WO2012150941A1

WO2012150941A1 - Apparatus and method for delivering a surgical fastener

Info

Publication number: WO2012150941A1
Application number: PCT/US2011/035355
Authority: WO
Inventors: Hugh H. TROUT; Terry Dahl; Kenneth A. Spector; Howard M. Tanner; Frank Patterson
Original assignee: Eva Corporation
Priority date: 2011-05-05
Filing date: 2011-05-05
Publication date: 2012-11-08

Abstract

The present invention is directed to a method and apparatus for inserting, positioning, attaching, and cutting endografts endovascularly. A catheter, catheter handle and a surgical fastener having a first and a second end for securing at least two surfaces together. The surgical fastener has a first configuration where the fastener is coupled to a restraining device that holds the fastener and a second configuration wherein the fastener is released from said restraining device. The second configuration has a substantially spiral shape and is spring biased along an axis perpendicular to the surfaces that it is securing. The surgical fastener also includes a rib that extends along the longitudinal axis of the fastener.

Description

APPARATUS AND METHOD FOR DELIVERING A SURGICAL

FASTENER

FIELD OF THE INVENTION

[0001] The present invention relates generally to an apparatus and method for use in surgical repair, more particularly for inserting, positioning, and attaching endovascular surgical grafts using a surgical fastener. An embodiment of the present invention also relates generally to surgical fasteners, and more

particularly surgical fasteners for use in attaching tissue to tissue, surgical component to tissue, and surgical component to surgical component.

BACKGROUND

[0002] An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.

[0003] 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.

[0004] It is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often 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 as no statistical benefit exists to do so.

[0005] 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 abdominal wall (i.e., abdominal aorta). 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.

[0006] Repair of an aortic aneurysm by surgical means 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 and the surgery carries attendant risk, certain patients may not be able to tolerate the stress of intraabdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention.

[0007] In recent years, methods have been developed to attempt to treat an abdominal aortic aneurysm without the attendant risks of intra-abdominal surgical intervention. Although techniques have been developed that may reduce the stress, morbidity, and risk of mortality associated with surgical intervention to repair aortic aneurysms, none of the prior art systems that have been developed effectively treat the aneurysm and exclude the affected section of aorta from the pressures and stresses associated with circulation. None of the devices disclosed in the references provide a reliable and quick means to reinforce an aneurysmal artery, and none of the devices disclosed provide a surgical fastener possessing the advantages of the fastener of the present invention. In addition, all of the prior references require a sufficiently large section of healthy aorta abutting the aneurysm to ensure attachment of the graft. The proximal aortic neck (i.e., above the aneurysm) is usually sufficient to support a graft's attachment means. However, when an aneurysm is located near the iliac arteries, there may be an ill- defined neck or no neck below the aneurysm. Such an ill-defined neck would have an insufficient amount of healthy aortic tissue to which to successfully attach a graft. Furthermore, much of the abdominal aortic wall may be calcified making it extremely difficult to attach a graft thereto.

[0008] One of the problems associated with current surgical fasteners is that these fasteners are difficult to insert and advance during surgical procedures because these fasteners lack adequate support. Additionally, current fasteners often result is excess bleeding. There is a need to develop a fastener that is easier to advance and curtails the amount of bleeding during surgical procedures. None of the prior art systems provide a surgical fastener that achieves the advantages of the present invention.

[0009] What is also needed in the industry is a delivery catheter and catheter control handle to perform the procedure and position and deliver the surgical fastener. There is no known system to enable a user to position and deliver a surgical fastener as disclosed herein.

[0010] Additionally, there are occasions when it is advantageous to use an unsupported endograft. A new approach to the endovascular treatment of aortic aneurysms involves using only unsupported endografts where the unsupported endograft can be inserted and the tube portion attached to the aortic neck and the distal limbs attached to the iliac arteries with commercially available stents. An endovascular approach using unsupported endografts would substantially lower costs associated with the procedure because a current supported endograft typically costs about $20,000. There is a need in the industry to develop apparatus and methods to insert, position, and attach the endograft, and trim excess graft material from an endograft following placement of the endograft at the surgical site

[0011] Additional advantages of various embodiments of the invention are set forth, in part, in the description that follows and, in part, will be apparent to those of ordinary skill in the art from the description and/or from the practice of the invention.

SUMMARY [0012] Embodiments of the present invention are directed to an apparatus, system, and method for inserting, positioning, attaching, and cutting endografts endovascularly, and to position and insert a surgical fastener at the surgical site. An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means. The insertion apparatus may comprise fastening means for fastening the surgical component to the vessel, and a graft. The release means supplies an electric current and/or heat to the attachment means. The attachment means may comprise at least one attachment wire and a support wire, and or an attachment hoop, at least one attachment wire, and a support wire. The insertion apparatus may comprise a short sheath, and the short sheath may comprise a flare.

[0013] An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is releaseably connected to the surgical component and the second end is connected to the support wire, and wherein the attachment wire and support wire positions the surgical component at a site in the vessel. The insertion apparatus may further comprise a fastener delivery catheter. The insertion apparatus may further comprise an introducer sheath. The introducer sheath may comprise a homostatic valve and a dilator.

[0014] An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising an attachment hoop releasably connected to the surgical component, at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is connected to the attachment hoop and the second end of the at least one attachment wire is connected to the support wire, and wherein the insertion apparatus positions the surgical component in the vessel.

[0015] An embodiment of the present invention is an insertion system for deploying a surgical component to a site in a vessel comprising a surgical component, an insertion apparatus, attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component, and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means. The system may also comprise a fastening means for fastening the surgical component to the vessel.

[0016] An embodiment of the present invention is a method for positioning a surgical component to a site in a vessel comprising the steps of, introducing an insertion apparatus proximal to the site in the vessel, activating the insertion apparatus, and withdrawing the insertion apparatus. The method may further comprise the step of inserting an introducer catheter to the site in the vessel prior to introducing the insertion apparatus to the site in the vessel.

[0017] An embodiment of the present invention is a method for positioning a surgical component with an insertion apparatus to a site in a vessel comprising the steps of: introducing the insertion apparatus proximal to the site in the vessel; fastening the surgical component to the vessel; activating the insertion apparatus; and withdrawing the insertion apparatus.

[0018] An embodiment of the present invention is a catheter handle capable of controlling the insertion apparatus and/or the fastener apparatus and deploying surgical fasteners at the surgical site.

[0019] The present invention is directed to a surgical fastener for use during a surgical procedure for securing a first component to a second component. The surgical fastener secures a first component to a second component under a force. The surgical fastener has a first stressed configuration where the fastener is coupled to a restraining device that can be used to insert the surgical fastener into both components. After insertion, the restraining device can be removed resulting in a second unstressed configuration in which the surgical fastener has a substantially spiral shape on the outer side of both components. The surgical fastener is spring biased towards the middle thereby securing the two components together. The surgical fastener also includes a rib that extends along the longitudinal axis of the surgical fastener. The rib may facilitate more reliable insertion and more consistent advancement. [0020] In accordance with an embodiment of the present invention, the surgical fastener may have a first configuration for inserting the surgical fastener through the second component and the first component, and a second

configuration when the surgical fastener is in a secured position.

[0021] In accordance with another embodiment of the present invention, surgical fastener further comprises of at least one ring that is created by having a finger connect to the rib that runs along the longitudinal axis of the surgical fastener. The ring assembly may further include using different ring dimensions and spring characteristics. By adjusting the variables of the ring width and tension, the rings can help facilitate a more effective surgical fastener. For example, in one embodiment, to reduce the chance of substantive bleeding, the rings are cut in a manner that results in closure of the rings when the surgical fastener assumes its second or spiraled configuration. Additionally, instead of the surgical fastener being constructed from wire, it may now be laser cut from tubing; for example, laser cut Nitinol or cut by any suitable method.

[0022] Embodiments of the present invention disclose various

improvements to the surgical fastener to assist in insertion and delivery of the surgical fasteners as well as reduce bleeding during surgical procedures.

[0023] Embodiments of the present invention are directed to a system, method and apparatus for inserting, positioning, attaching, and cutting endografts and surgical fasteners endovascularly. An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means. The insertion apparatus may comprise fastening means for fastening the surgical component to the vessel, and a graft. The release means supplies an electric current and/or heat to the attachment means. The attachment means may comprise at least one attachment wire and a support wire, and or an attachment hoop, at least one attachment wire, and a support wire. The insertion apparatus may comprise a short sheath, and the short sheath may comprise a flare. [0024] An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is releaseably connected to the surgical component and the second end is connected to the support wire, and wherein the attachment wire and support wire positions the surgical component at a site in the vessel. The insertion apparatus may further comprise a fastener delivery catheter. The insertion apparatus may further comprise an introducer sheath. The introducer sheath may comprise a homostatic valve and a dilator.

