The invention relates generally to the field of treatment of diseases and conditions by the regulation of blood flow in blood vessels. In particular, the invention is directed to the treatment of uterine disorders by detecting and regulating blood flow thereto.
Hysterectomy (surgical removal of the uterus) is performed on approximately 600,000 women annually in the United States. For approximately 340,000 women, hysterectomy is probably the best current therapeutic choice for the treatment of their uterine diseases and disorders, such as cancer, endometriosis, adenomyosis, menorrhagia, and prolapse. For approximately 60,000 women with dysfunctional uterine bleeding (abnormal menstrual bleeding that has no discrete anatomic explanation such as a tumor or growth), newer endometrial ablation techniques may be an alternative to hysterectomy. For approximately 200,000 women with benign but symptomatic (excessive bleeding, pain, and “bulk” sensations) muscular tumors of the uterus, known as leiomyoma or fibroids, newer treatment methods have been developed which may spare these women a hysterectomy, as well.
However, hysterectomy is a drastic treatment, having many undesirable characteristics. Thus, any method which can approximate the therapeutic result of a hysterectomy without removing the uterus would be a significant improvement in this field. Newer treatment methods have been developed for some diseases which may spare these women a hysterectomy.
In 1995, it was demonstrated that uterine fibroids could be treated without hysterectomy using a non-surgical therapy, specifically comprising bilateral intraluminal occlusion of the uterine arteries (Ravina et al., “Arterial Embolization to Treat Uterine Myomata”, Lancet Sep. 9, 1995; Vol. 346; pp. 671-672, incorporated in its entirety herein). This technique is known as “uterine artery embolization”. In this technique, uterine arteries are accessed via a transvascular route from a common femoral artery into the left and right uterine arteries.
The uterus has a dual (or redundant) blood supply, the primary blood supply being from the bilateral uterine arteries, and the secondary blood supply from the bilateral ovarian arteries. Consequently, when both uterine arteries are occluded, i.e. bilateral uterine artery occlusion, the uterus and the fibroids contained within the uterus are both deprived of their blood supply. However, as demonstrated by Ravina et al., the effect on the fibroid is greater than the effect on the uterus. In most instances, the fibroid withers and ceases to cause clinical symptoms.
However, many physicians do not possess the skill or equipment necessary to perform catheter-based uterine artery embolization under radiologic direction. Accordingly, only thousands of uterine artery embolizations have been performed, worldwide, over the past three years, whereas hundreds of thousands of hysterectomies have been performed each year for uterine fibroids which are symptomatic.
What is needed, therefore, are better devices and methods to treat uterine disorders that can be used by physicians of ordinary skill in a simple medical setting or environment.
The invention is directed to non-invasive devices, systems and methods for extravascularly detecting blood flow in a uterine artery, and for occluding a uterine artery effective to reduce or abolish blood flow in it to treat adenomyosis and endometriosis. The non-invasive devices, systems and methods embodying features of the invention are configured to be non-surgically applied externally of a uterine artery which they occlude, and are preferably applied at least in part extracorporeally. The occlusion is temporary, and may be partial or complete. One method of occluding a uterine artery comprises clamping the uterine artery effective to compress it so that blood flow through the artery is reduced, or is abolished. Such clamping of a uterine artery may be direct or may be indirect. Preferably, clamping of a uterine artery effective to compress it is accomplished by applying a non-invasive uterine artery occlusion device to tissue near to a uterine artery (e.g., onto tissue surrounding the artery). A uterine artery occlusion device may also be applied directly onto a uterine artery effective to compress the uterine artery.
