WO2005112786A2

WO2005112786A2 - T-type suture anchoring devices and methods of using same

Info

Publication number: WO2005112786A2
Application number: PCT/US2005/016618
Authority: WO
Inventors: Rudolph H. Nobis; Christopher Paul Swain; Frank Jankoski; Omar J. Vakharia; John A. Faux; Gregory J. Bakos; Duane A. Linenkugel
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2004-05-14
Filing date: 2005-05-12
Publication date: 2005-12-01
Also published as: US7785348B2; US20060025819A1; WO2005112785A2; US20050277957A1; WO2005112786A3; US8388653B2; WO2005112785A3; WO2005112784A3; US20060004410A1; WO2005112784A2

Abstract

Suture anchoring devices are disclosed, including a T-tag anchoring device (100) that is suitably small enough to fit into the hollow tip of a needle (152) and, furthermore, provide protection to a suture (150) against being cut or otherwise damaged by (he sharp edge of the needle tip (154). One disclosed device (100) includes a slot (112) for providing a pivot point between the suture (150) and the device body (110) when deployed, which can be employed to form a T-tag (100).

Description

U.S. NONPROVISIONAL PATENT APPLICATION

T-tvpe Suture Anchoring Devices and Methods of Using Same

Inventors: Rudolph H. Nobis Frank Jankoski Omar J. Vakharia John Faux Gregory J. Bakos Duane Linenkugel Christopher Paul Swain

Attorney Docket No. END5337WO

Express Mail Label No. ED 128 158 001 US T-type Suture Anchoring Devices and Methods of Using Same

[0001] Cross-References to Related Applications

[0002] This application claims priority to and incorporates by reference the following applications: US Provisional Application 60/571,117 filed May 14, 2004; US provisional Application 60/571,119 filed May 14, 2004; and US Provisional Application 60/571,000 filed May 14, 2004.

[0003] Field of the Invention

[0004] This invention relates to an endoscopic suturing device. More particularly, this invention relates to devices that can be sized to fit into the tip of a standard endoscopic ultrasound (EUS) needle.

[0005] Background

[0006] Application of sutures in the gastrointestinal tract is required for several different types of medical procedures, for example, for transoral endoscopic valvuloplasty for gastroesophageal reflux disease (GERD), gastroplasty, fundoplication, anterior gastropexy, posterior gastropexy, suturing esophageal perforations, or closure of the esophageal side of the tracheo-esophageal fistula. Traditionally, these procedures are performed by physicians, such as gastroenterologists or surgeons, either by laparoscopy or open surgical techniques. Such procedures are invasive, as laparoscopy requires that small access incision(s) be made in the body of the patient, through which a laparoscope and other surgical enabling tools are provided, while open surgical techniques are traditionally invasive and can have complications and cause long patient recovery periods.

END5337USNP [0007] The solution to these problems is to perform these medical procedures through the gastroesophageal tract via the mouth or other naturally occurring orifice. Already available flexible endoscopes, commonly called gastroscopes, can be provided through the gastroesophageal tract and enable illumination and visualization of tissue along the gastroesophageal tract on a video display for diagnostic purposes. These flexible endoscopes also provide an instrumentation means for applying sutures in tissue, such as in the wall of the stomach. What is needed are improved methods of providing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoid more-invasive laparoscopic procedures.

[0008] New endoscopic suturing methods performed through the gastroesophageal tract as an alternative to the invasive laparoscopic method of, for example, a posterior gastropexy procedure, are currently being developed. For example, suturing methods under the control of endoscopic ultrasound (EUS) are being evaluated. EUS is a procedure that combines endoscopy and ultrasound. In particular, a March 14, 2003 publication authored by Fritscher-Ravens, Mosse, Mukherjee, Yazaki, Park, Mills, and Swain, entitled, "Transgastric gastropexy and hiatal hernia repair for GERD under EUS control: a porcine model," (American Society for Gastrointestinal Endoscopy) describes how endoluminal operations for gastroesophageal reflux are currently limited by the inability of the surgeon to visualize and manipulate structures outside the wall of the gut. The publication describes a way to define the EUS anatomy of structures outside the gut that influence reflux, to place stitches in the median arcuate ligament (MAL), to perform posterior gastropexy, and to test the feasibility of crural repair, under EUS control, in pigs. More specifically, by using a linear-array EUS, the MAL and part of the right eras were identified and punctured with a needle, which served as a carrier for a tag and suture. These were anchored into the muscle. An endoscopic sewing device was used, which allowed stitches to be placed through a 2.8-mm accessory channel to any predetermined depth.

