Valve insertion tool

A valve insertion tool is disclosed. The valve insertion tool may be used in a minimally invasive cardiac surgery. The valve insertion tool includes a housing and a cover, the housing having at least one valve recess and a suture channel. The valve insertion tool is suitable for use in delivering a prosthetic heart valve into a thoracic cavity of a patient during a minimally invasive cardiac surgical procedure. One or more valve insertion tools may be stackable and be pre-loaded with one or more prepared prosthetic heart valves. These one or more valve insertion tools may be packaged as a valve insertion kit.

FIELD

The claimed invention relates to surgical devices, and more specifically to minimally invasive surgical devices for passing a prosthetic heart valve into the thoracic cavity of a surgical patient.

BACKGROUND

Great advances have been made in cardiac surgery with regard to performing more and more procedures using minimally invasive approaches. For example, aortic and mitral valve replacement are routinely performed using minimally invasive approaches. Most of the surgical actions in such valve replacement surgeries can be done through a very small incision with instruments having shafts often on the order of 10 mm or less. Smaller incisions result in less perioperative pain and better patient outcomes. Unfortunately, a larger incision is often needed to allow the prosthetic heart valve to be inserted into the patient's thoracic cavity. Care must be taken when doing this, as the prosthetic valve leaflets are quite fragile. Therefore, it would be desirable to have an economical and reliable valve insertion tool which would enable insertion of the prosthetic valve into the thoracic cavity through much smaller incisions than are currently available.

SUMMARY

A valve insertion tool is disclosed. The valve insertion tool includes a housing defining at least one valve recess, a suture channel passing from a distal end of the housing to a proximal end of the housing, and a cover configured to engage the housing for covering the at least one valve recess and a top of the suture channel. An alternate embodiment of the valve insertion tool includes a housing where the housing defining a first valve recess and a second valve recess.

A valve insertion kit is also disclosed. The valve insertion kit includes at least one valve insertion tool. The valve insertion tool includes a housing and a suture channel where the housing defines at least one valve recess, and the suture channel passes from a distal end of the housing to a proximal end of the housing. The valve insertion kit also includes at least one prosthetic valve having at least one suture stitched into a sewing cuff on the valve. The valve insertion kit also includes a cover configured to engage the housing for covering the at least one valve recess and a top of the suture channel.

DETAILED DESCRIPTION

FIGS. 1A and 1Bare top and bottom perspective views, respectively of one embodiment of a valve insertion tool30. The tool30has a delivery housing32that has a prosthetic valve recess34. On the edges of the valve recess34, there are a plurality of cuff supports36configured to support a sewing cuff of a prosthetic valve (not shown in this view) while the valve's leaflets are extended down into the valve recess34.

A distal suture channel38extends distally in the housing32from the valve recess34. Likewise, a proximal suture channel40extends proximally in the housing32from the valve recess34. When a prosthetic cardiac valve is ready to be inserted into a patient's thoracic cavity, the sewing cuff of the valve will already have a series of sutures stitched through it. When the valve is placed into the valve recess34, the sutures extending into the patient can be placed into the distal suture channel38, and the sutures extending from the valve cuff to the suture ends can be placed into the proximal suture channel40. This embodiment of a valve insertion tool30has one or more shelves42on one side of the suture channels38,40and another one or more shelves44on the opposite side of the suture channels38,40. The valve insertion tool30also has a series of lips46on either side of the delivery housing32, extending over portions of the shelves42,44.

FIG. 2shows an exploded view of the valve insertion tool30which includes a cover48having grips50and connection features52. After a valve54having a sewing cuff56is lowered into the valve recess34so that the sewing cuff56rests on the cuff supports36, the cover48is placed against the shelves42,44and slid distally under the lips46as shown inFIG. 3A. The cover48is slid distally58until the connection features52engage tabs60. At this point, the valve54is covered and protected. For simplicity, the sutures extending through the valve sewing cuff are not shown passing out of the distal suture channel38or the proximal suture channel40. The proximal end62of the valve insertion tool30may then be held to manipulate the valve end64through an incision and into the thoracic cavity. The incision only needs to be large enough for the valve insertion tool30to fit through, and it is acceptable if the valve insertion tool30comes into contact with the tissue around the incision since the valve54is protected within the tool30. Once the valve end64is inside the patient, the cover48may be removed, the valve carefully tipped out or otherwise removed from the valve recess, and the housing32is removed from the patient as well, leaving the valve inside the patient for further parachuting into place prior to fastening the valve into place within the heart.

