CONVERTIBLE MULTI-STAGE / BI-CAVAL FEMORAL VENOUS CANNULA
A venous drainage cannula, catheter, or other device is in certain embodiments convertible or adjustable for application in cardiac surgery procedures involving cardiopulmonary bypass. Such a convertible cannula device can be modified, for example, for use as both a multi-stage cannula and a bi-caval cannula, so that the same device can be used in multiple different procedures where one or the other cannula type is needed. Such convertible cannula or other device can simplify and reduce a number of parts needed for a bypass procedure, by providing one adjustable and versatile device to serve multiple functions where different cannulae are traditionally required. Various embodiments further provide cannula devices where a variety of different hole or opening arrangements and configurations can be achieved, to adapt to various different procedures.
This application is a continuation of International Patent Application No. PCT/US2017/013645, filed Jan. 16, 2017, the entire disclosure which in incorporated by reference.
BACKGROUND FieldThe present application generally concerns venous cannulae, and more specifically, to a venous drainage cannula or catheter that can be adjustable for application in various different cardiac surgery procedures involving cardiopulmonary bypass.
Description of Related ArtVarious different surgical procedures are or can be performed using cardiopulmonary bypass. Such “on-pump” cardiopulmonary bypass procedures may be necessary or favorable in situations where heart function must be interrupted, while circulation must be continued in a patient. For example, in cardiac surgeries where the heart wall is opened to gain access to one or more chambers of the heart, cardiopulmonary bypass can be used to temporarily replace the heart function and support blood oxygenation and circulation, while the heart can be emptied of blood in order to more easily facilitate the particular surgical procedure.
During a cardiopulmonary bypass, a pump or similar machine is connected to the veins and arteries near the heart. Deoxygenated or venous blood that is returning to the heart is removed from the body by one or more cannulae or other devices. Generally, such cannulae are positioned in the right atrium, in the superior vena cava and/or the inferior vena cava, and/or further away from the heart, for example, in the femoral vein, to intercept the deoxygenated blood that would otherwise return to the heart. Withdrawn blood is then oxygenated and further processed, and returned to the body, for example, into the ascending aorta. In this manner, a patient's body can remain oxygenated while, for example, a cardiac procedure is being performed.
Traditionally, cardiopulmonary bypass surgery involves insertion of two separate venous cannula for separate blood withdrawal at the superior vena cava and the inferior vena cava. To prevent blood from entering the heart during a cardiac surgical procedure, a first cannula is positioned in the superior vena cava, and a second cannula is positioned in the inferior vena cava. In some instances, both the superior and inferior venae cavae are then clamped or otherwise sealed from the right atrium. In this manner, blood is drained or withdrawn from the body by the two cannulae prior to reaching the heart.
Recently, more research and emphasis has been placed on less invasive surgical procedures which involve, for example, a lower number of and/or smaller incisions for performing the same procedures. In the field of cardiac surgery, such procedural modifications may include reducing wound opening sizes and/or reducing the number of parts required at the surgical site. For example, mini-sternotomy approaches to heart valve repair or replacement procedures, where only part of the sternum or breastbone is split or separated to gain access to the heart, are gaining popularity in lieu of, for example, the same procedures where a standard sternotomy (i.e., where the entire sternum is separated) is performed.
Since a mini-sternotomy may only yield an incision that may be approximately half the length of an incision made in a standard sternotomy, there is a need or desire to reduce the number of surgical parts and instruments which require access to the main incision site. In recent years, femoral venous cannula have gained popularity in such procedures. Femoral venous cannulae are inserted through the femoral vein at or near the groin or thigh area, away from the surgical field. The cannula is advanced through the femoral vein and up through the inferior vena cava towards the heart. The end region of a femoral venous cannula is generally long, with multiple stages of openings, and is positioned to traverse the right atrium, with at least one set of openings positioned in the superior vena cava and one set of openings positioned in the inferior vena cava to effect blood drainage. Such a femoral venous cannula can therefore replace the use of the two separate single stage cannula used in traditional cardiopulmonary bypass procedures, and so reduces the total number of parts required for a cardiopulmonary bypass, and may also reduce the number of incisions that are required at the surgical site. Furthermore, since the access site of the femoral venous cannula is away from the surgical site (e.g., at the groin or thigh), the use of femoral venous cannulae can also serve to reduce clutter or crowding at the surgical site.
