for transferring fluids into the vessel and a second tubular branch for venting fluids from the vessel wherein the first branch and the second branch include snap-release shut-off valves for selectively controlling the respective branches of the junction.
While the novel features of the invention are set forth in the appended claims, the invention will be better understood along with other features thereof from the following detailed description taken in conjunction with the drawings, in which:
Referring first to
The cannula 10 comprises, a tubular base 12 having a primary longitudinal passage 14 therein. The base has a primary distal portion 15, with a primary distal tip 16 thereon with aspiration vents 17 therein, and having a lateral flange 18. The base includes a proximal primary tubular portion 20 having a proximal primary end 22 for further connection to a fluid transfer system. The primary distal tip extends about 0.50 inches from the lateral flange, for inserting through the upper wall of the vessel (and through any layer of atherosclerotic plaque that may be present on the inner wall), and into the interior of the vessel. The lateral flange is used for supporting and securing (suturing) the base to the exterior wall of the vessel.
The base 12 further has a tubular junction 24 extending at an acute angle from the primary passage 14 and having a secondary passage 26 therein communicating with the primary passage. The junction further has a proximal secondary portion 28 having a proximal secondary end 30. The junction extends preferably at an acute angle of about 30 degrees; however, the angle can range from about 10 to 50 degrees, or can be arcuate and tangential, as desired for a smooth communication path of the secondary passage with the primary passage.
The cannula 10 further comprises an extendable flexible tube 32 slidably retained within the secondary passage 26. The flexible tube has a flexible distal portion 34 having a diameter corresponding to the inner diameter of the primary distal portion 15, with a flexible distal tip 36; and has a flexible proximal portion 38 having a diameter corresponding to the diameter of the primary passage 14. The flexible proximal portion has several (about two to four) radial side ports 40 therein, and has a flexible proximal handle 42. The flexible distal tip is preferably rounded to facilitate maneuvering within the passages of the cannula and within the vessel, and preferably further includes radial apertures 43 to facilitate venting. The flexible distal portion has a length suitable for extending the flexible distal tip from the junction of the first passage 14 and secondary passage 26, through the lower portion of the primary passage 14 and primary distal portion 15, to an extendable length of about 0.40 inches beyond the primary distal tip 16. In the current example, the flexible distal portion is a total of about 1.50 inches. The flexible proximal portion has a length that extends from the proximal secondary end 30 of the base, at least the length of the flexible distal portion (about 1.50 inches as discussed above) and can be longer to provide easy manipulation of the flexible proximal handle 42. A suitable overall length of the flexible tube is about 4.00 inches.
The slidable engagement of the flexible tube 32 within the passages of the base 12 could possibly be precisely produced whereby a seal is maintained within the base during manipulation of the flexible tube; however it is preferable to provide a means for sealing the flexible tube within the secondary proximal end of the base. A suitable sealing means is provided by a flexible collapsible sleeve 44 surrounding the flexible proximal portion of the flexible tube and enclosing it within the base. The sleeve has a proximal end 46 connected and sealed onto the proximal handle 42 of the flexible tube, and has a distal end 48 connected and sealed onto the proximal secondary end 30 of the base.
The sleeve 44 can be generally cylindrical as shown or can be formed generally cylindrical and having alternating reduced diameters that are uniformly spaced apart (somewhat as shown in
Referring also to
Referring also to
Referring particularly to
Referring particularly to
During a typical surgical procedure, the vent branch 66 is initially snapped closed, and cardioplegia solution is initiated through the perfusion branch 64 that is snapped open. After sufficient perfusion has taken place, the perfusion branch is snapped closed. The surgeon then prepares to perform a proximal anastomosis of a venous graft onto the aorta. As previously discussed, when this technique is used, the patient has been receiving retrograde cardioplegia, and the aortic root fills up with blood coming from the left main and right main coronary arteries. The operating field is usually flooded with blood, impairing adequate visibility of the field by the surgeon. The vent branch of the cannula is then opened and activated to vent and clear the operating field.