FIG. 4illustrates another embodiment of a valve insertion tool66. The valve insertion tool66is double ended. The tool66has a delivery housing68that has a first prosthetic valve recess70on one end and a second prosthetic valve recess72on the other end. On the edges of each of the valve recesses70,72, there are a plurality of cuff supports74configured to support a sewing cuff of a prosthetic valve (not shown in this view) while the valve's leaflets are extended down into one of the valve recesses70,72. The embodiment ofFIG. 4may be advantageous because prosthetic heart valves come in a wide variety of sizes or shapes, and this embodiment allows a single valve insertion tool66to have two different sized valve recesses70,72. Other embodiments may have multiple valve recesses having different shapes as well. The distal and proximal orientation of the tool66will depend on which valve recess70,72is used for the valve. The end which holds the valve will be the distal end, and the opposite end will be the proximal end. A suture channel76extends down the housing from the proximal end to the distal end. When a prosthetic cardiac valve is ready to be inserted into a patient's thoracic cavity, the sewing cuff of the valve will already have a series of sutures stitched through it. When the valve is placed into the desired valve recess70,72, the sutures can extend in two different directions (distally and proximally) within the suture channel76. This embodiment of a valve insertion tool66has one or more shelves78both sides of the suture channel76. The valve insertion tool66also has a series of lips80on either side of the delivery housing68, extending over portions of the shelves78. A cover (not shown in this view) can be slid along the shelves78and under the lips80from either end of the tool66to hold a valve in place within the tool66until the valve has been inserted into the thoracic cavity.

FIG. 5is an exploded view of an assembly of multiple valve insertion tools66A,66B, and66C, each one similar to the tool66discussed above, but each having different sized valve recess70A,72A,70B,72B,70C, and72C. Recess72C is larger than recess72B, which is larger than recess72A. Likewise, recess70C is larger than recess70B, which is larger than recess70A. This enables the set of tools66A,66B, and66C to be stacked or stackable in a kit82shown inFIG. 6. A single cover84may be included with the kit82and utilized as described above with the tool66A,66B,66C which is chosen as the needed size during a surgical procedure.

FIGS. 7A and 7Bare top and bottom perspective views, respectively of another embodiment of a valve insertion tool86. The tool86has a delivery housing88that has a first prosthetic valve recess90on one end and a second prosthetic valve recess92on the other end. On the edges of each of the valve recesses90,92, there are a plurality of cuff supports94configured to support a sewing cuff of a prosthetic valve (not shown in this view) while the valve's leaflets are extended down into one of the valve recesses90,92. This embodiment may be advantageous because prosthetic heart valves come in a wide variety of sizes, and this embodiment allows a single valve insertion tool86to have two different sized valve recesses90,92. The distal and proximal orientation of the tool86will depend on which valve recess90,92is used for the valve. The end which holds the valve will be the distal end, and the opposite end will be the proximal end. A suture channel96extends down the housing from the proximal end to the distal end. When a prosthetic cardiac valve is ready to be inserted into a patient's thoracic cavity, the sewing cuff of the valve will already have a series of sutures stitched through it. When the valve is placed into the desired valve recess90,92, the sutures can extend in two different directions (distally and proximally) within the suture channel96. This embodiment of a valve insertion tool86has grooves98on either side of the outside of the housing88(the grooves98are only visible on one side of the housing88in the views ofFIGS. 7A, 7B, but the grooves98on the opposite side are symmetrically located). A cover (not shown in this view) can be slid over the top of the housing88and around the sides of the housing88and into engagement with the grooves98in order to hold the cover in place while to valve is being delivered with the tool86.

