WO2008045635A2

WO2008045635A2 - Method and device for attaching a patch

Info

Publication number: WO2008045635A2
Application number: PCT/US2007/077439
Authority: WO
Inventors: Harvey L. Deutsch; To V. Pham
Original assignee: The Catheter Exchange, Inc.
Priority date: 2006-10-12
Filing date: 2007-08-31
Publication date: 2008-04-17
Also published as: WO2008045635A3

Abstract

A connector for connecting a patch to tissue in vivo. According to another embodiment of the present invention, there is provided a patch suitable for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity. A device for connecting a patch to tissue in vivo. According to another embodiment of the present invention, there is provided a patch delivery system for connecting a patch to tissue in vivo.

Description

METHOD AND DEVICE FOR ATTACHING A PATCH

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present Application claims the benefit of United States Provisional Patent

Application 60/829,249 titled "Method and Device for Attaching a Patch," filed October 12, 2006, the contents of which are incorporated in this disclosure by reference in their entirety.

BACKGROUND

[0002] There are a number of human diseases and conditions that cause an aberrant space or cavity as part of the disease or condition, such as for example a hernia sac of an inguinal hernia, where the aberrant space or cavity causes real or potential morbidity, and for which treatment of the disease or condition involves obliteration or sealing of the space or cavity. For example, many treatments have been developed for the obliteration of the hernia sac of an inguinal hernia, including both open surgical and laparoscopic procedures using a polypropylene patch (Marlex^®, Chevron Phillips Chemical Company LP, The Woodlands, TX US) to obliterate or seal the hernia sac. The polypropylene patch induces a fibrotic reaction leading to obliteration or sealing of the hernia sac.

[0003] Attachment of a patch to the tissue adjacent the hernia cavity is usually performed by suturing the edges of the patch to the adjacent tissue using surgical suture, or by clipping the edges of the patch to the adjacent tissue using surgical clips. Disadvantageously, however, attachment of the patch to the adjacent tissue can be very time- consuming leading to additional expense and possibly an increase in morbidity. [0004] Therefore, it would be useful to have a new method for obliterating or sealing of an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity. Preferably, the new method would be less time- consuming than present methods.

SUMMARY

[0005] According to one embodiment of the present invention, there is provided a connector for connecting a patch to tissue in vivo. The connector comprises: a) a proximal segment; and b) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue. In one embodiment, the patch approximation piece is a tube or wire. In another embodiment, the coupler that connects the distal end of the filament to the tissue anchor is a first coupler, the connector further comprises a second coupler, and the second coupler connects the filament to the patch approximation piece. The patch approximation piece is a tube, and the second coupler is part of the tube that has been crimped around the proximal end of the filament. [0006] According to another embodiment of the present invention, there is provided a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity. The patch comprises: a) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; b) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a flexible filament with a proximal end and a distal end; and where the distal segment comprises a tissue anchor for anchoring the connector to the tissue. In one embodiment, the patch comprises a single layer, where the single layer comprises both the first side and the second side. In another embodiment, the patch comprises two layers, a proximal layer and a distal layer, where the proximal layer comprises the first side; and where the distal layer comprises the second side. In one embodiment, the one or more than one layer comprises an autologous graft. In another embodiment, the proximal layer comprises expanded polytetrafluoroethylene (ePTFE), and the distal layer comprises polypropylene mesh. In one embodiment, the patch comprises between two and twenty connectors. In another embodiment, the patch comprises two, three, four, five, six, seven, eight, nine or ten connectors. In one embodiment, the patch further comprises a plurality of apertures near the circumference of the patch, where the filament of the proximal segment of each connector is attached to the patch around the circumference of the patch through one or more than one aperture near the circumference of the patch. In another embodiment, the patch further comprises a loop attached to the patch and extending proximally from the first side of the patch.

[0007] According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. In one embodiment, the device comprises a) a proximal portion, a central portion connected distally to the proximal portion, and a distal portion connected distally to the central portion; b) a long central axis extending from the proximal portion to the distal portion; c) a sheath assembly; d) a guide assembly at least partly within the sheath assembly; e) a plurality of needle assemblies at least partly within the guide assembly; and f) an inner shaft and a locking assembly associated with each needle assembly; where each locking assembly is connected to an inner shaft; where each inner shaft is at least partly within the guide assembly; where each need assembly is at least partly within an inner shaft; and where each locking assembly comprises a mechanism for converting the device from a first state where the needle assembly can translate axially within the inner shaft, to a second state where the needle assembly cannot translate axially within the inner shaft. In one embodiment, the sheath assembly comprises a sheath and a handle connected to the sheath proximally; and the handle of the sheath assembly is configured to allow an operator to grasp the sheath assembly and to translate the sheath assembly along the long central axis of the device with respect to the guide assembly. In another embodiment, the handle of the sheath assembly comprises a sealant configured to prevent gas leaks from an abdominal cavity during use of the device in a laparoscopic procedure involving the use of gas to inflate the abdomen. In another embodiment, the plurality of needle assemblies is two, three, four, five, six, seven, eight, nine or ten needle assemblies. In another embodiment, each needle assembly comprises a proximal end and a distal end and further comprises, from the proximal end to the distal end respectively, a stopper connected to a support tube connected to a pusher connected to a needle; and the stopper of the needle assembly is configured to allow an operator to grasp the proximal end of the needle assembly. In another embodiment, each needle assembly comprises a needle comprising a wall, and the needle comprises an axially directed slot extending completely through the wall of the needle. In another embodiment, the inner shaft is flattened on two opposing sides, and the pusher is flattened on two opposing sides to fit within the corresponding inner shaft. In another embodiment, the stopper comprises a knob with indentations to assist an operator in gripping the stopper. In one embodiment, the stopper further comprises a knob and a sleeve connected to the knob distally. In another embodiment, each needle assembly comprises a needle comprising a wall, and the needle assembly further comprises a needle plug within the wall of the needle. In one embodiment, each inner shaft comprises a proximal end, a distal end and a central portion, and where each inner shaft comprises an aperture at the distal end. In one embodiment, the guide assembly comprises an outer shaft comprising a plurality of channels comprising one channel for each needle assembly and associated inner shaft. In one embodiment, the guide assembly comprises an outer shaft and a handle connected to the outer shaft. In one embodiment, the device further comprises a mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis. In one embodiment, the guide assembly comprises an outer shaft, and the mechanism comprises a deflecting cable attached distally to the outer shaft, and attached proximally to a rotatable knob through a slotted screw. In one embodiment, the mechanism further comprises one or more than one aligning pin connected to the slotted screw. [0008] According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. In one embodiment, the device comprises a) a proximal portion, a central portion connected distally to the proximal portion, and a distal portion connected distally to the central portion; b) a long central axis extending from the proximal portion to the distal portion; c) a sheath assembly; d) a guide assembly at least partly within the sheath assembly; e) a plurality of needle assemblies at least partly within the guide assembly; and f) an inner shaft and a locking assembly associated with each needle assembly; where each locking assembly is connected to an inner shaft; where each inner shaft is at least partly within the guide assembly; where each need assembly is at least partly within an inner shaft; where each locking assembly comprises a mechanism for converting the device from a first state where the needle assembly can translate axially within the inner shaft, to a second state where the needle assembly cannot translate axially within the inner shaft; where the sheath assembly comprises a sheath and a handle connected to the sheath proximally; where the handle of the sheath assembly is configured to allow an operator to grasp the sheath assembly and to translate the sheath assembly along the long central axis of the device with respect to the guide assembly; where each needle assembly comprises a proximal end and a distal end and further comprises, from the proximal end to the distal end respectively, a stopper connected to a support tube connected to a pusher connected to a needle; where the stopper of the needle assembly is configured to allow an operator to grasp the proximal end of the needle assembly; where each needle assembly comprises a needle comprising a wall, and the needle comprises an axially directed slot extending completely through the wall of the needle; and where each inner shaft comprises a proximal end, a distal end and a central portion, and where each inner shaft comprises an aperture at the distal end. In one embodiment, the device further comprises a mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis.

[0009] According to another embodiment of the present invention, there is provided a patch delivery system for connecting a patch to tissue in vivo. The patch delivery system comprises: a) a device according to the present invention; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprises: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises: A) a proximal segment; and B) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; and where the patch delivery system can convert from an introductory form to a delivery form, and where the connector is seated at least partly within the needle assembly of the device when the device is in the introductory form. In one embodiment, the patch delivery system further comprises a loop attached to the patch and extending proximally from the first side of the patch, and the loop is partly within the aperture of each inner shaft, when the patch delivery system is in an introductory form. [0010] According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. In one embodiment, the device comprises: a) an inner segment; and b) an outer segment; where the inner segment is configured to fit within the outer segment; where the inner segment is axially slidable and axially removable from the outer segment; where the inner segment comprises a proximal end, a distal end and a central portion between the proximal end and the distal end; where the inner segment further comprises a knob at the proximal end of the inner segment to assist an operator in gripping the inner segment; where the inner segment further comprises a needle at the distal end of the inner segment; where the needle comprises a generally tube-like structure comprising a proximal end, a distal end and a wall defining an interior space; where the distal end of the needle is configured to pierce tissue in vivo; where the central portion of the inner segment is a rod or tube connecting the proximal end of the inner segment to the distal end of the inner segment; where the outer segment of the device is a generally tubular structure comprising a proximal end, a distal end and a central portion between the proximal end and the distal end; where the outer segment further comprises a wall, an inner circumference defining a central channel extending completely through the outer segment from the proximal end to the distal end, and an outer circumference; where the central canal of the outer segment has a long central axis; where the proximal end of the outer segment comprises a knob to restrict distal axial translation of the inner segment with respect to the outer segment; where the device can convert from an introductory form to a delivery form; where the device further comprises a connector for connecting a patch to tissue in vivo when the device is in the introductory form, the connector comprising: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue; where the tissue anchor of the distal segment of the connector is partly seated within the needle of the device, and the remainder of the connector is seated between the wall of the needle and the inner circumference of the wall of the outer segment. In one embodiment, the inner segment has a long central axis between the proximal end of the inner segment and the distal end of the inner segment; where the central portion of the inner segment is angled from the long central axis near the distal end of the inner segment; and where the outer segment has a long central axis between the proximal end of the outer segment and the distal end of the outer segment, and the central portion of the outer segment is angled from the long central axis near the distal end of the outer segment. In another embodiment, the distal end of the outer segment comprises a collar having a transverse diameter perpendicular to the long axis of the central canal. In another embodiment, the wall of the needle has an outer circumference and a cross-sectional area, and the central channel of the outer segment has a cross-sectional area that is larger than the cross-sectional area of the wall of the needle by at least 10%. In another embodiment, the outer segment further comprises a protrusion attached to the wall of the outer segment and extending into the central channel device; where the connector is a plurality of connectors; and at least one of the plurality of connectors is positioned proximal to the protrusion, between the inner segment and the wall of the outer segment. In another embodiment, the device further comprises a tissue grasper attached to the distal end of the outer segment, and further comprises a mechanism for actuating the tissue grasper connected to the tissue grasper.