END5337USNP [0009] The publication also describes new methods of knot tying and suture cutting through the 2.8-mm channel of the EUS. More specifically, stitches were placed through the gastric wall into the MAL, and one stitch was placed just beyond the wall of the lower esophageal sphincter. The stitches were tied together and locked against the gastric wall, and the surplus length of suture material was then cut and removed. While this publication describes a suitable transgastric gastropexy and hiatal hernia repair procedure, further improvements in methodology and equipment to perform such procedures would be beneficial. For example, the publication describes a process for placing stitches in the MAL, which involves placing a suture anchor device, e.g., a T-tag, into the MAL by using an EUS needle. However, the EUS needle, which serves as the carrier for the tag and suture, requires modification, in order to prevent the suture from being cut on the needle's sharp edge. More specifically, the EUS needle was modified by the addition of a slot in which the suture lies and by which clearance is provided to prevent the suture from being cut on the needle's sharp edge. This needle modification process adds complexity and cost to the medical procedure. What is needed are suture tag devices that may be deployed by the use of an unmodified, commercially available EUS needle. Additionally, what is needed is way to deploy a suture tag device by the use of an unmodified commercially available EUS needle while protecting the suture from being cut by the needle's sharp edge.

[00010] Summary of the Invention

[00011] Applicants recognize that it would be beneficial to provide suturing devices, such as suture tag devices, that are suitably small enough to fit into and be deployed by an unmodified, commercially available EUS needle.

[00012] Applicants recognize that it would be beneficial to provide suture devices, such as suture tag devices, that provide protection against the suture's being cut or otherwise damaged by the sharp edges when it inserted into a commercially available EUS needle.

END5337USNP [00013] Certain embodiments of the present invention are directed to providing improved devices for anchoring sutures into body tissue when medical procedures, such as a posterior gastropexy procedure, are performed, and thereby allowing commercially available hypodermic needles to be used without modification as carriers for a tag and suture. Certain embodiments of the present invention provide a T-tag anchoring device that is suitably small enough to fit into the hollow tip of a standard needle and, furthermore, provide protection against the suture's being cut by the sharp edges of the needle tip.

[00014] Certain embodiments of the invention provide a cylindrical hollow body that is suitably small enough to fit into a standard needle and into which a suture is attached. Furthermore, the body includes a slot for providing a pivot point between the suture and the body, when deployed, which thereby forms a T- tag. Certain embodiments provide features built into the body for protecting the suture from the sharp edges of the needle. Alternatively, certain other embodiments provide protective sleeves around the suture that, likewise, provide protection against cutting.

[00015] In another embodiment of the invention, rather than inserting the body inside the hollow needle, a cylindrical hollow body is provided that is sized to fit over the outside diameter of a standard needle that has the suture attached therein. Furthermore, the body includes a hole for providing a pivot point between the suture and the body when deployed, thereby forming a T-tag. In this embodiment, the suture is not in physical contact with the sharp edges of the needle and, thus, there is no danger that the suture will be cut.

[00016] Brief Description of the Drawings

[00017] While the novel features of the invention are set forth with particularity in the appended claims, the invention, in all its embodiments, may be more fully understood with reference to the following description and accompanying drawings.

END5337USNP [00018] Figure 1 A illustrates a side view of a suture T-tag device in accordance with a first embodiment of the invention;

[00019] Figure IB illustrates a bottom view of the suture T-tag device of the first embodiment of the invention;

[00020] Figure IC illustrates a perspective view of the suture T-tag device of the first embodiment of the invention being deployed with a standard needle;

[00021] Figure ID illustrates a side view of the suture T-tag device of the first embodiment of the invention in use after being deployed;

[00022] Figure 2A illustrates a side view of a suture T-tag device in accordance with a second embodiment of the invention;

[00023] Figure 2B illustrates a top view of the suture T-tag device of the second embodiment of the invention;

[00024] Figure 2C illustrates a perspective view of the suture T-tag device of the second embodiment of the invention being deployed with a standard needle;

[00025] Figure 2D illustrates a side view of the suture T-tag device of the second embodiment of the invention in use after being deployed;

[00026] Figure 3A illustrates a side view of a suture T-tag device in accordance with a third embodiment of the invention;

[00027] Figure 3B illustrates a bottom view of the suture T-tag device of the third embodiment of the invention;

[00028] Figure 3C illustrates a perspective view of the suture T-tag device of the third embodiment of the invention being deployed with a standard needle;

END5337USNP [00029] Figure 3D illustrates a side view of the suture T-tag device of the third embodiment of the invention in use after being deployed;

[00030] Figure 4A illustrates a side view of a suture T-tag device in accordance with a fourth embodiment of the invention;

[00031] Figure 4B illustrates a bottom view of the suture T-tag device of the fourth embodiment of the invention;

[00032] Figure 4C illustrates a perspective view of the suture T-tag device of the fourth embodiment of the invention being deployed with a standard needle;

[00033] Figure 4D illustrates a side view of the suture T-tag device of the fourth embodiment of the invention in use after being deployed;

[00034] Figure 5A illustrates a perspective view of a suture T-tag device in accordance with a fifth embodiment of the invention;

[00035] Figure 5B illustrates a side view of the suture T-tag device of the fifth embodiment of the invention in combination with a standard needle;

