Surgical suturing apparatus

(54) Title: SURGICAL SUTURE APPARATUS (30) Unionist Priority: 03/31/2006 us 11 / 394,162 (71) Depositor (s): Johnson & Johnson (US) (72) Inventor (s): Mark S. Ortiz , Michael J. Stokes, Frederick E. Shelton, IV (74) Attorney: Dannemann. Siemsen, Bigler & Ipanema Moreira (57) Abstract: SURGICAL SUTURE APPARATUS. A surgical suture apparatus includes a suture housing, a needle mounted within the suture housing to perform the movement around an arcuate path, and a drive assembly operatively associated with the needle to control the movement of the needle with a suture attached to the arched path in order to facilitate the application of the suture to the tissue. The drive assembly includes a frictional meat disposal element that moves along the suture housing under the control of the driving mechanism, where the activation of the driving mechanism causes the frictional meat disposal element to engage and disengage selectively the needle causing the needle to move around the arcuate path.

<img file="BRPI0704530A_D0001.tif" />

(• ve • d · · j ·

<img file="BRPI0704530A_D0002.tif" />

<img file="BRPI0704530A_D0003.tif" />

• * ····· - »&lt;· O ···· q • · · · · ·

PI0704530-1

Descriptive Report of the Invention Patent for SURGICAL SUTURE APPARATUS.

Cross-Reference to Related Order

This application is a continuation in part of the patent application 5 US N^s 11 / 150,481, entitled “ENDOSCOPIC SUTURE DEVICE”, filed on June 13, 2005, which is currently pending. Background of the Invention

Field of the Invention

The invention relates to a surgical suture device. More particularly, the invention relates to a surgical suture apparatus with a drive assembly for moving a needle around an arcuate path.

Description of the Prior Art

Endoscopic procedures have achieved rapid development over the past decade. These procedures often allow the performance of surgical procedures with a minimum of trauma when compared to previous techniques that required a large external opening to expose the internal organ or tissue that needed care.

In addition to the many areas in which endoscopic procedures are useful, endoscopic procedures have been developed for surgical procedures to treat morbid obesity. Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly increasing in the United States, as well as in other countries, and the trend seems to be moving in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, strokes, congestive heart failure, multiple orthopedic problems and lung failure with a marked drop in life expectancy. With that in mind, and as those skilled in the art will certainly appreciate, the monetary and physical costs associated with morbid obesity are substantial. In fact, obesity-related costs are estimated to be over $ 100 billion in the United States alone.

A variety of surgical procedures have been developed to treat obesity. One procedure is Roux-emY gastric bypass (RYGB). This operation is highly complex and is commonly used to treat people who have morbid obesity. Around 35,000 procedures are performed annually in the United States alone. Other forms of bariatric surgery include Fobi pouch, bilio-pancreatic bypass, and gastroplasty or “stomach stapling”. In addition, implantable devices are known to limit the passage of food through the stomach and affect satiety.

RYGB involves moving the jejunum to a high position using a Roux-in-Y handle. The stomach is completely divided into two unequal parts (a smaller upper part and a larger lower gastric pouch) using an automatic stapling device. The upper pouch typically measures less than about 20 cc, while the larger lower pouch generally remains intact and continues to secrete the stomach juices that flow through the intestinal tract.

A segment of the small intestine is then pulled from the lower abdomen and attached to the upper pouch to form an anastomosis created through a 1.27 cm opening, also called a stoma. This segment of the small intestine is called the Roux element of the "Roux loop" and carries food from the upper pouch to the rest of the intestines, where the food is digested. The remaining lower pouch and the attached segment of the duodenum are then reconnected to form another tomotic 25 connection with the Roux loop element at a location approximately 50 to 150 cm from the stoma, typically using a stapling instrument. It is in this connection that the digestive juices of the outdated stomach, pancreas and liver enter the jejunum and ileum to aid in the digestion of food. Due to the small size of the upper pouch, patients are forced to eat more slowly and feel full much more quickly. This results in a reduction in calorie intake.

As those skilled in the art will certainly appreciate, the conventional RYGB procedure requires a lot of uptime. Due to the degree of invasion, the postoperative time can be quite long and painful. In view of the highly invasive nature with respect to the current RYGB procedure, other less invasive procedures have been developed. With that in mind other procedures for reducing the size of the stomach have been developed. The most common form of gastric reduction surgery involves applying vertical staples across the stomach to create a suitable pouch. This procedure is commonly performed laparoscopically and as such requires substantial preoperative, operative and postoperative resources.

As endoscopic devices and procedures evolved, surgeons began to employ endoscopic techniques for gastric procedures such as those discussed above in an effort to minimize trauma and reduce the time required for procedures and recovery. With the above in mind, procedures and devices that allow the performance of gastric reduction surgery to be performed quickly and less unpleasantly for the patient are needed.

One area that has not been adequately resolved is the need to apply sutures, while these gastric and other endoscopic procedures are being performed. The present invention provides an endoscopic suture device adapted for the continuous application of sutures.

Summary of the Invention

It is, therefore, an object of the present invention to provide a surgical suture apparatus. The suture apparatus includes a suture housing, a needle mounted within the suture housing to perform movement around an arcuate path, and a drive assembly operatively associated with the needle to control the movement of the needle with a suture it is attached around the airway in order to facilitate the application of the suture to the tissue. The drive assembly includes a friction meat element that moves along the suture housing under the control of the drive mechanism, where actuation of the drive mechanism causes the friction cam element to selectively engage and disengage the needle causing the needle to move around the arcuate path.

It is also an object of the present invention to provide a suture apparatus in which the drive assembly moves the needle around a continuous circular path.

It is another objective of the present invention to provide a suture apparatus in which the suture housing is shaped and sized for insertion through a patient's natural orifice.

It is an additional object of the present invention to provide a suture apparatus in which the suture housing is shaped and sized to pass through a hole of approximately 3 mm to approximately 24 mm in diameter.

It is another additional objective of the present invention to provide a suture apparatus in which the suture housing is shaped and sized for laparoscopic insertion through a trocar.

It is yet another additional object of the present invention to provide a suture apparatus in which the suture housing is shaped and sized to pass through a hole of approximately 3 mm to approximately 18 mm in diameter.

It is a further object of the present invention to provide a suture apparatus including a spring to guide the friction cam element in contact with the needle.

It is another object of the present invention to provide a suture apparatus 25 in which a friction interface of the friction cam element is smooth.

It is a further object of the present invention to provide a suture apparatus in which a friction interface of the friction cam element is toothed.

It is a further object of the present invention to provide a suture apparatus in which the drive mechanism is operatively coupled to the needle and includes means for translating the rotary movement ι around a first geometric axis into an arcuate movement of the needle around of a second geometry axis different from the first geometry axis.

Other objectives and advantages of the present invention will become apparent from the detailed description below when viewed in conjunction with the accompanying drawings, which show certain embodiments of the invention.

Brief Description of Drawings

Figure 1 is a perspective view of the present invention with the vacuum chamber attached;

Figure 2 is a perspective view of the present invention without the vacuum chamber;

Figures 3 to 19 are cut-outs showing the operation of the present invention;

Figure 11 is a perspective view showing a suture body with a vacuum chamber in accordance with a preferred embodiment attached thereto;

Figure 12 illustrates an alternative vacuum chamber attached to the suture body;

Figures 13 and 14 are top views of another vacuum chamber attached to the suture body, where figure 13 illustrates the vacuum chamber in its expanded configuration and figure 14 illustrates the vacuum chamber in its low profile configuration;

Figure 15 is a cut-away view of the suture body illustrating a smoothly rubbed flesh member;

Figure 16 is an alternative embodiment of the suture body showing a toothed friction cam element;

Figure 17 is a cut-away view of another embodiment of the suture body with a gear driven friction cam element;

Figures 18 and 19 are cut-away views of the suture body illustrating alternative support mechanisms that can be used in accordance with the present invention;

<img file="BRPI0704530A_D0004.tif" />

\ .