In one embodiment of the invention, a non-invasive uterine artery occluding device (such as a clamp with a sensor) may be applied to a portion of a vaginal wall to detect and/or locate, and then to occlude the uterine arteries. A vaginal clamp embodying features of the invention is used to sense the location of a uterine artery adjacent a vaginal wall, and may be used to compress and occlude a uterine artery adjacent a vaginal wall. The vaginal wall may be distended by an occlusion device so as to more closely approach a uterine artery; such an approach may aided by applying pressure or force to the uterus (e.g., by pulling on the uterine cervix). A uterine cervix may be grasped or pulled by any suitable device or implement, including forceps, suction devices, and other instruments, such as a tenaculum.
A non-invasive uterine artery occluding device embodying features of the invention comprises a pair of pressure-applying members having opposed tissue-contacting surfaces on distal portions thereof; at least one supporting shaft extending from a proximal extremity of at least one of the pressure-applying members which is configured to adjust the distance between the opposed tissue-contacting surfaces of the pressure-applying members; and at least one blood flow sensing sensor on one of the opposed tissue-contacting surfaces. An embodiment of a non-invasive uterine artery occlusion device embodying features of the invention may have, for example, a handle, a clamping member configured to apply pressure or force to body tissue, and a sensor for locating a uterine artery.
A pressure-applying member, such as a clamping member, is, e.g., a jaw or jaws configured to engage a uterine artery or to engage tissue adjacent a uterine artery. A supporting shaft, such as a handle, is preferably configured for manipulating the jaw or jaws. In some embodiments of devices having features of the invention, a pressure-applying member is attached to a connecting portion that is configured so that a jaw may be placed within a vagina while a handle remains outside a patient's body and available for use by an operator.
A sensor for locating a uterine artery senses sound, pulsation, blood flow or other indicator related to a uterine artery. Thus, a sensor for locating a uterine artery may be a blood flow sensor, a sound sensor, a pressure sensor, a strain sensor, a stress sensor, a chemical sensor, an electromagnetic radiation sensor, or other sensor, and may be a combination of such sensors. A sound sensor may be an ultrasound sensor, including a Doppler ultrasound sensor. The sensor for locating a uterine artery, including a sensor for measuring blood flow, is preferably disposed in or on a pressure-applying member, and is preferably mounted to the face of a tissue-contacting surface, such as the face of a jaw of a clamp. A sensor is preferably oriented perpendicularly to the clamp face, although in embodiments of devices having features of the invention a sensor may assume other orientations.
A system embodying features of the invention includes a uterine artery occluding device having a pair of pressure-applying members configured to apply pressure or force to body tissue, at least one supporting shaft, a sensor for locating a uterine arterty, and a sensor controller which may include an energy source. A system may further include a device for grasping a portion of a patient's body, such as a device for grasping a uterine cervix.
A sensor controller is configured to aid in detecting a location of a uterine artery, by, e.g., providing a signal related to the output of a sensor that may be readily used by an operator. A sensor controller preferably includes an energy source configured to provide energy for operating a sensor for sensing a location of a uterine artery, such as ultrasound energy, electrical energy, or electromagnetic energy. The energy is directly provided by the energy source or is provided by the sensor with the aid of the energy source. Ultrasound energy useful for sensing a location of a uterine or of blood flow in a uterine artery may have a frequency of less than about 20 MegaHertz (MHz), such as between about 5 MHz and about 19 MHz, preferably between about 6 MHz and about 10 MHz, more preferably a frequency of about 8 MHz. Electromagnetic energy useful for sensing a location of a uterine artery or of blood flow in a uterine artery may have a wavelength of between about 500 nanometers (nm) and about 2000 nm, preferably between about 700 nm and about 1000 nm.
In one embodiment of the invention a non-invasive uterine artery occluding device embodying features of the invention includes a pair of pressure applying members having opposed tissue contacting surfaces on distal portions thereof and at least one blood flow sensing sensor on each of the opposed tissue contacting surfaces. Preferably the device is configured to be insertable through the vagina of a female patient, along a side of the exterior of the cervix, and to the vaginal wall at the vaginal fornix. The bilateral structures of the device permit both the left and right uterine arteries to be compressed at the same time upon upward pushing of the device, and using the body of the uterus as an anvil against which to compress the arteries.