[0025] An embodiment of the present invention is an insertion apparatus for deploying a surgical component to a site in a vessel comprising an attachment hoop releasably connected to the surgical component, at least one attachment wire with a first end and a second end, a support wire, wherein the first end of the at least one attachment wire is connected to the attachment hoop and the second end of the at least one attachment wire is connected to the support wire, and wherein the insertion apparatus positions the surgical component in the vessel.

[0026] An embodiment of the present invention is an insertion system for deploying a surgical component to a site in a vessel comprising a surgical component, an insertion apparatus, attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component, and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means. The system may also comprise a fastening means for fastening the surgical component to the vessel.

[0027] An embodiment of the present invention is a method for positioning a surgical component to a site in a vessel comprising the steps of, introducing an insertion apparatus proximal to the site in the vessel, activating the insertion apparatus, and withdrawing the insertion apparatus. The method may further comprise the step of inserting an introducer catheter to the site in the vessel prior to introducing the insertion apparatus to the site in the vessel.

[0028] An embodiment of the present invention is a method for positioning a surgical component with an insertion apparatus to a site in a vessel comprising the steps of: introducing the insertion apparatus proximal to the site in the vessel; fastening the surgical component to the vessel; activating the insertion apparatus; and withdrawing the insertion apparatus.

[0029] An embodiment of the present invention is a catheter handle capable of controlling the insertion apparatus and/or the fastener apparatus and deploying surgical fasteners at the surgical site.

[0030] Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and with the description, serve to explain the principles of the invention. Where appropriate, the same reference numerals refer to the same or similar elements.

[0032] Figures 1 - 150 are views of an apparatus and method for inserting, positioning, attaching, and cutting an endograft, and for positioning and delivering a surgical fastener.

[0033] Figure 151 is a schematic view of a prior art surgical fastener.

[0034] Figure 152 is a schematic view of a surgical fastener according to an embodiment of the present invention in a relaxed coiled configuration.

[0035] Figure 153 is a schematic view of a surgical fastener according to an embodiment of the present invention in a stressed straight configuration.

[0036] Figure 154 is a schematic view of a surgical fastener according to an embodiment of the present invention attaching a surgical component to tissue.

[0037] Figure 155 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention.

[0038] Figure 156 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention.

[0039] Figure 157 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention. [0040] Figure 158 is a schematic view of the rings of the surgical fastener according to an embodiment of the present invention

[0041] Figure 159 is a schematic view of a partially coiled surgical fastener according to an embodiment of the present invention.

[0042] Figure 160 is a schematic view of an occlusive device according to an embodiment of the present invention.

[0043] Figure 161 is a schematic view of an occlusive device according to an embodiment of the present invention.

[0044] Figure 162 is a schematic view of an occlusive device according to an embodiment of the present invention.

[0045] Figure 163 is a schematic view of an occlusive device according to an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0046] Reference now will be made in detail to the apparatus and methods consistent with implementations of the present invention, examples of which are illustrated in the accompanying drawings. The appended claims define the scope of the invention, and the following description does not limit that scope.

[0001] As shown in Figures 1 -4, the intra-abdominal arterial anatomy of a patient with an abdominal aortic aneurysm may consist of a suprarenal aorta 1 , renal arteries 2, a portion of infrarenal aorta that is not dilated 3 that makes up a part of the aortic neck 4, the aneurysm itself which is a dilated portion of the aorta 5, and the common iliac arteries 6, which creates the bifurcation 7 of the aorta at the level of the umbilicus.

[0002] Endovascular treatment of an abdominal aortic aneurysm may be achieved by inserting an endograft through a femoral or iliac artery and using this endograft to bypass the dilated aneurismal aorta. This endograft can be fully supported meaning that a endoskeleton or an exoskeleton made of somewhat rigid struts from metal or plastic support the entire endograft. If the endograft has an exoskeleton or an endoskeleton over or within just a portion of the endograft this endograft can be said to be partially supported.

[0003] As shown in Figure 2, the minimally supported endograft 8 according to an embodiment of the present invention comprises an unsupported graft quite similar to the one used in the open operation for repair of an abdominal aortic aneurysm. At the top end 9 of the tube portion 10 of the endograft a short exoskeleton or endoskeleton stented portion 11 made of a flexible material such as Nitinol with shape memory characteristics (this can be any semi rigid material that can be deformed by a constraining mechanism and that will revert to its original shape once the constraint is removed). Stented portion 11 may be from about 0.5-4 cm in height, or preferably between 1 -2 cm in height. Aside from the portion of the tube graft 10 that has the short exoskeleton or endoskeleton known as the stented portion 11 the remainder of the tube graft and the two limbs of the bifurcation endograft will be unsupported.

[0004] Figure 3 depicts the minimally supported endograft 8 inserted into position with the stented portion 11 of the endograft within the non-dilated aortic neck 4 and the two bifurcation limbs 12 within the iliac arteries 6.

[0005] Figure 4 depicts the minimally supported endograft 8 in position and the two limbs 12 positioned within the common iliac arteries 6. Commercially available stents 13, either bare or covered, may be placed within the portion of the graft limbs 12 that is within the common iliac arteries 6. The graft limbs 12 have been transected at end 14 proximal to the internal iliac arteries 15.

[0006] In order to achieve the goal of inserting a minimally supported endograft as depicted in Figure 3 it is necessary to position the minimally supported endograft within the aortic neck and then hold the endograft in place until the endograft is attached to the aortic wall by a more substantial method than just friction. Once the proximal portion of the graft is more securely attached, the device used to hold the endograft in place must be detached from the endograft and removed.

[0007] The connection between the graft holder and the endograft could be disconnected by an electrical current, heat, a specialized light or by applying a mechanical force to the junction. Many of these approaches are disclosed in Patent Application Nos. 10/424,775; 1 1 /366,604; 10/389,972; and U.S. Patent Nos. 6,409,757; 6,855,159; 6,648,912; 6,607,555; 6,706,047; 105,012; and

7,101 ,366, which are herein incorporated in their entirety by reference. It also can be achieved by removing wires as described elsewhere in this application. [0008] A delivery catheter 20 may be used to deliver surgical fasteners 26 to the surgical site in order to attach the graft 8 to the aortic wall 15. As shown in Fig. 5, note that the tip 21 of the delivery catheter 20 is near the top of the stent- graft 8. Note also that there may not be a tight seal between the graft 8 and the aortic wall 15. Fig 6 depicts the inner sheath 22 advanced out the outer sheath 23 until the inner sheath 22 meets the stent-graft 8. As the inner sheath 22 is advanced further (Fig 7) the back portion 24 of the delivery catheter 20 is pushed backward toward the portion of the aortic wall 15 opposite where the delivery catheter tip 21 has engaged the stent-graft 8.

[0009] The laser is activated and the optical fiber 25 and overlying surgical fastener 26 (but not the inner sheath) are advanced a fixed distance through the aortic wall 15 (Fig 8). The laser is turned off and the optical fiber 25 is withdrawn with the surgical fastener 26 partially deployed (Fig 9). The surgical fastener 26 is then fully deployed as the optical fiber 25 and inner sheath 22 are withdrawn inside the outer sheath 23 (Fig 10). The surgical fastener 26 is left attaching the stent-graft 8 to the aortic wall 15. See also U.S. Patent Nos. 6,607,555 and 7,101 ,366, the disclosures of which are incorporated by reference in their entirety.

[0010] As shown in Fig. 1 1 a guidewire 30 is inserted through the iliac artery 6 past the dilated aorta 5. Fig. 12 shows introducer sheath 31 containing minimally supported graft 8 inserted over guidewire 30. Graft holder 32 is inserted to a position in the suprarenal aorta wherein the entire graft 8 is positioned above the aortic bifurcation 7. Fig. 13 shows introducer sheath 31 withdrawn to a level of the external iliac 6. Distal graft limbs 33 are free. As shown in Fig. 14 if insertion or introducer sheath 31 is inserted on left the guidewire 30 is then passed into the right iliac artery and snare 34 is attached to guidewire 30. As shown in Fig. 15 snare 34 is pulled by guidewire 30. Right limb sutures 36 remain in the right iliac artery 6. By using snare 34 left graft limb sutures 35 are passed into the left iliac artery 6 as shown in Fig. 16. As shown in Fig. 17 distal graft limbs 33 are pulled into the common iliac arteries 6. Top portion 9 of minimally supported endograft 8 is now located in the infrarenal aortic neck. As shown in Fig. 18 a top portion 9 of minimally supported graft 8 is expanded within aortic neck 4. As shown in Fig. 19 guidewire 30 is inserted into the left limb 35 of graft 8 to a position above renal arteries 2. As shown in Fig. 20 sheath 31 is inserted over guidewire 30 into the left limb 35 of graft 8. As shown in Fig. 21 guidewire 30 and dilator 37 is removed from left introducer sheath 31 leaving introducer sheath 31 in tube portion 10 of graft 8. As shown in Fig. 22 surgical fastener catheter 16 is inserted into left introducer sheath 35. As shown in Fig. 23A surgical fasteners 26 are inserted circumferentially through top portion 9 of graft 8 into aortic wall 15. As shown in Fig. 23B the fastener delivery catheter 20 is removed, and if needed more surgical fasteners 26 may be inserted after the endograft holder 18 is removed.