[0011] According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. In one embodiment, the device comprises: a) a proximal end, a distal end, and a central portion between the proximal end and the distal end; b) a plurality of inner segments; c) an outer segment; and d) an inner shaft and a locking assembly connected to the inner shaft, associated with each inner segment; where each inner segment is configured to fit within the outer segment; where each inner segment is axially slidable and axially removable from the outer segment; where each inner segment comprises a proximal end, a distal end and a central portion between the proximal end and the distal end; where each inner segment further comprises a knob at the proximal end of each inner segment to assist an operator in gripping each inner segment; where each inner segment further comprises a needle at the distal end of each inner segment; where the needle comprises a generally tube-like structure comprising a proximal end, a distal end and a wall defining an interior space; where the distal end of the needle is configured to pierce tissue in vivo; where the central portion of each inner segment is a rod or tube connecting the proximal end of each inner segment to the distal end of each inner segment; where the outer segment of the device is a generally tubular structure comprising a proximal end, a distal end and a central portion between the proximal end and the distal end; where the outer segment further comprises a wall, an inner circumference defining a central canal or a plurality of channels extending completely through the outer segment from the proximal end to the distal end, and an outer circumference; where the central canal of the outer segment has a long central axis; where the proximal end of the outer segment comprises a knob to restrict distal axial translation of each inner segment with respect to the outer segment; where the device can convert from an introductory form to a delivery form; where the device further comprises a plurality of connectors for connecting a patch to tissue in vivo when the device is in the introductory form, each connector comprises: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue; and where the tissue anchor of the distal segment of the connector is partly seated within the needle of the device, and the remainder of the connector is seated between the wall of the needle and the inner circumference of the wall of the outer segment. In one embodiment, the plurality of connectors is two, three, four, five, six, seven, eight, nine or ten connectors. In another embodiment, the plurality of connectors comprises between two and twenty. In one embodiment, the central portion of the outer segment further comprises a handle to assist an operator in gripping the device.

[0012] According to another embodiment of the present invention, there is provided a kit for connecting a patch to tissue in vivo. In one embodiment, the kit comprises a patch delivery system according to the present invention, and instructions for using the patch delivery system. In another embodiment, the kit comprises a device according to the present invention, and instructions for using the patch delivery system.

[0013] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprises: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 32, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect. In another embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. In another embodiment, the method further comprises inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

[0014] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 33, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect. In another embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. In another embodiment, the method further comprises inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

[0015] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 34, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect. In another embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. In one embodiment, connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo. In one embodiment, the method further comprises inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

[0016] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 36, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect. In another embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. In one embodiment, the method further comprises inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo. In one embodiment, connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo. [0017] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprises: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 37 where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect. In one embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. In one embodiment, the method further comprises inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo. In another embodiment, positioning the distal portion of the device further comprises actuating the mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis. In another embodiment, connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo. [0018] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) providing a device of claim 38 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; and c) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue. [0019] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) providing a device of according to the present invention, where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue; d) retracting the needle back into the outer segment; e) repeating step c), thereby deploying another connector connecting the patch to the tissue. In one embodiment, the method further comprises repeating step d) and step e) one or more than one time.

[0020] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) providing a device according to the present invention, where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) actuating the mechanism, thereby grasping the patch and tissue between the tissue grasper; d) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue; and e) retracting the needle back into the outer segment.

[0021] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. The method comprises: a) providing a device of claim 44 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) inserting the distal end of one needle through the patch, thereby deploying one connector connecting the patch to the tissue; d) retracting the needle back into the outer segment; e) repeating steps c) and d) using another needle, thereby deploying another connector connecting the patch to the tissue. FIGURES

[0022] These and other features, aspects and advantages of the present invention will become better understood from the following description, appended claims, and accompanying figures where: [0023] Figure 1 is a lateral perspective view of one embodiment of a connector according to the present invention;

[0024] Figure 2 is a lateral perspective view of another embodiment of a connector according to the present invention;

[0025] Figure 3 is a lateral cutaway, perspective view of one embodiment of a patch according to the present invention; [0026] Figure 4 is a close-up, partial, lateral, cutaway perspective view of the embodiment of the patch shown in Figure 3; [0027] Figure 5 is a lateral perspective view of one embodiment of a device according to the present invention for connecting a patch to tissue in vivo according to the present invention, where the device is in the deployment form;

[0028] Figure 6 is a lateral perspective view of a patch delivery system according to the present invention comprising the device shown in Figure 5, and further comprising a patch according to the present invention, where the patch delivery system is shown in the introduction form;

[0029] Figure 7 is a lateral perspective view of a patch delivery system according to the present invention comprising the device shown in Figure 5, and further comprising a patch according to the present invention, where the patch delivery system is shown in the deployment form;

[0030] Figure 8 is a lateral perspective view of the proximal portion of the device shown in Figure 5;

[0031] Figure 9 is a partial, lateral, cutaway perspective view of the central portion of the device shown in Figure 5;

[0032] Figure 10 is a partial, lateral, cutaway perspective view of the outer shaft of the device shown in Figure 5 taken along line 10-10;

[0033] Figure 11 is a lateral perspective view of a single needle assembly, inner shaft and locking assembly of the device shown in Figure 5; [0034] Figure 12 is a partial, cutaway, lateral perspective view of the distal portion and the part of the central portion of the single needle assembly shown in Figure 11 ;

[0035] Figure 13 is a partial, lateral perspective view of the proximal portion of the single needle assembly in Figure 11 ;

[0036] Figure 14 is a close-up, lateral perspective view of the proximal portion of the single needle assembly, inner shaft, and the locking assembly shown in Figure 11;

[0037] Figure 15 is a lateral perspective view of the distal portion and the part of the central portion of the single needle assembly and inner shaft shown in Figure 11 with a connector according to the present invention loaded into the needle assembly;

[0038] Figure 16 is a close-up, lateral perspective view of the distal portion of the single needle assembly and inner shaft shown in Figure 15 with a connector according to the present invention loaded into the needle assembly; [0039] Figure 17 is a lateral perspective view of another embodiment of a device according to the present invention for connecting a patch to tissue in vivo according to the present invention, where the device is in the deployment form;

[0040] Figure 18 is a close-up, partial cutaway, lateral perspective view of the central portion of the device shown in Figure 17;

[0041] Figure 19 is a lateral perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo;

[0042] Figure 20 is an inferior, lateral perspective view of the device shown in Figure

19; [0043] Figure 21 is a lateral perspective view of the outer body segment of the device shown in Figure 19;

[0044] Figure 22 is a lateral perspective view of the inner body segment of the device shown in Figure 19;

[0045] Figure 23 is a partial cutaway, inferior, lateral perspective view of the distal portion of the device shown in Figure 19;

[0046] Figure 24 is a lateral perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo;

[0047] Figure 25 is a partial, distal, lateral perspective view of the embodiment of the device shown in Figure 24; [0048] Figure 26 is a partial, lateral, cutaway perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo;

[0049] Figure 27 is another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26;

[0050] Figure 28 is another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26;

[0051] Figure 29 is another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26;

[0052] Figure 30 is a partial, lateral, perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo; [0053] Figure 31 is a partial, lateral perspective view of the embodiment of the device shown in Figure 30; [0054] Figure 32 is a partial, lateral perspective view of the embodiment of the device shown in Figure 30; and

[0055] Figure 33 through Figure 35 are partial, proximal, lateral, cutaway perspective views of a patch according to the present invention and distal portion of a device according to the present invention in some steps in one embodiment for connecting a patch to tissue in vivo.

DESCRIPTION

[0056] According to one embodiment of the present invention, there is provided a connector for connecting a patch to tissue in vivo. According to another embodiment of the present invention, there is provided a patch suitable for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity. According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. According to another embodiment of the present invention, there is provided a patch delivery system for connecting a patch to tissue in vivo. In a preferred embodiment, the patch delivery system comprises a device for connecting a patch to tissue in vivo according to the present invention, and the patch delivery system further comprises a patch according to the present invention. According to another embodiment of the present invention, there is provided a kit for connecting a patch to tissue in vivo. In one embodiment, the kit comprises a patch delivery system according to the present invention. In one embodiment, the kit comprises a device for connecting a patch to tissue in vivo according to the present invention. According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo. In a preferred embodiment, the method comprises providing a patch delivery system according to the present invention. In another preferred embodiment, the method comprises providing a patch according to the present invention. In another preferred embodiment, the tissue to which the patch is connected surrounds an aberrant space or cavity caused by a disease or condition, and the cavity causes real or potential morbidity. The method of the present invention permits rapid attachment of a patch and, therefore, decreases the chance of morbidity and the expense related to a procedure for treating the disease or condition. The connector, patch, device, patch delivery system and method will now be disclosed in greater detail. [0057] As used herein, except where the context requires otherwise, the term

"comprise" and variations of the term, such as "comprising," "comprises" and "comprised" are not intended to exclude other additives, components, integers or steps. [0058] All dimensions specified in this disclosure are by way of example only and are not intended to be limiting. Further, the proportions shown in these Figures are not necessarily to scale. As will be understood by those with skill in the art with reference to this disclosure, the actual dimensions of any device or part of a device disclosed in this disclosure will be determined by its intended use. [0059] As used in this disclosure, except where the context requires otherwise, the method steps disclosed and shown are not intended to be limiting nor are they intended to indicate that each step is essential to the method or that each step must occur in the order disclosed.