Generally, different femoral venous cannulae are used for procedures on the left and right sides of a heart, respectively. For example, for aortic valve or mitral valve replacement or repair, a multi-stage femoral venous cannula may be utilized, where drainage is performed on each of the superior vena cava, the inferior vena cava, and the right atrium. The use of a multi-stage cannula for these procedures may be beneficial, for example, for more effective blood drainage. Such multi-stage cannulae may include drainage openings along an entire end portion of the cannulae, for example, as seen in
However, for some procedures, surgical access to the right atrium, or more generally to the right chambers of the heart, may be required, for example, for tricuspid valve replacement or repair. In these situations, a bi-caval drainage approach may be more desirable, where drainage occurs only at the superior vena cava and the inferior vena cava, but not at the right atrium, so that the surgical procedure can be more easily performed there. Typically, a different bi-caval cannula may be used in these circumstances, where openings at the end portion of the cannula are interrupted by a central or middle portion that does not include any openings, for example, as seen in
In some instances, multiple surgical procedures need to be made on a single patient. For example, a patient may require replacement or repair of an aortic or mitral valve, as well as a separate procedure on a tricuspid valve. Or more generally, a surgeon may need to perform separate procedures on the right and left sides of the heart of a patient. Previously, such situations involved the complete removal of a first type of femoral venous cannula after completion of the first procedure, and insertion of a second type of femoral venous cannula before beginning the second procedure.
An object of the invention is to provide a femoral venous cannula device that is adjustable between a multi-stage cannula and a bi-caval cannula, for example, to reduce the number of parts needed for cardiopulmonary bypass surgery. Another object of the invention is to provide such an adjustable cannula, to add flexibility and simplify procedures in situations where different cannulae are traditionally required. In accordance with the objects of the invention, embodiments of the invention provide a convertible femoral venous cannula that can be modified to be used in both procedures requiring a multi-stage cannula and procedures requiring a bi-caval cannula. Embodiments of the invention further provide a femoral venous cannula where a variety of different hole or opening configurations can be achieved, to adapt to various different procedures.
According to one embodiment, a device for use in cardiopulmonary bypass includes a cannula configured to be positioned in at least one of a right atrium, a superior vena cava, or an inferior vena cava of a patient, the cannula having a first end, a second end, and a longitudinal axis extending between the first end and the second end. The cannula includes a first section at the first end, the first section including an outer wall and having at least one opening therethrough, a second section connected to the first section along the longitudinal axis, the second section including an outer wall and having at least one opening therethrough, and a third section connected to the second section along the longitudinal axis on a side of the second section opposite the first section, the third section including an outer wall and having at least one opening therethrough. In a first configuration, the openings in each of the first section, the second section, and the third section are respectively open to inner spaces defined by the first section, the second section, and the third section. In a second configuration, the at least one opening in the second section is occluded to restrict communication with the inner space defined by the second section, while the openings in the first section and the third section remain open to the inner spaces defined by the first section and the third section, respectively.
According to another embodiment, a method is provided for adjusting and positioning a femoral venous cannula in a patient for cardiopulmonary bypass during a cardiac procedure. The cannula has a first end, a second end, and a longitudinal axis extending between the first end and the second end, and includes a first section at the first end and including an outer wall and having at least one opening therethrough, a second section connected to the first section along the longitudinal axis and including an outer wall and having at least one opening therethrough, and a third section connected to the second section along the longitudinal axis on a side of the second section opposite the first section and including an outer wall and having at least one opening therethrough. In a first configuration, the openings in each of the first section, the second section, and the third section are respectively open to inner spaces defined by the first section, the second section, and the third section, while in a second configuration, the at least one opening in the second section is occluded to restrict communication with the inner space defined by the second section, while the openings in the first section and the third section remain open to the inner spaces defined by the first section and the third section, respectively. The method includes adjusting the cannula to one of the first configuration or the second configuration, inserting the cannula through the femoral vein of the patient and advancing the cannula towards the heart of the patient, and positioning the cannula at a first position in the patient wherein the at least one opening of the first section of the cannula is arranged in the superior vena cava, the at least one opening of the second section of the cannula is arranged in the right atrium, and the at least one opening of the third section of the cannula is arranged in the inferior vena cava.
Embodiments of the invention therefore provide a femoral venous cannula device that is convertible between a multi-stage cannula and a bi-caval cannula for different surgical procedures.
The foregoing and other features and advantages of the invention will become apparent from the following detailed description of embodiments, by means of the accompanying drawings. In the drawings:
In
As can be seen in
In the embodiment of
The sections 10, 20, 30 may further be connected to an elongated tubular section 40 that connects the cannula 1 to the outside of the patient, for example, first for facilitating insertion and positioning of the cannula 1, and later for connection to a cardiopulmonary bypass pump.