Figures 20, 21 and 22 are various views of a suture body including a cam pin assembly mechanism used in the selective opening of the suture housing;

Figures 23 and 24 are bottom views of a suture body 5 illustrating a tear strip mechanism used in the selective opening of the suture housing;

Figures 25 and 26 are bottom views of a suture body illustrating another mechanism used in the selective opening of the suture housing;

Figures 27 and 28 are bottom views of a suture body illustrating a spreading plate mechanism used in the selective opening of the suture housing;

Figures 29, 30 and 31 are several views of a suture body illustrating an alternative mechanism for the selective opening of the suture housing 15;

Figure 32 is a cut-out view of the suture body illustrating a needle position indication mechanism;

Figure 33 is a cut-away view of the suture body illustrating an alternative needle position indication mechanism;

Figure 34 is a perspective view of a suture body employing an alternative needle position indication mechanism where an indicator pin is shown in its hidden position;

Figure 35 is a cross-sectional view of the needle position indication mechanism shown in Figure 34 with the indicator pin shown in its hidden position;

Figure 36 is a perspective view of the suture body illustrated in Figure 34 with the indicator pin in its exposed position;

Fig. 37 is a cross-sectional view of the needle position indication mechanism shown in Fig. 36 with the indicator pin in its exposed position;

Fig. 38 is a detailed side cut-out showing a colored needle used to identify the needle position;

Figure 39 is a perspective view illustrating a visual indicator connected to several sensors to identify the needle position;

Figures 40, 41, 41a, 42, 42a and 43 are several views illustrating a fixation mechanism for securing the present suture apparatus to an endoscope;

Figures 44, 45 and 46 illustrate a guidewire introduction mechanism for use in conjunction with the present suture apparatus;

Figures 47, 48, 49, 50 and 51 describe a detachable loop mechanism for use in conjunction with the present suture apparatus;

Figures 52 to 61 describe various suture loop techniques according to the present invention;

Fig. 62 is a perspective view of a mooring element by us in accordance with the present invention;

Figure 63 is a perspective view illustrating the fusion of the 15 sutures tied by us;

Figures 64, 65, 66, 67 and 68 are seen in perspective illustrating various vacuum suction assist mechanisms according to the present invention;

Fig. 69 illustrates a suture technique using an adhesive / sealant;

Figures 70, 71 and 72 illustrate a perforated suture used to supply adhesive / sealant to a suture line;

Figures 73 to 82 describe a procedure by which a stomach pouch is created by applying an adhesive / sealant;

Figures 83 and 84 are a perspective view of a suture device incorporating an imaging device within the suture body;

Fig. 85 is a cut-away view of the suture body illustrating a cartridge mechanism for use with it;

Fig. 86 is a cut-away view of the suture body illustrating a cartridge mechanism having a smaller needle;

Figures 87 and 88 are side views illustrating a mechanism &lt;

<img file="BRPI0704530A_D0005.tif" />

I

I.

needle loading according to the present invention;

Figures 89, 90 and 91 describe mechanisms with a screwed base for adjusting the size of the vacuum chamber and central opening;

Figure 92 is a cut-away view illustrating a wire-based mechanism for adjusting the effective depth of the vacuum chamber and the central opening;

Fig. 93 is a top view illustrating a clamping line used to adjust the effective size of the vacuum chamber and the central opening.

Description of Preferred Modalities

The detailed embodiments of the present invention are described here. It should be understood, however, that the described modalities are merely illustrative of the invention, which can be incorporated in various ways. Therefore, the details described here should not be construed as limiting, but merely as a basis for the claims and as a basis for teaching those skilled in the art of how to create and / or use the invention.

With reference to figures 1 to 10, an endoscopic suture apparatus 10 for the continuous application of a suture 12 is described. The term "suture" as used throughout the body of the present application must refer to a variety of flexible fixing filaments being made of natural, synthetic or polymeric filaments, or metallic wire filaments.

Although the present suture apparatus is particularly adapted for use in endoscopic gastric reduction procedures, those skilled in the art will certainly appreciate that the apparatus can be used for a wide variety of applications without departing from the spirit of the present invention. More particularly, the present suture apparatus is shaped and sized for insertion through a patient's natural orifice, in a transoral way, and therefore is shaped and sized for insertion through an orifice of approximately 3 mm to approximately 24 mm in diameter. . Although the present suture device is particularly adapted for insertion through a patient's natural orifice, the present suture device can be shaped and scaled for laparoscopic insertion through a trocar, and therefore is shaped and scaled for insertion through from a hole of approximately 3 mm to approximately 18 mm in diameter.

The suture apparatus 10 includes a suture body 14 shaped and sized for attachment to the distal end 16 of a commercially available endoscope, or other support structure, 18 in order to allow its activation and create a vacuum. With this in mind, the suture body 14 is attached to the endoscope 18 using the known fixation structures appreciated by those skilled in the art.

The suture body 14 consists of a first housing element 20 and a second housing element 22 attached together to create a suture housing 24 in which the functional components of this apparatus 10 are housed to carry out the movement according to present invention. The suture housing 24 includes a first inner rail 26 on which a needle 28 is positioned to perform movement around a predetermined continuous circular path under the control of a drive assembly 30.

Although the present suture apparatus is described according to a preferred embodiment as providing the translation of the needle around a continuous circular path, it is contemplated that many of the concepts underlying the present invention can be applied to systems in which the needle is merely moved along an arched path, and not necessarily along a continuous circular path.

The drive assembly 30 is supported within the second and third tracks 32, 34 positioned around the first inner rail 26. The drive assembly 30 applies an axial movement to cause the needle 28 to move around its continuous circular path. The drive assembly 30 generally consists of a friction plate 36 statically mounted along the second rail 32 and a friction meat element 38 that moves along the second rail 32 while a pin 40 moves along the third external rail 34. A drive cable 42 is coupled to pin 40 to control its drive as described in more detail below. The drive cable 42 is driven to move the drive assembly 30 by a loop (for example, as illustrated in figures 47 to 51). Although a preferred loop is described below, it is contemplated that a variety of loop structures can be used to drive the drive cable without departing from the spirit of the present invention.

For reasons that will become apparent based on the operation of the present suture apparatus 10 as described in greater detail below, the suture body 14 is substantially C-shaped with a central opening 44 in which the tissue is positioned during suturing. The C shape of the suture body 14 allows the needle 28 to move around a circular path during operation and to pass through the tissue positioned with the central opening.

With reference to figures 1 and 2, and according to a preferred embodiment, the present endoscopic suture apparatus 10 is attached to a commercially available endoscope 18 by means of a clamp 17. As briefly mentioned above, and as discussed below in In more detail, the suture apparatus 10 can be attached to the endoscope 18 in a variety of ways without departing from the spirit of the present invention. The suture device 10 is oriented in a way that allows the user to maintain visibility of the needle 28 and operational field, in addition to creating a small cross section to assist in transoral insertion (when the suture device 10 is used in gastric surgical procedures) .

A vacuum chamber 46 surrounds and / or otherwise contains the suture body 14 of the present suture apparatus 10. This defines a cavity 48 in which the suture body 14 rests. The vacuum chamber 46 is coupled to the vacuum line 50, which is coupled together with the endoscope 18, but not in the working channel of the endoscope 18, so that the vacuum is created within the cavity 48 defined by the vacuum chamber 46 , in addition to the central opening 44 of the suture body 14. In this way, the application of vacuum pulls the adjacent tissue into the central opening 44 of the suture body 14.

As briefly mentioned above, the present suture apparatus 10 is provided with a vacuum chamber 46 designed to improve the ability to pull tissue into a suture position. The vacuum chamber 46 is shaped and sized to facilitate retraction of the tissue wall into the vacuum chamber 46, and particularly, the central opening 44 of the suture body 14, under the control of the applied vacuum. One pulled into the vacuum chamber 46 and the central opening 44, the fabric is held there as the needle 28 is passed through it, while the suture body 14 makes the stitches. The required size of the vacuum chamber 46 is based on the thickness of the tissue being sutured. The vacuum required to pull the desired thickness of the fabric is proportional to the thickness of the fabric and the size of the vacuum chamber 46.

As a result, the present vacuum chamber 46 attempts to increase its size to minimize the vacuum required to perform the task, without making the vacuum chamber 46 too large to pass into the stomach. The ability of the present vacuum chamber 46 to achieve the desired suction with the vacuum pressure provided in a hospital or other medical facility is especially important considering the magnitude of the vacuum forces available in different hospitals, as well as inside operating rooms. different, which varies a lot.

With that in mind, and according to the preferred embodiments of the present invention, as illustrated in figures 11 and 12, (where similar numerical references are used for similar parts), the vacuum chamber 146 is constructed from a resilient elastomer. It has a cup-like configuration and generally includes an inner wall 170 and an outer wall 172. The inner wall 170 of the vacuum chamber 146 is preferably provided with projections, for example, ribs and / or hooks, 174, (as shown in figure 12) to further improve the ability of the vacuum chamber 146 to retain the sucked tissue. These projections 174 provide gripping surfaces to which the fabric is attached when the vacuum is applied to the vacuum chamber 146. The projections 174 also increase the vacuum holding energy, thereby minimizing the amount of vacuum required.

According to a preferred embodiment, the vacuum chamber 146 consists of a first and second vacuum chamber elements 176, 178 attached to opposite sides of the suture body 114 in order to contain, or otherwise surround, the functional components of the suture body 114. The first and second chamber elements 176, 178 are mirror images of each other and define a space surrounding the suture body 114 for creating a vacuum. According to a preferred embodiment, the first and second vacuum chamber elements 176, 178 define a cup-like space in which the suture body 114 is positioned.