[0060] According to one embodiment of the present invention, there is provided a connector for connecting a patch to tissue in vivo. Referring now to Figure 1 and Figure 2, there are shown, respectively, a lateral perspective view of one embodiment of a connector according to the present invention (Figure 1); and a lateral perspective view of another embodiment of a connector according to the present invention (Figure 2). As can be seen, the connector 10 comprises a proximal segment 12, and a distal segment 14 joined to the proximal segment 12. In a preferred embodiment, the connector 10 further comprises a coupler 16 that joins the proximal segment 12 to the distal segment 14.

[0061] Referring again to Figure 1 and Figure 2, the proximal segment 12 of the connector 10 comprises a highly flexible filament 18, such as a thread or wire, comprising a proximal end 20 and a distal end 22. In one embodiment, the filament 18 comprises black mono nylon, non-absorbable surgical suture, size 2.0 USP (3.0 metric). The distal segment 14 comprises a tissue anchor 24 for anchoring the connector 10 to tissue. In the embodiments shown in Figure 1 and Figure 2, the tissue anchor 24 is v-shaped or u-shaped. The tissue anchor 24 can, however, be any suitable shape, such as for example "2-shaped" or barbed as will be understood by those with skill in the art with reference to this disclosure. In one embodiment, the filament 18 is a thread or suture material. In a preferred embodiment, the filament 18 comprises a bio-resorbable suture material. In another preferred embodiment, the filament 18 comprises a surgical grade, suture material selected from the group consisting of nylon, polyester, prolene and silk. In another embodiment, the filament 18 comprises a material selected from the group consisting of braided-polyester, braided- silk, nylon monofilament and propylene monofilament. In a preferred embodiment, the cross-sectional diameter of the filament 18 is between 0.1 mm and 0.5 mm. [0062] The distal end 22 of the filament 18 is connected to the tissue anchor 24. In one embodiment, the distal end 22 of the filament 18 is connected to the tissue anchor 24 using an adhesive. In another embodiment, the connector 10 further comprises a coupler 16, where the coupler 16 connects the distal end 22 of the filament 18 to the tissue anchor 24. In the embodiments shown in Figure 1 and Figure 2, the coupler 16 comprises a circumferential band that has been crimped around the tissue anchor 24 and the distal end 22 of the filament 18; however, the coupler 16 can be any suitable structure as will be understood by those with skill in the art with reference to this disclosure.

[0063] In one embodiment, the proximal end 20 of the filament 18 comprises a knot or a ball for fixing the connector 10 to a patch as disclosed in this disclosure. The proximal end 20 of the filament 18 can, however, comprise any suitable structure for fixing the connector 10 to a patch as disclosed in this disclosure, as will be understood by those with skill in the art with reference to this disclosure. In another embodiment, as shown in Figure 2, the proximal segment 12 further comprises a patch approximation piece 26 for approximating a patch as disclosed in this disclosure to tissue as the connector 10 connects the patch to the tissue. The patch approximation piece 26 can be a tube or stiff wire, or can be any other suitable structure as will be understood by those with skill in the art with reference to this disclosure. In one embodiment, the coupler 16 that connects the distal end 22 of the filament 18 to the tissue anchor 24 is a first coupler 16, and the connector 10 further comprises a second coupler 28, where the second coupler 28 joins the filament 18 to the patch approximation piece 26. In one embodiment, as can be seen in Figure 2, the patch approximation piece 26 is a tube, and the second coupler 28 is part of the tube that has been crimped around the proximal end 20 of the filament 18; however, the second coupler 28 can be any suitable structure as will be understood by those with skill in the art with reference to this disclosure. [0064] The connector 10 can comprise any suitable material for the intended purpose, as will be understood by those with skill in the art with reference to this disclosure. When the connector 10 is intended to be used in vivo, each element of the connector 10 comprises one or more than one biocompatible material, such as for example nitinol, nylon, platinum, polypropylene, stainless steel and titanium. In one embodiment, the patch approximation piece 26 comprises a tube comprising a material selected from the group consisting of nitinol, stainless steel and titanium. In one embodiment, the patch approximation piece 26 comprises a tube made of biocompatible material, such as a shaped metal alloy or a shaped memory alloy. In one embodiment, the distal segment 14 comprises a biocompatible wire, such as a shaped metal alloy or a shaped memory alloy. In a preferred embodiment, the distal segment 14 comprises a material selected from the group consisting of magnesium, nitinol, polyglycolic acid, stainless steel and titanium. In one embodiment, the first coupler 16 and the second coupler 28 comprise a material selected from the group consisting of gold, platinum, stainless steel, titanium, or can be injection molded from any suitable implantable polymer such as nylon or poly(ethylene terephthalate) (PET). Each element of the connector 10 can, however, comprise any material suitable for the intended purpose, as will be understood by those with skill in the art with reference to this disclosure.

[0065] The dimensions of the connector 10, proximal segment 12 and distal segment

14 are selected according to the intended use of the connector 10, as will be understood by those with skill in the art with reference to this disclosure. [0066] According to another embodiment of the present invention, there is provided a patch suitable for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity. Referring now to Figure 3 and Figure 4, there are shown respectively, a lateral, cutaway perspective view of one embodiment of a patch according to the present invention (Figure 3); and a close- up, partial, lateral, cutaway perspective view of the embodiment of the patch shown in Figure 3 (Figure 4). As can be seen, the patch 30 comprises one or more than one layer, and comprises a first side 32 (a proximal side), an opposing second side 34 (a distal side), and a circumference 36. In one embodiment, the patch 30 comprises a single layer, where the single layer comprises both the first side 32 and the second side 34. In a preferred embodiment, as shown in Figure 3 and Figure 4, the patch 30 comprises two layers, a proximal layer 38 and a distal layer 40, where the proximal layer 38 comprises the first side 32, and where the distal layer 40 comprises the second side 34. The patch 30 can, however, comprise three or more than three layers, as will be understood by those with skill in the art with reference to this disclosure. In one embodiment, the layer or layers comprise a naturally derived material, such as for example an autologous graft. In another embodiment, the layer or layers comprises a synthetic material such as for example a synthetic polymer. In another embodiment, the layer or layers comprise a combination of both a naturally derived material and a synthetic material. In one embodiment, the layer or layers comprises a material selected from the group consisting of polypropylene, polypropylene mesh, expanded polytetrafluoroethylene (ePTFE) graft material and silicone rubber. In a preferred embodiment, the patch 30 comprises a single layer of expanded polytetrafluoroethylene (ePTFE) graft material. In another preferred embodiment, the patch comprises two layers, as shown in Figure 3 and Figure 4, a proximal layer 38 comprising expanded polytetrafluoroethylene (ePTFE), and a distal layer 40 comprising polypropylene mesh. In this embodiment, the layer of polypropylene mesh can be heat sealed to the layer of ePTFE, or the layer of polypropylene mesh can be sewn to the layer of expanded polytetrafluoroethylene (ePTFE) using expanded polytetrafluoroethylene (ePTFE) or polypropylene monofilament thread. In one embodiment, the layers are sewn together using nylon suture (size 6.0 USP to 9.0 USP); however, the layer of polypropylene mesh can be joined to the layer of expanded polytetrafluoroethylene (ePTFE) using any other suitable technique, as will be understood by those with skill in the art with reference to this disclosure.

[0067] As will be understood by those with skill in the art with reference to this disclosure, both the material that the patch 30 comprises and the dimensions of the patch 30 are selected for its intended use. For example, when used for obliterating or sealing the hernia sac of an inguinal hernia in vivo, the patch can comprise two layers, a first layer comprising the first side 32 made of a first material, and a second layer comprising the second side 34 made of a second material, where the first material comprises expanded polytetrafluoroethylene (ePTFE), and where the second material comprises polypropylene mesh. In a preferred embodiment, the patch comprises one layer of expanded polytetrafluoroethylene (ePTFE) forming both the first side 32 and the second side 34. In another example, when used for obliterating or sealing the hernia sac of an inguinal hernia in vivo, the circumference 36 of the patch 30 is between 6 cm and 20 cm. [0068] Referring again to Figure 3 and Figure 4, the patch 30 further comprises a plurality of connectors 10 according to the present invention, where each of the plurality of connectors is attached to the layer or layers of the patch 30. In one embodiment, the patch 30 comprises between two and twenty connectors 10. In another embodiment, the patch 30 comprises two, three, four, five, six, seven, eight, nine or ten connectors 10. In a preferred embodiment, as shown in Figure 3, the patch 30 comprises four connectors 10. In one embodiment, as can be seen in Figure 3 and Figure 4, the patch comprises a plurality of apertures 42 near the circumference 36 of the patch 30, and each connector 10 comprises a connector according to the present invention as shown in Figure 1, where the filament 18 of the proximal segment 12 of each connector 10 is attached to the patch 30 around the circumference 36 of the patch 30 through one or more than one aperture 42 near the circumference 36 of the patch. In one embodiment, each connector 10 is held in position to the patch 30 by a knot or equivalent structure at the proximal end 20 of the filament 18. In a preferred embodiment, the patch 30 further comprises a loop 44 attached to the patch 30 and extending proximally from the first side 32 of the patch 30, where the loop 44 is configured to permit placement of the patch 30 using a device 100 according to the present invention, as will be disclosed in more detail below.