[00036] Figure 5C illustrates a perspective view of the suture T-tag device of the fifth embodiment of the invention being deployed with a standard needle;

[00037] Figure 5D illustrates a side view of the suture T-tag device of the fifth embodiment of the invention in use after being deployed;

[00038] Figure 6A illustrates a side view of a suture T-tag device in accordance with a sixth embodiment of the invention;

[00039] Figure 6B illustrates a bottom view of the suture T-tag device of the sixth embodiment of the invention;

END5337USNP [00040] Figure 6C illustrates a perspective view of the suture T-tag device of the sixth embodiment of the invention being deployed with a standard needle;

[00041] Figure 6D illustrates a side view of the suture T-tag device of the sixth embodiment of the invention in use after being deployed; and

[00042] Figure 7 illustrates a flow diagram of an example method of using the T-tag devices in accordance with embodiments one through six of the present invention.

[00043] Detailed Description of the Invention

[00044] Figures 1 A and IB illustrate a side and bottom view, respectively, of a T-tag device 100 in accordance with a first embodiment of the invention. T-tag device 100 includes a cylindrical tag body 110. The outside diameter of tag body 110 is small enough to fit within the hollow tip of a standard EUS needle, which typically has an inside diameter of about 0.034 inches. The inside diameter of tag body 110 is sized to accommodate a length of suture material, which has an outside diameter that typically ranges from 0.004 to 0.010 inches. T-tag device 100 further includes a slot 112 within the wall of tag body 110. Slot 112 runs from one end of tag body 110 to approximately midway of tag body 110 and is suitably wide enough to accommodate a suture passing therethrough. Furthermore, arranged at the end of tag body 110, which has slot 112, is a profiled tab 114. T-tag device 100 is formed of, for example, molded plastic or stainless steel.

[00045] Figure IC illustrates a perspective view of T-tag device 100 of the first embodiment of the invention being deployed with a standard needle, such as an EUS needle manufactured by Wilson-Cook (Winston-Salem, NC). More specifically, Figure IC shows T-tag device 100 with a length of standard suture material, i.e., a suture 150, installed therein and inserted into the hollow tip of a standard needle 152. A sharp tip 154 of needle 152 is angled and, thus,

END5337USNP its opening has an elliptical shape with sharp edges, i.e., an inner edge 156 and an outer edge 158. Additionally, a protective sleeve 160 surrounds the hollow shaft of needle 152. Needle 152 is axially slidable within protective sleeve 160.

[00046] The angle of profiled tab 114 matches the angle of tip 154, and the shape of profiled tab 114 matches the elliptical shape of inner edge 156 of tip 154. Critical to the operation of T-tag device 100, the overall outside dimension of profiled tab 114, in combination with tag body 110, cannot be less than the inside diameter of needle 152 and cannot be greater than the outside diameter of needle 152. Profiled tab 114 also orients T-tag device 100 and prevents it from rotating inside needle 152. See Table 1 for example dimensions of T-tag device 100.

Table 1 Example dimensions of T-tag device 100

[00047] The operation of T-tag device 100 is described in reference to Figures 1A, IB, IC, and Figure ID, which illustrates a side view of T-tag device 100 of the first embodiment of the invention in use after being deployed. An end of suture 150 is inserted through slot 112 and secured into the end of tag body 110 opposite slot 112. Methods of securing suture 150 within tag body 110 include swaging, crimping, knotting, or gluing. With suture 150 lying axially within slot 112, the end of tag body 110 opposite profiled tab 114 is inserted into hollow tip 154 of needle 152, until such point that profiled tab 114 abuts inner edge 156 of the opening of needle 152 and a length of suture 150

END5337USNP remains outside needle 152. With T-tag device 100 loaded within needle 152, the user pushes needle 152 through a first tissue 162 and then through a second tissue 164. After needle 152 passes through second tissue 164, the user pushes a stylet (not shown), i.e., a pushrod, that is part of the needle assembly against the proximal end of T-tag device 100, which forces T-tag device 100 to exit needle 152. The user then withdraws needle 152 from first tissue 162 and second tissue 164 and, subsequently, applies fraction upon suture 150. The pulling action upon suture 150 causes tag body 110 to pivot upon suture 150 at the inner edge of slot 112, as suture 150 forms a 90-degree angle (or nearly so) with slot 112 and, thus, tag body 110 aligns itself against second tissue 164, as shown in Figure ID. The user then locks and cuts the opposite end of suture 150 (locking and cutting mechanisms not shown).

[00048] Figures 2A and 2B illusfrate a side and top view, respectively, of a T-tag device 200 in accordance with a second embodiment of the invention. T-tag device 200 includes a cylindrical tag body 210. The outside diameter of tag body 210 is small enough to fit within the hollow tip of a standard EUS needle, which typically has an inside diameter of about 0.034 inches. The inside diameter of tag body 210 is sized to accommodate a length of suture material, which is typically about 0.009 inches in thickness. T-tag device 200 further includes a slot 212 within the wall of tag body 210. Slot 212 runs from one end of tag body 210 to approximately midway of tag body 210 and is suitably wide enough to accommodate suture 150 passing therethrough. Furthermore, arranged at the end of tag body 210, which has slot 212, is a raised profile 214. T-tag device 200 is formed of, for example, molded plastic or coined stainless steel.