Each of the first and second vacuum chamber elements 176, 178 includes a semicircular top edge 184 and a concave bottom part 186. As such, when the first and second vacuum chamber elements 176, 178 are attached along opposite sides of the suture body 114, the cup-like space is defined around the suture body 114. The cup-like space provides a confined space in which the suction provided by the vacuum is restricted in order to draw the tissue safely and efficiently into the central opening 144 of the suture body 114.

The first and second vacuum chamber elements 176, 178 of the vacuum chamber 146 are manufactured from an elastomer, for example, urethane, adiprene or santoprene. The vacuum chamber 146 is designed to allow its expansion and contraction. The provision of an expandable vacuum chamber 146 maximizes the chamber size to increase tissue inclusion during the application of vacuum, while allowing for a reduced vacuum chamber size 146 during insertion of the suture apparatus 110. More particularly, the capacity expanding and contracting the vacuum chamber 146 facilitates the transoral passage of the suture apparatus 10 while similarly optimizing the size of the vacuum chamber 146 during tissue suction.

As those skilled in the art will appreciate, the need for a transoral passage to the suture apparatus 110 defines a final limit on the dimensions of the suture apparatus 110 and, therefore, to the vacuum chamber 146 that can be introduced to capture the tissue according to the present invention. The larger the vacuum chamber 146, the greater the “bite” of the tissue that can be captured in a release of the suture apparatus 110. With that in mind, and as discussed above, vacuum chamber 146 is created from an elastomer allowing it to be disassembled during insertion and then "assembled" back to its original shape after being fully inserted.

According to an alternative embodiment, and with reference to figures 13 and 14, the expansion of the vacuum chamber 246 is further facilitated by providing live joints 280 at predefined fold points of the cavity 248 defined by the vacuum chamber 246. This allows the vacuum chamber 246 to be constructed from a wider variety of materials, including non-elastic plastics, as the living joints 280 allow more rigid structures to “bend” rather than arch in an elastic manner. More particularly, and with reference to the previous embodiment, the vacuum chamber 246 consists of a first vacuum chamber element 276 and a second vacuum chamber element

278. The first and second vacuum chamber elements 276, 278 are mirror images of each other, and each includes a semicircular upper section 284 and a concave lower section 286. As a result, the first and second vacuum chamber elements 276, 278 are coupled on opposite sides of the suture body 214 to form the present vacuum chamber 246, which may similarly include the ribs and / or hooks discussed above with respect to the previous embodiment.

According to a preferred embodiment, the first and second vacuum chamber elements 276, 278 are constructed from a semi-rigid material and, therefore, include, respectively, the living joints 280 which allow for its expansion and contraction. The living joints 280 are positioned at predefined fold points of the first and second vacuum chamber elements 276, 278 in order to optimize the folding of the same. The living joints 280 allow controlled expansion and contraction of the vacuum chamber 246 as the first and second vacuum chamber elements 276, 278 are moved relative to each other according to the present invention. One is, therefore, capable of passing through a vacuum chamber 246 which is, finally, when used, larger than the transoral space through which it passed.

Those skilled in the art will appreciate that it would be desirable to create a vacuum chamber and central opening adapted to accommodate any type of tissue, any thickness of tissue and to be able to allow the user to adjust the size of the bite (that is, to the extent of the tissue through which the suture is passed). For this purpose, several modalities for adjusting the effective vacuum chamber and the central opening size have been developed and are described here. These modalities also allow the longitudinal and lateral adjustment of the vacuum chamber, in addition to the depth adjustment of the central opening and the vacuum chamber, to allow use with different fabric thicknesses, different types of fabric and variable fabric bites per loop. suture. In this way, the surgeon can readily adjust the depth, width and / or length of the effective central opening / vacuum chamber to allow adjustment of the depth of tissue life, which controls the depth of the needle path through the tissue (this ie, full thickness or partial thickness). The adjustability also allows the same suture device to be used for multiple types and thicknesses of tissue. While limiting the maximum amount of tissue that can be pulled into the vacuum chamber and the central cover, the present techniques can also be applied to ensure that a predetermined and controlled amount of tissue is pulled into the vacuum chamber and opening central.

According to a preferred embodiment, and with reference to figures 89, 90 and 91, the adjustment is carried out by supplying adjustment screws 3970 to the base 3972 of the vacuum chamber 3946. The screws 3970 respectively allow the longitudinal or lateral adjustment of the chamber vacuum 3946 by adjusting a screw 3970 in the base 3972 of the vacuum chamber 15 or 3946 which expands and contracts the vacuum chamber 3946 in a desired direction.

According to another embodiment, and with reference to figure 88, a wire 4070 is used to lift the effective base of the vacuum chamber 4046 and the central opening 4044 controlling the effective depth of the vacuum chamber 4046 and the central opening 4044. This wire 4070 it is a folded spacing yarn that can be further folded or straightened, effectively reducing the depth at which the fabric can enter the cavity defined by the central opening 4044 and the vacuum chamber 4046.

The straighter the 4070 spring wire becomes, the higher the setting of the effective cavity bottom. The spring wire 4070 thus prevents the deep entry of the fabric (that is, the entrance beyond the protection created by the spring wire 4070) into the central opening 4044. The clearance in the wire 4070 is controlled by means of a screw element 4072 found inside the 4014 suture body for the activation of the 4070 thread.

With reference to figure 93, and according to another embodiment, a 4170 clamping cable is used to adjust the effective length of the vacuum chamber 4148. In particular, a 4170 clamping cable is threaded around the outer perimeter of the vacuum chamber 4146, with free ends 4172, 4174 thereof exiting at the proximal end of vacuum chamber 4146. As such, the free ends 4172, 4174 can be tensioned to shorten the length of the vacuum chamber 4146, and similarly, released when it is desirable to increase the length of the vacuum chamber 4146 allowing the walls of it to expand into position not oriented.

As mentioned above, the housing 24 contains the needle 28 used in applying a suture 12 to the tissue pulled into the central opening 44. The suture 12 is attached to the proximal end, that is, to the blind end, of the needle 28 and is pulled through the fabric as the needle 28 is triggered according to the present invention as described herein. According to a preferred embodiment, the needle 28 is curved to rotate around a predetermined continuous circular path and extend along a 240 degree arc creating a 120 degree opening. However, those skilled in the art will appreciate that the opening may vary; for example, it was contemplated the use of a needle offering an opening of 140 degrees.

Needle 28 includes an inner surface 52 along the inner surface of the bow defined by needle 28 and an outer surface 54 along the outer surface of the bow defined by needle 28. A series of notches 56 are cut on the outer surface 54 of needle 28 As will be appreciated based on the description below, the notches 56 are shaped and sized for use by the drive set 30 in the grip, drive and release of the needle 28. Although the indentations along the outer surface of the needle are described for use according to a preferred embodiment of the present invention, it is contemplated that the needle may be formed without indentations so that the drive assembly merely grips the substantially smooth outer surface of the needle. needle to drive it forward.

The operation of the drive set 30 and movement of the needle 28 is described with reference to figures 3 to 10, where half of the housing 24 is removed exposing the internal components of the present suture apparatus 10. The drive cable 42 (shown in the figure 3) is rigidly fixed to pin 40. As described in more detail below, the drive cable 42, the pin 40 and the friction cam element 38 are extended and retracted to engage and disengage the needle 28 to perform its movement around its circular path. The drive cable 42 is flexible enough to bend in the housing 24 and flex together with the endoscope 18, but it is rigid enough to be compressed to drive the friction cam element 38 to its initial drive stage (see figure 4 ).

The friction cam element 38 consists of an arcuate latch element 58 and a cam element 60 working together with pin 40 to control the position of latch element 58 to effect selective engagement with needle 28. The engaging element 58 is constructed with internal grooves 62 shaped and dimensioned to engage the needle 28 to actuate it in a clockwise direction, but allows its free movement as the friction meat element 38, that is, the engaging element 58 and the cam 60, are moved in a counterclockwise direction in the direction of the initial actuation stage.

The engaging element 58 of the friction meat element 38 is designed to move in housing 24 both in the radial direction and away from needle 28, in addition to moving in an arcuate manner in a clockwise and counterclockwise manner around the arc defined by the housing 24. This is achieved through the meat action offered by the interaction between meat element 60, pin 40 and coupling element 58. The meat element 60 is rigidly coupled to the latch element 58 so that the latch element 58 is moved in and out of the latch with the needle 28 as the radial position of the meat element 60 is changed with based on the interaction with pin 40. As discussed below according to an alternative embodiment, it is contemplated that a flexible element can be used to force the friction meat element 38 against the needle 28.

More particularly, as the drive cable 42 is compressed (i.e., the drive cable 42 is pushed distally away from the operation of the suture apparatus 10) to move the friction meat element 38 in a counterclockwise direction. , the pin 40 slides into a slot 64 formed in the meat element 60 forcing the engaging element 58 and the meat element 60 to move counterclockwise in addition to outward from the needle 28. The friction plate 36 assists in expelling the engaging element 58 outward from the needle 28 as the meat element 38 is moved in its counterclockwise direction.