[0011] Figure 24A depicts the distal end 41 of a Malecot type catheter graft holder 40 with four lumens 42 within the catheter with one in each of the

graft/stent positioning arms 43. As shown in Figure 24B, a small portion of the outer wall 44 of the graft/stent positioning arm 43 has been removed to expose the stent attachment wire 45 that is inserted into each of the four lumens 42.

Figure 24C shows the detail of the stent attachment of the endograft 8 to the Malecot type catheter 40 in that the wire 45 is passed up the catheter, then through a loop 46 in the stent 8, and then into the remainder of the distal catheter lumen. When the movable core wire 47 (B Fig 24E below) is moved toward distal end 41 C (Fig 24F) the top of the endograft 8 will be partially collapsed and when the movable core wire 47 is partially withdrawn away from C distal end 41 (Fig 24F), the partially stented endograft 8 will be fully expanded. Figure 24D shows an endograft 8 with a stent within it that is, in turn, attached to the Malecot type catheter 40 by the four stent attachment wires 45. Once the stent 8 is

satisfactorily attached to the aortic neck 4 with urgical fasteners 17, the four attachment wires 45 can be removed from the Malecot type catheter 40. This will allow reliable detachment of the Malecot type catheter 40 from the minimally stented endograft 8.

[0012] The advantages of this approach are: 1 ) it is simple; 2) it is purely mechanical and doesn't rely on bonds that must be disrupted by heat, electrical current etc. ; 3) it will be easier to prevent accidental and premature endograft release and; 4) it has an extremely high degree of reliability.

[0013] As shown in Fig. 25, wires 45 removed Malecot pipe catheter 40 and the now released endograft holder 18 is contracted, as can be seen in Fig. 24F. As shown in Fig. 26 endograft holder 40 is removed and left introducer sheath 31 is retracted. As shown in Fig. 27, guidewires 30 may be inserted into both right and left limbs 33 of graft 8. If desired, stent 13 may be inserted over guidewire 30 in right limb 33 and positioned in the common iliac artery 6 within the graft limb 33. As shown in Fig. 29, the right limb stent 13 is unsheathed and expanded into right limb 33. As shown in Fig. 30, the left limb stent 13 may be inserted in a similar manner. As shown in Fig. 31 , a snare type graft cutter 38 may be inserted over right graft limb 33 and positioned distal to the previously placed stent 13 and the excessed right limb graft 33 may be transected. Left limb of graft 33 may be transected in a similar manner. As shown in Fig. 34, graft limbs 33 are transected to appropriate length and the excess is removed. Sheaths 31 are removed and the femoral arteries are repaired.

[0014] One embodiment of the present invention is a catheter within a catheter so that when the inner catheter 22 is advanced and the outer catheter 23 has been pressed against the contralateral wall 15 such that there is now a force of the inner catheter 22 compressing the endograft 8 against the aortic wall 15, as shown in Figures 5-10.

[0015] Example 1 Catheter Handle

The following example provides the step-by-step instructions to assemble and test catheter handle 50, as shown in Fig. 35, according to an embodiment of the present invention. The description is divided into sections specific to subassembly fabrication and contains illustrations and text to highlight the assembly procedure. The instructions are written around a single unit but can be adapted by the user to accommodate batch production where appropriate. Detailed instruction for the check is provided and disposition for non-conforming product is defined.

[0016] This tabulated Bill of Materials in Table 1 provides a list of the parts, hardware and supplies that may be needed to assemble one embodiment of the catheter handle according to the present invention. The Quantity Required callout defines the quantity necessary to fabricate a single device. Batch production quantities must be adjusted accordingly. [0017] TABLE 1

Item Part Number Description Quantity Used in

Required Section/Step

21 VC01688 Inner Catheter Tip ¹ 11/1

22 VC02641 Front RH Handle ¹ 1/1

23 VC02642 Rear RH Handle ¹ 1/1

24 VC02647 Front LH Handle ¹ 1/1

25 VC02648 Rear LH Handle ¹ 1/1

26 VC02649 Catheter Clamp ¹ 11/12

27 VC02651 Pull Wire Clamp ¹ 11/14

28 VC02656 Coupler ¹ II/2

29 VC02661 Lead-in Bushing ¹ II/3

30 VC02662 LH Drive Pin Bracket ¹ II/8

31 VC02663 RH Drive Pin Bracket ¹ II/9

32 VC02664 Control 2 Rack ¹ 11/10

33 VC02667 Control 4 Rack ¹ 111/1

34 VC02668 Rack Tooth 30 111/12, IN/20

35 VC02669 Fiber Optic Adjustment Ml/5

¹

Housing

36 VC02670 Control 4 Drive Pin Adaptor ¹ Ml/2

37 VC02671 Fiber Optic Adjustment Nut ¹ Ml/8

38 VC02675 Fiber Optic Adjustment Ml/6

¹

Screw

39 VC02676 Fiber Optic Adjustment Boss ¹ III/7

40 VC02677 Funnel Tube ¹ 111/13

41 VC02678 Funnel Bracket ¹ 111/13

42 VC02681 Control 2 Rack ¹ 111/16

43 VC02682 Control 3 Rack ¹ 111/16

44 VC02683 Pusher ¹ IV/1

45 VC02684 Pusher Tube ¹ IV/1

46 VC02685 Control 1 Drive Pin 2 VIII/3, VIII/4

47 VC02686 Retainer Ring 5 IX/3, IX/5, IX/1 1 ,

X/3, X/5 Item Part Number Description Quantity Used in

Required Section/Step

48 VC02687 Control Sleeve 1 1 V/1

49 VC02688 Control Sleeve 1 Drive Pin 4 V/1

50 VC02689 Spacer 1 VIII/5

51 VC02690 Control 1 Ratchet 1 VIII/6

52 VC02691 Washer 1 VIII/8

53 VC02692 Retainer Ring 4 VIII/1 , VIII/7,

XII/4, XII/5

54 VC02694 Knob 1 2 VIII/10, VIII/1 1

55 VC02695 Cylindrical Nut 8 VIII/12, IX/14,

XI 1/14, XIII/3

56 VC02696 Control 2 Drive Pin 2 IX 8, IX/10

57 VC02697 Control 2 Washer 1 IX/2

58 VC02698 Control 2 Ratchet 1 IX/4

59 VC02699 Control 2 Spacer 1 IX/6

60 VC02700 Control Sleeve 2 1 V/2

61 VC02701 Control Sleeve 2 Drive Pin 4 V/2

62 VC02702 Knob 2 2 IX/12, IX/13

63 VC02703 Grip 2 XI 11/1 , XIII/2

64 VC02704 Control 3 Washer 1 X/2

65 VC02705 Control 3 Ratchet 1 X/4

66 VC02706 Control Sleeve 3 1 V/3

67 VC02707 Control Sleeve 3 Drive Pin 2 V/3

68 VC02708 Control 2 Rack Drive Pin 2 X 9, XII/9

69 VC02709 Control 4 Drive Pin 2 X/8, XII/7

70 VC02710 Knob 3 1 X/13

71 VC0271 1 Control 3 Knob Bottom 1 X/1 1

72 VC02712 Pawl Spring 2 X/10, XI 1/10

73 VC02713 Pawl 2 X/10, XI 1/10

74 VC02714 Bracket 1 XI/1

75 VC02716 Release Spring 1 VI/1 Item Part Number Description Quantity Used in

Required Section/Step

76 VC02717 Detent Spring ¹ VI/1

77 VC02718 End Plate ¹ VI/3

78 VC02719 Control 4 Ratchet ¹ XII/3

79 VC02720 Washer ¹ XII/2

80 VC02721 Control Sleeve 4 ¹ V/4

81 VC02722 Control Sleeve 4 Drive Pin 2 V/4

82 VC02723 Knob 4 ¹ XII/13

83 VC02724 Control 4 Knob Bottom ¹ XII/1 1

84 VC02725 Cover ¹ XII/15

[0018] An embodiment of the catheter handle may be comprised of the following components. Section numbers refer to the following sections describing the assembly of the catheter handle.

