Source: https://patents.google.com/patent/WO2004026113A2/en
Timestamp: 2019-04-21 15:20:12+00:00

Document:
The present invention provides an occlusive system (10) and method of use at a surgical procedure. The occlusive system (10) comprises a fastener (30) and an occlusive device (50) in cooperation with the fastener (30). An embodiment of the invention may further comprise a fastener tip (40) and a penetration apparatus (20). According to an embodiment of the present invention, a method of reducing the loss of fluid at a surgical site comprises the steps of: advancing an occlusive system (10) comprising a fastener having an occlusive device (50) to the surgical site; and deploying the surgical fastener (10) having the occlusive device (50) at the surgical site.
 The present invention relates to, and is entitled to the benefit of the earlier filing date and priority of, Application No. 60/412,549, filed on September 23, 2002, and Application No. 60/415,778, filed on October 4, 2002.
 The present invention relates to an apparatus and method for reducing fluid loss during a surgical procedure. In particular, the present invention relates to an apparatus and method for reducing blood loss from a vessel during a surgical procedure.
 Aortic aneurysms are the most common form of arterial aneurysm and are life threatening. The aorta is the main artery which supplies blood to the circulatory system. The aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen. Among other arterial vessels branching off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the renal arteries, the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries. The iliac arteries, in turn, supply blood to the lower extremities and perineal region.  It is common for an aortic aneurysm to occur in the portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, often resulting in an aortic aneurysm. Such an aneurysm may be located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on aneurysms smaller than 5 cm because it has not been established that surgical intervention is beneficial for aneurysms that size.  Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the aortic aneurysm. A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.  Repair of an aortic aneurysm is a major operative procedure. Substantial morbidity accompanies the procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated, the surgery carries attendant risks and certain patients may not be able to tolerate the stress of intra-abdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention.
 In recent years, methods have been developed to attempt to treat an aortic aneurysm without the attendant risks of intra-abdominal surgical intervention. Among them are inventions disclosed and claimed in Kornberg, U.S. Patent No. 4,562,596 for Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair; Lazarus, U.S. Patent No. 4,787,899 for Intraluminal Graft Device, System and Method; and Taheri, U.S. Patent No. 5,042,707 for Intravascular Stapler, and Method of Operating Same.  None of the known systems provide an apparatus that selectively reduces blood loss from a vessel during attachment of a surgical component, such as a prosthetic graft, to a vessel wall in the manner of the embodiments of the present invention. In particular, attachment devices, including, but not limited to surgical fasteners, have been developed that are intended to attach a surgical component to tissue, component to component, or tissue to tissue. An example is the attachment of a prosthetic graft to an aortic wall as described in U.S. Patent Nos. 5,944,750 and 5,957,940, which are hereby incorporated in their entirety by reference. When the attachment device is inserted independently, or in conjunction with a penetration apparatus, the attachment device will have an opening through its center that could allow the exodus of blood from within the aortic lumen unless some sort of occlusive mechanism is built into the attachment device itself or into an additional component used in conjunction with the attachment device.  Therefore, it is an advantage of some, but not necessarily all, embodiments of the present invention to provide a device that may be added either to the attachment device or to an additional component used in conjunction with the attachment device to reduce blood loss during a surgical procedure.  Additional advantages of various embodiments of the invention are set forth, in part, in the description that follows for reducing blood loss from a vessel during a surgical procedure.
 Responsive to the foregoing challenges, Applicant has developed an innovative apparatus and method for reducing blood loss from a vessel during a surgical procedure at a surgical site.
 An alternative embodiment of the present invention is an occlusive system for use at a surgical site comprising a fastener and an occlusive device in cooperation with the fastener. The system may further comprise a fastener tip in communication with the fastener. The system may further comprise a penetration apparatus in communication with the fastener. The occlusive device may comprise one or more selected from the group consisting of a coil, band, ribbon, valve, and flap. In an alternative embodiment, the occlusive device may comprise at least one of a coil, band, ribbon, valve, flap, or any other suitable element.
 In an alternative embodiment, the occlusive device may have a substantially closed configuration, or a first substantially open configuration and a second substantially closed configuration. In an alternative embodiment, the occlusive device may either collapse or expand into a substantially closed configuration. In an alternative embodiment, the occlusive device may be disposed within the fastener, adjacent to the fastener, or have a first portion disposed within the fastener and a second portion extending outside the fastener.
 An alternative embodiment of the present invention is an occlusive system for use at a surgical site comprising a fastener, a fastener tip in cooperation with the fastener, and an occlusive device in cooperation with the fastener or the fastener tip. The occlusive device may be in cooperation with the fastener, the fastener tip, or both.