With the friction meat element 38 in its initial actuation position, as shown in figure 4, and as the tension is applied to the actuation cable 42 (that is, the actuation cable 42 is pulled proximally in the direction of operation of the suture apparatus 10) and finally pin 40, pin 40 engages the meat member 60 forcing the friction cam element 38, and, more particularly, the engagement element 58 to travel inwardly in contact with the outer surface 54 of the needle 28 due to the cam action resulting from the interaction of the pin 40 and the slot 64 within the cam element 60 (see figure 5). As tension is applied continuously to the drive cable 42, the notches 62 formed along the inner surface of the engagement element 58 grasp the notches 56 cut on the outer surface 54 of the needle 28, causing the needle 28 to rotate in the direction clockwise until pin 40 reaches the limit of rail 34 and the procedure needs to be started again (see figure 6).

When the step limit is reached as shown in the figure

6, the operator compresses the drive cable 42 causing the latch element 58 to disengage the needle 28 by means of the cam accessory resulting from the interaction of the pin 40 within the slot 64 of the cam element 60 as the pin 40 slides inside the slot 64 causing the engaging element 58 and the cam element 60 to move outward and in a counterclockwise direction (see figure 7). The compression in the drive cable 42 is continuous until the friction cam element 38 moves counterclockwise reaching the opposite end of the housing 24 (see figure 8). The tension is then applied again to move needle 28 in a clockwise direction and the procedure is repeated until the needle has traveled 360 degrees (see figures 9 and 10).

As briefly discussed above, the drive assembly 30 of the present invention is capable of driving the needle 28 around its circular path in a highly controlled and efficient manner. Referring to figure 15, the functionality of the present drive assembly 330 is enhanced by providing the friction cam element 338, which drives needle 328 when pulling needle 328 along its path through the friction means. The contact surface of the friction interface 358 of the friction cam element 338 is manufactured to improve its frictional relationship with the needle 328 in order to smoothly and reliably move the needle 328 according to the present invention.

The interaction between the friction cam element 338 and the needle

<img file="BRPI0704530A_D0006.tif" />

328 it is improved by providing a laminated spring 370. The laminated spring 370 extends within the suture housing 324 of the suture apparatus 310 and is oriented to contact the friction meat element 338 during actuation of the needle 328 to force the friction meat element 338 in contact with the needle 328. The laminated spring 370 is a flexible element cantilevered proximal to the friction meat element 338. As the friction meat element 338 is forced distally, the laminated spring 370 increases the engagement forces radially the further away the friction meat element 338 is removed. As those skilled in the art will certainly appreciate, a spring structure is described according to a preferred embodiment of the present invention and other spring structures can be employed without departing from the spirit of the invention.

According to an alternative embodiment, and with reference to figure 16, the soft friction meat element 338 discussed above can be replaced by a toothed friction meat element 438. According to this embodiment, the contact surface of the contact interface friction 458 of friction meat element 438 is provided with teeth 472 shaped and sized to engage teeth of similar shape 474 formed along the outer surface of needle 428. In this way, the teeth 472 along the friction interface 458 of the friction meat element 438 engage the cut teeth 474 on needle 428 and drag the needle 428 along its drive path when pulled. As with the previous embodiment, the interaction between the friction meat element 438 and the needle 428 is improved by providing a laminated spring 470. The laminated spring 470 extends within the suture housing 424 of the suture apparatus 410 and is oriented to contact the friction meat element 438 during actuation of the needle 428 to force the friction meat element 438 into contact with the needle 428 .

According to an alternative modality, and with reference to figure 17, the movement of the friction meat element 538 (either a soft friction meat element 338 as illustrated in figure 15 or a toothed friction meat element 438 as illustrated in figure 16) used in driving needle 528 can also be achieved through the use of a cogwheel gear 570 engaging the teeth 572 on the back side 574 of the friction cam element 538 driving the needle 528 a5 through the same movements that the linear retraction system created. Such a gear arrangement provides the translation of the rotary movement along the drive cable 582, and around a first geometric axis substantially aligned with the longitudinal geometric axis of the suture apparatus 510 which extends through the suture apparatus 510, in a rotary movement of the needle 538 around an arcuate path having a central geometric axis substantially perpendicular to the longitudinal geometric axis of the suture apparatus 510. According to this modality, the sprocket gear 570 is rotated by a rotary cable drive system 576 connected to a rotating element in the handle (not shown) that replaces the linear retraction system. According to this modality, the movement of the rotating cable (rotation around the longitudinal axis of the device axis) is converted into rotary movement (rotation perpendicular to the longitudinal axis of the device axis) to drive the needle 528 directly along its circular path or to drive the toothed friction cam element 538 in its path.

More particularly, the drive cable 582 is designed for rotation about a geometric axis substantially parallel to the longitudinal geometric axis of the apparatus 510. The distal end 584 of the drive cable 582 is provided with spur gear 586 which is connected to a similar spur gear 588 mounted between the spur gear 586 at the distal end 584 of the drive cable 582 and a contact surface gear 574 of the friction cam element 538. As a result, the rotation of the drive cable 582 causes the spur gear 586 to rotate, which in turn translates into the movement of the friction cam element 538. The movement of the friction cam element 538 then makes the needle

528 moves in a desired arcuate path, since the friction meat element 538 engages and disengages needle 528 in a manner similar to the embodiment described above, the movement of needle 528 is achieved by alternately reversing the rotation of the rotary cable system. The advance rotation raises the friction meat element 538 in engagement and drives the friction meat element 538 counterclockwise in order to trigger the needle 528. The inverted rotation of the drive cable 582 disengages the friction meat element 538 from the needle 528 and rotates the friction meat element 538 clockwise by reconfiguring it for the next drive movement.

Regardless of the design of the friction meat element, the drive mechanism employed in accordance with the preferred embodiments of the present invention provides a rotary needle drive system for suture capable of multiple loops of tissue during a single device insertion. As discussed above, according to a preferred embodiment of the present invention, this is accomplished by a friction meat element that advances the needle by means of a toothed engagement or friction coupling, and provides the advance of the needle allowing variation in the size of both the needle and the suture used in accordance with the present invention.

Two non-return structures are described with reference to figures 18 and 19. These non-return structures control the movement of the needle so that the needle can only pass in one direction. This prevents the needle from coming out between the actuation steps of the friction meat element as it moves between its final position (or limit) of the step as shown in figure 6 and its initial actuation position as shown in figure 8. More particularly, the needle of the present suture apparatus is designed to move in a first predetermined direction around an arcuate path, and movement in a second opposite direction is undesirable. As such, the present anti-return structures prevent movement of the needle in the second direction while allowing free movement of the needle in the first direction.

More particularly, and according to a preferred embodiment described with reference to figure 18, a friction non-return device 670 is attached along the front end of the needle path 628 to contact the needle 628 in order to prevent the independent return from it. The frictional non-return device 670 is a lever arm 672 including a first end 674 and a second end 676. The first end 674 of the lever arm 672 is pivotally attached to the suture body 614 of the suture apparatus 610. The second end 676 of the lever arm 672 extends in the direction of, and contacts the contact surface of the needle 628. Lever arm 672 is oriented so that when needle 628 is moved in a counterclockwise direction as seen in Figure 18, lever arm 672 slides over the outer surface of needle 628 allowing needle 628 to rotate freely.

However, if needle 628 attempts to rotate in a clockwise direction as seen in figure 18, the second end 676 of lever arm 672 rubs the outer surface of needle 628 in a frictional manner to stop clockwise rotation. This is a result of the orientation of the lever arm 672 which creates a frictional impediment to the movement of the needle 628, for example, similar to a gear mechanism. With that in mind, lever arm 672 is oriented to maintain engagement with the outer surface of needle 628 in the event that the needle is rotated in a clockwise or counterclockwise direction.

According to an alternative embodiment and with reference to figure 19, the suture body 714 is provided with an integral spring-oriented lock 770, which is shaped and sized to fit within the recesses 772 formed on the outer surface of the needle 728. With that in mind, lock 770 and recesses 772 are shaped and sized to allow substantially free rotation of needle 728 in one direction while preventing rotation of needle 728 in the opposite direction.

Since it is possible for the needle to get stuck inside the fabric during unfolding, it sometimes becomes necessary to release the \

\ suture device needle for emergency extraction of both apareV,.

Suture son and needle. With that in mind, and with reference to the various modalities presented below, techniques have been developed to release the needle in case it gets stuck and needs to be released. In general, the modalities described below are different methods of separating or opening the suture housing of the suture apparatus to release the needle and allow the suture apparatus to be removed. Releasing the needle in this way may require the subsequent removal of the needle from its obstructed position, but will allow the rest of the suture device to be removed since the suture device is no longer hanging on the tissue based on the release of the needle.