SECTION I - HANDLE HALVES

SECTION II - CATHETER ASSEMBLY

SECTION III - RACK ASSEMBLIES

SECTION IV - PUSHER ASSEMBLY

SECTION V - CONTROL SLEEVE ASSEMBLY

SECTION VI - INTERLOCK ASSEMBLY

ENDOSTAPLE LOADING HANDLE ASSEMBLY

SECTION VII - INTERNAL DRIVE MECHANISM

SECTION VIII - CONTROL 1 INSTALLATION

SECTION IX - CONTROL 2 INSTALLATION

SECTION X - CONTROL 3 INSTALLATION

SECTION XI - INTERLOCK INSTALLATION

SECTION XII - CONTROL 4 INSTALLATION

SECTION XIII - GRIP INSTALLATION

[0019] Some components in the illustrations are shown in a transparent state to highlight other features. [0020] SECTION I - HANDLE HALVES

Step 1 , Fig. 36.1 Apply four (4) evenly spaced droplets of #4061 Loctite Adhesive to the joint interface of Front RH Handle, PN VC02641 and Rear RH Handle, PN VC02642. Align joint interface and press and hold parts together for a minimum of 30 seconds for a complete bond. Set aside for additional assembly. Repeat for Front, LH Handle, PN VC02647 and Rear LH Handle, PN VC02648. PN VC02641 plus VC02642 becomes PN 1 192-P-0083. PN VC02647 plus VC02648 becomes PN 1 192-P-0084

[0021] Step 2, Fig. 36.2 The two inner handle halves fabricated in Step 1 will be formed into a "clam shell" during the handle assembly process. To ensure their proper alignment, fourteen (14) .031 " D x .188" L Dowel Pins are pressed into holes along the edge of PN 1 192-P-0083. Press the Pins until they bottom- out in their holes.

[0022] Step 3, Fig. 36.3 Heat set a 0-80 Threaded Insert in the hole located in the rear half of each of the Handle halves. It is important that once set, the Insert is flush with the surface of the Handle. If not set to the proper depth it may interfere with control hardware installed later in the assembly process. If necessary, re-set to make flush. END OF SECTION I

[0023] SECTION II - CATHETER ASSEMBLY

Step 1 , Fig. 37.1 Apply a droplet of #4061 Loctite Adhesive to the outside of the small diameter of a Inner Catheter Tip, PN VC01688, and press into the flex end of a Dual Durometer - Flex Tube, PN VC01 171 , until the large diameter of the Tip contacts the Tube. Hold in place for a minimum of 10 seconds to eliminate possibility of movement. The hole in the Tip cannot be occluded by dried

Adhesive. Inspect with 10X magnification. Clean hole with a small diameter pin if necessary.

[0024] Step 2, Fig. 37.2 Relative orientation between the two parts assembled here is very important. Keep the orientation of the Dual Durometer - Flex Tube the same as shown in Step 1 . Orient a Coupler, PN VC02656 as illustrated above. It is also important that the small diameter end of the Flex Tube passes easily into the small bore inside the block. Test the fit between the two parts before proceeding. Apply a droplet of #4061 Loctite Adhesive to the large diameter of the non-flex end of the Tube and press into the Coupler. Hold in place for a minimum of 10 seconds to eliminate possibility of movement. Visualize the orientation between the Tube and the Coupler. The cutouts in the flex end of the Tube must be on the same axis as the two holes in the Coupler. Reject if orientation is not correct.

[0025] Step 3, Fig. 37.3 Insert a Lead-in Bushing, PN VC02661 , into a Hemostasis Port, PN 4F1 . Apply a droplet of Loctite Adhesive #4061 to the interface between the Bushing and the Port.

[0026] Step 4, Fig. 37.4 Relative orientation between the two parts assembled here is very important. Apply a droplet of Loctite Adhesive #4061 to the outside of the small diameter on the Port, and press Port into Coupler as illustrated above. Hold in place for a minimum of 10 seconds to eliminate the possibility of movement.

[0027] Step 5, Fig. 37.5 Insert a 0.042 gauge pin into the opening in the Hemostasis Port and pass it through the Port, through the Lead-in Bushing and into the Inner Tube. The Pin must pass smoothly without snagging any edges. Reject assembly if the transition between parts is not smooth. Remove Pin after test. Note: There may be some normal and acceptable resistance as the pin passes through the rubber seal in the Port.

[0028] Step 6, Fig. 37.6 Press a 0.062" D x 1 .875" L Dowel Pin into the non-threaded hole in Coupler. Press the Pin until it bottoms-out in the hole.

[0029] Step 7, Fig. 37.7 Press an identical Dowel Pin into the hole on the other side of the Coupler. Press the Pin until it bottoms-out in the hole.

[0030] Step 8, Fig. 37.8 Position the hole in a LH Drive Pin Bracket (short), PN

VC02662, over the Dowel Pin in the Coupler and fasten the Bracket to the

Coupler with a 2-56 x .188" SHCS. Snug with a hex wrench.

[0031] Step 9, Fig. 37.9 Turn the Coupler over and attach a RH Drive Pin Bracket (long), PN VC02663 in the same manner as Step 8 using a 2-56 x

.188" SHCS. Snug with a hex wrench.

[0032] Step 10, Fig. 37.10 Attach a Rack Control 2, PN VC02664 to the RH Drive Pin Bracket (long) with two (2) 2-56 x .188" SHCS backed-up by .250" x .094" x .025" Flat Washers. Snug with a hex wrench. Adjustment to the their relative position will be made later.

[0033] Summary, Section II, Steps 1 - 10, Fig. 37.1 OA

[0034] Step 1 1 , Fig. 37.1 1 The dimension from where the pull wire enters the Outer Catheter, PN VC01 175-04-2, and the proximal end of the Catheter must be in a length range of 1 .41 " to 1 .51 ". Using a suitable tubing cutter and inner support mandrel, trim the proximal end of the Catheter sheath to achieve the required length. Always use a sharp blade to make the cut. A new blade may be required for each cut if more than one Catheter is trimmed. The cut must be free of burrs and flash.

[0035] An inadequate or incomplete cut may result in an unacceptable condition where the PTFE lining of the Catheter delaminates from the inner wall of the outer sheath (see photo). Re-trim (if length specification can be maintained) or reject the Outer Catheter if delamination occurs.

[0036] Step 12, Fig. 37.12 Slide a Catheter Clamp, PN VC02649, over the proximal end of the Outer Catheter and position it just ahead of where the pull wire enters (exits) the Catheter.

[0037] Step 13, Fig. 37.13 Using a hex wrench, screw two (2) 2-56 x .250"

SHCS into the Catheter Clamp and snug.

[0038] Step 14, Fig. 37.14 Slide a Pull Wire Clamp, PN VC02651 , over the proximal end of the Outer Catheter and position it just behind the Catheter Clamp.

[0039] Step 15, Fig. 37.15 Set the gap between the Catheter Clamp and the Pull Wire Clamp to 0.03". Remove any slack from wire. Using a hex wrench, secure the pull wire to the Clamp using a (1 ) 2-56 x .188" SHCS backed-up by a (1 ) .250" x .094" x .025" Flat Washer. Pinch the pull wire between the Clamp and the Flat Washer as the Screw is tightened.

[0040] Step 16, Fig. 37.16 Relative orientation between the parts assembled here is very important. Press a Hemostasis Valve, PN R1 c-1 , onto the proximal end of the Outer Catheter. Set the distance from the medial notch in the Outer Catheter Clamp to the reduced diameter in the Port to 1 .598". Confirm the relative orientation of the parts as illustrated above. Apply a droplet of #4061 Adhesive to the joint interface between the Catheter and Port and hold in place for a minimum of 10 seconds to eliminate the possibility of movement. [0041] Step 17, Fig. 37.17 Gently feed the Inner Catheter assembled in Steps 3-10 into the Hemostasis Port and through the Outer Catheter until the Tip on the Inner Catheter is located just inside the distal end of the Outer Catheter (inset). Set this assembly aside. Endostaples will be loaded later.

END OF SECTION II

SECTION III - RACK ASSEMBLIES

[0042] Step 1 , Fig. 38.1 . Locate the three (3) 2-56 threaded thru holes on the back-right of a Control 4 Rack, PN VC02667. The inset illustration provides a guide to their location(s) using the raised feature on the Rack as a point of reference.

[0043] Step 2, Fig. 38.2. Position a Control 4 Drive Pin Adaptor, PN VC02670, on the back of the Rack so that the thru holes on the Adaptor line up with the threaded holes on the Rack.

[0044] Step 3, Fig. 38.3. Align the two parts by inserting a 0.070" gauge pin through the holes as shown.

[0045] Step 4, Fig. 38.4. Secure the Adaptor to the Rack with three (3) 2- 56 x .125 SHCS. Remove the gauge pin.

[0046] Step 5, Fig. 38.5 Attach a Fiber Optic Adjustment Housing, PN VC02669, to the front-right of the Rack with four (4) 0-80 x 0.188 SHCS.

[0047] Step 6, Fig. 38.6 Apply a droplet of Loctite Adhesive #4061 to the flat on the end of a Fiber Optic Adjustment Screw, PN VC02675.

[0048] Step 7, Fig. 38.7 Press a Fiber Optic Adjustment Boss, PN VC02676, onto the Adjustment Screw until completely seated and hold for a minimum of 10 seconds for adhesive to set. Set aside until Step 9.