[00049] Figure 2C illustrates a perspective view of T-tag device 200 of the second embodiment of the invention being deployed with a standard needle, such as a Wilson-Cook EUS needle. More specifically, Figure 2C shows T-tag device 200 with suture 150 installed therein and inserted into the hollow tip of standard needle 152, which is slidable within protective sleeve 160. The sharp tip 154 of needle 152 is angled and, thus, its opening has an elliptical shape

END5337USNP with sharp edges, i.e., inner edge 156 and outer edge 158, as described in reference to Figure IC.

[00050] The angle of raised profile 214 matches the angle of tip 154, and the shape of raised profile 214 matches the elliptical shape of inner edge 156 of tip 154. Critical to the operation of T-tag device 200, the overall outside dimension of raised profile 214, in combination with tag body 210, cannot be less than the inside diameter of needle 152 and cannot be greater than the outside diameter of needle 152. Raised profile 214 also orients T-tag device 200 and prevents it from rotating inside needle 152. See Table 2 for example dimensions of T-tag device 200.

Table 2 Example dimensions of T-tag device 200

[00051] The operation of T-tag device 200 is described in reference to Figures 2A, 2B, 2C, and Figure 2D, which illustrates a side view of T-tag device 200 of the second embodiment of the invention in use after being deployed. An end of suture 150 is inserted through slot 212 and secured into the end of tag body 210 opposite slot 212. Methods of securing suture 150 within tag body 210 include swaging, crimping, knotting, or gluing. With suture 150 lying axially within slot 212, the end of tag body 210 opposite raised profile 214 is inserted into hollow tip 154 of needle 152, until such point that raised profile 214 abuts inner edge 156 of the opening of needle 152 and a length of suture 150

END5337USNP remains outside needle 152. With T-tag device 200 loaded within needle 152, the user pushes needle 152 through first tissue 162 and then through second tissue 164. After needle 152 passes through second tissue 164, the user pushes a stylet (not shown) against the proximal end of T-tag device 200, which forces T-tag device 200 to exit needle 152. The user then withdraws needle 152 from first tissue 162 and second tissue 164 and, subsequently, applies traction upon suture 150. The pulling action upon suture 150 causes tag body 210 to pivot upon suture 150 at the inner edge of slot 212, as suture 150 forms a 90-degree angle (or nearly so) with slot 212 and, thus, tag body 210 aligns itself against second tissue 164, as shown in Figure 2D. The user then locks and cuts the opposite end of suture 150 (locking and cutting mechanisms not shown).

[00052] Figures 3A and 3B illustrate a side and bottom view, respectively, of a T-tag device 300 in accordance with a third embodiment of the invention. T-tag device 300 includes a cylindrical tag body 310. The outside diameter of tag body 310 is small enough to fit within the hollow tip of a standard EUS needle, which typically has an inside diameter of about 0.034 inches. The inside diameter of tag body 310 is sized to accommodate a flexible sleeve 314 (see Figure 3C), which has suture 150 fitted therein. The outside diameter of flexible sleeve 314 typically ranges from 0.010 to 0.020 inches. T-tag device 300 further includes a slot 312 within the wall of tag body 310. Slot 312 runs from one end of tag body 310 to approximately midway of tag body 310 and is suitably wide enough to accommodate flexible sleeve 314 passing therethrough. T-tag device 300 is formed of, for example, molded plastic or coined stainless steel. Flexible sleeve 314 is formed of extruded or cast polymer material, such as Polyimide. Alternatively, flexible sleeve 314 is formed of flexible woven stainless steel.

[00053] Figure 3C illustrates a perspective view of T-tag device 300 of the third embodiment of the invention being deployed with a standard needle, such as a Wilson-Cook EUS needle. More specifically, Figure 3C shows T-tag device 300 with flexible sleeve 314, within which suture 150 is fitted, installed

END5337USNP therein and inserted into the hollow tip of standard needle 152 that is slidable within protective sleeve 160. The sharp tip 154 of needle 152 is angled and, thus, its opening has an elliptical shape with sharp edges, i.e., inner edge 156 and outer edge 158, as described in reference to Figure IC. Flexible sleeve 314 provides a protective barrier between suture 150 and the sharp inner edge 156 of needle 152. See Table 3 for example dimensions of T-tag device 300.