A method for occluding a uterine artery includes locating a uterine artery with one or more sensors and compressing a portion of the uterine artery with a non-invasive uterine artery occluding device which includes the sensor. A method of occluding a uterine artery of a patient may include locating a uterine artery with a sensor and compressing a portion of the uterine artery with a non-invasive uterine artery occluding device which includes the sensor. Compressing a portion of a uterine artery may include applying pressure or force to a vaginal wall. In addition, methods for occluding a uterine artery include applying tension to a uterus and applying pressure or force to a vaginal wall, and include engaging a uterine cervix with a grasping implement (e.g., by pulling on the uterine cervix) while applying force or pressure to a vaginal wall to occlude a uterine artery.
Also methods for occluding uterine arteries include occluding both the left and right uterine arteries simultaneously by inserting the pressure applying members along the exterior of the cervix and to the vaginal wall at the vaginal fornix, then compressing both arteries against the uterus.
The non-invasive devices, systems and methods embodying features of the invention allow the non-surgical location and occlusion of uterine arteries, providing therapeutic temporary, partial or complete, reduction or abolition of blood flow in the located and occluded uterine arteries. Use of the devices, systems and methods of the present invention thus allow the occlusion of a uterine artery without the puncture of bodily tissue, and without the need for radiographic equipment or for skill in the use of radiographic techniques. The devices and methods are simpler and more readily used and removed than other methods and devices, and provide improved treatments for serious uterine disorders, including uterine fibroids, dysfunctional uterine bleeding (DUB), endometriosis, adenomyosis, post-partum hemorrhage, and other uterine disorders. The devices, systems and methods embodying features of the invention thus provide tools and methods for effective treatment of diseases and conditions that otherwise require invasive and irreversible treatments such as removal of a uterus.
A non-invasive uterine artery-occluding system 10 also includes a sensor component 28, such as a blood flow detection system, which includes a sensor 30 and a cable 32 having a proximal connector 34 configured to operably engage with a sensor control device 36. A connector 34 is preferably a releasable connector configured to readily engage and disengage with a sensor control device 36. Alternatively, a cable 32 directly and permanently engage a sensor control device 36 without having a connector 34. A sensor control device 36 may be configured to supply power that may be required by a sensor 30, to receive signals from a sensor 30, and to carry sensor signal outputs to a sensor controller for interpretation by an operator. A sensor 30 is a passive sensor (e.g., configured to detect intrinsic signals indicating the presence of a uterine artery) or active (e.g., configured to emit a signal, and to detect a signal in response to, or derived from, the emitted signal). An emitted signal is pulsed or continuous. A sensor controller 36 preferably produces and provides signals or signal energy used for sensing (e.g., ultrasound or infra-red signals or energy) or provides energy to a sensor 30 to aid the sensor 30 to produce or provide signals or signal energy. Cable 32 preferably includes an electrical cable, an optical fiber, a waveguide, other conduit for carrying energy or signals, or a combination of these.
A sensor 30 preferably is a blood flow sensor configured to identify and locate a uterine artery and for determining the degree of occlusion of the uterine artery. In particular, a sensor 30 preferably is configured to indicate the location of a uterine artery with respect to a jaw 20 of a device embodying features of the invention. A sensor 30 may thus be a blood flow sensor, but may also be a microphone (e.g., to sense heart sounds or other sounds not directly “blood flow” sounds, although turbulence due to flow may also produce detectable sounds), a pressure transducer or stress or strain gauge to detect pulsations in an artery due to heart action, a pH sensor, an electromagnetic radiation sensor, such as an infrared sensor, to detect a uterine artery (e.g., to detect hemoglobin), or other sensor. Preferably, sensor 30 is a Doppler ultrasound sensor, configured to emit and to detect ultrasound effective to detect blood flow and to locate a uterine artery.