[0049] Step 8, Fig. 38.8 Position a Fiber Optic Adjustment Nut, PN VC02671 , into the window in the Adjustment Housing as shown.

[0050] Step 9, Fig. 38.9 Insert the Fiber Optic Adjustment Screw assembled in Step 7 into the bore in the Housing. Thread the Nut onto the Screw by turning in the direction noted. Be careful not to damage the Nut by cross- threading. The position of the Screw will be adjusted later. [0051] Step 10, Fig. 38.10 Fix the position of the Screw and Nut in the Housing by pressing a 0.078" x 0.375" Dowel Pin in the thru hole in the Housing.

[0052] Step 1 1 , Fig. 38.1 1 Press a Fiber Optic Strain Relief, PN XXX onto the end of the Screw assembly. Leave a small amount of clearance between the Strain relief and the Housing to prevent rotational interference.

[0053] Step 12, Fig. 38.12 Press a Rack Tooth, PN VC02668, into fifteen (15) positions along the front of the Rack. Note the direction of the Tooth relative to the Fiber Optic Adjustment Housing.

[0054] Step 13, Fig. 38.13 Carefully feed a Funnel Tube, PN VC02677, through the hole in a Funnel Bracket, VC02678 as shown. The Tube must remain straight. Do not bend or kink.

[0055] Step 14, Fig. 38.14 Feed the end of the Tube in the hole in the Fiber Optic Adjustment Housing. Align the holes in the Funnel Bracket over the corresponding holes in the front of the Rack and attach with two (2) 0-80 x 0.125" SHCS.

[0056] Step 15, Fig. 38.15 The length of Funnel Tube exposed beyond the Funnel Bracket is very important. Set length to 0.770 + .020 prior to applying adhesive. Apply a droplet of Loctite Epoxy, M-121 HP to the joint interface between the Funnel Tube and the Funnel Bracket. Allow adhesive to dry 15 minutes prior to proceeding with assembly.

[0057] Summary, Section III, Steps 1 -15, Fig. 38.15A

[0058] Step 16, Fig. 38.16 Locate the two (2) 2-56 threaded thru holes on the back-right of a Control 3 Rack, PN VC02681 . The inset illustration provides a guide to the holes location using the raised feature on the Rack as a point of reference.

[0059] Step 17, Fig. 38.17 Position a Control 3 Drive Pin Adaptor, PN VC02682, on the back of the Rack so that the thru holes on the Adaptor line up with the threaded holes on the Rack.

[0060] Step 18, Fig. 38.18 Align the two parts by inserting a 0.070" gauge pin through the holes as shown.

[0061] Step 19, Fig. 38.19 Secure the Adaptor to the Rack with two (2) 2- 56 x .125 SHCS. Remove the gauge pin. [0062] Step 20, Fig. 38.20 Press a Rack Tooth, PN VC02668, into fifteen (15) positions along the front of the Rack. Note the direction of the Tooth relative to the back-stop on the Rack.

[0063] Summary, Section III, Steps 17 - 20, Fig. 38.20A

END SECTION III

SECTION IV - PUSHER ASSEMBLY

[0064] Step 1 , Fig. 39.1 The overall length of the Pusher Assembly is very important. Set length to 20.95 + 0.02 (from back of Pusher to distal end of Tube) prior to applying adhesive. Press one end of a Pusher Tube, PN VC02684, into the hole in the knife-edge of a Pusher, PN VC02683 and apply a droplet of Loctite Epoxy, M-121 HP to the joint. Allow to dry for a minimum of 10 minutes before further handling.

END OF SECTION IV

SECTION V - CONTROL SLEEVE ASSEMBLY

[0065] Step 1 , Fig. 40.1 Press four (4) Control Sleeve 1 Drive Pins, PN VC02688 into the thru holes in a Control Sleeve 1 , PN VC02687. The Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.

[0066] Step 2, Fig. 40.2 Press four (4) Control Sleeve 2 Drive Pins, PN VC02701 into the thru holes in a Control Sleeve 2, PN VC02700. The Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.

[0067] Step 3, Fig. 40.3 Press two (2) Control Sleeve 3 Drive Pins, PN VC02707 into the thru holes in a Control Sleeve 3, PN VC02706. The Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.

[0068] Step 4, Fig. 40-4 Press two (2) Control Sleeve 4 Drive Pins, PN VC02722 into the thru holes in a Control Sleeve 4, PN VC02721 . The Pins must be flush with the inner diameter of the Sleeve. Reset if necessary.

END OF SECTION V SECTION VI - INTERLOCK ASSEMBLY

[0069] Step 1 , Fig. 41 .1 Position a Detent Spring, PN VC02717, inside an Interlock Release Ring, PN VC02716, as shown. The Spring will grip the molded features in the Ring.

[0070] Step 2, Fig. 41 .2 Apply two (2) droplets of UV Cure Adhesive, #331 1 , in the locations shown.

[0071] Step 3, Fig. 41 .3 Position an End Plate, PN VC02718, against the adhesive and over the pins and lug of the Ring. Hold under UV light until completely cured (see Adhesive manufacturer's recommendations).

END OF SECTION VI

HANDLE ASSEMBLY

[0072] The assembly steps illustrated here in the following sections are necessary to assemble the Endostapler. Please note - Some components in the following illustrations are shown in a transparent state to highlight other features.

General requirement: Lubricate all plastic to plastic and plastic to metal

movements with a light coat of zinc stearate.

SECTION VII - INTERNAL DRIVE MECHANISM

[0073] Step 1 , Fig. 42.1 Position the assembly completed in Section II in the RH Handle shell assembled in Sec. I. The longer Rack fits between the tabs molded into the Handle. Note the location of the Hemostasis Ports relative to the cut-outs in the Handle shell.

[0074] Step 2, Fig. 42.2A and 42.2B Position the Control 4 Rack Assembly (Section III) between the two Drive Pin Brackets as shown. The

Assembly will nest in the molded features in the RH Handle shell.

[0075] Step 3, Fig. 42.3A and 42.3B Position the Control 3 Rack Assembly (Section III) between the two Drive Pin Brackets and above Control 4 Rack Assembly as shown. The Assembly will nest in the molded features in the RH Handle shell. The leading edges of both Rack Assemblies will be in alignment.

[0076] The next assembly step provides instruction for the installation of the LH Handle shell. This will close the unit and obscure the Internal Drive Mechanism from visual inspection. Before proceeding, re-check the components for proper placement and alignment.

[0077] Step 4, Fig. 42.4 Align the LH Handle shell over the pins in the RH shell and close the Handle. Care should be taken to make sure that all pins are in alignment and that the Hemostasis Ports do not interfere with complete closure. Temporary bands should be placed at the locations noted in the next assembly step to keep the unit closed during installation of the Controls.

[0078] Step 5, Fig. 42.5 Place temporary bands around the Handle Assembly at or near the locations noted. They will hold the halves of the Handle together as the Controls are installed and will be removed when instructed.

END OF SECTION VII

SECTION VIII - CONTROL 1 INSTALLATION

[0079] Step 1 , Fig. 43.1 Install a Retainer Ring, PN VC02692, into the groove in Handle as shown.

a) Pass the Retainer Ring over the Catheter Assy. ;

b) Spread with Retainer Ring Pliers and pass Ring along Handle;

c) Release Ring into groove as shown.

[0080] Step 2, Fig. 43.2 Feed a Control Sleeve 1 (assembled in Section V), over Catheter, onto Handle and up against Retainer Ring. Chamfer on Sleeve must be away from Ring as shown.

[0081] Step 3, Fig. 43.3 Screw a Control 1 Drive Pin, PN VC02685, into place by orienting Sleeve as shown. Screw Pin into internal Rack until snug.

[0082] Step 4, Fig. 43.4 Turn the Handle over and screw the second Control 1 Drive Pin, PN VC02685 into place. Screw the Pin into the internal Rack until Snug.

[0083] Step 5, Fig. 43.5 Feed a Spacer, PN VC02689, over Catheter, onto Handle and up against the Control Sleeve.

[0084] Step 6, Fig. 43.6 In similar fashion to Step 5, feed a Control Ratchet 1 , PN VC02690, over Catheter, onto Handle and up against Spacer.

[0085] Step 7, Fig. 43.7 Fix the position of the Ratchet by installing a Retainer Ring, PN VC02692, in the groove as shown. [0086] Step 8, Fig. 43.8 Feed a Washer, PN VC02691 , over the

Catheter, onto Handle and up against the Retainer Ring.

[0087] Step 9, Fig. 43.9 Feed a 1 .375" x 1 .030" x 0.300" Wave Spring over Catheter, onto Handle and up against the Washer.

[0088] Step 10, Fig. 43.10 Fit the lower half of a Knob 1 , PN VC02694 to

Control 1 . The lower Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. The Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[0089] Step 1 1 , Fig. 43.1 1 Fit the upper half of a Knob 1 , PN VC02694 to

Control 1 . The upper Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[0090] Step 12, Fig. 43.12 Fasten together the upper and lower halves of

Knob 1 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN

VC02695. The SHCS and Nuts fit into recessed holes in either half of the Covers as shown. Full view is shown in Fig. 44.