 An alternative embodiment of the present invention is an occlusive system for use at a surgical site comprising a fastener, an occlusive device in cooperation with the fastener, and a penetration apparatus in reversible communication with the fastener and the occlusive device. The occlusive device may have a first substantially open configuration and a second substantially closed configuration.
 An alternative embodiment of the present invention is an occlusive system for use at a surgical site comprising fastener means for fastening a first component to a second component, and occlusive means in cooperation with the fastener means for reducing fluid flow at the surgical site. The first component and second component may be comprised of a surgical component, a tissue, or both.
 An alternative embodiment of the present invention is a method for reducing the loss of fluid at a surgical site comprising the steps of advancing an occlusive system comprising a fastener having an occlusive device to a surgical site and deploying the surgical fastener having the occlusive device at the surgical site. The method may further comprise the step of reducing the loss of fluid at the surgical site. The fluid may be blood, or any blood component.  It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention as claimed.
 Figure 1 A and B is a schematic view of an occlusive system in accordance with an embodiment of the present invention.
 Figure 2A is a cut-away pictorial view of an occlusive system including a penetration apparatus, fastener, occlusive device (not shown), and a fastener tip according to an embodiment of the present invention.
 Figure 2B is a perspective view of a fastener tip according to an embodiment of the present invention.  Figure 3 is a cut-away pictorial view of the insertion of the penetration apparatus and the fastener through the surgical component and the vessel wall in accordance with an embodiment of the present invention.
 Figure 4 is a cut-away pictorial view of the fastener deployed through the surgical component and the vessel in accordance with an embodiment of the present invention.
 Figures 5 and 6 are schematic views of an occlusive system according to an embodiment of the present invention.
 Figure 7A and B is a schematic view of an occlusive system according to an embodiment of the present invention.
 Figure 8A, B, C, D, E, and F is a perspective view of an occlusive device according to an embodiment of the present invention.
 Figure 9 is a cross-sectional view of an occlusive system according to an embodiment of the present invention having an opened flap valve.  Figure 10 is a cross-sectional view of the embodiment of Fig. 9 with the flap valve in a closed configuration.
 Figure 11A and B is a schematic view of an example embodiment of the device comprising a thin wall material.
 Figure 12A and B is a schematic view of another example embodiment of the device comprising a thin wall material.
 Figures 13, 14, and 15 are perspective views of further example embodiments of the device directed to a valve.
 Figure 16A and B is a schematic view of an embodiment of the device directed to the tapered tip.  Figure 17A, B, and C is a schematic view of an embodiment of the device directed to a thin wall material.
 Figure 18A, B, and C is a schematic view of an example embodiment of the device directed to a polymeric cord.  Figures 19A and B and 20A, B, and C are schematic views of further embodiments of the occlusive device directed to an expandable material.  Figures 21 and 22 are cut-away pictorial views of further embodiments of the occlusive device directed to a mass of shape memory material in an opened and a closed configuration.
expanding, and/or collapsing. In an alternative embodiment, occlusive device 50 may remain in a first substantially closed position, or may have a first substantially closed position and a second substantially open position. In an embodiment having a first and second position, occlusive device 50 is biased toward the first substantially closed position.  In alternative embodiments, occlusive system 10 comprises occlusive device 50 and surgical fastener 30 alone, or occlusive device 50 and surgical fastener 30 in combination with surgical fastener tip 40, and/or penetration apparatus 20, or any combination of the above. Various embodiments are discussed in greater detail in the following paragraphs.
occlusive device 50, surgical fastener 30, and surgical fastener tip 40. Surgical fastener tip 40 is located adjacent to surgical fastener 30. Occlusive device 50 may be disposed within and/or located adjacent to fastener 30, or disposed within and/or located adjacent to surgical fastener tip 40, as shown in Fig. 5.
 In an alternative embodiment, occlusive system 10 may comprise occlusive device 50, surgical fastener 30, and penetration apparatus 20.
vessel wall 200 are shown with inside or interluminal potion 200A and outside or adventitial portion 200B. The surgical site, however, is not limited to a surgical component and a vessel but may be any combination of the surgical component and/or the vessel, such as, but not limited to, a surgical component to a surgical component, a surgical component to a vessel, or a vessel to a vessel.
December 17, 1998, now U.S. Patent No. 5,997,556; U.S. Patent Application No. 08/958,524, filed October 27, 1997, now U.S. Patent No. 5,957,940; U.S. Patent Application No. 08/896,415, filed July 18, 1997, now U.S. Patent No. 5,944,750; and U.S. Provisional Patent Application No. 60/051 ,209, filed June 30, 1997. The subject matter of these patents and patent applications is incorporated herein in its entirety specifically by reference. In further example embodiments, fastener 30 may or may not apply a compressive force to attach surgical component 100 to vessel wall 200.