[0069] According to another embodiment of the present invention, there is provided a device for connecting a patch to tissue in vivo. According to another embodiment of the present invention, there is provided a patch delivery system for connecting a patch to tissue in vivo. In a preferred embodiment, the patch delivery system comprises a device for connecting a patch to tissue in vivo according to the present invention, and the patch delivery system further comprises a patch according to the present invention. Referring now to Figure 5 through Figure 16, there are shown, respectively, a lateral perspective view of one embodiment of a device according to the present invention for connecting a patch according to the present invention to tissue in vivo, where the device is in the deployment form (Figure 5); a lateral perspective view of a patch delivery system according to the present invention comprising the device shown in Figure 5, and further comprising a patch according to the present invention, where the patch delivery system is shown in the introduction form (Figure 6); a lateral perspective view of a patch delivery system according to the present invention comprising the device shown in Figure 5, and further comprising a patch according to the present invention, where the patch delivery system is shown in the deployment form (Figure 7); a lateral perspective view of the proximal portion of the device shown in Figure 5 (Figure 8); a partial, lateral, cutaway perspective view of the central portion of the device shown in Figure 5 (Figure 9); a partial, lateral, cutaway perspective view of the outer shaft of the device shown in Figure 5 taken along line 10-10 (Figure 10); lateral perspective view of a single needle assembly, inner shaft and locking assembly of the device shown in Figure 5 (Figure 11); a partial, cutaway lateral perspective view of the distal portion and the part of the central portion of the single needle assembly shown in Figure 11 (Figure 12); a partial, lateral perspective view of the proximal portion of the single needle assembly in Figure 11 (Figure 13); a close-up, lateral perspective view of the proximal portion of the single needle assembly, inner shaft, and locking assembly shown in Figure 11 (Figure 14); a lateral perspective view of the distal portion and the part of the central portion of the single needle assembly and inner shaft shown in Figure 11 with a connector according to the present invention loaded into the needle assembly (Figure 15); a close-up, lateral perspective view of the distal portion of the single needle assembly and inner shaft shown in Figure 15 with a connector according to the present invention loaded into the needle assembly (Figure 16). As can be seen, in one embodiment the present invention is a device 100 for connecting a patch to tissue in vivo. In another embodiment, the present invention is patch delivery system 102 for connecting a patch to tissue in vivo. The patch delivery system comprises a device 100 for connecting a patch to tissue in vivo according to the present invention, and the patch delivery system 102 further comprises a patch 30. In a preferred embodiment, the patch 30 is a patch according to the present invention as disclosed in this disclosure, comprising a plurality of connectors 10 according to the present invention. The device 100 comprises a proximal portion 104, a central portion 106 connected distally to the proximal portion 104, and a distal portion 108 connected distally to the central portion 106. The device 100 comprises a long central axis extending from the proximal portion 104 to the distal portion

108.

[0070] The device 100 further comprises, from exterior to interior respectively, a sheath assembly 110, a guide assembly 112 at least partly within the sheath assembly 110, a plurality of needle assemblies at least partly within the guide assembly 112, and a plurality of needle assemblies 114. In a preferred embodiment, the device 100 further comprises an inner shaft 116 and a locking assembly 118 associated with each needle assembly 114. Each locking assembly 118 is connected to an inner shaft. Each inner shaft 116 is at least partly within the guide assembly 112 and each needle assembly 114 is at least partly within an inner shaft 116. The sheath assembly 110 comprises a sheath 120 which is a generally tubular structure comprising a wall with an axial length, an inner circumference and an outer circumference. The sheath 120 encloses the patch 30 and the distal portion 108 of the device 100 when the patch delivery system 102 is in the introduction form, as can be seen particularly in Figure 6. In one embodiment, the sheath 120 is sufficiently transparent to allow visualization of the distal portion 108 of the device 100. In one embodiment, when the patch delivery system 102 is being used for connecting the patch to tissue in vivo, the axial length of the sheath 120 is between 15 cm and 20 cm. In one embodiment, when the patch delivery system 102 is being used for connecting the patch to tissue in vivo, the inner circumference of the sheath 120 is between 2 cm and 4 cm. In a preferred embodiment, the sheath 120 comprises a material selected from the group consisting of poly etherether ketone and polypropylene. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the sheath 120 comprise are selected according to the intended use of the device 100.

[0071] In one embodiment, the sheath assembly 110 further comprises a handle 122 connected to the sheath 120 proximally. The handle 122 of the sheath assembly 110 is configured to allow an operator to grasp the sheath assembly 100 and to translate the sheath assembly along the long central axis of the device 100 with respect to the guide assembly 112. In a preferred embodiment, the handle 122 of the sheath assembly 110 comprises a sealant, such as for example a self-sealing silicone washer, a silicone membrane or a silicone o-ring, configured to prevent gas leaks from an abdominal cavity during use of the device 100 in a laparoscopic procedure involving the use of gas to inflate the abdomen.

[0072] The device 100 further comprises a plurality of needle assemblies 114. In one embodiment, the device 100 comprises between two and ten needle assemblies 114. In another embodiment, the device 100 comprises two, three, four, five, six, seven, eight, nine or ten needle assemblies 114. In a preferred embodiment, as shown particularly in Figure 5, Figure 6 and Figure 7, the device 100 comprises four needle assemblies 114. In another preferred embodiment, the device 100 comprises six needle assemblies 114. In another preferred embodiment, the device 100 comprises eight needle assemblies 114. [0073] Referring now particularly to Figure 5 through Figure 9, and Figure 11 through Figure 16, in a preferred embodiment, each needle assembly 114 comprises a proximal end 124 and a distal end 126 and further comprises, from the proximal end 124 to the distal end 126 respectively, a stopper 128 connected to a support tube 130 connected to a pusher 132 connected to a needle 134. As will be understood by those with skill in the art with reference to this disclosure, other configurations of needle assemblies 114 suitable for use in the device 100 are within the scope of this invention, and this configuration is given merely as an example of a preferred embodiment. As can be seen particularly in Figure 11 , Figure 12 and Figure 16, the needle 134 comprises a generally tube-like structure comprising a proximal end 136, a distal end 138 and a wall 140. The distal end 138 is configured to pierce tissue in vivo. In one embodiment, the distal end 138 is beveled with a sharp, cutting tip, as shown particularly in Figure 12 and Figure 16; however, the distal end 138 can be any configuration suitable for the intended purpose as disclosed in this disclosure, as will be understood by those with skill in the art with reference to this disclosure. In a preferred embodiment, also as shown particularly in Figure 12 and Figure 16, each needle assembly 114 comprises a needle 134 comprising a wall 140, and the needle 134 further comprises an axially directed slot 142 extending completely through the wall 140 of the needle 134 from the distal end 138 of the needle 134 toward the proximal end 136 of the needle 134. In one embodiment, the needle 134 has an axial length of between 1.25 cm and 2.5 cm. In one embodiment, the needle 134 comprises stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the needle 134 comprise are selected according to the intended use of the device 100, as will be understood by those with skill in the art with reference to this disclosure. [0074] Referring now particularly to Figure 11 and Figure 12, the pusher 132 comprises a generally tube-like structure, but can be solid or hollow, and further comprises a proximal end 144 and a distal end 146. In a preferred embodiment, the pusher 132 is flattened on at least one side to fit within the corresponding inner shaft 116, as disclosed in this disclosure. In a particularly preferred embodiment, the pusher 132 is flattened on two opposing sides to fit within the corresponding inner shaft 116, as disclosed in this disclosure. The pusher 132 is configured to add lateral flexibility to the needle assembly 114. The proximal end 136 of the needle 134 is connected to the distal end 146 of the pusher 132, such as for example by an adhesive, or by crimping. In one embodiment, the pusher 132 has an axial length of between 30 cm and 80 cm. In one embodiment, the pusher 132 comprises a material selected from the group consisting of nitinol and stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the pusher 132 comprise are selected according to the intended use of the device 100.

[0075] Referring now particularly to Figure 11, Figure 13 and Figure 14, the support tube 130 comprises a generally tube-like structure, but can be solid or hollow, and comprises a proximal end 148 and a distal end 150. The support tube 130 is configured to add lateral and axial stability to the needle assembly 114. The proximal end 144 of the pusher 132 is connected to the distal end 150 of the support tube 130, such as for example by an adhesive, or by crimping. In one embodiment, the support tube 130 has an axial length of between 20 cm and 50 cm. In one embodiment, the support tube 130 comprises stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the support tube 130 comprise are selected according to the intended use of the device 100.

[0076] Referring now particularly to Figure 11, Figure 13 and Figure 14, the stopper

128 of the needle assembly 114 is configured to allow an operator to grasp the proximal end of the needle assembly 114. In a preferred embodiment as shown, the stopper 128 comprises a proximal end 152 and a distal end 154, and further comprises a knob 156 with indentations to assist an operator in gripping the stopper 128. The stopper 128 can, however, comprise any other suitable structure, such as for example a ball or a loop, as will be understood by those with skill in the art with reference to this disclosure. In a preferred embodiment, device 100 comprises an inner shaft 116 as disclosed in this disclosure, and the stopper 128 of the needle assembly 114 comprises a knob 156 proximally and further comprises a sleeve 158 connected to the knob 156 distally as shown particularly in Figure 13 and Figure 14 to prevent excessive proximal axial translation of the inner shaft 116 as disclosed in this disclosure. The proximal end 148 of the support tube 130 is connected to the distal end 154 of the stopper 128. When the stopper 128 comprises a sleeve 158, the proximal end 148 of the support tube 130 is connected to the sleeve 158, such as for example by an adhesive, or by crimping. In one embodiment, the stopper 128 comprises both a knob 156 and a sleeve 158, and the sleeve 158 has an axial length of between 3 mm and 8 mm. In one embodiment, the stopper 128 comprises stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the stopper 128 are selected according to the intended use of the device 100.

[0077] Referring now to Figure 12, in a preferred embodiment, the needle assembly

114 further comprises a needle plug 160, within the wall 140 of the needle 134, where the needle plug 160 decreases the amount of space within the wall 140 sufficient to prevent proximal translation of a tissue anchor 24 of the connector 10 when the connector 10 is loaded within the needle 134 when the patch delivery system 102 is in the introduction form. In one embodiment, as shown in Figure 12, the needle plug 160 is a tube-like structure fitting snugly against the wall 140 of the needle 134. In one embodiment, the needle plug 160 has an axial length of between lmm and 5 mm. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the needle plug 160 comprise are selected according to the intended use of the device 100.