END OF SECTION VIII SECTION IX - CONTROL 2 INSTALLATION

[0091] Before starting with this assembly carefully remove the temporary bands placed on the Handle in Section VI, Step 5. BE AWARE. With the temporary bands removed and until the three (3) remaining Controls are installed, the Handle halves can become separated from one another; a condition that could result in damage to the Assembly.

[0092] Step 1 , Fig. 45.1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position against the large diameter of the Handle (as shown above). [0093] Step 2, Fig. 45.2 In a similar fashion, pass a Control 2 Washer, PN VC02697, a 1 .375" x 1 .030" x 0.300" Wave Spring onto the Handle and into position against the Wave Spring.

[0094] Step 3, Fig. 45.3 Install a Retainer Ring, PN VC02686, into the groove in Handle as shown.

a) Pass the Retainer Ring over the Fiber Optic Adjustment Housing. ;

b) Spread with Retainer Ring Pliers and pass Ring along Handle;

c) Release Ring into groove next to Washer installed in Step 2 as shown.

[0095] Step 4, Fig. 45.4 In similar fashion to Steps 1 and 2, position a Control 2 Ratchet, PN VC02698, against the Ring installed in Step 3. Note the orientation of the teeth on the Ratchet. The keyway in the Ratchet must engage the key on the Handle.

[0096] Step 5, Fig. 45.5 In similar fashion to Step 3, install a Retainer Ring, PN VC02686, in the groove next to the boss on the Ratchet.

[0097] Step 6, Fig. 45.6 Feed a Control 2 Spacer, PN VC02699, onto the Handle and position against the Retainer Ring as shown.

[0098] Step 7, Fig. 45.7 Feed a Control Sleeve 2 assembly (assembled in Sect. V) onto Handle and position against the Spacer. The chamfer on the Sleeve must be towards the Spacer. Rotate the helical slot in the Sleeve so that the threaded hole in the Rack is visible as shown.

[0099] Step 8, Fig. 45.8 Screw into place a Control 2 Drive Pin, PN VC02696, keeping rotational orientation of Sleeve as shown. Screw the Pin into internal Rack until snug.

[00100] Step 9, Fig. 45.9 Turn the Handle over and locate the second threaded hole in the internal Rack. Ensure rotational orientation of Sleeve is as shown.

[00101] Step 10, Fig. 45.10 Screw the second Control 2 Drive Pin, PN VC02696 into place Thread the Pin into the internal Rack until Snug.

[00102] Step 1 1 , Fig. 45.1 1 Fix the position of the Control Sleeve by installing a Retainer Ring, PN VC02686, in the groove as shown.

[00103] Step 12, Fig. 45.12 Fit the lower half of a Knob 2, PN VC02702, to Control 2. The lower Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. The Wave Spring may need to be compressed slightly to allow it to nest in the Knob. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00104] Step 13, Fig. 45.13 Fit the upper half of a Knob 2, PN VC02702 to Control 2. The upper Drive Pins in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00105] Step 14, Fig. 45.14 Fasten together the upper and lower halves of Knob 2 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN

VC02695. The SHCS and Nuts fit into recessed holes in either half of the Covers as shown. Full view is shown in Fig. 46.

END OF SECTION IX

SECTION X - CONTROL 3 INSTALLATION

[00106] BE AWARE. With the temporary bands removed and until the two (2) remaining Controls are installed, the Handle halves can become separated from one another; a condition that could result in damage to the Assembly.

[00107] Step 1 , Fig. 47.1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position as shown.

[00108] Step 2, Fig. 47.2 Pass a Control 3 Washer, PN VC02704,

over the FO Housing onto the Handle and into position against the Spring as shown.

[00109] Step 3, Fig. 47.3 Install a Retainer Ring, PN VC02686, into the groove in Handle as shown.

a) Pass the Retainer Ring over the Fiber Optic Adjustment Housing. ;

b) Spread with Retainer Ring Pliers and pass Ring along Handle;

c) Release Ring into groove next to Control 3 Washer installed in Step 2 as shown. [00110] Step 4, Fig. 47.4 In similar fashion to Steps 1 and 2, position a Control 3 Ratchet, PN VC02705, against the Ring installed in Step 3. Note the orientation of the teeth on the Ratchet. The notch in the Ratchet must be UP.

[00111] Step 5, Fig. 47.5 In similar fashion to Step 3, install a Retainer Ring, PN VC02686, in the groove behind the Ratchet.

[00112] Step 6, Fig. 47.6 Install a Retainer Ring, PN VC02686, in the groove shown.

[00113] Step 7, Fig. 47.7 Feed a Control Sleeve 3 assembly (assembled in Sect. V) onto Handle and position above the thru slot in the Handle. The chamfer on the Sleeve must be towards the Retainer Ring.

[00114] Step 8, Fig. 47.8 Screw into place a Control 4 Drive Pin, PN VC02709, by orienting the Sleeve as shown. Screw Pin into the internal Rack until snug. Note: Handle half is transparent to show internal Rack detail.

[00115] Step 9, Fig. 47.9 Turn the Handle over and screw into place a Control 2 Rack Drive Pin, PN VC02708. Screw the Pin into the internal Rack until Snug. Note: The Handle half is transparent to show internal Rack detail.

[00116] Step 10, Fig. 47.10 Install a Pawl Spring, PN VC02712, into a Pawl, PN VC02713, by inserting the shorter of the two extensions into the small hole in the Pawl.

[00117] Step 1 1 , Fig. 47.1 1 Position the Pawl and Spring into the cradle in a Control 3 Knob Bottom, PN VC0271 1 . The long extension of the Spring fits into the small thru hole in the cradle. When installed properly, the Pawl will pivot freely in the cradle.

[00118] Step 12, Fig. 47.12 Fit the bottom of the Knob 3 assembly, to Control 3. There are two points of engagement. One, the lower Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half and two, the dog on the Pawl should rest on the first tooth of the Ratchet as illustrated. The Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00119] Step 13, Fig. 47.13 Fit the upper half of Knob 3, PN VC02710 to Control 3. The upper Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half. It is important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00120] Step 14, Fig. 47.14 Fasten together the upper and lower halves of Knob 3 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN

VC02695. The SHCS and Nuts fit into recessed holes in either half of the Covers as shown. Full view is shown in Fig. 48. END OF SECTION X

SECTION XI - INTERLOCK INSTALLATION

[00121] BE AWARE. With the temporary bands removed and until the two (2) remaining Controls are installed, the Handle halves can become separated from one another; a condition that could result in damage to the Assembly.

[00122] Step 1 , Fig. 49.1 Identify the chamfer on either boss on an Interlock Bracket, PN VC02714, and using the chamfer as a lead-in, pass the Bracket over the Fiber Optic Housing, onto the Handle and into position adjacent to Control Knob 3 so that the hole in the boss (both sides) are in alignment with the brass inserts in the Handle.

[00123] Step 2, Fig. 49.2 Fasten the Bracket to the Handle with two (2) 0- 80 X 0.250" SHCS. Tighten until snug. Do not over-tighten.

[00124] Step 3, Fig. 49.3 Identify the lug on the Interlock Assembly (assembled in Section VI) and positioning the lug DOWN, pass the Interlock Assembly over the Fiber Optic Housing, onto the Handle and into position on the Bracket. Compress the Assembly slightly at the finger grips to allow the internal spring to pass over and into the notches in the Bracket. Full view is shown in Fig. 50. END OF SECTION XI

SECTION XII - CONTROL 4 INSTALLATION [00125] BE AWARE. With the temporary bands removed and until the remaining Control is installed, the Handle halves can become separated from one another; a condition that could result in damage to the Assembly.

[00126] Step 1 , Fig. 51 .1 Pass a 1 .375" x 1 .030" x 0.300" Wave Spring over the Fiber Optic Housing, onto the Handle and into position adjacent to the Interlock Bracket as shown.

[00127] Step 2, Fig. 51 .2 Pass a Washer, PN VC02720, over the Fiber Optic Housing, onto the Handle and into position adjacent to the Wave Spring as shown.

[00128] Step 3, Fig. 51 .3 In similar fashion to Steps 1 and 2, position a Control 4 Ratchet, PN VC02719, against the Washer installed in Step 2. Note the orientation of the teeth on the Ratchet. The notch in the Ratchet must be UP.

[00129] Step 4, Fig. 51 .4 Install a Retainer Ring, PN VC02692, into the groove in Handle as shown.

a) Pass the Retainer Ring over the Fiber Optic Adjustment Housing. ;

b) Spread with Retainer Ring Pliers and pass Ring along Handle;

c) Release Ring into groove next to Ratchet installed in Step 3 as

shown.

Note: Previously installed Ratchet is transparent to show position of the Ring.