According to the various modalities described below, a surgical suture apparatus includes a suture housing and a needle mounted within the suture housing to perform the movement around an arcuate path. The suture apparatus also includes a drive assembly operatively associated with the needle to control the movement of the needle with a suture attached to it around the arcuate path in order to facilitate the application of the suture to the tissue. The suture housing has an open position and a closed position, and the needle can be removed from the suture housing when in the open position.

The various modalities provide a controlled opening mechanism for the user that allows the suture housing to be selectively opened in case the needle fails to advance and the suture device needs to be removed. As will be described in more detail below, this is achieved by employing an articulated, spring-loaded suture body opening when a breakable coupling mechanism is actuated, a removable pin / cable mechanism that retains the two halves of the suture body joined together or an unfoldable suture unfolding system that can be closed several times to extract the body.

According to a first embodiment, and with reference to figures 20 to 22, and as discussed in greater detail above, the suture body 814 consists of a first housing element 820 and a second housing element 822 creating the suture housing 824. A meat pin assembly 870 locks the first housing element 820 and the second housing element 822 together, however, with the ability to remove the meat pin assembly 870 from the second housing element 822 when it is desirable to separate the first and second housing elements 820,822 for removing a stuck needle 828.

More particularly, the first and second housing elements 820, 822 are hinged 872 along one end thereof, and the meat pin assembly 870 is positioned opposite the hinge 872 so that the first and second housing elements 820, 822 are held together securely. However, when the meat pin assembly 870 is removed, or otherwise removed from its locking position with a second housing element 822, the first and second housing elements 820, 822 are free to separate by pivoting around of joint 872. The opening of the suture housing 824 is further facilitated by the inclusion of a spring 874 in the joint 872 to encourage the opening of the suture housing 824 by removing the meat pin assembly 870.

The actuation of the meat pin set 870 is achieved through the use of a release element 876 that interacts to allow controlled locking and release of the meat pin set 870. In particular, the release element 876 includes a series of interference elements 878 that interact with the heads 880 of the meat pin assembly 870 to retain them within the recesses 882 formed in the second housing element 822 (see figure 21). When it is desirable to separate the first and second housing elements 820, 822, the release element 876 will be lifted, for example, through a cable 884 that extends to be operated by a user, to move the interference element 878 and allow the meat pin assembly 870 to move from within the second housing element 822 (see figure 22).

According to another embodiment, and with reference to figures 23 and 24, a tear strip 970 is described. As with the previous embodiments, the suture body 914 consists of a first housing element 920 and a second housing element 922 creating the suture housing 924. The first and second housing elements 920, 922 are hinged 972 along one end thereof, with a spring 974 oriented the first and second housing elements 920, 922 for an open orientation.

The tear strip 970 is positioned across the center line of the first and second housing elements 920, 922. According to a preferred embodiment, the tear strip 970 is attached to the first and second housing elements 920, 922 by means of adhesive or another plastic, frangible and mechanical coupling accessory. When pulled, the tear strip 970 "tears" the center out of the first and second housing elements 920, 922 allowing the suture apparatus 910 to open. The tear strip 970 can be a straight or molded adhesive strip, or the tear strip 970 can include a meat disposal accessory (as discussed below) as part of the more distal end further opening the halves as it is removed.

An additional modality is described with reference to figures 25 and 26. This modality employs a retraction cable 1070 to facilitate the selective opening of the suture body 1014 to release a stuck needle. According to this embodiment, the suture body 1014 consists of a first housing element 1020 and a second housing element 1022 creating a suture housing 1024. The first and second housing elements 1020, 1022 are hinged 1072 along one end thereof (or are separate, unassociated halves). The first and second housing elements 1020, 1022 are additionally provided with loop handles 1074 along the open end thereof. The loop loops 1074 are shaped and sized to allow the placement of a 1070 retract cable through them in order to hold the first and second housing elements 1020, 1022 together.

More particularly, the retract cable 1070 is looped through loop loops 1074 positioned alternately in the first and second housing elements 1020,1022, much like the hinge of a door. As long as the retraction cable 1070 is present around the perimeter of the first and second housing elements 1020, 1022, the first and second housing elements 1020, 1022 are held together and the needle 1028 is retained. However, when it is desirable to remove the needle 1028 or otherwise open the suture body 1014 of the suture apparatus 1010, the retraction cable 1070 is pulled out by removing it from the loop handles 1074 and releasing the first and second elements housing 1020, 1022 from each other. With the first and second housing elements 1020, 1022 released, the spring-oriented hinge 1072 separates the first and second housing elements 1020, 1022 pivoting them along the hinge 1072.

One embodiment of the spreading plate 1170 is described with reference to figures 27 and 28. This is a variation of the tear strip design described above with reference to figures 23 and 24. According to this embodiment, the central connection element 1172 not only joins and releases the two housing elements 1120, 1122, but has a ca20 m and 1174 element at the distal end of the central connection element 1172 which, as it is pulled through the system, it raises the first and second housing elements 1120, 1122 away from each other not only allowing them to separate freely.

More particularly, and as discussed above with the various other modalities, the suture body 1114 includes a first housing element 1120 and a second housing element 1122 creating the suture housing 1124. The first and second housing elements 1120,1122 are hinged 1176 along one end thereof, with a spring 1178 orienting the first and second housing elements 1120, 1122 to an open orientation (or are non-spring oriented halves, not associated, separate). The central connection element

1172 it is positioned through the center line of the first and second housing elements 1120, 1122. According to a preferred embodiment, the central connecting element 1172 is attached to the first and second housing elements 1120, 1122 through an element that is rigid enough to prevent inadvertent deployment of the system but it can be broken or disengaged from the distal end of the suture housing 1124. When pulled, the central connecting element 1172 releases the first and second housing elements 1120, 1122 allowing the suture housing 1124 to open.

Opening the suture body 1114 by removing the central connection element 1172 is facilitated by the inclusion of a cam element 1174 at the distal end 1180 of the central connection element 1172. The cam element 1174 is positioned and shaped to extends between the first and second housing elements 1120, 1122 in order to push the first and second housing elements 1120,

1122 away from each other to remove needle 1128 or to provide another access to the internal structure of suture body 1114.

With reference to figures 29, 30 and 31 another further embodiment of the present invention is described. The modality employs a series of interlocking fasteners that can be broken 1270 at the selective opening of the suture body 1214. As with the cam pin assembly, the interlocking fasteners 1270 hold the first and second housing elements 1220, 1222 together during normal function. When a cable 1272 attached to the interlock fasteners 1270 is pulled, the interlock fasteners 1270 are broken, unlocking the first and second housing elements 1220, 1222 and allowing them to open in an articulated manner under the control of the articulation oriented by spring 1274.

In addition to the inclusion of a release structure for the housing structures described above, each of these modalities is provided with an external housing profile, shaped and dimensioned to allow limited closure of the suture body as it is removed from the stomach. In particular, the outer profile is rounded with a convex profile designed in such a way that the first and second housing elements are at least partially forced to join when the suture device is removed through a transoral tube.

With the convex profile in mind, it is contemplated that it may be desirable to articulate the first and second housing elements along their proximal ends (see figures 27 and 28). Any of the various release mechanisms can be used according to this modality. However, by positioning the joint at its proximal end, the first and second housing elements are directly connected to the shaft allowing them to be easily closed again during extraction instead of having several loose parts free to move and fall into any location.

One of the challenges of a suture device offering a needle that moves through a continuous circular path is the identification to the user of where the needle is in the step of the device in addition to providing the user with a method to stop at the end of a complete step near the start of the next step. Current imaging techniques allow doctors to view a variety of endoscopic procedures. However, techniques and devices must be designed to allow visualization. Additionally, and where visualization is important for the completion of the technique, it is important that the physical feedback is combined with the visual feedback to ensure redundancy in case visualization is not possible.

As such, the present suture device is provided with a variety of indicators for both physical and visual identification of the procedure being performed. Briefly, and as will be discussed in more detail below, the present endoscopic suture device includes means for identifying the position of the needle along its path, both locally in the surgical field and externally in the drive mechanism. In addition, the endoscopic suture device includes a secondary mechanism designed to stop the needle at the end of a complete actuation to indicate to the user that it is the appropriate time in the sequence to reposition the device for subsequent actuations.

More particularly, and according to the various modalities described below, the surgical suture apparatus includes a suture housing and a needle mounted within the suture housing to perform the movement around an arcuate path. A drive set operatively associated with the needle to control the movement of the needle with a suture attached to it around the arcuate path in order to facilitate the application of the suture to the tissue. A mechanism is provided to determine the position of at least one distal end of the needle and the proximal end of the needle at all points along the arcuate path around which the needle moves.