As can best be seen in
Meanwhile, embodiments of the invention provide a convertible cannula, where the central section 30 of the cannula 1 can be adjusted so that the openings 31 are sealed shut instead of kept open, to effectively convert the cannula 1 from a multi-stage cannula to a bi-caval cannula, so that the same cannula 1 can be used for different cardiac surgeries and procedures which require either type of cannulation.
In the embodiment of
In a first position, as illustrated in
In the manner described above, the internal sliding wall 33 slides over the holes 31 in section 30, effectively opening and closing the holes 31 based on the requirements of the particular procedure. In one embodiment, the shutter system in
In a second embodiment, illustrated in
Various modifications can also be made to the embodiments of the femoral venous cannula 1 in
A third embodiment of the invention is illustrated in
The elastic sheath or tube 3 is generally constructed of a material so as to be impermeable to blood. Furthermore, the tube 3 may include, for example, an adhesive 4 that is applied along the ends of the tube 3 (as illustrated), or alternatively, along an entire inner surface of the tube 3. The adhesive 4 provided will generally be strong enough to allow the tube 3 to permanently adhere to the cannula 2. The adhesive may initially be rolled out or covered, and then uncovered or rolled down once the tube 3 is arranged at a desired position relative to the cannula 2. Other variants of the adhesive type and/or application with respect to the surfaces of the tube 3 can also be used. For example, the tube 3 can adhere to the cannula through adhesives as discussed, or for example, via elastic properties or an interference fit. In some embodiments, a shrink wrap or similar material may be utilized for covering the desired openings 11 in cannula 2.
In operation, for example, after a procedure where a multi-stage cannula is utilized has been completed, a surgeon or other practitioner can attach the tube 3 over the cannula 2 through, for example, a puncture or access site through the heart wall, or alternatively, tube 3 can be attached upon removal of the cannula 2 from the patient's body. The adhesive or other adhering means will hold the tube 3 in position on the cannula 2, generally to cover the central openings 11 corresponding to the position of the right atrium, so that the modified cannula 2 can function as a bi-caval cannula during a subsequent procedure.
In the embodiment of
The parts of the cannulae 1, 2 according to embodiments of the invention are preferably made from one or more biocompatible materials, and may all be made of the same material, or can be made of different materials.
Each of the embodiments discussed above provides a single cannula that can be converted from a multi-stage cannula to a bi-caval cannula on demand, where a physician or other practitioner can close different holes along the cannula to adjust the hole configurations of the cannula to suit the particular clinical application. In some embodiments, the cannula can further be converted from a bi-caval cannula to a multi-stage cannula as well, for example, by opening different holes, adding more flexibility for the physician.
Embodiments of the invention would provide a cannula that would allow for customization of hole configurations, which could potentially reduce the number of products or product codes to stock. For example, cannulae according to embodiments of the invention could replace both multi-stage cannula and bi-caval cannula, so that only a single type of cannulae can be stocked to cover both types of applications. Embodiments of the invention would also allow more flexibility with respect to customization based on surgeon preference and patient anatomy, for example, different heart and/or vein sizes.
In addition, embodiments of the invention provide a more flexible cannula that can be adjusted mid-procedure. Previously, in instances where one of a multi-stage cannula or a bi-caval cannula is required for a first procedure, and then the other of the multi-stage cannula or the bi-caval cannula is required for a second procedure, upon completion of the first procedure, the first cannula had to be removed and the second cannula then inserted and repositioned before the second procedure could be performed. With embodiments of the invention, a single cannula can be positioned for the first procedure, and for example, adjusted to first serve as a multi-stage cannula, and can then be converted for the second procedure, for example, to serve as a bi-caval cannula, while still correctly positioned relative to the heart, so that removal and repositioning of the cannula is no longer required, thereby reducing surgical times and simplifying the surgical process. In addition, for example, with the third embodiment discussed above, a conventional multi-stage cannula can still be used for a first procedure, and tubing of different lengths can be provided, where an appropriate sealing tube can potentially be selected or cut mid-procedure, and then applied to the cannula, to seal the desired number of openings on the cannula based on the patient's anatomy, thereby providing a more customizable and effective bi-caval cannula.
For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
In view of the many possible embodiments to which the principles of the disclosure can be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims.