[00130] Step 5, Fig. 51 .5 In similar fashion to Step 4, install a Retainer Ring, PN VC02692, in the groove shown.

[00131] Step 6, Fig. 51 .6 Feed Control Sleeve 4 assembly (assembled in Sect. V) onto Handle and position above the thru slot in the Handle. The chamfer on the Sleeve must be towards the Retainer Ring.

[00132] Step 7, Fig. 51 .7 Screw into place a Control 4 Drive Pin, PN

VC02709, by orienting Sleeve as shown. Screw Pin into internal Rack until snug.

[00133] Step 8, Fig. 51 .8 Rotate the Handle approximately 90o to locate the hole for the second Drive Pin.

[00134] Step 9, Fig. 51 .9 Screw into place a (1 ) Control 2 Rack Drive Pin, PN VC02708, by orienting Sleeve as shown. Screw Pin into internal Rack until snug. [00135] Step 10, Fig. 51 .10 Install a Pawl Spring, PN VC02712, into a Pawl, PN VC02713, by inserting the shorter of the two extensions into the small hole in the Pawl.

[00136] Step 1 1 , Fig. 51 .1 1 Position the Pawl and Spring into the cradle in a Control 4 Knob Bottom, PN VC02724. The long extension of the Spring fits into the small thru hole in the cradle. When installed properly, the Pawl will pivot freely in the cradle.

[00137] Step 12, Fig. 51 .12 Fit the Bottom of Knob 4 assembly, to Control 4. There are two points of engagement. One, the lower Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half and two, the dog on the Pawl should rest on the first tooth of the Ratchet as illustrated. The Wave Spring may need to be compressed slightly to allow it to nest in the Knob. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00138] Step 13, Fig. 51 .13 Fit the upper half of a Knob 4, PN VC02723 to Control 4. The upper Drive Pin in the Control Sleeve must fit in the molded-in track in the Knob half. It is very important that the parts are not forced to fit. When properly aligned, the parts will come together with little or no effort. Avoid rotating the Sleeve from its installed position. This could alter the timing of the internal mechanism.

[00139] Step 14, Fig. 51 .14 Fasten together the upper and lower halves of Knob 4 with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN

VC02695. The SHCS and Nuts fit into recessed holes in either half of the Covers as shown

[00140] Step 15, Fig. 51 .15 Install the Cover, PN VC02725, onto the tail of the Handle over the Fiber Optic Strain Relief. Secure the Cover by pushing onto the Handle until the locating hole snaps onto the pin on the Handle. Full view is shown in Fig. 52.

END OF SECTION XII

SECTION XIII - GRIP INSTALLATION [00141] Step 1 , Fig. 53.1 Fit the lower half of a Grip, PN VC02703, to the Handle between Controls 2 and 3. The Grip half will fit into molded-in features that will locate the Grip and keep it from rotating.

[00142] Step 2, Fig. 53.2 In similar fashion to Step 1 , fit the upper half of a Grip, PN VC02703 to the Handle.

[00143] Step 3, Fig. 53.3 Fasten together the upper and lower halves of the Grip with two (2) 2-56 x 0.250" SHCS and two (2) Cylindrical Nuts, PN

VC02695. The SHCS and Nuts fit into recessed holes in either half of the Grip as shown. Full view is shown in Fig. 54.

END OF SECTION XIII

[00144] One embodiment of the present invention is a complete delivery system including the delivery catheter.

[00145] Figures 55 - 150 are additional views of the catheter handle and its component parts according to an embodiment of the present invention. The handle, its component parts, and the assembly of the handle are discussed in the paragraphs provided above and previously shown in Figs. 35 - 54.

[00146] In one embodiment of the present invention, there may be two components to the insertion of a minimally supported endograft. The first comprises various ways of expanding and constructing the stented portion within the tube portion of the endograft. One approach is the Malecot concept whereby the stent can be constricted by advancement of a rigid rod against the tip of the Malecot and expanded by retraction of the rod. Another possibility might be an umbrella type structure that can be screwed open and closed.

[00147] A second component to the insertion of a minimally supported endograft may be how the holder of the endograft is safely and reliably separated from the endograft once the endograft is sufficiently attached to the aortic wall. It is highly likely that the holder will be attached to the stented portion of the endograft. This connection between the holder and the endograft must be in some way severed so that the holder can be removed. This connection can be made with a substance that could reliably be disrupted by applying a current, heat, cold, vibration, a light source, or some other form of energy that is known to disrupt substances that are providing binding to two disparate (or similar) materials. While one embodiment is predicated on disrupting this connection by pulling out wires, a variety of suitable attachment mechanisms that allow reliable disruption may be used.

[00148] One embodiment permits one to transect the endograft limbs within the common iliac arteries. One embodiment may comprise an insulated snare where the snare is an electrical filament that is insulated on the outside. Any other suitable methods other than heat that may also reliably and easily transect the limbs of an endograft within a flowing blood stream.

[00149] Alternatively, in an embodiment of the present invention, the catheter could be equipped with alternative means of transecting the endograft limb. In addition to heat and lasers, the endograft could be transected using any mechanical, electrical, or optical force, including but not limited to mechanical cutting, or any other suitable method that can be adapted for the catheter.

[0047] Figure 151 depicts a surgical fastener as described in U.S. Patent Nos. 5,997,556, 6,248,1 18, 6,520,974, and 7,699,858 herein incorporated in their entirety by reference.

[0048] Figures 152-158 illustrate a surgical fastener according to embodiments of the present invention. Surgical fastener 50 may be composed of any suitable material, such as, but not limited to, shape memory metal alloy wire or plastic, such as, but not limited to Nitinol, or any other suitable material. The material may include additional elements which affect the yield strength of the material or the temperature or other stimulus, including but not limited to electrical, magnetic, or aqueous at which particular pseudoelastic or shape transformation characteristics occur. The transformation temperature or stimulus may be defined as the temperature or stimulus at which a shape memory or plastic alloy finishes transforming from martensite to austenite upon heating or stimulus. The shape memory alloy preferably exhibits pseudoelastic (superelastic) behavior when deformed at a temperature slightly above its transformation temperature. At least a portion of the shape memory alloy is converted from its austenitic phase to its martensitic phase when the wire is in its deformed configuration. As the stress is removed, the material undergoes a martensitic to austenitic conversion and springs back to its original undeformed configuration. When the surgical fastener 50 is positioned within the tissue 55 in its undeformed configuration, a residual stress is present to maintain the tissue tightly together. In order for the surgical fastener 50 to retain sufficient compression force in its undeformed configuration, the surgical fastener 50 should not be stressed past its yield point in its deformed configuration to allow complete recovery of the wire to its undeformed

configuration. The shape memory alloy is preferably selected with a

transformation temperature suitable for use with a stopped heart condition where cold cardioplegia has been injected for temporary paralysis of the heart tissue (e.g., temperatures as low as 8-10 degrees Celsius). It is to be understood that the shape memory alloy may also be heat activated, or a combination of heat activation and pseudoelastic properties may be used, as is well known by those skilled in the art.

[0049] The surgical fastener 50 is distorted into a first configuration to allow it to be placed sequentially over or within a penetration apparatus, such as, but not limited to, an optical fiber, and inserted sequentially through a first component and a second component. The first component or second component may be a tissue, surgical component, or any combination, such as, but not limited to, a prosthetic graft and vessel or aortic wall. There are also many other potential uses for surgical fastener 50, including, but not limited to, hernia repair, bowel anastomosis, dissection of an artery, etc.

[0050] Surgical fastener 50 may be of about 0.0254 mm to about 2.54 mm diameter, such as, but not limited to, about 0.508 to about 1 .524 mm diameter with a lumen of about 0.0254 mm to about 2.54 mm diameter, such as, but not limited to, about 0.127 to about 1 .27 mm diameter.

[0051] According to an embodiment of the present invention surgical fastener 50 is a tubular structure and may comprise a rib 80 that may reduce compression, facilitate more consistent advancement, and may be of varying width. Rib 80 may be straight or helical, and may be integrated into, or form a wall of, surgical fastener 50, or may be disposed within the tubular structure or disposed on the exterior of surgical fastener 50. Surgical fastener 50 may also comprise at least one ring 90 attached to rib 80. At least one rib 80 and/or at least one ring 90 may extend beyond the tubular structure to assist in anchoring of surgical fastener 50 in the first and/or second component. At least one rib 80 and/or at least one ring 90 may contain a rough or serrated edge or edges to assist in anchoring of surgical fastener 50 in the first and/or second component. Surgical fastener 50 may also comprise tip 100, which may be disposed on the leading or trailing end portion of surgical fastener 50.