36. Each portion of fastener 30 may be similar or different in structure and may be composed of similar or different materials such as, but not limited to, plastic, metal, metal alloy, or any other suitable material.
site and in further embodiments, includes occlusive device 50 for reducing blood loss at the surgical site, as shown in Fig. 5. In one embodiment, tip 40 is attached to leading portion 32 of fastener 30, but also may be located elsewhere on fastener 30, such as, but not limited to, middle portion 34 and/or trailing portion 36. As shown in Figure 2B, tip 40 may include inner lumen 42, leading edge 44, middle portion 46, and trailing edge 48. Tip 40 may facilitate penetration with or without the use of penetration apparatus 20, and may be composed of any suitable material, such as, but not limited to, plastic, metal, or metal alloy. Tip 40 shown in Figs. 2A and 2B is of a conical or a bell shape, but may be of any suitable shape.
and/or tip 40. Occlusive device 50 may be attached to fastener 30 in various ways such as, but not limited to, extension of the fastener wires, welded, threaded over the fastener, or any other suitable method of attachment. When penetration apparatus 20 is engaged with fastener 30 in Fig 1A, occlusive device 50 is in a second substantially open configuration. When penetration apparatus 20 is removed, occlusive device 50 retracts toward fastener 30 into a first substantially closed configuration, as shown in Fig. 1 B. This retraction of occlusive device 50 assists in the reduction of fluid loss during and following the surgical procedure. Various embodiments of occlusive device 50 may be disposed at leading portion 32, middle portion 34, or trailing portion 36 of fastener 30 and/or with an apparatus, such as, but not limited to, tip 40. Illustrated in Figs. 5 and 6, occlusive device 50 is located within tip 40.
substantially open configuration. When penetration apparatus 20 is withdrawn, as shown in Fig. 7B, occlusive device 50 assumes its first substantially closed configuration or retracted shape and provides resistance to fluid and/or blood flow. Occlusive device 50, according to this embodiment, may be fabricated from a metal, a polymeric material or any other suitable material and may be attached to fastener 30 in a number of ways, including, but not limited to, material specific welding, or any other suitable bonding techniques.
embodiments, occlusive device 50 is disposed within or attached to fastener 30 or into another structure such as, but not limited to, tip 40. Figs. 8B through 8F depict further, non-limiting embodiments of occlusive device 50 with sagittal cuts there through. In particular, Fig. 8B is a straight cone; Fig. 8C is an insloping cone; Fig. 8D is an outsloping cone; Fig. 8E is a hemisphere; and Fig. 8F is an abbreviated hourglass.
 In the alternative embodiments of the present invention depicted in Figs. 9 and 10, occlusive device 50 comprises a flap valve from a sagittal cut through tip 40 that may be attached to leading portion 32 of fastener 30. In Fig.
apparatus 20 is removed, occlusive device 50 assumes its first substantially closed configuration. Occlusive device 50 depicted in Figs. 13 through 15 is illustrated in the first substantially closed configuration.
apparatus 20 is withdrawn resulting in a collapse of occlusive device 50 to its first substantially closed position to reduce fluid and/or blood flow through the fastener 30.
device 50 may be secured to fastener 30 by crimping, screwing, shrink- wrapping, heating, welding, or attachment by any other suitable means. In example embodiments depicted in Fig. 17A, occlusive device 50 may be polymeric tubing shrunk over leading portion 32 of fastener 30. Illustrated in Fig. 17B, the cross section shows occlusive device 50 in a second substantially open configuration with penetration apparatus 20 in position within fastener 30. Fig.
17C depicts occlusive device 50 in its first substantially closed configuration after removal of penetration apparatus 20 from the surgical site.
penetration apparatus 20. Occlusive device 50 is also in a second substantially open configuration in the presence of penetration apparatus 20. In contrast, Fig.
with removal of penetration apparatus 20.
 Various alternative embodiments of the present invention are also illustrated in Figs. 19A and 19B. Occlusive device 50 may comprise one or more expandable members comprised of a polymeric foam or elastomer, or any other suitable expandable component. In an alternative embodiment, occlusive device 50 is located in tip 40 where it is compressed in the presence of penetration apparatus 20 into its second substantially open position, as shown in Fig. 19A. When penetration apparatus 20 is removed, as shown in Fig. 19B, occlusive device 50 may assume its first substantially closed position within tip 40 thereby reducing fluid and/or blood flow through fastener 30.