A sensor 30 is effective to detect the location of a uterine artery and to detect blood flow in a uterine artery. Such detection is used to direct a system 10 so as to ensure that body tissue including a portion of a uterine artery to be occluded is between jaws 20 of the clamping component 12. In preferred methods of use, the uterine artery and surrounding tissue is disposed between jaws 20 and pressure or force is applied to the tissue by tissue-contacting surfaces 22, applying pressure to the tissue, effective to compress a portion of a uterine artery and to at least partially occlude the uterine artery. Such compression and resulting occlusion of a uterine artery is effective to reduce or abolish blood flow in the artery. Sensor 30, disposed on jaws 20, may be effective to sense the reduction or abolition of blood flow in a compressed uterine artery.
In one embodiment a sensor 30 is a blood flow sensor for locating a uterine artery, and is a passive sensor, configured to detect intrinsic signals indicating the presence of a uterine artery (i.e., a sound sensor, a motion sensor, a pH sensor, or other sensor configured to detect a physical, chemical, electrical, or physiological indication of the location of a uterine artery). In other embodiments, a blood flow sensor for locating a uterine artery is an active sensor, configured to emit energy or a signal, and configured to detect signals in response to, or derived from, the emitted energy or signal indicating the presence of a uterine artery (i.e., a source of ultrasound having an ultrasound sensor configured to detect ultrasound reflections from a uterine artery, a source of infrared radiation configured to detect reflections from a uterine artery, or other source of energy and a sensor configured to detect a response indicating the location of a uterine artery). The operation of a sensor may be aided by an energy source (which may be provided by a sensor controller 36), which may directly provide the energy detected by the sensor, or which may aid the sensor to provide the energy to be sensed. For example, an energy source may provide electrical energy which aids an ultrasound sensor to produce and to detect ultrasound energy (as, e.g., in the MedaSonics® CardioBeat® Blood Flow Doppler with Integrated Speaker (Cooper Surgical, Inc., Trumbull Conn. 06611)). Other commercially available Doppler ultrasound sensors suitable for use in the present invention include the Koven model ES 100X MiniDop VRP-8 probe (St. Louis, Mo.) and the DWL/Neuro Scan Medical Systems' Multi-Dop B+ system (Sterling, Va.).
Non-invasive uterine artery occluding devices embodying features of the invention include clamping devices having a pressure-applying member configured to apply pressure or force to a uterine artery and a blood flow sensor. A pressure-applying member preferably has a distal portion configured to engage tissue. Non-invasive uterine artery occluding devices embodying features of the invention preferably has two, or more, pressure-applying members. Two pressure-applying members preferably are disposed opposite each other and configured to move and/or to apply pressure or force towards each other, such as to close together, effective to engage tissue and to clamp a uterine artery between them. Alternatively, a pressure-applying member may have two portions disposed in apposition to one another, effective to clamp tissue between the portions.
Partial or total closure of a uterine artery, is effected by pressure applied through a body wall, such as the vaginal mucosa. Sufficient pressure or force applied to tissue is effective to apply pressure to that tissue and to underlying tissues and so to compress and to at least partially occlude a uterine artery. An amount of pressure applied through a body wall to effect closure of a uterine artery may be between about 15 pounds per square inch (psi) and about 125 psi, and preferably is between about 30 psi and about 60 psi. For example, where the pressure-applying surface has a surface area of about 0.16 square inches (e.g., a surface with dimensions of about 0.2 inches by about 0.8 inches), the amount of force applied by a non-invasive artery occluding device embodying features of the invention is preferably between about 3 pounds and about 20 pounds, and more preferably between about 6 pounds and about 9 pounds.