[0078] Referring now particularly to Figure 8, Figure 9, Figure 11, and Figure 14 through Figure 16, in a preferred embodiment, the device 100 further comprises a plurality of inner shafts 116, where each inner shaft 116 is associated with one of the plurality of needle assemblies 114. The inner shaft 116 is a generally tube-like structure configured to surround and fit snugly over the support tube 130, the pusher 132 and the needle 134 of the needle assembly 114 when the device 100 is in the introductory form. Each inner shaft 116 comprises a proximal end 162, a distal end 164 and a central portion 166. In a preferred embodiment, the central portion 166 of the inner shaft 116 is flattened on at least one side. In a particularly preferred embodiment, the central portion 166 of the inner shaft 116 is flattened on two opposing sides offset at an angle of 90°, as shown particularly in Figure 15. In a particularly preferred embodiment, each inner shaft 116 comprises an aperture 168 as seen particularly in Figure 16 for containing the loop 44 of the patch 30. In a particularly preferred embodiment, the patch delivery system 102 can convert from an introductory form to a delivery form, and the patch delivery system 102 further comprises a loop 44 attached to the patch 30 and extending proximally from the first side 32 of the patch 30, where the loop 44 is partly within the aperture 168 of each inner shaft 116, when the patch delivery system 102 is in an introductory form. In one embodiment, the inner shaft 116 has an axial length of between 30 cm and 80 cm. In one embodiment, the inner shaft 116 comprises a material selected from the group consisting of nitinol and stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the inner shaft 116 comprise are selected according to the intended use of the device 100.

[0079] In a preferred embodiment, the device 100 further comprises a plurality of locking assemblies 118, where each locking assembly 118 is connected to one of the plurality of inner shafts 116. The locking assembly 118 comprises a mechanism for converting the device 100 from a first state where the needle assembly 114 can translate axially within the inner shaft 116, to a second state where the needle assembly 114 cannot translate axially within the inner shaft 116. In one embodiment, as shown particularly in Figure 14, the locking assembly 118 comprises a thumb screw mating with a corresponding aperture in the inner shaft 116; however, any suitable locking assembly 118 can be used, as will be understood by those with skill in the art with reference to this disclosure.

[0080] The device 100 further comprises a guide assembly 112. Referring again to

Figure 5, Figure 6, Figure 7, Figure 9 and 10, and particularly Figure 6, the guide assembly 112 comprises a proximal end 170 and a distal end 172, and surrounds part of each needle assembly 114 and the central portion 166 of each inner shaft 116. In a preferred embodiment, as shown particularly in Figure 6, the distal end 172 of the guide assembly 112 comprises an outer shaft 174. In one embodiment, the outer shaft 174 is a hollow tube. In a preferred embodiment, the outer shaft 174 comprises a plurality of channels 176. In a particularly preferred embodiment, the outer shaft 174 comprises a plurality of channels 176 comprising one channel 176 for each needle assembly 114 and associated inner shaft 116. For the embodiment of the device 100 as shown in Figure 5, the device 100 comprises four needle assemblies 114 and four associated inner shafts 116, and the outer shaft 174 comprises four channels 176, one channel 176 for each needle assembly 114 and associated inner shaft 116 as can best be seen in Figure 10. In a preferred embodiment, the guide assembly 112 further comprises a handle 178 connected to the proximal end 170 of the outer shaft 174. The handle 178 is configured to allow an operator to grasp the proximal end of the guide assembly 112 to translate the sheath assembly 110 axially, and further to prevent proximal translation of the sheath assembly 110 proximal to the handle 178. In one embodiment, the outer shaft 174 has an axial length of between 20 cm and 50 cm. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the outer shaft 174 comprise are selected according to the intended use of the device 100.

[0081] In a preferred embodiment, such as shown in Figure 5 and Figure 7, the distal end 146 of each pusher 132 and the distal end 164 of each inner shaft 116 associated with one of the plurality of needle assemblies 114 comprises a shape metal alloy configured to separate circumferentially when the device is in the deployment form into a series of fixed, preset angles varying from the long central axis of the device 100.

[0082] Referring now to Figure 17 and Figure 18, there are shown, respectively, a lateral perspective view of another embodiment of a device according to the present invention for connecting a patch to tissue in vivo according to the present invention, where the device is in the deployment form (Figure 17); and is a close-up, partial cutaway, lateral perspective view of the central portion of the device shown in Figure 17 (Figure 18). As can be seen in this embodiment, the device 100 comprises six needle assemblies 114, each with an associated inner shaft 116 and locking assembly 118. In this embodiment, the device further comprises a mechanism 180 for reversibly and adjustably deflecting the distal portion 108 of the device 100 away from the central axis. The mechanism 180 can be any suitable structure or set of structures for this purpose, as will be understood by those with skill in the art with reference to this disclosure. In one embodiment, the mechanism 180 comprises a deflecting cable 182 attached distally to the outer shaft 174 through a bushing, and attached proximally to a rotatable knob 184 through a slotted screw 186. In a preferred embodiment, the mechanism 180 further comprises one or more than one aligning pin 188 connected to the slotted screw. The mechanism 180 shown in Figure 17 and Figure 18 functions as follows. Rotating the rotatable knob 184 causes the slotted screw 186 to translate axially, guided by the one or more than one aligning pin 188 which prevent axial rotation of the slotted screw 186, when present, and the axial translation of the slotted screw 186 applies or releases tension on the deflecting cable 182, thereby deflecting the distal end 172 of the guide assembly 112, and thereby deflecting the distal portion 108 of the device 100 away from the long central axis of the device 100. In a particularly preferred embodiment, the distal end 172 of the guide assembly 112, such as for example the distal 5 cm to 15 cm of the guide assembly 112, is laser cut into a spiral pattern to create flexibility of the distal end 172 of the guide assembly 112, or comprises a material, such as for example, a coiled tube of braided polymer, to create flexibility of the distal end 172 of the guide assembly 112. The mechanism 180 allows an operator to deflect the distal portion 108 of the device 100 of a patch delivery system 102 according to the present invention to more precisely align the patch 30 of the patch delivery system 102 before connecting the patch 30 to the tissue in vivo. [0083] According to one embodiment of the present invention, there is provided a patch delivery system for connecting a patch to tissue in vivo. The patch delivery system can convert from an introductory form to a delivery form. Referring again particularly to Figure 7, Figure 15 and Figure 16, in one embodiment, the patch delivery system 102 comprises a device 100 for connecting a patch according to the present invention, and the patch delivery system 102 further comprises a patch 30 according to the present invention. As can be seen most clearly in Figure 16, in one embodiment of the patch delivery system 102, the tissue anchor 24 of the distal segment 14 of the connector 10 is seated within the slot 142 of needle 134 of the needle assembly 114 of the device 100 and the filament 18 extends out of the slot 142 of the needle 134 and is connected to the one or more than one layer of the patch 30 (as shown in Figure 3, Figure 4 and Figure 7). Further, the loop 44 of the patch 30 surrounds the needle 134 and extends out of the aperture 168 of the inner shaft 116 when the patch delivery system 102 is in the introductory form, and is connected to the one or more than one layer of the patch 30 (as shown particularly in Figure 3 and Figure 4). [0084] According to another embodiment of the present invention, there is provided another device for connecting a patch to tissue in vivo. Referring now to Figure 19 through Figure 23, there are shown, respectively, a lateral perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo (Figure 19); an inferior, lateral perspective view of the device shown in Figure 19 (Figure 20); a lateral perspective view of the outer body segment of the device shown in Figure 19 (Figure 21); a lateral perspective view of the inner body segment of the device shown in Figure 19 (Figure 22); a partial cutaway, inferior, lateral perspective view of the distal portion of the device shown in Figure 19 (Figure 23). As can be seen, the device 200 comprises an inner segment 202 and an outer segment 204, where the inner segment 202 is configured to fit within the outer segment 204, and where the inner segment 202 is axially slidable and axially removable from the outer segment 204. The device 200 can convert from an introductory form to a delivery form.

[0085] The inner segment 202 comprises a proximal end 206, a distal end 208 and a central portion 210 between the proximal end 206 and the distal end 208. The inner segment 202 further comprises a knob 212 at the proximal end 206 of the inner segment 202 to assist an operator in gripping the inner segment 202. The inner segment 202 further comprises a needle 214 at the distal end 208 of the inner segment 202, where the needle 214 comprises a generally tube-like structure comprising a proximal end 216, a distal end 218 and a wall 220 defining an interior space. The distal end 218 of the needle 214 is configured to pierce tissue in vivo. In one embodiment, the distal end 218 of the needle 214 is beveled with a sharp, cutting tip; however, the distal end 218 of the needle 214 can be any configuration suitable for the intended purpose as disclosed in this disclosure, as will be understood by those with skill in the art with reference to this disclosure. In one embodiment, the needle 214 has an axial length of between 1.25 cm and 2.5 cm. In one embodiment, the needle 214 comprises stainless steel. As will be understood by those with skill in the art with reference to this disclosure, however, both the dimensions and material which the needle 214 comprise are selected according to the intended use of the device 200. The central portion 210 of the inner segment 202 is a rod or tube connecting the proximal end 206 of the inner segment 202 to the distal end 208 of the inner segment 202. In a preferred embodiment, as shown particularly in Figure 22, the inner segment 202 has a long central axis between the proximal end 206 of the inner segment 202 and the distal end 208 of the inner segment 202, and the central portion 210 of the inner segment 202 is angled from the long central axis near the distal end 208 of the inner segment 202. In one embodiment, the central portion 210 of the inner segment 202 is angled between 5° and 20° from the central axis near the distal end 208 of the inner segment 202.