FIG. 8shows an exploded view of the valve insertion tool86which includes a cover100having rolled edges102(only visible on one side, but there are symmetrical rolled edges on the opposite facing side). After a valve54having a sewing cuff56is lowered into the desired valve recess90so that the sewing cuff56rests on the cuff supports94, the cover100is placed over the top of the housing88so that the rolled edges102either slide into or snap into the grooves98in the housing.

FIGS. 9A and 9Bare top and bottom perspective views, respectively of another embodiment of a valve insertion tool104. The tool104has a delivery housing106that has a first prosthetic valve recess108on one end and a second prosthetic valve recess110on the other end. On the edges of each of the valve recesses108,110, there are a plurality of cuff supports112configured to support a sewing cuff of a prosthetic valve (not shown in this view) while the valve's leaflets are extended down into one of the valve recesses108,110. This embodiment may be advantageous because prosthetic heart valves come in a wide variety of sizes, and this embodiment allows a single valve insertion tool104to have two different sized valve recesses108,110. Looking at the bottom view ofFIG. 9B, this embodiment also has the feature that the housing106on the outsides walls114,116of the valve recesses108,110is smoothed to avoid the sharper contours of the previous embodiments, resulting in atraumatic outer housing walls. This can be advantageous when inserting the tool104through an incision as it may be less traumatic, causing minimal tissue injury during use. The distal and proximal orientation of the tool104will depend on which valve recess108,110is used for the valve. The end which holds the valve will be the distal end, and the opposite end will be the proximal end. A suture channel118extends down the housing106from the proximal end to the distal end. When a prosthetic cardiac valve is ready to be inserted into a patient's thoracic cavity, the sewing cuff of the valve will already have a series of sutures stitched through it. When the valve is placed into the desired valve recess108,110, the sutures can extend in two different directions (distally and proximally) within the suture channel118. This embodiment of a valve insertion tool104has a recessed shelf120on both ends of the housing106. A portion of the shelves120has a lip122which can be used to hold a cover (not shown in this view) over the valve recess108,110being used.

FIG. 10Aillustrates a valve54which has three sutures124A,124B, and124C stitched through its sewing cuff56. Although each suture124A,124B,124C may at first look like two separate sutures, it should be understood that the distal end126of each suture124A,124B,124C is a loop which is sutured through an aortic annulus (not shown), so what is seen are ends128A,128B of suture124A which have been passed through the sewing cuff56of the aortic valve54. Likewise, ends130A,130B of suture124B have been passed through the sewing cuff56. Similarly, ends132A,132B of suture124C have been passed through the sewing cuff56. The sutures124A,124B,124C and their ends128A,128B,130A,130B,132A,132B can be placed into the suture channel118when the valve54is placed into the desired valve recess108. Alternately, each pair of suture ends128A/128B,130A/130B, and132A/132B may be snared through a corresponding semi-rigid or rigid tube134A,134B,134C as shown inFIG. 10B. The tubes134A,134B,134C may be placed into the suture channels118and then the cover136brought into alignment as shown inFIG. 10B. The cover136can be set down on the appropriate shelf120as shown inFIG. 10Cand then slid distally138underneath the lips122to hold the valve in place for insertion in the thoracic cavity as with the above embodiments.

Once the valve is inside the thoracic cavity and the valve insertion tool104and its cover136have been removed, the suture ends extending proximally from each tube may be cinched while holding each tube to hold the distal end of the tube against the sewing cuff of the valve. The tubes can then be manipulated to help move the valve within the thoracic cavity. When the valve is properly positioned, the tubes can be removed and the suture ends fastened against the sewing cuff to hold the valve in place.

In actual practice, there will usually be far more than three sets of suture ends stitched through a prosthetic valve. If using the tube method with the valve insertion tool, it is not necessary to place each set of suture ends through a tube. Using three tubes, one for each of the three commissure stitches in the valve sewing cuff, may be sufficient to manipulate the valve while the valve is parachuted down the remainder of the sutures in a more traditional fashion.

Various advantages of a valve insertion tool have been discussed above. Embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the forgoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and the scope of the claimed invention. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the claims to any order, except as may be specified in the claims. Accordingly, the invention is limited only by the following claims and equivalents thereto.