Table 3 Example dimensions of T-tag device 300

[00054] The operation of T-tag device 300 is described in reference to Figures 3 A, 3B, 3C, and Figure 3D, which illustrates a side view of T-tag device 300 of the third embodiment of the invention in use after being deployed. An end of flexible sleeve 314 with suture 150 fitted therein is inserted through slot 312 and secured into the end of tag body 310 opposite slot 312. Methods of securing flexible sleeve 314 within tag body 310 include swaging, crimping, knotting, or gluing. With flexible sleeve 314 lying axially within slot 312, the end of tag body 310 opposite slot 312 is inserted into hollow tip 154 of needle 152, and a length of flexible sleeve 314 with suture 150 fitted therein remains outside needle 152, as shown in Figure 3C. T-tag device 300 is allowed to pass entirely into needle 152, while flexible sleeve 314 forms a protective barrier between suture 150 and the sharp inner edge 156 of needle 152. With T-tag device 300 loaded within needle 152, the user pushes needle 152 through first tissue 162 and then through second tissue 164. After needle 152

END5337USNP passes through second tissue 164, the user pushes a stylet (not shown) against the proximal end of T-tag device 300, which forces T-tag device 300 to exit needle 152. The user then withdraws needle 152 from first tissue 162 and second tissue 164 and, subsequently, applies fraction upon suture 150. The pulling action upon suture 150 causes tag body 310 to pivot upon flexible sleeve 314 at the inner edge of slot 312, as flexible sleeve 314 forms a 90- degree angle (or nearly so) with slot 312 and, thus, tag body 310 aligns itself against second tissue 164, as shown in Figure 3D. The user then locks and cuts the opposite end of flexible sleeve 314 with suture 150 fitted therein (locking and cutting mechanisms not shown).

[00055] Figures 4A and 4B illustrate a side and bottom view, respectively, of a T-tag device 400 in accordance with a fourth embodiment of the invention. T-tag device 400 includes a cylindrical tag body 410. The outside diameter of tag body 410 is small enough to fit within the hollow tip of a standard EUS needle, which typically has an inside diameter of about 0.034 inches. The inside diameter of tag body 410 is sized to accommodate a preformed sleeve 414 (see Figure 4C) that has suture 150 fitted therein. The outside diameter of preformed sleeve 414 typically ranges from 0.010 to 0.020 inches. T-tag device 400 further includes a slot 412 within the wall of tag body 410. Slot 412 runs from one end of tag body 410 to approximately midway of tag body 410 and is suitably wide enough to accommodate preformed sleeve 414 passing therethrough. T-tag device 400 is formed of, for example, molded plastic or stainless steel. Preformed sleeve 414 is formed of molded polymer material, such as a molded Polyimide tube. Preformed sleeve 414 is preformed at approximately a 90-degree angle at the region where preformed sleeve 414 emerges from slot 412 when deployed (described in detail in Figure 4D).

[00056] Figure 4C illustrates a perspective view of T-tag device 400 of the fourth embodiment of the invention being deployed with a standard needle, such as a Wilson-Cook EUS needle. More specifically, Figure 4C shows T-tag device 400 with preformed sleeve 414, within which suture 150 fitted, installed therein and inserted into the hollow tip of standard needle 152, which is

END5337USNP slidable within protective sleeve 160. The sharp tip 154 of needle 152 is angled and, thus, its opening has an elliptical shape with sharp edges, i.e., inner edge 156 and outer edge 158, as described in reference to Figure IC. Preformed sleeve 414 provides a protective barrier between suture 150 and the sharp inner edge 156 of needle 152. Also shown in Figure 4C, optionally, are a plurality of locking features 416 that are arranged along the proximal end of preformed sleeve 414. See Table 4 for example dimensions of T-tag device 400.

Table 4 Example dimensions of T-tag device 400

[00057] The operation of T-tag device 400 is described in reference to Figures 4A, 4B, 4C, and Figure 4D, which illustrates a side view of T-tag device 400 of the fourth embodiment of the invention in use after being deployed. An end of preformed sleeve 414 with suture 150 fitted therein is inserted through slot 412 and secured into the end of tag body 410 opposite slot 412. Methods of securing preformed sleeve 414 within tag body 410 include swaging, crimping, knotting, or gluing. With the preformed region of preformed sleeve 414 temporarily flattened, it lies axially within slot 412; the end of tag body 410 opposite slot 412 is inserted into hollow tip 154 of needle 152, and a length of preformed sleeve 414 with suture 150 fitted therein remains outside needle 152, as shown in Figure 4C. T-tag device 400 is allowed to pass

END5337USNP entirely into needle 152, while preformed sleeve 414 forms a protective barrier between suture 150 and the sharp inner edge 156 of needle 152. With T-tag device 400 loaded within needle 152, the user pushes needle 152 through first tissue 162 and then through second tissue 164. After needle 152 passes through second tissue 164, the user pushes a stylet (not shown) against the proximal end of T-tag device 400, which forces T-tag device 400 to exit needle 152. The user then withdraws needle 152 from first tissue 162 and second tissue 164 and, subsequently, applies fraction upon suture 150. The pulling action upon suture 150, in combination with the preformed region of preformed sleeve 414's naturally seeking to restore its shape to 90 degrees, causes tag body 410 to pivot upon preformed sleeve 414 at the inner edge of slot 412, as preformed sleeve 414 forms a 90-degree angle (or nearly so) with slot 412 and, thus, tag body 410 aligns itself against second tissue 164, as shown in Figure 4D. By using locking features 416 with an associated locking device, the user then locks and cuts the opposite end of preformed sleeve 414 with suture 150 fitted therein (locking and cutting mechanisms not shown).