 In other alternative embodiments, tip 40 may be composed of expandable material or biodegradable material (not shown). In this instance, fastener 30 is aligned over penetration apparatus 20 and over a reduced diameter of tip 40. With the removal of penetration apparatus 20, tip 40 may enlarge thereby forming a barrier to reduce the flow of fluid and/or blood through fastener 30.  As illustrated in Figs. 20A, 20B and 20C, the expandable material of occlusive device 50 comprises an expandable plug. In various embodiments, occlusive device 50 is comprised of a polymeric or electrometric foam or any other suitable expandable component. Occlusive device 50, as illustrated in Fig.
now be described. Occlusive system 10 comprising fastener 30 and occlusive device 50 is advanced to a surgical site through a lumen, such as, but not limited to, a vessel as disclosed in the following U.S. Patents and Patent Applications: U.S. Provisional Patent Application No. 60/181 ,230, filed February 9, 2000; U.S. Patent Application No. 09/442,768, filed November 18, 1999; U.S. Patent Application No. 09/213,233, filed December 17, 1998, now U.S. Patent No.
and/or vice versa (not shown). Occlusive system 10 may be deployed at the surgical site as described in U.S. Patent Nos. 5,972,023; 5,957,940; 6,371 ,919; 5,997,556; 6,248,118; 6,520,974; 6,607,555, and U.S. Patent Application No. 10/417,163, filed April 17, 2003, herein incorporated in their entirety by reference. Occlusive system 10 may be advanced to the surgical site and deployed without the use of a penetration apparatus 20, or without the use of a surgical tip 40. Various embodiments of occlusive system 10 may be used to attach one or more of a surgical component, such as, but not limited to a prosthetic graft, and a tissue, such as, but not limited to a vessel. In one example embodiment occlusive system 10 comprising occlusive device 50 and surgical fastener 30 is deployed during the surgical procedure to attach a surgical component to a vessel, a surgical component to another surgical component, a vessel to vessel, or any combination thereof.  Numerous characteristics and advantages have been set forth in the foregoing description, together with details of structure and function. The novel features are pointed out in the appended claims. The disclosure, however, is illustrative only, and changes may be made in detail, especially in matters of shape, size and arrangement of parts, within the principle of the invention, to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.
I. An occlusive system for use at a surgical site comprising: a fastener; and an occlusive device in cooperation with the fastener.
2. The system of Claim 1 , further comprising a fastener tip in communication with the fastener.
3. The system of Claim 1 , further comprising a penetration apparatus in communication with the fastener.
4. The system of Claim 1 , wherein the occlusive device comprises one or more selected from the group consisting of a coil, band, ribbon, valve, and flap.
5. The system of Claim 1 , wherein the occlusive device comprises at least one coil.
6. The system of Claim 1 , wherein the occlusive device comprises at least one band.
7. The system of Claim 1 , wherein the occlusive device comprises at least one ribbon.
8. The system of Claim 1 , wherein the occlusive device comprises at least one valve.
9. The system of Claim 1 , wherein the occlusive device comprises at least one flap.
10. The system of Claim 1 , the occlusive device having a substantially closed configuration.
I I . The system of Claim 1 , the occlusive device having a first substantially open configuration and a second substantially closed configuration.
12. The system of Claim 1 , wherein the occlusive device collapses into a substantially closed configuration.
13. The system of Claim 1 , wherein the occlusive device expands into a substantially closed configuration.
14. The system of Claim 1 , wherein the occlusive device is disposed within the fastener.
15. The system of Claim 1 , wherein the occlusive device is disposed adjacent to the fastener.
16. An occlusive system for use at a surgical site comprising: a fastener; a fastener tip in cooperation with the fastener; and an occlusive device in cooperation with the fastener or the fastener tip.
17. The system of Claim 16, wherein the occlusive device is in cooperation with the fastener.
18. The system of Claim 16, wherein the occlusive device is in cooperation with the fastener tip.
19. An occlusive system for use at a surgical site comprising: a fastener; an occlusive device in cooperation with the fastener; and a penetration apparatus in reversible communication with the fastener and the occlusive device.
20. The system of Claim 19, the occlusive device having a first substantially open configuration and a second substantially closed configuration.
21. An occlusive system for use at a surgical site comprising: fastener means for fastening a first component to a second component; and occlusive means in cooperation with the fastener means for reducing fluid flow at the surgical site.
22. A method for reducing the loss of fluid at a surgical site comprising the steps of: advancing an occlusive system comprising a fastener having an occlusive device to a surgical site; and deploying the surgical fastener having the occlusive device at the surgical site.
23. The method of Claim 22, further comprising the step of: reducing the loss of fluid at the surgical site.
24. The method of Claim 22, wherein the fluid is blood.

References: Application No. 60
 Application No. 60
 Application No. 08
 Application No. 08
 Application No. 60
 Application No. 60
 Application No. 09
 Application No. 09
 Application No. 10