Claims
1. A device for use in cardiopulmonary bypass, the device comprising a cannula configured to be positioned in at least one of a right atrium, a superior vena cava, or an inferior vena cava of a patient, the cannula having a first end, a second end, and a longitudinal axis extending between the first end and the second end, the cannula comprising:
- a first section at the first end, the first section comprising an outer wall and having at least one opening therethrough;
- a second section connected to the first section along the longitudinal axis, the second section comprising an outer wall and having at least one opening therethrough; and
- a third section connected to the second section along the longitudinal axis on a side of the second section opposite the first section, the third section comprising an outer wall and having at least one opening therethrough;
- wherein in a first configuration, the openings in each of the first section, the second section, and the third section are respectively open to inner spaces defined by the first section, the second section, and the third section; and
- wherein in a second configuration, the at least one opening in the second section is occluded to restrict communication with the inner space defined by the second section, while the openings in the first section and the third section remain open to the inner spaces defined by the first section and the third section, respectively.
2. The device of claim 1, wherein in the first configuration, the cannula is configured as a multi-stage femoral venous cannula.
3. The device of claim 1, wherein in the second configuration, the cannula is configured as a bi-caval femoral venous cannula.
4. The device of claim 1, wherein a material of the second section of the cannula is more rigid than a material of at least one of the first section of the cannula or the third section of the cannula.
5. The device of claim 1, wherein the cannula further comprises a wall movable relative to the second section between a first position wherein the device is in the first configuration and the at least one opening in the second section of the cannula is open, and a second position wherein the device is in the second configuration and the at least one opening in the second section of the cannula is occluded by the wall.
6. The device of claim 5, wherein the wall is positioned along an inner surface of the outer wall of the second section of the cannula.
7. The device of claim 5, wherein the wall rotates circumferentially around the longitudinal axis to move between the first position and the second position.
8. The device of claim 5, wherein the wall moves laterally relative to the longitudinal axis towards either the first end or the second end of the cannula to move between the first position and the second position.
9. The device of claim 5, wherein the wall comprises a plurality of wall segments.
10. The device of claim 1, further comprising a tubular cover configured to be placed around the outer wall of the second section to occlude the at least one opening in the second section when the device is in the second configuration.
11. The device of claim 10, wherein the cannula is a multi-stage cannula.
12. The device of claim 10, wherein the cover is impermeable to blood.
13. The device of claim 10, wherein an adhesive on the cover permanently adheres the cover to the second section of the cannula when the device is in the second configuration.
14. The device of claim 10, wherein one cover is selected from a plurality of covers having different sizes for placement around the outer wall of the second section of the cannula when the device is in the second configuration.
15. A method for adjusting and positioning a femoral venous cannula in a patient for cardiopulmonary bypass during a cardiac procedure, the cannula having a first end, a second end, and a longitudinal axis extending between the first end and the second end, the cannula comprising a first section at the first end and comprising an outer wall and having at least one opening therethrough, a second section connected to the first section along the longitudinal axis and comprising an outer wall and having at least one opening therethrough, and a third section connected to the second section along the longitudinal axis on a side of the second section opposite the first section and comprising an outer wall and having at least one opening therethrough, wherein in a first configuration, the openings in each of the first section, the second section, and the third section are respectively open to inner spaces defined by the first section, the second section, and the third section, and wherein in a second configuration, the at least one opening in the second section is occluded to restrict communication with the inner space defined by the second section, while the openings in the first section and the third section remain open to the inner spaces defined by the first section and the third section, respectively, the method comprising:
- adjusting the cannula to one of the first configuration or the second configuration;
- inserting the cannula through the femoral vein of the patient and advancing the cannula towards the heart of the patient; and
- positioning the cannula at a first position in the patient wherein the at least one opening of the first section of the cannula is arranged in the superior vena cava, the at least one opening of the second section of the cannula is arranged in the right atrium, and the at least one opening of the third section of the cannula is arranged in the inferior vena cava.
16. The method of claim 15, wherein the cannula is adjusted to the first configuration when at least one of the left atrium or the left ventricle of the heart of the patient is accessed during the cardiac procedure.
17. The method of claim 15, wherein the cannula is adjusted to the second configuration when at least one of the right atrium or the right ventricle of the heart of the patient is accessed during the cardiac procedure.
18. The method of claim 15, further comprising adjusting the cannula to the other one of the first configuration or the second configuration when the cannula is at the first position in the patient.
Type: Application
Filed: Jul 16, 2019
Publication Date: Nov 7, 2019
Inventor: William T. Biller (Tustin, CA)
Application Number: 16/513,575