[0086] The outer segment 204 of the device 200 is a generally tubular structure comprising a proximal end 222, a distal end 224 and a central portion 226 between the proximal end 222 and the distal end 224. The outer segment 204 further comprises a wall 228, an inner circumference 230 defining a central channel 232 extending completely through the outer segment 204 from the proximal end 222 of the outer segment 204 to the distal end 224 of the outer segment 204, and an outer circumference 234. The central channel 226 of the outer segment 204 has a long central axis. The proximal end 222 of the outer segment 204 comprises a knob 236 to restrict distal axial translation of the inner segment 202 with respect to the outer segment 204. The distal end 224 of the outer segment 204 comprises a collar 238 having a transverse diameter perpendicular to the long axis of the central channel 226 of the outer segment 204. In a preferred embodiment, as shown particularly in Figure 19 and Figure 20, the outer segment 204 has a long central axis between the proximal end 222 of the outer segment 204 and the distal end 224 of the outer segment 204, and the central portion 226 of the outer segment 204 is angled from the long central axis near the distal end 224 of the outer segment 204. In one embodiment, the central portion 226 of the outer segment 204 is angled between 5° and 20° from the central axis near the distal end 224 of the outer segment 204.

[0087] In a preferred embodiment, the device 200 further comprises a connector 10 according to the present invention, of the type as shown in Figure 2, where the connector 10 comprises a tissue anchor 24. As can be seen most clearly in Figure 23, in one embodiment of the device 200, the tissue anchor 24 of the distal segment 14 of the connector 10 is partly seated within the needle 214 of the device 200, the patch approximation piece 26 is seated against the collar 232 of the distal end 224 of the outer segment 204, and the remainder of the connector 10 is seated between the wall 220 of the needle 214 and the inner circumference 230 of the wall 228 of the outer segment 204.

[0088] According to another embodiment of the present invention, there is provided another device for connecting a patch to tissue in vivo. Referring now to Figure 24 and Figure 25, there are shown respectively, a lateral, perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo (Figure 24); and a partial, distal, lateral, perspective view of the embodiment of the device shown in Figure 24 (Figure 25). As can be seen, the device 300 comprises a proximal end 302, a distal end 304, and a central portion 306 between the proximal end 302 and the distal end 304. The device 300 further comprises a plurality of inner segments 308 corresponding to the inner segment 202 of the device 200 and comprising corresponding elements. The device 300 further comprises an inner shaft 310 and a locking assembly 312 connected to each inner shaft 310, corresponding to the inner shaft 116 and locking assembly 118 of the device 100 and comprising corresponding elements, associated with each inner segment 308. The device 300 further comprises an outer segment 314 corresponding to the outer segment 204 of the device 200, and comprising corresponding elements except that the outer segment 314 comprises one channel 316 for each combination inner segment 308 and inner shaft 310. The device 300 further comprises a plurality of connectors 10 according to the present invention, of the type as shown in Figure 2, where the connector 10 comprises a tissue anchor 24. In the device 300, the tissue anchor 24 of the distal segment 14 of the connector 10 is partly seated within the needle of the inner segment 308, the patch approximation piece 26 is seated against the collar of the distal end of the outer segment 314, and the remainder of the connector 10 is seated between the wall of the needle and the inner circumference of the wall of the channel 316 of the outer segment 314. As can be seen in Figure 24 and Figure 25, in one embodiment, the device 300 comprises six inner segments 308, each with an associated inner shaft 310 and locking assembly 312, and one outer segment 314 with six channels 316. The device 300 can, however, comprise any number of inner segments 308, each with an associated inner shaft 310 and locking assembly 312, and a corresponding number of channels 316 in the outer segment, as will be understood by those with skill in the art with reference to this disclosure. In a preferred embodiment, the number is between two and twenty. In another preferred embodiment, the number is two, three, four, five, six, seven, eight, nine or ten connectors. In a preferred embodiment, the number is between four and eight. In a preferred embodiment, the outer segment 314 of the device 300 further comprises a handle 318 to assist an operator in gripping the device 300. [0089] According to another embodiment of the present invention, there is provided another device for connecting a patch to tissue in vivo. Referring now to Figure 26 through Figure 27, there are shown, respectively, a partial, lateral, cutaway perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo (Figure 26); another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26 (Figure 27); another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26 (Figure 28); and another partial, lateral, cutaway perspective view of the embodiment of the device shown in Figure 26 (Figure 29). As can be seen, the device 400 is similar to the device 200 disclosed in this disclosure; however, in the embodiment of the device 400, the wall 220 of the needle 214 has an outer circumference 402 and a cross-sectional area, and the central channel of the outer segment 204 has a cross-sectional area that is larger than the cross-sectional area of the wall 220 of the needle 214 by at least 10% . Additionally, the outer segment 204 further comprises a protrusion 404 attached to the wall of the outer segment 204 and extending into the central channel 224 of the device. In this embodiment, the connector 10 is a plurality of connectors 10, of the type as shown in Figure 2, where each connector 10 comprises a tissue anchor 24. When the device 400 is in the introductory form, at least one of the plurality of connectors 10 is positioned proximal to the protrusion 404, between the inner segment 202 and the wall of the outer segment 204. [0090] According to another embodiment of the present invention, there is provided another device for connecting a patch to tissue in vivo. Referring now to Figure 30 through Figure 32, there are shown, respectively, a partial, lateral, perspective view of one embodiment of another device according to the present invention for connecting a patch to tissue in vivo (Figure 30); another partial, lateral, perspective view of the embodiment of the device shown in Figure 30 (Figure 31); and another partial, lateral, perspective view of the embodiment of the device shown in Figure 30 (Figure 32). As can be seen, the device 500 is similar to the device 200 and device 400 disclosed in this disclosure; however, the device 500 additionally comprises a tissue grasper 502 attached to the distal end 224 of the outer segment 204, and further comprises a mechanism 504 for actuating the tissue grasper 502 connected to the tissue grasper. In one embodiment, as shown in Figure 30 through Figure 32, the tissue grasper 502 comprises a sleeve 506 fitting over the distal portion 108 of the device 500. In one embodiment, as seen in Figure 30 through Figure 32, the tissue grasper 502 comprises pair of jaws 508 attached to the sleeve 506 and comprising uneven opposing surfaces; however the tissue grasper 502 can comprise any suitable structure, as will be understood by those with skill in the art with reference to this disclosure. As can be seen in Figure 30 through Figure 32, the tissue grasper 502 is used to grasp tissue 510 between the grasper to position the tissue for insertion of a connector 10 according to the present invention. [0091] According to another embodiment of the present invention, there is provided a kit for connecting a patch to tissue in vivo. In one embodiment, the kit comprises one or more than one patch delivery system 102 according to the present invention. In a preferred embodiment, the kit additionally comprises instructions for using the patch delivery system 102. In one embodiment, the instructions are written. In another embodiment, the instructions are recorded in a computer readable media. In another embodiment, the kit comprises one or more than one device for connecting a patch to tissue in vivo according to the present invention, such as for example one or more than one device 200, device 300, device 400 or device 500, or a combination of the foregoing. In a preferred embodiment, the kit additionally comprises instructions for using the one or more than one device for connecting a patch to tissue in vivo according to the present invention. In one embodiment, the instructions are written. In another embodiment, the instructions are recorded in a computer readable media. [0092] According to another embodiment of the present invention, there is provided a method for connecting a patch to tissue in vivo, a patient. In a preferred embodiment, the method comprises providing a patch delivery system according to the present invention. In another preferred embodiment, the method comprises providing a patch according to the present invention. In another preferred embodiment, the method comprises one or more than one device for connecting a patch to tissue in vivo. In a preferred embodiment, the one or more than one device for connecting a patch to tissue in vivo is a device according to the present invention. In another preferred embodiment, the tissue to which the patch is connected surrounds an aberrant space or cavity caused by a disease or condition, and the cavity causes real or potential morbidity. [0093] In one embodiment, the method comprises, first, selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo. In a preferred embodiment, the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity. In one embodiment, the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

[0094] Next, the method comprises providing a patch delivery system according to the present invention, where the patch delivery system comprises a device according to the present invention and comprising a patch according to the present invention, and where the patch delivery system is in the introduction form, such as for example the patch delivery system 102 shown in Figure 6. Then, the distal portion of the device of the patch delivery system, and the patch of the patch delivery system are positioned adjacent to the aberrant space or cavity caused by the disease or condition. In one embodiment, positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises making an opening into the abdominal cavity of the patient, placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity, and advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity. [0095] Next, the method comprises connecting the patch to the tissue in vivo. The exact steps which connecting the patch comprises will depend on the exact structure of the patch delivery system, as will be understood by those with skill in the art with reference to this disclosure. Referring now to Figure 33 through Figure 35, there are shown partial, proximal, lateral, cutaway perspective views of a patch according to the present invention and distal portion of a device according to the present invention in some steps in one embodiment for connecting a patch to tissue in vivo. Referring again to Figure 5 through Figure 16 and Figure 33 through Figure 35, as can be seen, the patch delivery system is a patch delivery system 102 according to the present invention, connecting the patch 30 comprises i) translating the sheath 120 of the sheath assembly 110 proximally relative to the guide assembly 112, thereby exposing the distal portion 108 of the device 100 and patch 30, and allowing the distal end 126 of the needle assemblies 114 and distal end 164 of the inner shafts 116 to separate circumferentially into a series of fixed, present angles varying from the central axis of the device 100, and thereby fully extending the patch 30, as shown in Figure 7; ii) unlocking a first locking assembly 118 associated with a first needle assembly 114; iii) translating the first needle assembly 114 distally relative to the guide assembly 112 until the needle 134 of the first needle assembly 114 pierces the patch 30 proximally to distally, and also pierces the tissue 600, thereby inserting the tissue anchor 24 of the connector 10 into the tissue 600, as particularly shown in Figure 33; iv) translating the first needle assembly 114 proximally relative to the guide assembly 112 until the needle 134 of the first needle assembly 114 retracts into the inner shaft 116 proximal to the loop 44 of the patch 30, as shown particularly in Figure 34; v) allowing the loop 44 to exit the aperture 168 of the inner shaft 116, as shown particularly in Figure 35; vi) repeating steps i) through v) with each additional needle assembly 114 that the device 100 comprises, until the patch 30 is separated from the device 100, thereby connecting the patch 30 to tissue 600 in vivo. In a preferred embodiment, once the tissue anchor 24 is inserted into the tissue 600, the tissue anchor 24 expands into an unstressed configuration thereby more firmly embedding the tissue anchor 24 in the tissue 600 and preventing migration of the tissue anchor 24 out of the tissue 600. In a preferred embodiment, the method further comprises removing the device from the patient. [0096] In one embodiment, there is provided a method for inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo. Inserting additional connectors into the patch and tissue can be accomplished by a variety of methods and using a variety of devices, as will be understood by those with skill in the art with reference to this disclosure. In one embodiment of the present method, inserting additional connectors into the patch and tissue comprises, first, providing a device 200 as shown in Figure 19 through Figure 23, in the introductory form. Then, the distal end of the outer segment is positioned adjacent the patch, and the distal end of the needle is inserted through the patch, thereby deploying a connector connecting the patch to the tissue, and converting the device to the deployment form. In a preferred embodiment, the device provided is a device 400 according to the present invention, and the method further comprises retracting the needle back into the outer segment, thereby reloading another connector, and inserting the needle into the patch again, thereby deploying another connector connecting the patch to the tissue. In a preferred embodiment, the device provided is a device 500 according to the present invention, and the method further comprises actuating the mechanism, thereby grasping the patch and tissue between the tissue grasper. [0097] According to another embodiment of the present invention, there is provided a method for inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo. The method comprises, first, providing a device 300 as shown in Figures 24 and 25, where the device is in the introductory form. Next, the distal end of the outer segment is positioned adjacent the patch. Then, the distal end of one needle is inserted through the patch, thereby deploying one connector connecting the patch to the tissue. Next, the needle is retracted back into the outer segment. Then, the insertion step and retraction step are repeated using another needle, thereby deploying another connector connecting the patch to the tissue.