[00058] Figure 5A illustrates a perspective view of a T-tag device 500 in accordance with a fifth embodiment of the invention. T-tag device 500 includes a cylindrical tag body 510. T-tag device 500 further includes two or more holes 512 spaced apart within the wall of tag body 510. The diameter of holes 512 is suitably large enough to accommodate suture 150 passing therethrough. T-tag device 500 is formed of, for example, molded plastic or stainless steel.

[00059] Figure 5B illustrates a side view of T-tag device 500 in accordance with a fifth embodiment of the invention in combination with a standard needle, such as a Wilson-Cook EUS needle. More specifically, Figure 5B shows T-tag device 500 with suture 150 installed therein and disposed around the distal end of needle 152, which is slidable within protective sleeve 160. Suture 150 is secured to tag body 510 by the user's having threaded suture 150 in and out of holes 512 in an alternating fashion and then having knotted or glued suture 150 at one or more holes 512. Consequently, in order to provide a light press fit, the inside diameter of tag body 510 is slightly smaller than the total

END5337USNP dimension of the outside diameter of needle 152 plus two times the thickness of suture 150. The outside diameter of tag body 510 is preferably equal to or less than the outside diameter of protective sleeve 160. Optionally, the edges of tag body 510 are tapered, in order to assist passage through body tissue. See Table 5 for example dimensions of T-tag device 500.

Table 5 Example dimensions of T-tag device 500

[00060] Figure 5C illustrates a perspective view of T-tag device 500 of the fifth embodiment of the invention being deployed with a needle 152 and a length of suture 150 emerging from one of holes 512.

[00061] The operation of T-tag device 500 is described in reference to Figures 5A, 5B, 5C, and Figure 5D, which illustrates a side view of T-tag device 500 of the fifth embodiment of the invention in use after being deployed. An end of suture 150 is threaded in and out of holes 512 in an alternating fashion and then knotted or glued at one or more holes 512 of tag body 510. With suture 150 threaded therethrough, tip 154 of needle 152 is inserted into one end of tag body 510, and a length of suture 150 remains outside needle 152, as shown in Figure 5C. Because suture 150 within T-tag device 500 is not in physical contact with the sharp inner edge 156 of needle 152, there is no danger of it's being cut. With T-tag device 500 loaded upon needle 152, the user pushes needle 152 and a portion of protective sleeve 160 through first tissue 162 and then through second tissue 164. After needle 152 passes through second tissue 164, the user refracts needle 152 within protective sleeve 160, which forces the end of protective sleeve 160 against tag body 510 and off needle 152. The user then withdraws protective sleeve 160 with needle 152 retracted therein from

END5337USNP first tissue 162 and second tissue 164 and, subsequently, applies traction upon suture 150. The pulling action upon suture 150 causes tag body 510 to pivot upon suture 150 at one of holes 512 and form a 90-degree angle (or nearly so); thus, tag body 510 aligns itself against second tissue 164, as shown in Figure 5D. The user then locks and cuts the opposite end of suture 150 (locking and cutting mechanisms not shown).

[00062] Figures 6A and 6B illustrate a side and bottom view, respectively, of a T-tag device 600 in accordance with a sixth embodiment of the invention. T-tag device 600 includes a cylindrical tag body 610. The outside diameter of tag body 610 is small enough to fit within the hollow tip of a standard EUS needle, which typically has an inside diameter of about 0.015 inches. The inside diameter of tag body 610 is sized to accommodate a metal suture 614 (see Figure 6C), which is formed of a nontoxic metal, such as stainless steel or a nickel-titanium alloy, commercially known as Nitinol, a shape memory alloy, which has an outside diameter that typically ranges from 0.004 to 0.010 inches. T-tag device 600 further includes a slot 612 within the wall of tag body 610. Slot 612 runs from one end of tag body 610 to approximately midway of tag body 610 and is suitably wide enough to accommodate metal suture 614 passing therethrough. T-tag device 600 is formed of, for example, molded plastic or stainless steel.

[00063] Figure 6C illustrates a perspective view of T-tag device 600 of the sixth embodiment of the invention being deployed with a standard needle, such as a Wilson-Cook EUS needle. More specifically, Figure 6C shows T-tag device 600 with metal suture 614 installed therein and inserted into the hollow tip of standard needle 152, which is slidable within protective sleeve 160. The sharp tip 154 of needle 152 is angled and, thus, its opening has an elliptical shape with sharp edges, i.e., inner edge 156 and outer edge 158, as described in reference to Figure IC. Metal suture 614 is a material, suitably hard enough so that it is not cut against the sharp inner edge 156 of needle 152. In the case of metal suture 614's being formed of Nitinol, metal suture 614 has "memory" properties and high elasticity properties that allow it to be preformed at

END5337USNP approximately a 90-degree angle at the region where metal suture 614 emerges from slot 612 when deployed (described in detail in Figure 6D). See Table 6 for example dimensions of T-tag device 600.