The fixed length of the primary distal tip 16 of the cannula extends a fixed (relatively short) distance into the aorta, and does not always adequately vent the lower portion of the surgical field (see
The proximal anastomoses can then be efficiently and safely performed onto the wall of the ascending aorta. Upon completion of the anastomoses, the proximal handle 42 is pulled outward, and the flexible tube 32 is thereby retracted to the first position so that the air can be vented from the upper portion of the aorta through the aspiration vents 17 in the primary distal tip 16 of the cannula. The cannula is then removed and the insertion opening in the aorta is sealed with suitable sutures.
Referring now to
The cannula 70 includes essentially the same base 12 having the primary passage 14, the junction 24 having secondary passage 26, the primary proximal tube portion 20, the proximal end fitting 22, and the proximal secondary portion 28, as previously discussed. (However, cannula 70 does not include the secondary end 30 of the base, or the flexible collapsible sleeve 44 as in cannula 10.)
The junction 24 includes the secondary proximal portion 28 and further includes a secondary tubular member 84 extending therefrom for further retaining the flexible tube 72. The tubular member has an annular end flange 86 (forming a suitable fitting) thereon. The cannula 70 further includes a cylindrical end cap 88 having an inner diameter 90 forming a suitable fitting for engaging the end flange 86, and having a central aperture 92 therein with a diameter corresponding to the diameter of the flexible proximal portion of the flexible tube 72.
The cannula 70 utilizes the extendable flexible tube 72 further having a flexible distal portion 74 with a flexible distal tip 76 thereon; a flexible middle portion 78 having several radial side ports 79 therein, and a flexible proximal portion 80 having a flexible proximal handle 82. The flexible distal portion is slideable retained within the secondary passage 26 and the secondary tubular member 84, With the flexible proximal handle 82 extending from the secondary tubular member. The flexible distal tip 76 is preferably rounded to facilitate maneuvering within the passages of the cannula and within the vessel and preferably further includes radial apertures 77 to facilitate venting. The flexible distal portion has a length suitable for extending the flexible distal tip from the junction of the first passage 14 and secondary passage 26, through the lower portion of the primary passage 14 and primary distal portion 15, to an extendable length of about 0.40 inches beyond the primary distal tip 16. In the current example, the flexible distal portion is about 1.25 inches. The flexible intermediate portion extends for about 1.00 inch, and the flexible proximal portion has a length that extends from the proximal secondary end 30, through the proximal tubular member 84 of the base, and at least the length of the flexible distal portion (about 1.25 inches as discussed above) to provide easy manipulation of the flexible proximal handle 82. A suitable overall length of the flexible tube is about 5.00 inches.
Referring particularly to
The flexible proximal portion 80 of the extendable flexible tube 72 is sealed within the secondary tubular member 84 by one or more elastomeric sealing washers interposed between the end flange 86 and the end cap 88. For example, as particularly shown in
Another suitable example is a second elastomeric sealing washing 96 having a flexible hemispherical distal diaphragm 97 with a flanged outer diameter 98 corresponding to the inner diameter of the end cap 88 and with an opening therein (preferably radial slits forming a leaflet type valve) for sealing the diameter of the proximal portion of the flexible tube.
A variety of single and multiple elastomeric sealing washers can provide a suitable seal. It has been found that the combination of the first washer 94 positioned on the flexible proximal behind the second washer 96, and both interposed between the end flange 86 and the end cap 88, provides an excellent slideable sealed engagement of the extended flexible tube within the base of the cannula 70.
As discussed in reference to the first embodiment, the cannula 70 further initially utilizes the proximal primary tubular portion 20 with a trocar 50 (see
As discussed in reference to the first embodiment, the cannula 70 finally utilizes the proximal primary tubular portion 20 with the “Y” junction 60 (see
Thus, first and second embodiments have been described as examples of the present invention wherein a vent cannula includes an extendable distal tip that can be extended, if necessary, to more effectively clear the surgical field during cardiac surgery. The extendable distal tip cannulas of the present invention are completely compatible with the insertion, use and procedures as used with current cardioplegia/vent cannulas.
While specific embodiments and examples of the present invention have been illustrated and described herein, it is realized that modifications and changes will occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within the spirit and scope of the invention.