[0098] Although the present invention has been discussed in considerable detail with reference to certain preferred embodiments, other embodiments are possible. Therefore, the scope of the appended claims should not be limited to the description of preferred embodiments contained in this disclosure. All references cited herein are incorporated by reference in their entirety.

Claims

WHAT IS CLAIMED IS:

1. A connector for connecting a patch to tissue in vivo, the connector comprising: a) a proximal segment; and b) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; and where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue.

2. The connector of claim 1, where the patch approximation piece is a tube or wire.

3. The connector of claim 1, where the coupler that connects the distal end of the filament to the tissue anchor is a first coupler; where the connector further comprises a second coupler; and where the second coupler connects the filament to the patch approximation piece.

4. The connector of claim 3, where the patch approximation piece is a tube; and where the second coupler is part of the tube that has been crimped around the proximal end of the filament.

5. A patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: a) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; b) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a flexible filament with a proximal end and a distal end; and where the distal segment comprises a tissue anchor for anchoring the connector to the tissue.

6. The patch of claim 5, comprising a single layer, where the single layer comprises both the first side and the second side.

7. The patch of claim 5, comprising two layers, a proximal layer and a distal layer; where the proximal layer comprises the first side; and where the distal layer comprises the second side.

8. The patch of claim 5, where the one or more than one layer comprises an autologous graft.

9. The patch of claim 7, where the proximal layer comprises expanded polytetrafluoroethylene (ePTFE), and the distal layer comprises polypropylene mesh.

10. The patch of claim 5, comprising between two and twenty connectors.

11. The patch of claim 5, comprising two, three, four, five, six, seven, eight, nine or ten connectors.

12. The patch of claim 5, further comprising a plurality of apertures near the circumference of the patch; where the filament of the proximal segment of each connector is attached to the patch around the circumference of the patch through one or more than one aperture near the circumference of the patch.

13. The patch of claim 5, further comprising a loop attached to the patch and extending proximally from the first side of the patch.

14. A device for connecting a patch to tissue in vivo, the device comprising: a) a proximal portion, a central portion connected distally to the proximal portion, and a distal portion connected distally to the central portion; b) a long central axis extending from the proximal portion to the distal portion; c) a sheath assembly; d) a guide assembly at least partly within the sheath assembly; e) a plurality of needle assemblies at least partly within the guide assembly; and f) an inner shaft and a locking assembly associated with each needle assembly; where each locking assembly is connected to an inner shaft; where each inner shaft is at least partly within the guide assembly; where each need assembly is at least partly within an inner shaft; and where each locking assembly comprises a mechanism for converting the device from a first state where the needle assembly can translate axially within the inner shaft, to a second state where the needle assembly cannot translate axially within the inner shaft.

15. The device of claim 14, where the sheath assembly comprises a sheath and a handle connected to the sheath proximally; and where the handle of the sheath assembly is configured to allow an operator to grasp the sheath assembly and to translate the sheath assembly along the long central axis of the device with respect to the guide assembly.

16. The device of claim 15, where the handle of the sheath assembly comprises a sealant configured to prevent gas leaks from an abdominal cavity during use of the device in a laparoscopic procedure involving the use of gas to inflate the abdomen.

17. The device of claim 14, where the plurality of needle assemblies is two, three, four, five, six, seven, eight, nine or ten needle assemblies.

18. The device of claim 14, where each needle assembly comprises a proximal end and a distal end and further comprises, from the proximal end to the distal end respectively, a stopper connected to a support tube connected to a pusher connected to a needle; and where the stopper of the needle assembly is configured to allow an operator to grasp the proximal end of the needle assembly.

19. The device of claim 14, where each needle assembly comprises a needle comprising a wall; and where the needle comprises an axially directed slot extending completely through the wall of the needle.

20. The device of claim 18, where the inner shaft is flattened on two opposing sides; where the pusher is flattened on two opposing sides to fit within the corresponding inner shaft.

21. The device of claim 18, where the stopper comprises a knob with indentations to assist an operator in gripping the stopper.

22. The device of claim 18, where the stopper further comprises a knob and a sleeve connected to the knob distally.

23. The device of claim 18, where each needle assembly comprises a needle comprising a wall; and where the needle assembly further comprises a needle plug within the wall of the needle.

24. The device of claim 14, where each inner shaft comprises a proximal end, a distal end and a central portion, and where each inner shaft comprises an aperture at the distal end.

25. The device of claim 14, where the guide assembly comprises an outer shaft comprising a plurality of channels comprising one channel for each needle assembly and associated inner shaft.

26. The device of claim 14, where the guide assembly comprises an outer shaft and a handle connected to the outer shaft.

27. The device of claim 14, further comprising a mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis.

28. The device of claim 27, where the guide assembly comprises an outer shaft; and where the mechanism comprises a deflecting cable attached distally to the outer shaft, and attached proximally to a rotatable knob through a slotted screw.

29. The device of claim 28, where the mechanism further comprises one or more than one aligning pin connected to the slotted screw.

30. A device for connecting a patch to tissue in vivo, the device comprising: a) a proximal portion, a central portion connected distally to the proximal portion, and a distal portion connected distally to the central portion; b) a long central axis extending from the proximal portion to the distal portion; c) a sheath assembly; d) a guide assembly at least partly within the sheath assembly; e) a plurality of needle assemblies at least partly within the guide assembly; and f) an inner shaft and a locking assembly associated with each needle assembly; where each locking assembly is connected to an inner shaft; where each inner shaft is at least partly within the guide assembly; where each needle assembly is at least partly within an inner shaft; where each locking assembly comprises a mechanism for converting the device from a first state where the needle assembly can translate axially within the inner shaft, to a second state where the needle assembly cannot translate axially within the inner shaft; where the sheath assembly comprises a sheath and a handle connected to the sheath proximally; where the handle of the sheath assembly is configured to allow an operator to grasp the sheath assembly and to translate the sheath assembly along the long central axis of the device with respect to the guide assembly; where each needle assembly comprises a proximal end and a distal end and further comprises, from the proximal end to the distal end respectively, a stopper connected to a support tube connected to a pusher connected to a needle; where the stopper of the needle assembly is configured to allow an operator to grasp the proximal end of the needle assembly; where each needle assembly comprises a needle comprising a wall, and the needle comprises an axially directed slot extending completely through the wall of the needle; and where each inner shaft comprises a proximal end, a distal end and a central portion, and where each inner shaft comprises an aperture at the distal end.

31. The device of claim 30, further comprising a mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis.

32. A patch delivery system for connecting a patch to tissue in vivo, the patch delivery system comprising: a) a device of claim 14; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises:

A) a proximal segment; and B) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; and where the patch delivery system can convert from an introductory form to a delivery form, and where the connector is seated at least partly within the needle assembly of the device when the device is in the introductory form.

33. A patch delivery system for connecting a patch to tissue in vivo, the patch delivery system comprising: a) a device of claim 18; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises:

A) a proximal segment; and

B) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; and where the patch delivery system can convert from an introductory form to a delivery form, and where the connector is seated at least partly within the needle assembly of the device when the device is in the introductory form.

34. A patch delivery system for connecting a patch to tissue in vivo, the patch delivery system comprising: a) a device of claim 24; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises:

A) a proximal segment; and

35. The patch delivery system of claim 34, the patch delivery system further comprises a loop attached to the patch and extending proximally from the first side of the patch, and the loop is partly within the aperture of each inner shaft, when the patch delivery system is in an introductory form.