Table 6 Example dimensions of T-tag device 600

[00064] Furthermore, Figure 6C shows a coupling/splice 616, which provides an interface for joining a length of metal suture 614 to another suture material, such as the typical polymer material of suture 150. Due to the difficulty in cutting metal suture 614, coupling/splice 616 provides a region that allows the physician to either release the polymer suture 150 (i.e., a coupling feature) or cut the polymer suture 150 (i.e., a splice feature).

[00065] The operation of T-tag device 600 is described in reference to Figures 6A, 6B, 6C, and Figure 6D, which illustrates a side view of T-tag device 600 of the sixth embodiment of the invention in use after being deployed. An end of metal suture 614 is inserted through slot 612 and secured into the end of tag body 610 opposite slot 612. Methods of securing metal suture 614 within tag body 610 include swaging, crimping, knotting, or gluing. With metal suture 614 lying axially within slot 612, the end of tag body 610 opposite slot 612 is inserted into hollow tip 154 of needle 152, and a length of metal suture 614 remains outside needle 152, as shown in Figure 6C. T-tag device 600 is allowed to pass entirely into needle 152 and, because of its hard material properties, metal suture 614 is unable to be cut by the sharp inner edge 156 of

END5337USNP needle 152. With T-tag device 600 loaded within needle 152, the user pushes needle 152 through first tissue 162 and then through second tissue 164. After needle 152 passes through second tissue 164, the user pushes a stylet (not shown) against the proximal end of T-tag device 600, which forces T-tag device 600 to exit needle 152. The user then withdraws needle 152 from first tissue 162 and second tissue 164 and, subsequently, applies fraction upon metal suture 614. The pulling action upon metal suture 614 in combination, optionally, with the preformed region of metal suture 614 's naturally seeking to restore its shape to 90 degrees, causes tag body 610 to pivot upon metal suture 614 at the inner edge of slot 612, as metal suture 614 forms a 90-degree angle (or nearly so) with slot 612 and, thus, tag body 610 aligns itself against second tissue 164, as shown in Figure 6D. The user then locks metal suture 614 (locking mechanism not shown) and either releases the polymer suture 150 (i.e., a coupling feature) or cuts the polymer suture 150 (i.e., a splice feature) at coupling/splice 616.

[00066] Figure 7 illustrates a flow diagram of an example method 700 of using the T- tag devices in accordance with embodiments one through six of the present invention. More specifically, method 700 provides an example of a posterior gastropexy procedure that uses the T-tag devices of the present invention. The use of the T-tag devices of the present invention is not limited to a posterior gastropexy procedure; the T-tag devices of the present invention may be used in any of various, similar medical procedures.

[00067] At step 710, a physician passes an EUS endoscope through a patient's mouth and esophagus and into the stomach. Example EUS endoscopes include endoscope model GF-UC160P-AT8, manufactured by Olympus Europe (Hamburg, Germany) and endoscope model EG-3630U, manufactured by Pentax Medical Company (Orangeburg, NY). The working channel of the EUS endoscope is preloaded with a standard EUS needle, such as is manufactured by Wilson-Cook (Winston-Salem, NC), that serves as a carrier for a tag and thread, such as T-tag devices 100, 200, 300, 400, or 500, with suture 150, or T-tag device 600 with metal suture 614. The sutures may run

END5337USNP either through the needle or outside the needle, but still inside the working channel of the EUS endoscope; alternatively, the sutures can run along the outside of the EUS endoscope.

[00068] At step 712, under the guidance of the EUS endoscope, the physician locates and identifies structures outside of the stomach wall and selects a fixation point, such as the median arcuate ligament.

[00069] At step 714, under the guidance of the EUS endoscope, the physician pushes the EUS needle (i.e., needle 152), which is carrying T-tag device 100, 200, 300, 400, or 500 with suture 150 or T-tag device 600 with metal suture 614, through the stomach wall, which is represented by first tissue 162 in Figures ID, 2D, 3D, 4D, 5D, and 6D.

[00070] At step 716, under the guidance of the EUS endoscope, the physician deploys and affixes T-tag device 100, 200, 300, 400, or 500, with suture 150 attached thereto, or T-tag device 600 with metal suture 614 attached thereto, to the fixation point, such as to the MAL, which is represented by second tissue 164 in Figures ID, 2D, 3D, 4D, 5D, and 6D. The deployment of T-tag device 100 is as described in reference to Figures 1A, IB, IC, and ID. The deployment of T-tag device 200 is as described in reference to Figures 2A, 2B, 2C, and 2D. The deployment of T-tag device 300 is as described in reference to Figures 3A, 3B, 3C, and 3D. The deployment of T-tag device 400 is as described in reference to Figures 4A, 4B, 4C, and 4D. The deployment of T- tag device 500 is as described in reference to Figures 5A, 5B, 5C, and 5D. The deployment of T-tag device 600 is as described in reference to Figures 6A, 6B, 6C, and 6D.