Referring to figure 32, the endoscopic suture device 1610 includes a flexible spherical lock 1670 shaped and sized to provide an indication of the physical position of the needle 1628. According to a preferred embodiment, a small spherical support 1672 is oriented by spring 1674 inside of the 1628 entry needle path to stop its movement at the end of its path. The spherical support 1672 is mounted within the suture body 1614 to access and contact the outer surface of the needle 1628. The spherical support 1672 is spring oriented 1674 towards the outer surface of the needle 1628. As such, when the needle 1628 is moved along its arched path and contacts the 1672 ball support, tactile feedback is provided to the user. The needle 1628 is provided with a recess 1676 along its outer surface (preferably adjacent the tip of the needle, although multiple recesses may be employed at various locations along the length of the needle to provide physical indications of the needle position). The recess 1676 is shaped and sized to allow the spherical support 1672 to sit within it when the recess of the needle 1676 comes into alignment with the spherical support 1672 providing the user with the tactile feedback of the positioned needle 1628. According to a preferred embodiment, the spherical support 1672 is positioned adjacent to the entry point for needle 1628 as it begins to loop and the recess 1676 of needle 1628 is formed along it in a position so that the operator be provided with an additional tactile feedback that a complete loop of the needle has been achieved.

It is contemplated that the spherical support can be used in combination with a meat disposal mechanism to move it out of the way for the next step to occur or it can be used in a restraining force that only applies the return to the user informing that the end of a step has been reached, but can be overcome by the user by applying more force.

In accordance with an alternative embodiment, and with reference to figure 33, a flexible toothed claw lock 1770 is oriented to interfere with the movement of the needle 1728 to identify the position of the needle 1728 and the completion of a loop of the needle. More particularly, a claw lock lever 1772 is attached along the leading end of the needle path to contact needle 1728 to provide a physical indication as to the position of the 1728 needle. The lock lever arm claw 1772 is attached along the front end of the needle path to contact the 1728 needle to provide a physical indication. The claw lock lever 1772 includes a first end 1774 and a second end 1776. The first end 1774 of the lever arm 1772 is pivotally attached to the suture body 1714 of the suture device 1710. The second end 1776 of the lever arm 1772 SE extends towards and comes into contact with the outer surface of the 1728 needle. The lever arm 1772 is oriented so that when the needle 1728 is moved in a counterclockwise direction, the lever arm 1772 slides over the outer surface of the needle 1728.

However, and with this previous embodiment, the outer surface of the needle 1728 is provided with a recess 1778 along its outer surface. The recess 1778 is shaped and sized to allow the second end 1776 of the lever arm 1772 to sit

I within it when the needle recess 1778 comes into alignment with the second end 1776 of the lever arm 1772. As mentioned above, and according to a preferred embodiment, the lever arm 1772 is positioned adjacent to the entry point for the needle

1728 as its loop begins and the 1778 recess of the 1728 needle is formed along it in a position so that the operator is provided with a tactile feedback that a complete loop of the needle has been achieved.

Referring to Figures 34, 35, 36, and 37, the suture apparatus 10 includes an output pin 1870. Pin 1870 is shaped and sized to exit the side of suture body 1814 when needle 1828 is in position providing the surgeon with visible feedback on the position of the 1828 needle within the surgical site of the endoscope. Once needle 1828 is fully advanced, pin 1870 is spring-loaded to the hidden position or position indicating that the 1810 suture is ready for repositioning (see figures 34 and 35). The visualization of the same is provided by the coloring of the exposed part 1871 of the pin 1870 in a different color to allow the immediate identification that the needle 1828 is positioned in a desired orientation.

More particularly, the pin 1870 is spring oriented within an opening 1872 formed in the wall of the suture body 1814. The pin 1870 is oriented to a hidden position and includes a first end 1876 and a second end 1878. The first end 1876 is positioned to contact the needle 1828 as it moves along its arcuate path, while the second end 1878 is positioned adjacent to the outer surface of opening 1872 for movement between a hidden position and an exposed position. With this in mind, the second end 1878 of the 1870 pin is colored in a different way allowing its immediate visualization.

The movement of pin 1870 is facilitated by the movement of needle 1828 in contact with the first end 1876 of pin 1870. In particular, the first end 1876 of pin 1870 is seated within the path of needle 1828, although it is shaped and sized to move promptly once the 1828 needle moves to make contact with it (without unduly interfering with the movement of the needle as it makes its arcuate path).

According to another embodiment and with reference to figure 38, the needle 1928 is colored to provide a ready view of it. More particularly, the 1928 needle is made with colors contrasting with the surgical field to improve the surgeon's visibility to identify where the 1928 needle is currently positioned. According to a preferred embodiment, the 1970 tip is colored with a contrasting color to provide immediate identification that the needle is leaving the suture body.

With reference to figure 39, another additional embodiment is described. According to this modality, the position of the 2028 needle is calibrated with a 2070 indicator attached to the handle of the 2010 suture device. It is contemplated that the 2070 indicator may consist of several standardized semi-spherical lights, a disc indicator or other indicator circular path. According to this modality, the 2014 suture body is supplied with one or more Hall effect 2074 sensors working in conjunction with the 2028 needle to provide the operator with an indication of the position of the 2028 needle. As the steel or steel needle magnetized 2028 passes adjacent to the three sensors 2074 illustrated in figure 39 the system turns on the appropriate indicator lights for the needle position 2070 in loop 2072. Although Hall effect sensors are described according to a preferred embodiment of the present invention, other electronic means known to those skilled in the art can be used within the spirit of the present invention. For example, sensors can be spring-oriented mechanical switches, or even inductance or extremely low voltage contact switches that contact the needle itself by making contact with both sides of the switches (one placed on each side of the needle rail) .

The improved functionality of the present suture apparatus is achieved by providing a mechanical fixation mechanism specifically adapted for fixing the vacuum chamber and suture body to the endoscope end, allowing for the rotational positioning of the endoscopic suture device with respect to the endoscope. The various modes described below provide a mechanical fixing mechanism that secures the vacuum chamber and the suture body to the endoscope end, allowing flexible positioning of the vacuum chamber and suture body away from the endoscope to increase pocket visibility . According to an embodiment described below, the mechanical fixation mechanism includes a flexible connecting arm that dismounts against the endoscope during insertion to perform a low profile insertion, but then flexes away from the endoscope once inside the body to improve the visibility of the vacuum chamber and the suture body for positioning and unfolding the suture.

According to another embodiment, the mechanical fixation mechanism secures the vacuum chamber and the suture body at the end of the endoscope through the use of a detachable mechanism that can be removed and passed into a body cavity before the endoscope is introduced. , or to exchange the suture apparatus with another suture body or even another endoscopic device. This can also allow for the exchange between a vacuum-assisted suture device and an unassisted device.

The mechanisms provide a unique method for accessing a body cavity through a natural or surgically initiated orifice. In particular, the present invention provides a method of inserting a suture device, or other surgical instrument, through a hole in the body. The instrument has a low profile orientation and an unfolded orientation that is larger than the size of the body hole through which it must be inserted. The method is achieved by attaching the instrument to an endoscope and placing the instrument in its low profile orientation, inserting the endoscope and the instrument through a natural hole to a target position within a body, while the instrument is in its position. low profile orientation, and turning the instrument on for its unfolded orientation. Finally, the instrument is returned to its low profile orientation and removed from the body through the natural orifice.

With reference to figure 40, a first embodiment according to the present invention is described. In accordance with this embodiment, a scope fixing ring 2170 is attached around the distal end 2172 of the endoscope 2174 on which the present suture apparatus 2110 is to be mounted. The fixing ring 2170 generally includes a ring body 2176 having parallel openings 2178, 2180 shaped respectively for receiving the endoscope 2174 and the support shaft 2182 of the present suture apparatus 2110 to which the suture body 2114 and the vacuum chamber 2146 are fixed. With respect to the endoscope 2174, the first opening 2178 is shaped to engage frictionally with the outer surface of the endoscope 2174 in order to prevent rotation of the fixing ring 2170 with respect to the endoscope 2174.

The second opening 2180 is shaped and dimensioned to receive the axis 2182 of the suture device 2110, and according to a preferred embodiment thereof, the second opening 2180 is slightly larger than the axis 2182 of the suture device 2110. Thus, the 2110 suture apparatus can be rotated with respect to the 2174 endoscope for optimum access to tissue. The positioning of the suture device 2110 with respect to the fixing ring 2170 is achieved by the positioning of the support elements 2184, 2186 along the axis 2182 of the suture device

2110 on opposite sides of the fixing ring 2170. These elements 2184,

2186 can be coupled to the 2182 shaft using screw threads during manufacture, pressed in place during manufacture or molded as part of the clamping ring itself. In this way, the suture apparatus 2110 can be rotated freely with respect to the endoscope 2174 while the suture apparatus 2110 is substantially prevented from performing the longitudinal movement with respect to it.