[0052] According to a method of use of an embodiment of the present invention, and referring to Figures 153 and 154, surgical fastener 50 is shaped into a primary coil (that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter) that is, in turn, set into a secondary coil, by heat or any other suitable means (that may be, but is not limited to, approximately between 0.0254 mm and 2.54 mm in diameter). As described previously, the surgical fastener 50 is deflected into a single coil and loaded onto or around a penetration apparatus, such as, but not limited to, an optical fiber; the penetration apparatus is positioned adjacent to a first component, such as, but not limited to, a prosthetic graft, a penetration means, such as, but not limited to, a Holmium laser is pulsed through the fiber allowing the laser energy to create a hole through the prosthetic graft and a second component, such as, but not limited to, an adjacent aorta as the fiber and overlying surgical fastener 50 are advanced; the optical fiber is then withdrawn and the fastener 50 then assumes its first coiled coil

configuration. Figure 154 depicts the coiled coil that has been inserted from within the aortic lumen through a prosthetic graft 54 and an adjacent vessel wall 55. One of the primary coils has been left positioned within the vessel lumen, a portion of the coiled coil 60 traverses the prosthetic graft and vessel and the remainder of the coiled coil 70 (secondary coil) is positioned adjacent to the outside of the vessel in an area called the periadvential tissue. Once in position, tissue ingrowth into the interstices of the coils may provide further resistance to surgical fastener 50 dislodgment. In one embodiment, the primary coil contains only one coil so as to minimize the amount of fastener that is left inside the vessel. The secondary coil can contain more coils because it is located outside of the vessel.

[0053] According to another embodiment of the present invention, surgical fastener 50 may be comprised of a metal alloy, plastic or any other suitable material that may be set in a first configuration and distorted into a second configuration without losing its ability to resume its first configuration when a distorting force is removed. Figure 153 shows a rib 80 with rings 90 attached. The rib 80 can be of varying width and can be helically positioned, as shown, or it can be straight.

[0054] Figures 155-159 show views of various embodiments of rib 80 and attached rings 90. Rings 90 can be cut in any configuration; specifically the width may vary, the space between ribs 80 may vary, and the bias at which ribs 80 are cut may vary. The desired ring 90 configurations, as shown, may be broader near rib 80 and narrower at the portion opposite rib 80 to enhance closure of rings 90 when surgical fastener 50 is in its second, or relaxed coiled coil configuration. The desired bias at which rings 90 are cut may facilitate the closure of rings 90, although there could be instances when the bias could be different in order to more readily achieve other goals such as facilitating resistance to distracting forces (hernia repair for instance). By altering some of these variables, such as, but not limited to, surgical fastener 50 tube thickness and or diameter, rib 80 width, ring 90 dimensions, the bias at which rings 90 are cut and the way the secondary coil may be heat set i.e. right-handed or left-handed, the force ("pinch force") required to distract one secondary coil from its adjacent coil can be increased or decreased. Connection 110 of ring 90 to rib 80 may be of any suitable configuration and width. Connection 110 of the embodiment depicted in Figure 154 has a "bow tie" shape and selected for its ability to facilitate ring 90 closure and to reduce rib 80 and ring 90 interface stress.

[0055] Figure 159 shows an embodiment of the present invention in a coiled configuration illustrating rib 80 and a plurality of rings 90 attached to rib 80 and compressed into a closed configuration 120. Combined with rib 80 opposite the radius of the turn, this structure reduces the likelihood of bleeding through the interstices of rings 90. Because the space between ribs 80 may be large, it may be desirable to dispose or attach a foam or sponge, or any other suitable material, in these spaces in order to allow movement of rings 90 when a penetration apparatus is bent or removed but also provide a barrier to bleeding through the spaces between rings 90. Rings 90 can be cut at any width and/or any angle and the distance between rings 90 can vary as well. There can also be more than one rib 80. [0056] Figure 160 shows the occlusive device 140. A number of different occlusive devices 140 may be used as previously described in U.S. Patent Application Serial No. 10/667,521 , herein incorporated in its entirety by reference. In one embodiment occlusive device 140 is comprised of a single flap valve 190 with a double hinge 200 that may be laser cut at the same time rings 90 are cut as part of surgical fastener 50. Occlusive device 140 may positioned at the leading edge of surgical fastener 50 but, regardless of its design, may also be located at the trailing edge or anywhere between the two ends of surgical fastener 50, or in a tip 100 attached to surgical fastener 50. In one embodiment shown in Figure 160, occlusive device 140 is positioned as if it were being held open by a penetration device, such as, but not limited to, an optical fiber passing through its lumen. Occlusive device 140 may be composed of any suitable material, such as, but not limited to, shape memory metal alloy wire or plastic, such as, but not limited to Nitinol, or any other suitable material.

[0057] Figure 161 depicts the occlusive device 140 in its relaxed state once the penetration apparatus has been removed from the lumen of the tubing 150.

[0058] Figure 162 depicts tip 100 with a taper 170. The occlusive device 140 consisting of a single flap valve 190 with a single hinge 180. The taper 170 and occlusive device 140 can be each be manufactured separately and combined with the staple described above or, in the preferred iteration, the staple, taper tip and occlusive mechanism can be cut from the same piece of material.

[0059] Figure 163 shows an end view with the occlusive device 140 in its relaxed state occluding almost all of the lumen of surgical fastener 50. Only small spaces 160 may remain that could allow passage of blood through surgical fastener 50 lumen.

[00150] 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.

Claims

What is claimed is:

1 . An insertion apparatus for deploying a surgical component to a site in a vessel comprising: attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component; and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.

2. The insertion apparatus of Claim 1 , further comprising fastening means for fastening the surgical component to the vessel.

3. The insertion apparatus of Claim 1 , wherein the surgical component is a minimally supported graft.

4. The insertion apparatus of Claim 1 , wherein the attachment means comprises an attachment loop, and at least one attachment wire.

5. An insertion apparatus for deploying a surgical component to a site in a vessel comprising: at least one attachment wire with a first end and a second end; wherein the first end of the at least one attachment wire is releaseably connected to the surgical component; and wherein the attachment wire positions the surgical component at a site in the vessel.

6. The insertion apparatus of Claim 5, further comprising a fastener delivery catheter.

7. The insertion apparatus of Claim 5, further comprising an introducer sheath.

8. An insertion system for deploying a surgical component to a site in a vessel comprising: a surgical component, wherein the surgical component is a minimally supported graft; an insertion apparatus; attachment means for attaching the surgical component to the insertion apparatus, wherein the attachment means is releasably connected to the surgical component; and release means for releasing the attachment means from the surgical component, wherein the release means is in communication with the attachment means.

9. The insertion system of Claim 8, further comprising a fastening means for fastening the surgical component to the vessel.

10. The insertion system of Claim 8, further comprising a fastener delivery catheter.

1 1 . An insertion system for deploying a surgical component to a site in a vessel comprising: a catheter handle, wherein the catheter handle comprises; a handle; a catheter assembly; a rack assembly; a pusher assembly; a control sleeve assembly; and an interlock assembly.

12. A method for positioning a surgical component with an insertion apparatus to a site in a vessel comprising the steps of: introducing the insertion apparatus proximal to the site in the vessel; fastening the surgical component to the vessel; activating the insertion apparatus; and withdrawing the insertion apparatus.

13. A surgical fastener having a first and a second end for securing at least two surfaces together comprising,

a first configuration wherein said fastener is coupled to a restraining device holding said fastener,

a second configuration wherein said fastener is released from said restraining device, said second configuration having a substantially spiral shape, wherein said second configuration is spring biased along an axis

perpendicular to said at least two surfaces that are being secured together, wherein said first end and said second end are spring biased towards each other, and

a rib extending along the longitudinal axis of said surgical fastener.

14. The surgical fastener of Claim 13 further comprising at least one finger having a top end and a bottom end wherein at least either said top end or said bottom end are in communication with said rib.

15. The surgical fastener of Claim 14 wherein both said top end and said bottom end are in communication with said rib.

16. The surgical fastener of Claim 15 having at least two fingers and having occlusive material disposed between said fingers.

17. The surgical fastener of Claim 16 wherein said occlusive material is foam or sponge.

18. The surgical fastener of Claim 15 wherein said finger further comprises at least one serrated edge.

19. The surgical fastener of Claim 15 wherein said finger has a tapered width that is generally greater proximate to said top and said bottom end.

20. The surgical fastener of Claim 13 having diameter between 0.0254 mm and 2.54 mm.

21 . The surgical fastener of Claim 13 having diameter between 0.508 mm and 1 .524 mm.

22. The surgical fastener of Claim 13 wherein said rib extends helically along said vertical axis of said fastener.

23. The surgical fastener of Claim 13 wherein said fastener is composed of a shape memory metal alloy.

24. The surgical fastener of Claim 23 wherein said shape memory metal alloy is Nitinol.

25. The surgical fastener of Claim 13 wherein said surgical fastener is laser cut.

26. The surgical fastener of Claim 13 wherein said rib in said second configuration is opposite a radius of the turn of said spiral shape.

27. An occlusive system for use at a surgical site comprising;

a surgical fastener, and

an occlusive device in cooperation with said surgical fastener.