A sensor for detecting or locating a uterine artery may be any sensor configured to detect a uterine artery in place within body tissue. Such a sensor may detect sound, such as heart sounds, or other sounds intrinsically associated with uterine arteries. Alternatively, a sensor for locating an artery may produce or be associated with artificially created light or sound, such as ultrasound, and detect reflections or other signals derived from the artificially-produced light or sound. In preferred embodiments, a sensor is a blood flow sensor. A blood flow sensor, such as a Doppler blood flow sensor, may be disposed perpendicular to the tissue-contacting surface 22 of a jaw 20, effective that only arteries facing a jaw 20, or within the jaws 20, are detected by the blood flow sensor.
A sensor may detect a uterine artery, or blood flow, or signals related to the location of a uterine artery or of blood flow, in a particular direction. For example, a sensor disposed on a tissue-contacting surface of a pressure-applying member, such as a jaw of a clamp, may detect signals from a direction perpendicular to the surface of the jaw, and so be effective to locate uterine arteries or detect blood flow opposite the jaw. Such an orientation is effective to insure that a uterine artery to be occluded is positioned opposite a jaw, and between a pair of jaws, and so is properly placed for occlusion. A sensor may also be configured to detect signals from directions parallel to a tissue-contacting surface, or at some other angle with respect to a tissue-contacting surface; such configurations are useful, for example, for directing the movement of a non-invasive artery occluding device towards a uterine artery.
A blood flow sensor preferably includes Doppler ultrasound sensor. A blood flow sensor may be disposed on a clamping member, preferably on a distal portion configured to engage tissue, more preferably near the middle of the distal portion. A blood flow sensor disposed on a pressure-applying member preferably is configured to detect blood flow in a uterine artery near to the pressure-applying member, and may be configured to detect blood flow in a uterine artery clamped by a pressure-applying member or between pressure-applying members. Non-invasive uterine artery occluding devices embodying features of the invention may include more than one blood flow sensor. Preferred blood flow sensor include Doppler ultrasound blood flow sensors and near infrared blood flow sensors.
In one embodiment a non-invasive uterine artery occluding device embodying features of the invention is configured to lock into a clamping position. Such a locked configuration is temporary and releasable, or is permanent. Non-invasive uterine artery occluding devices embodying features of the invention preferably have a locking mechanism, such as a ratchet, configured to hold at least one pressure-applying member in a pressure-applying position. Such locking mechanisms preferably include a release mechanism effective to allow the cessation of pressure or force application when desired. Thus, a non-invasive uterine artery occlusion device embodying features of the invention preferably is configured to release a locking mechanism effective to relieve the occlusion of a uterine artery by ending the application of pressure or force that had been previously applied to occlude a uterine artery.
The apparatus and systems of the present invention are configured for use within a body cavity and for use adjacent a patient's skin or other body surface, but are non-invasive and configured for external use. Clamping devices may be of any suitable size, which is determined in part by the location and dimension of the artery to be occluded. The handle, jaws, and if present, connecting portion, are configured to allow access to tissue adjacent a uterine artery such as a uterine artery and to provide a clamping pressure or force to the tissue sufficient to occlude the uterine artery to reduce or abolish blood flow in it.
For accessing and occluding a uterine artery, the dimensions of a vagina help to determine suitable sizes for clamping devices and clamp applicators embodying features of the invention so that at least a portion of a vaginal clamp is configured to fit within a vagina, and can readily reach the vaginal fornix when operated from outside of a patient's body. For example, a clamping device may be between about 0.5 inch and about 16 inches in length, preferably between about 1 inch and about 12 inches in length.
Apparatus and systems configured for detecting and occluding blood flow embodying features of the invention are configured to invaginate vaginal mucosa when disposed within a vagina near to a uterine artery. Such apparatus and systems are configured to invaginate vaginal mucosa without puncturing a vaginal wall; that is, Without passing through the vaginal mucosa. A sensor may be configured, for example, to detect blood flow in an artery such as a uterine artery without puncturing a patient's skin or mucosal surface. A jaw or jaws of a device and of a system embodying features of the invention are configured to compress tissue adjacent an artery such as a uterine artery without puncturing a patient's skin or mucosal surface. Thus, a vaginal clamp embodying features of the invention is effective to detect the location of an artery such as a uterine artery and to occlude it.