36. A patch delivery system for connecting a patch to tissue in vivo, the patch delivery system comprising: a) a device of claim 30; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises: A) a proximal segment; and

37. A patch delivery system for connecting a patch to tissue in vivo, the patch delivery system comprising: a) a device of claim 31 ; and b) a patch for obliterating or sealing an aberrant space or cavity caused by a disease or condition, where the aberrant space or cavity causes real or potential morbidity, the patch comprising: i) one or more than one layer, and comprises a first side (a proximal side), an opposing second side (a distal side), and a circumference; ii) a plurality of connectors; where each of the plurality of connectors is attached to the layer or layers of the patch; where each of the plurality of connectors comprises:

A) a proximal segment; and

38. A device for connecting a patch to tissue in vivo, the device comprising: a) an inner segment; and b) an outer segment; where the inner segment is configured to fit within the outer segment; where the inner segment is axially slidable and axially removable from the outer segment; where the inner segment comprises a proximal end, a distal end and a central portion between the proximal end and the distal end; where the inner segment further comprises a knob at the proximal end of the inner segment to assist an operator in gripping the inner segment; where the inner segment further comprises a needle at the distal end of the inner segment; where the needle comprises a generally tube-like structure comprising a proximal end, a distal end and a wall defining an interior space; where the distal end of the needle is configured to pierce tissue in vivo; where the central portion of the inner segment is a rod or tube connecting the proximal end of the inner segment to the distal end of the inner segment; where the outer segment of the device is a generally tubular structure comprising a proximal end, a distal end and a central portion between the proximal end and the distal end; where the outer segment further comprises a wall, an inner circumference defining a central channel extending completely through the outer segment from the proximal end to the distal end, and an outer circumference; where the central canal of the outer segment has a long central axis; where the proximal end of the outer segment comprises a knob to restrict distal axial translation of the inner segment with respect to the outer segment; where the device can convert from an introductory form to a delivery form; where the device further comprises a connector for connecting a patch to tissue in vivo when the device is in the introductory form, the connector comprising: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue; where the tissue anchor of the distal segment of the connector is partly seated within the needle of the device, and the remainder of the connector is seated between the wall of the needle and the inner circumference of the wall of the outer segment.

39. The device of claim 38, where the inner segment has a long central axis between the proximal end of the inner segment and the distal end of the inner segment; where the central portion of the inner segment is angled from the long central axis near the distal end of the inner segment; and where the outer segment has a long central axis between the proximal end of the outer segment and the distal end of the outer segment, and the central portion of the outer segment is angled from the long central axis near the distal end of the outer segment.

40. The device of claim 38, where the distal end of the outer segment comprises a collar having a transverse diameter perpendicular to the long axis of the central canal.

41. The device of claim 38, where the wall of the needle has an outer circumference and a cross-sectional area, and the central channel of the outer segment has a cross-sectional area that is larger than the cross-sectional area of the wall of the needle by at least 10%.

42. The device of claim 38, where the outer segment further comprises a protrusion attached to the wall of the outer segment and extending into the central channel device; where the connector is a plurality of connectors; and where at least one of the plurality of connectors is positioned proximal to the protrusion, between the inner segment and the wall of the outer segment.

43. The device of claim 38, further comprising a tissue grasper attached to the distal end of the outer segment; and further comprises a mechanism for actuating the tissue grasper connected to the tissue grasper.

44. A device for connecting a patch to tissue in vivo, the device comprising: a) a proximal end, a distal end, and a central portion between the proximal end and the distal end; b) a plurality of inner segments; c) an outer segment; and d) an inner shaft and a locking assembly connected to the inner shaft, associated with each inner segment; where each inner segment is configured to fit within the outer segment; where each inner segment is axially slidable and axially removable from the outer segment; where each inner segment comprises a proximal end, a distal end and a central portion between the proximal end and the distal end; where each inner segment further comprises a knob at the proximal end of each inner segment to assist an operator in gripping each inner segment; where each inner segment further comprises a needle at the distal end of each inner segment; where the needle comprises a generally tube-like structure comprising a proximal end, a distal end and a wall defining an interior space; where the distal end of the needle is configured to pierce tissue in vivo; where the central portion of each inner segment is a rod or tube connecting the proximal end of each inner segment to the distal end of each inner segment; where the outer segment of the device is a generally tubular structure comprising a proximal end, a distal end and a central portion between the proximal end and the distal end; where the outer segment further comprises a wall, an inner circumference defining a central canal or a plurality of channels extending completely through the outer segment from the proximal end to the distal end, and an outer circumference; where the central canal of the outer segment has a long central axis; where the proximal end of the outer segment comprises a knob to restrict distal axial translation of each inner segment with respect to the outer segment; where the device can convert from an introductory form to a delivery form; where the device further comprises a plurality of connectors for connecting a patch to tissue in vivo when the device is in the introductory form, each connector comprising: i) a proximal segment; and ii) a distal segment joined to the proximal segment; where the proximal segment of the connector comprises a highly flexible filament with a proximal end and a distal end; where the distal segment comprises a tissue anchor for anchoring the connector to the tissue; where the distal end of the filament is connected to the tissue anchor by a coupler; where the proximal end of the proximal segment comprises a patch approximation piece joined to the filament for approximating the patch to the tissue as the connector connects the patch to the tissue; and where the tissue anchor of the distal segment of the connector is partly seated within the needle of the device, and the remainder of the connector is seated between the wall of the needle and the inner circumference of the wall of the outer segment.

45. The device of claim 44, where the plurality of connectors is two, three, four, five, six, seven, eight, nine or ten connectors.

46. The device of claim 44, where the plurality of connectors comprises between two and twenty.

47. The device of claim 44, where the central portion of the outer segment further comprises a handle to assist an operator in gripping the device.

48. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a patch delivery system of claim 32; and b) instructions for using the patch delivery system.

49. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a patch delivery system of claim 33; and b) instructions for using the patch delivery system.

50. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a patch delivery system of claim 34; and b) instructions for using the patch delivery system.

51. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a patch delivery system of claim 35; and b) instructions for using the patch delivery system.

52. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a patch delivery system of claim 36; and b) instructions for using the patch delivery system.

53. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a device of claim 37; and b) instructions for using the patch delivery system.

54. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a device of claim 38; and b) instructions for using the patch delivery system.

55. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a device of claim 42; and b) instructions for using the patch delivery system.

56. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a device of claim 43; and b) instructions for using the patch delivery system.

57. A kit for connecting a patch to tissue in vivo, the kit comprising: a) a device of claim 44; and b) instructions for using the patch delivery system.

58. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 32, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo.

59. The method of claim 58, where the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

60. The method of claim 58, where positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity.

61. The method of claim 58, further comprising inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

62. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 33, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo.

63. The method of claim 62, where the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

64. The method of claim 62, where positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity.

65. The method of claim 62, further comprising inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

66. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 34, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo.

67. The method of claim 66, where the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

68. The method of claim 66, where positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity.

69. The method of claim 66, where connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; and vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo.

70. The method of claim 66, further comprising inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

71. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 36, where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo.

72. The method of claim 71, where the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

73. The method of claim 71 , where positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity.

74. The method of claim 71, further comprising inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

75 The method of claim 71, where connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo.

76. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) selecting a patient having a disease or condition, where treatment of the disease or condition comprises connecting a patch to tissue in vivo; b) providing a patch delivery system of claim 37 where the patch delivery system is in the introductory form; c) positioning the distal portion of the device of the patch delivery system, and the patch of the patch delivery system adjacent to the aberrant space or cavity caused by the disease or condition; and d) connecting the patch to the tissue in vivo.

77 The method of claim 76, where the disease or condition is selected from the group consisting of an inguinal hernia, a ventral hernia, a post-surgical body wall defect and a post-traumatic body wall defect.

78. The method of claim 76, where positioning the distal portion of the device of the patch delivery system and the patch of the patch delivery system comprises: i) making an opening into the abdominal cavity of the patient; ii) placing the distal portion of the device of the patch delivery system and the patch of the patch delivery system into the abdominal cavity; and iii) advancing the distal portion of the device of the patch delivery system and the patch of the patch delivery system under laparoscopic guidance until the distal portion of the device of the patch delivery system and the patch of the patch delivery system are adjacent to the aberrant space or cavity.

79. The method of claim 76, further comprising inserting additional connectors into the patch and tissue to more firmly connect the patch to the tissue in vivo.

80. The method of claim 76, where positioning the distal portion of the device further comprises actuating the mechanism for reversibly and adjustably deflecting the distal portion of the device away from the central axis.

81. The method of claim 76, where connecting the patch comprises: i) translating the sheath of the sheath assembly proximally relative to the guide assembly, thereby exposing the distal portion of the device and patch, and allowing the distal end of the needle assemblies and distal end of the inner shafts to separate circumferentially into a series of fixed, present angles varying from the central axis of the device, and thereby fully extending the patch; ii) unlocking a first locking assembly associated with a first needle assembly; iii) translating the first needle assembly distally relative to the guide assembly until the needle of the first needle assembly pierces the patch proximally to distally, and also pierces the tissue, thereby inserting the tissue anchor of the connector into the tissue; iv) translating the first needle assembly proximally relative to the guide assembly until the needle of the first needle assembly retracts into the inner shaft proximal to the loop of the patch; v) allowing the loop to exit the aperture of the inner shaft; and vi) repeating steps i) through v) with each additional needle assembly that the device comprises, until the patch is separated from the device, thereby connecting the patch to tissue in vivo.

82. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) providing a device of claim 38 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; and c) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue.

83. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) providing a device of claim 42 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue; d) retracting the needle back into the outer segment; and e) repeating step c), thereby deploying another connector connecting the patch to the tissue.

84. The method of claim 83, further comprising repeating step d) and step e) one or more than one time.

85. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) providing a device of claim 43 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) actuating the mechanism, thereby grasping the patch and tissue between the tissue grasper; d) inserting the distal end of the needle through the patch, thereby deploying a connector connecting the patch to the tissue; and e) retracting the needle back into the outer segment.

86. A method for connecting a patch to tissue in vivo in a patient, where the tissue to which the patch is connected is adjacent to an aberrant space or cavity caused by the disease or condition, and the cavity causes real or potential morbidity, the method comprising: a) providing a device of claim 44 where the device is in the introductory form; b) positioning the distal end of the outer segment adjacent the patch; c) inserting the distal end of one needle through the patch, thereby deploying one connector connecting the patch to the tissue; d) retracting the needle back into the outer segment; and e) repeating steps c) and d) using another needle, thereby deploying another connector connecting the patch to the tissue.