[00071] At step 718, the physician withdraws the EUS endoscope and associated instrumentation from the patient, but leaves a length of suture 150 or metal suture 614 still threaded through the patient's gastroesophageal tract and anchored to second tissue 142 (e.g., MAL). The length of suture 150 or metal

END5337USNP suture 614 extends out of the patient's mouth and is accessible to the physician.

[00072] At step 720, the physician threads the length of suture 150 or metal suture 614 that is extending out of the patient's mouth through any well-known suture locking device.

[00073] At step 722, the physician threads the length of suture 150 or metal suture 614 that is extending out of the well-known suture locking device through the working channel of a standard endoscope that has a standard vision system (i.e., not an EUS endoscope).

[00074] At step 724, while holding tension on suture 150 or metal suture 614, the physician passes a standard endoscope that has a standard vision system (i.e., not an EUS endoscope) and the suture locking device through the patient's mouth and esophagus and into the stomach. The suture locking device is sliding freely along suture 150 or metal suture 614.

[00075] At step 726, having determined that the desired geometry change between the stomach and the MAL (represented by first tissue 162 and second tissue 164) is achieved and while continuing to hold tension on suture 150 or metal suture 614, the physician locks and cuts suture 150 or metal suture 614 by any conventional means.

[00076] At step 728, the physician withdraws the endoscope and surplus material of suture 150 or metal suture 614 from the patient. Method 700 ends.

[00077] In an alternative embodiment, method 700 uses a single EUS endoscope device that also has a standard vision system. As a result, only one endoscope device is needed throughout the entirety of method 700. In this case, the EUS endoscope device with a standard vision system is passed into the patient at step 710. It need not be withdrawn at step 718, and a second standard endoscope need not be passed into the patient at step 724.

END5337USNP While the present invention has been illustrated by description of various embodiments, it is not the intention of the applicants to restrict or limit the spirit and scope of the appended claims to such detail. Numerous other variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. It will be understood that the foregoing description is provided by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended Claims.

END5337USNP

Claims

What is Claimed is;

1. A medical device for anchoring suture comprising: a. A tag body is sized to fit within a needle; b. A suture attached to a portion of said tag body; and c. A means for protecting said suture from being damaged by a sharp edge of said needle.

2. The medical device of claim 1 wherein said means for protecting said suture comprises a profiled tab formed on said tag body.

3. The medical device of claim 1 wherein said means for protecting said suture comprises a flexible sleeve covering a portion of said suture.

4. The medical device of claim 3 wherein said flexible sleeve comprises a polyamide tube.

5. The medical device of claim 1 wherein said tag body comprises a cylindrical body and a slot in said cylindrical body extending along a long axis of said cylindrical body.

6. The medical device of claim 1 wherein said suture is constructed of a metal fiber.

7. The medical device of claim 1 wherein said needle is an endoscopic ultrasound needle.

8. The medical device of claim 1 wherein said tag body has an outside diameter of no more than about 0.030 inches.

9. A medical device for anchoring suture comprising: a tag body is sized to fit within a needle; a suture attached to a portion of said tag body; and wherein at least a portion of the tag body is adapted to protect the suture from being damaged by a sharp edge of the needle.

END5337USNP

10. A medical device for anchoring suture comprising: a tag body sized to fit within a needle; a suture attached to a portion of said tag body; and a locking feature.

11. The medical device of claim 10 wherein said tag body and said locking feature are formed as a unitary piece.

12. A medical device for anchoring suture comprising: a tag body, wherein said tag body is sized to slide over a needle; and a suture attached to said tag body.

13. The medical device of claim 12 wherein said tag body comprises a cylinder having an outer diameter of no more than about 0.05 inches.

14. The medical device of claim 12 wherein said tag body includes a distal end that tapers from a first diameter to a second diameter.

15. A method of assembling a suture anchor comprising the steps of: providing a medical device comprising: a tag body, wherein said tag body is sized to fit within a needle; a suture attached to a portion of said tag body; and a protector for preventing said suture from being damaged by an edge of said needle; providing a needle; and loading said medical device into an inner diameter of said needle.

16. The method of Claim 15 wherein the step of loading the medical device comprises positioning the the protector over a sharp edge of said needle.

17. A method of assembling a suture anchor comprising the steps of: providing a medical device comprising: a tag body having a proximal end, wherein said tag body is sized to slide over a needle; and a suture attached to said tag body; providing a needle including a protective sleeve having a distal end; and

END5337USNP placing said medical device over the outside diameter of said needle such that a distal end of said protective sleeve is directed toward a proximal end of said tag body.

END5337USNP