A vaginal clamp embodying features of the invention has a jaw or jaws configured to engage a uterine artery or to engage tissue adjacent a uterine artery, and has an ultrasound sensor, such as a Doppler ultrasound sensor, mounted in a jaw. A Doppler ultrasound sensor operating at ultrasound frequencies less than about 20 MHz, such as between about 5 MHz and about 19 MHz, preferably between about 6 MHz and about 10 MHz, more preferably at about 8 Hz, is suitable for detecting blood flow in an artery with apparatus embodying features of the invention. A sensor is preferably mounted to the face of the clamp jaw and oriented perpendicularly to the jaw face. For example, a blood flow sensor may be mounted between about 0.1″ and about 1″ from the distal tip of a clamp jaw, and is preferably mounted about 0.2 to about 0.6″, more preferably about 0.4″ from the distal tip of a clamp jaw. A clamp jaw may be configured to tightly engage tissue, i.e., may have a surface that is serrated, scored, roughened, coated with a rough material including sandpaper, or otherwise configured to grip tissue. For example, a clamp jaw may be serrated in order to obtain sufficient grip force to remain in position over a uterine artery when clamped onto vaginal mucosa. A non-invasive artery occluding device may have more than two jaws. Multiple jaws are preferably disposed approximately symmetrically about a central axis, and configured so that all jaws approach a central position when closed, so that, for example, three jaws may be oriented approximately 120° from each other and disposed to close to a central point effective to capture tissue between them.
The dimensions of a vaginal clamp embodying features of the invention are chosen to facilitate use within a vagina, and so that the clamp can readily reach the vaginal fornix when operated from outside of a patient's body.
A jaw or jaws may be configured to join with the connecting portion on a line substantially parallel to a line along the connecting portion, or may join at an angle to such a line. An angle between a jaw or jaws and a connecting portion may be acute or may be obtuse. In preferred embodiments, the connection between a jaw or jaws and a connecting portion or portions is a rigid connection; in some embodiments, a jaw may be an extension of a connecting portion, and both may be formed of a single piece of material.
In one embodiment the pressure applying members of the non-invasive uterine artery occluding device in accordance with the present invention are sized to be insertable through the vagina of a female human patient, along a side of the exterior of the cervix, and to the vaginal wall at the vaginal fornix. The bilateral structures of the non-invasive uterine artery occluding system permit both the left and the right uterine arteries 48 and 50 to be compressed at the same time upon upward pushing of the device 10, and using the body of the uterus as an anvil against which to compress the arteries.
The spacing between the portions of the jaws 20 which bare on the vaginal wall can be dimensioned to accommodate the urethra and bladder neck on the anterior side of the cervix, and the rectum on the posterior side of the cervix. That is, the distalmost compressing ends of the device 10 can optionally be sized, both in their circumferential length and their longitudinal depth, so that when the device 10 is used to compress the left and right uterine arteries of a female human patient, the urethra, bladder neck, and rectum are not compressed as much, or are not compressed at all, which can limit or eliminate complications with these structures.
In the embodiment shown in
One or both of the first and second parts 128, 130 include at least one, and preferably a plurality or array of holes, bores, or channels 136 which are sized and configured to receive Doppler chips. Thus, when the device 10 includes the holes 136 and Doppler chips positioned therein, the device 10 can further be used to identify the location of a uterine artery of interest based upon its blood flow characteristics and monitor the blood flow through the uterine artery during the course of a procedure.
As the system is advanced upwardly along the cervix towards the uterus, as with prior embodiments described above, the uterine artery or arteries are entrapped between the uterine body and the device 10, and are compressed between the body of the uterus and the vaginal wall at the vaginal fornix; in turn, the vaginal wall is pushed by the distal end faces 132, 134, of the device 10.