According to another embodiment and with reference to figures 41, and 43, an endoscope fixing ring 2270 similar to the one described above is attached around the distal end 2272 of endoscope 2274 to which the present suture apparatus 2210 is to be mounted. The fixation ring 2270 generally includes a ring body 2276 having parallel openings 2278, 2280 shaped respectively for receiving the endoscope 2274 and the present suture shaft 2282. With respect to endoscope 2274, opening 2278 is shaped for friction engagement with the outer surface of endoscope 2274 in order to prevent rotation of the fixing ring 2270 with respect to endoscope 2274.

As for the second opening 2280 receiving the shaft 2282 of the suture device 2210, and according to a preferred embodiment thereof, the second opening 2280 is almost the same size as the shaft 2282 of the suture device 2210. Thus, the Suture 2210 is prevented from rotating with respect to endoscope 2274 allowing elastic unfolding out of the endoscope 2274 to allow for better viewing. The positioning of the suture apparatus 2210 with respect to the fixation ring 2270 is achieved by the positioning of the support elements 2284, 2286 along the axis 2282 of the suture apparatus 2210 on opposite sides of the fixation ring 2270. In an alternative embodiment, the fit between the endoscope fixing ring and the elastic arm can be a loose fit as discussed above with respect to the modality illustrated in figure 40, allowing it to be freely rotated with respect to the endoscope while the suture device endoscope is substantially prevented from performing the longitudinal movement in relation to it.

Improved access to the suture apparatus is further facilitated by manufacturing the shaft 2282 distally from the second opening 2280 of the fixing ring 2270 from a flexible material that is oriented to a position removed from the endoscope 2274. In this way, the 2210 suture device can be kept close to the 2274 endoscope during insertion, reducing the profile of the structure being inserted transorally, while allowing the 2210 suture device to move away from the 2274 endoscope when the 2210 suture device reaches its desired location.

More particularly, the part of the shaft 2282a providing the flexing of the suture body away from the endoscope 2274 is an elastomeric lever arm designed to move the suture apparatus 2210 outwardly to the geometric axis of the endoscope 2274 in order to optimize the view of the apparatus suture 2210 and its use while still allowing it to deform against the endoscope during insertion and extraction, reducing its overall profile during these activities.

According to an alternative embodiment of the present invention and with reference to figures 41a and 42a, the fixing ring 2270a can be constructed with a connecting element 2283a extending distally from the second opening 2280a. The connection element 2283a is an elastomeric lever arm designed to move the suture device 2210a, with the axis 2282a extending through connection element 2283a out of the geometric axis of the endoscope 2274a in order to improve the visualization of the suture device 2210 and its use while still allowing it to deform against the 2274a endoscope during insertion and extraction, reducing its overall profile during these activities.

As briefly mentioned above, the connecting element 2283a is shaped and dimensioned to fit around the axis 2282a of the suture apparatus 2210a. Connector 2283a is constructed from resilient material and is oriented to a position removed from the endoscope 2274a. In this way, the connecting element 2283a with the shaft 2282a of the suture apparatus 2210 extending through it can be kept close to the endoscope 2274a during insertion, reducing the profile of the structure being inserted transorally. However, once the suture body 2214a is positioned within the body cavity, the connecting element 2283a is released, allowing it to extend away from the endoscope 2274a. Since the shaft 2282a of the suture apparatus 2210 is positioned within the connecting element 2283a, the shaft 2282a and the suture body 2214a are moved away from the endoscope 37 by 2274a as the connecting element 2283a moves away from the endoscope 2274a.

In addition to the various modalities discussed above and with reference to figures 44, 45 and 46, it is contemplated that a 2470 guide wire introducer for a 2410 suture apparatus can be employed. Such a device is used in combination with a detachable vacuum chamber 2446 suture body 2414 detailed above. The distal end components, that is, the vacuum chamber 2446 and the suture body 2414 are passed, for example, through the oral cavity in front of the endoscope 2472 and subsequently fixed to the endoscope fixing ring 2474 using a guide wire 2470 which is pulled through a support shaft 2476 in order to pull the suture body 2414 and the vacuum chamber 2446 onto the support shaft 2476. The endoscope 2472 itself can be used to advance the detached vacuum chamber 2446 and a suture body 414 down into the oral cavity. The pre-positioned guide wire 2470 within the working channel of the endoscope 2472 is terminated at its distal end 2471 by connection with the vacuum chamber 2446 and suture body 2414. Once passed into the stomach, vacuum chamber 2446 and suture body 2414 are pulled back attached to the distal end of endoscope 2472 and to a support shaft 2476 by pulling suture body 2414 and vacuum chamber 2446 from coupled with endoscope 2472 through the action of guide wire 2470 to which vacuum chamber 2446 and suture body 2414 are connected. This allows the use of a vacuum chamber 2446 and suture body 2414 that are larger in width and thickness than could be passed in fixation with the endoscope during insertion.

As an alternative modality, the vacuum chamber can be used interchangeably with non-vacuum equipment that looks similar or identical to the vacuum version, but does not use vacuum to position the tissue and is merely based on the placement of the chamber adjacent to the tissue to be sutured. This dramatically reduces the bite size, but it also reduces the possible trauma to the tissue that the vacuum of the tissue into the pocket can cause.

In particular, there are some procedures that would preferably be used without a vacuum assisting the retraction of the tissue into the vacuum chamber, but instead would merely launch the suture with the minimum bite depth of the tissue. There are even clinical situations in which the vacuum could induce tissue damage. An interchangeable vacuum layer that has a different depth of cavity and profile can be used with the suture device without a vacuum aid.

A quick loop disconnect is also contemplated in accordance with the present invention and is illustrated with reference to figures 47, 48, 49, 50 and 51. This accessory can be used in combination with or separately from the guide wire introducer as described above. Briefly, this modality employs a 2524 suture housing, a needle

2528 mounted within suture housing 2524 to perform movement around an arcuate path, a drive assembly operatively associated with needle 2528 to control movement of needle 2528 with a suture attached to it around the arcuate path to facilitate the application of the suture to the fabric, a 2570 loop, an elongated flexible element, for example, a drive cable 2542 having a distal end attached to the suture housing 2524 and a proximal end attached to loop 2570, and a mechanism for releasing and retracting loop 2570 for flexible element 2542.

The use of a quick loop disconnect facilitates distal detachment and pre-passage of the suture device 2510 through the selective attachment and release of the handle 2570 of the flexible drive cable 2542 to which the suture body 2514 and the vacuum chamber 2564 are connected. According to this modality, the driving cable 2542 can function as the guide wire previously discussed allowing the suture body 2514 and the vacuum chamber 2546 to be passed to the position before complete assembly. This improvement allows the suture device 2510 to be previously passed from the distal end of the endoscope in order to reduce the necessary profile since the suture device 2510 is positioned distally with respect to the endoscope during its passage instead of passing the suture device 2510 of the proximal end of the endoscope in order to increase the necessary passage since the profile must accommodate both.

More particularly, the handle 2570 consists of a handle body 2574 to which the drive cable 2542 is releasably secured for actuation. With this in mind, the handle body 2574 includes a central passage 2578 in which the drive cable 2542 is stored and assembled. The handle body 2574 consists of a central grip 2580 and a sliding element 2581 that moves with respect to the central grip 2580 in a manner discussed in more detail below. The central passage 2578 includes a first open end 2582 and a second closed end 2584. Adjacent to the second closed end 2584 there is a spring loaded trigger lock 2586 attached to the central grip

2580. The trigger lock 2586 is shaped and sized to engage a 2594 protrusion (for example, a bullet nose tip) along the proximal tip 2588 of the 2542 drive cable. In this way, the proximal end 2588 of the drive cable 2542 is mounted within a recess 2590 at the proximal end 2592 of the passage 2578 and within the central grip 2580 (for centralization purposes), and the trigger lock 2586 is moved downwards in engagement with the protrusion 2594 for maintaining the 2576 drive cable inside the 2574 handle body. When it is desirable to remove the handle 2570 from the drive cable 2578, it is only necessary to activate the trigger lock 2586 to its release position and the handle body 2574 can be removed freely from the drive cable 2542. Retention of the cable from drive 2542 within the handle body 2574 is further facilitated by the inclusion of a locking slide 2596 along the slide element 2581. The locking slide 2596 interacts with a frictional collar 2598 formed in the drive cable 2542 to retain the handle body 2574.

In practice, the distal end of the drive cable 2542 is inserted into the passage 2578 formed in the sliding element 2581. The drive cable 2542 is inserted so that the collar 2598 of the drive cable 2576 is aligned with the openings 2583 formed at the along the sliding element 2581. At that point, the locking slide 2596 is slid along the sliding element 2581 and is moved through collar 2598 in engagement with it. The drive cable 2542 is then attached to the sliding element 2581. The sliding element 2581 is then moved proximally with respect to the central grip 2580 until the proximal end 2588 of the driving cable 2542 is seated within the formed recess 2590 in the central grip 2580. The trigger lock 2586 is then spring-loaded to engage the protrusion ⁴ 2594 at the proximal end 2588 of the drive cable 2542 to secure it to the central grip 2580 and handle body 2574.

