Surgery – Internal organ support or sling
Reexamination Certificate
2000-10-19
2003-05-06
Hindenburg, Max F. (Department: 3736)
Surgery
Internal organ support or sling
Reexamination Certificate
active
06558314
ABSTRACT:
TECHNICAL FIELD
The invention relates to devices capable of providing adherence to organs of the body for purposes of medical diagnosis and treatment. More particularly, the invention relates to devices capable of adhering to, holding, moving, stabilizing or immobilizing an organ.
BACKGROUND
In many areas of surgical practice, it may be desirable to manipulate an internal organ without causing damage to the organ. In some circumstances, the surgeon may wish to turn, lift or otherwise reorient the organ so that surgery may be performed upon it. In other circumstances, the surgeon may simply want to move the organ out of the way. In still other cases, the surgeon may wish to hold the organ, or a portion of it, immobile so that it will not move during the surgical procedure. Unfortunately, many organs are slippery and are difficult to manipulate. Holding an organ with the hands may be undesirable because of the slipperiness of the organ, and because the hands may be bulky, becoming an obstacle to the surgeon. Moreover, the surgeon's hands ordinarily will be necessary for the procedure to be performed. Holding an organ with an instrument may damage the organ, especially if the organ is unduly squeezed, pinched or stretched.
The heart is an organ that may be more effectively treated if it can be manipulated. Many forms of heart manipulation may be useful, including holding the heart, moving it within the chest and immobilizing regions of it. Some forms of heart disease, such as blockages of coronary vessels, may best be treated through procedures performed during open-heart surgery. During open-heart surgery, the patient is typically placed in the supine position. The surgeon performs a median sternotomy, incising and opening the patient's chest. Thereafter, the surgeon may employ a rib-spreader to spread the rib cage apart, and may incise the pericardial sac to obtain access to the heart. For some forms of open-heart surgery, the patient is placed on cardiopulmonary bypass (CPB) and the patient's heart is arrested. Stopping the patient's heart is a frequently chosen procedure, as many coronary procedures are difficult to perform if the heart continues to beat. CPB entails trauma to the patient, with attendant side effects and risks.
Once the surgeon has access to the heart, it may be necessary to lift the heart from the chest or turn it to obtain access to a particular region of interest. Such manipulations are often difficult tasks. The heart is a slippery organ, and it is a challenging task to grip it with a gloved hand or an instrument without causing damage to the heart. Held improperly, the heart may suffer ischemia, hematoma or other trauma. Held insecurely, the heart may drop back into the chest, which may cause trauma to the heart and may interfere with the progress of the operation.
A coronary bypass operation, for example, may involve concerns as to immobilization and as to reorientation of the heart. Once the surgeon has obtained access to the heart, the affected coronary artery may not be accessible without turning or lifting of the heart. Furthermore, the procedure of grafting a new vessel is a delicate one, and contractions of the heart muscle multiply the difficulties in performing the procedure.
Similar concerns may arise in cases where the surgery is far less invasive. In a lateral thoracotomy, for example, the heart may be accessed through a smaller incision in the chest. Arresting of the heart may not be feasible. Yet it may be necessary or desirable for a surgeon to manipulate the heart, such as by moving it or by immobilizing a portion of it during the operation.
SUMMARY
The present invention provides a device for providing adherence to an organ, allowing the organ to be manipulated or immobilized. It should be noted that any references to “adhesion” or related terms do not use the term as it is frequently used in medicine, namely to describe an abnormal union of an organ or part with some other part by formation of fibrous tissue. Rather, “adhesion” and related words refer to adherence, the process of one thing holding fast to another, without them becoming pathologically joined.
There are many circumstances where it may be beneficial to have the present invention provide adherence to an organ. A surgeon may have a need, for example, simply to lift a gall bladder out of the way to access another organ. A more complex environment in which the present invention may be used is that of open-heart surgery. In this context, a surgeon may employ several forms of the present invention during a single operation, depending upon the need and the application. By selecting the form of the present invention that suits the task at hand, the surgeon may reduce the risk of trauma to the patient and improve the effectiveness of the surgery. Because the device may have multiple uses within open heart surgery, application of the device to heart tissue will be described in detail herein, with the understanding that the device may have application to other areas of medical practice as well.
The device may include a seal member that allows it to adhere to slippery bodily tissue, such as the surface of a heart. The surgeon may lift the heart or reposition it by manipulating the device, with the seal member adhering to the surface of the heart. The device may also be applied to the heart in a form in which the coronary contractions near the site of adhesion are minimized, effectively stabilizing or immobilizing an area of the heart. Adherence of the device is temporary, not permanent. The device can be configured to apply easily to the tissue, adhere firmly, remain adhered as long as needed, minimize the risk of accidental release, and release easily when needed. Importantly, the device can be designed to minimize the risk of tissue trauma that may result from adherence and release.
Upon engagement of the seal member with the surface of the heart, the seal member defines a chamber. The seal member may further define a vacuum port in fluid communication with the chamber. The seal member can be made, in part, of a compliant material that will permit it to conform to the surface of the heart and that will further permit it to maintain contact while the heart is contracting. In some cases, adherence may be improved by application of the vacuum pressure from a pump by way of the vacuum port, where at least a portion of the seal member deforms and substantially forms a seal against the surface. In other cases, adherence may be improved by other mechanical or hydraulic devices.
In some embodiments, the seal member may define multiple cavities and multiple vacuum ports, each vacuum port in fluid communication with each cavity. Upon application of independent vacuum pressure to each vacuum port, at least a portion of the seal member deforms and substantially forms a seal against the surface, providing vacuum-assisted adhesion between the device and the heart. Employment of multiple chambers and multiple vacuum ports, with independent vacuum pressure applied to each port, can provide an additional measure of safety. Leakage in one of the sealed chambers will not affect the others, and adhesion may be maintained even if the seal on one chamber fails.
The adherence of the device can be aided by the use of particular materials to form the seal member. In particular, the chamber may be defined in part by a semi-rigid material, e.g., formed in a cup-like shape, that provides the device with structural integrity, and prevents the seal member from collapsing under vacuum pressure. The seal member also may include a skirt-like member, however, that is coupled to the chamber. The skirt-like member can be formed from a tacky, deformable material that promotes adhesion to the heart tissue at the point of contact. In some embodiments, the tacky, deformable material may take the form of a silicone gel that is molded, cast, deposited, or otherwise formed to produce the skirt-like member. With such a material, it may be possible to fix the seal member to the heart tissue even when no vac
Adelman Thomas G.
Foley Frederick J.
Hoey Michael F.
Reeve Lorraine E.
Sharrow James S.
Hindenburg Max F.
Iotek, Inc.
Shumaker & Sieffert PA
Szmal Brian
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