Further optionally, the system, and in particular, the finger rings 16, can be manipulated to move the first and second parts 128, 130 of the jaws 20 toward one another, thereby moving the entrapped uterine arteries toward the body of the uterus and additionally compressing the uterine arteries. At this point, one or more of the distal end faces 132, 134 and the lateral surfaces 138, 140 include the surfaces which transmit force from the device 10 to the patient's tissues. As will be readily appreciated by those of skill in the art, and schematically illustrated in
In the embodiment shown in
Methods and devices embodying features of the invention may be used to occlude any artery; in the following discussion, the uterine artery is used as an example. It will be understood that the methods and devices discussed in regard to this example may also be applied to any other artery, particularly any other artery located near a body wall such as a vaginal wall, a rectal wall, and abdominal wall, skin surface, or other body surface.
A method of occluding an artery includes sensing an artery, and compressing an artery with a clamping device having a blood flow sensor. Sensing an artery may include sensing blood flow, such as blood flow in an artery. Compressing an artery may include grasping tissue near to an artery, and may include compressing tissue surrounding an artery effective to compress the artery.
One method of occluding a uterine artery includes applying an artery occluding device to the artery so that blood flow through the artery is reduced, or is abolished. Such occlusion is effected by clamping an artery such as a uterine artery. Clamping of a uterine artery preferably is accomplished by applying a clamping device to tissue near to a uterine artery effective to compress the uterine artery.
A uterine artery may be accessed via the vagina of a patient, and compressing a uterine artery may be accomplished by compressing a portion of the vaginal wall around a portion of a uterine artery. The vaginal clamp is able to access the uterine arteries via the vagina 42, by pressing with jaws 20 on the vaginal wall near the vaginal fornix 58 so as to distend portions 64 and 66 of the vaginal wall to more closely approach the right uterine artery 48. Pressure from jaws 20 is thus effective to invaginate the vaginal wall in order to bring tissue around uterine artery 48 as shown in
A method of occluding uterine arteries includes occluding both uterine arteries simultaneously by inserting the pressure applying members along the exterior of the cervix and to the vaginal fornix and compressing both arteries against the body of the uterus.
A clamping device suitable for use in a method embodying features of the invention has a releasable clamping device, so that a uterine artery remains occluded for only a limited time. A suitable limited time may be between about 0.2 hours and about 12 hours, or preferably between about 0.5 hours and about 4 hours.
Non-invasive artery occluding devices embodying features of the invention may be made from any suitable material or combination of materials, including metals such as stainless steel and shape memory alloys such as nickel titanium alloys, plastics, ceramics, and other materials known in the art. Biocompatible polymers, such as for example, polycarbonate, polysulfone, polyester, polyacetal, and other polymers may be particularly suitable for embodiments of the invention. The device or system may be designed for single use (disposable) or may be sterilizable and capable of multiple use.
While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention be defined by the scope of the appended claims as broadly as the prior art will permit.
Terms such as “element”, “member”, “device”, “sections”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C §112(6) unless the following claims expressly use the terms “means” or “step” followed by a particular function without reference to a specific structure or action. All patents and all patent applications referred to above are hereby incorporated by reference in their entirety.
This application relates to and claims priority of U.S. patent application Ser. No. 09/556,934 filed Apr. 21, 2000, now U.S. Pat. No. 6,550,482, U.S. patent application Ser. No. 10/300,115 filed Nov. 19, 2002, U.S. patent application Ser. No. 09/909,815 filed Jul. 20, 2001, U.S. patent application Ser. No. 10/113,096 filed Mar. 28, 2002, U.S. patent application Ser. No. 10/107,810 filed Mar. 28, 2002, U.S. patent application Ser. No. 11/151,808, filed Jun. 13, 2005 which is a continuation of application Ser. No. 10/107,810, and provisional application 60/279,477 filed Mar. 28, 2001. Each of the applications are incorporated by reference in their entirety.