Once the handle 2570 is attached to the drive cable 15 2542, its release is achieved by reversing the fixing steps discussed above. In particular, trigger lock 2586 is rotated forward to allow release of protrusion 2594 from within the recess

2590 of the central grip 2580.

As discussed above, the present loop 2570 allows the drive cable 2542 to be operated in order to operate the present suture apparatus 2510. In particular, the relative movement of the central grip 2580 and the sliding element 2581 while the drive cable 2542 is seated inside the central grip 2580 causes it to be activated, allowing the drive assembly to function as described above.

Although the selectively releasable connection is described above with reference to the handle of a suture apparatus, it is contemplated that the releasable connection can be applied in a similar way to the selective connection of the suture body to the shaft connecting the suture body to the loop. In this way, the suture body can be selectively connected to the shaft once the suture body is positioned within the body cavity and ready for use in applying a suture to the tissue.

Desirable vacuum pressure in different operating rooms

I varies a lot from place to place. Improvements to the vacuum chamber by minimizing the required vacuum required were discussed above. However, such structural changes may not be sufficient to ensure that the present endoscopic suture device can be used anywhere.

The modalities detailed here are improvements to the handle to locally increase the vacuum in the vacuum chamber.

Each of these modalities provides an endoscopic instrument, for example, a suture device, adapted for use with an endoscope. The instrument includes an elongated tube having a distal end and a proximal end, an end effector, for example, the suture body of the suture apparatus, attached to the distal end of the elongated tube, and a loop attached to the proximal end. The handle includes a mechanism for attaching the instrument to a first vacuum source. The handle additionally includes a second integral vacuum source with the handle to amplify the first vacuum source, where the first and second vacuum sources combine to operate the end effector.

With reference to figure 64, this problem is solved by providing a vacuum aid device for handle based on 2970 syringe. According to a preferred embodiment of the present invention, a 2972 ​​syringe mechanism is placed in parallel with the fixation main vacuum unit 2973 of the 2910 suture apparatus. This allows the normal operating room vacuum source to be used to achieve as much as possible, if additional vacuum is still needed to obtain a good bite of the tissue, the 2972 ​​syringe mechanism can be pulled by the surgeon to increase the vacuum in the 2946 vacuum chamber. Since the vacuum source normally available in the operating room is the primary mechanism for pulling tissue into the 2946 vacuum chamber, the volume required in the 29972 syringe mechanism is minimized as the tissue will already be engaged in the 2946 vacuum chamber , although not until its total depth. An additional benefit of this method of assisting an operating room vacuum source is that fluids will have been evacuated from the 2946 vacuum chamber by the normal or primary suction means of the operating room and the 2972 ​​syringe mechanism will not be filled with body fluids.

According to another embodiment, and with reference to figure 65, a 3070 battery powered 3070 multi-step vacuum assist device for suction drive is provided. The vacuum assisted device 3070 includes a rotary fluid pump 30722 (lobe pump, gear pump, peristaltic pump, etc.) to be used with multiple steps to increase the maximum volume of gases that can be extracted from the vacuum chamber afterwards that the primary vacuum source in the operating room is fully engaged. This has the same benefits as the syringe-based system, but provides the ability to exchange a larger volume of gas.

Similarly, and with reference to figure 66, a 3171 battery operated disposable vacuum pump 3171 is associated with a disposable deployment handle 3172 used in conjunction with the present 3110 suture apparatus. As the multi-step mechanical mechanism detailed above , a 3170 battery operated, battery operated disposable fluid pump is included in handle 3172 to supplement the vacuum available from the operating room.

Although figures 65 and 66 describe systems that are automatically activated to create a secondary vacuum source, figure 67 describes a 3070a trigger system. Trigger 3074a employs trigger handles 3076a in conjunction with a gear arrangement 3078a to drive a fluid pump, for example, a single lobe fluid pump 3072a. As with the previous embodiments, actuation of trigger 3074a and fluid pump 3072a increases the maximum volume of gases that can be extracted from the vacuum chamber after the primary vacuum source in the operating room has been fully engaged. This has the same benefits as the syringe-based system and the automated system, but provides manual override providing greater control by the surgeon.

It is further contemplated that the vacuum assistance can be created by means of a clamping element with a single-way valve or an accordion-type mechanism with a single-way valve or a secondary suction line. In addition, an inactive fin 3271a can also be incorporated to provide intermittent vacuum assistance (see figure 68).

As discussed above, visualization of the 3510 suture apparatus is often critically important for its proper use. With that in mind, the 3510 suture device can be modified to optimize imaging. In particular, apparatus 3510 includes a flexible element 3516, for example, a support shaft or endoscope, having a distal end attached to a suture body 3514 for insertion of suture body 3514 through an orifice and into a cavity of body. The suture body 3514 includes a suture housing 3524 in which a needle 3528 and drive set are housed to effect movement of the needle 3528 with a suture attached thereto around an arcuate path facilitating the application of the suture to the tissue. A 3570 non-visible spectrum sensor element is associated with the 3514 suture body for communicating a procedure parameter for a visual display 572. According to a preferred embodiment, the non-visible spectrum sensor element is connected wirelessly to the visual monitor.

For example, it is contemplated that the 3510 suture device can be modified by implementing 3570 ultrasonic transducers in the 3514 suture body (see figures 83 and 84). Similarly, the 3510 suture apparatus can be modified by the inclusion of a magnetic resonance imaging source transducer based within the suture body or vacuum chamber to create images of the suture site. Additionally, it is contemplated that the endoscopic suture device can be modified with the inclusion of an infrared-based imaging sensor inside the suture body or vacuum chamber to assess blood flow to the sutured area after the suture unfolds. or to identify areas rich in blood in the inner lining prior to folding the suture to visualize blood flow. The endoscopic suture device can also include sensors based on Doppler Laser, oxygen, or carbon dioxide located within the suture device to assess blood flow characteristics before or after the suture line is deployed.

These various visualization techniques provide the creation of a non-visible image (outside the normal visible spectrum) integrated in the suture apparatus to optimize the visualization of the site during the suture. As mentioned above, the mechanisms contemplated can be ultrasonic, infrared, MRI, Doppler Laser, oxygen and carbon dioxide sensors or another sensor system. Additionally, the sensors provide means of visualizing tissue penetration for visualizing the geometry location of the surrounding organ and means of visualizing tissue penetration for visualizing the depth of the unfolding of the suture and the size of the bite.

Referring to Figure 85, a cartridge 3670 for loading 3628 needles and 3612 sutures of different sizes is described. According to a preferred embodiment, a refillable cartridge 3670 is capable of loading needles of different sizes 3628 and sutures of different sizes 3612. The cartridge 3670 is shaped and sized for prompt fixation within the channel 3672 in which the needle 3628 is mounted according to the described mode. In particular, the suture body 3614 is provided with a cover 3674 providing access to and closure of the channel 3672 in which the needle 3628 is located. By implementing a cartridge-based system the detachable cartridge 3670 can be removed and replaced with a new needle 3628 and suture 3612 or even a different size of needle or suture.

According to a preferred embodiment, needle 3628 is supported on a rail element 3676, which readily rests within channel 3672 to create an assembly substantially similar to that described above with reference to figures 3 to 10.

The cartridge-based system can be additionally adapted to allow adjustment of the needle size through a simple cartridge replacement. In particular, and with reference to figure 86, the rail 3780 of the cartridge 3770 is provided with a spacer wedge 3782 occupying the space lost with the inclusion of a smaller needle 3728. The spacer cuff 3782 is shaped and sized to interact with the friction meat element 3738 in order to allow the 3710 suture apparatus to operate in accordance with that spirit of the present invention.

While a cartridge-based system is described above, the suture body of the suture apparatus can be designed to allow simple needle replacement only. With reference to figures 87 and 88, this is achieved by providing a 3814 opening suture body. Instead of having a cartridge-based refill, this refill mode merely controls the 3828 needle and the 3812 suture, performing the rapid loading of a device without a removable section. The 3828 needle will be attached to the 3870 reloader via a 3872 fastener that will be released or easily broken and the 3812 suture will be held in the 3874 manual section 3874. This facilitates the handling of the 3828 needle without directly touching it and provides some form suture management before being loaded into the 3828 suture apparatus.

One of the difficulties in performing endoscopic procedures is the efficient and safe formation of knots once the suture is completed. It is desirable that the two ends, or threads, of the suture can be pulled tightly simultaneously and a knot-forming element can then be used to tighten the adjacent ends. This maximizes the number of stitches that are performed before the suture needs to be tightened downwards as both ends of the suture can be pulled so as to squeeze both ends of the suture equally.

According to a preferred embodiment of the present invention, a suture is secured by inserting the suture through a passage entering a patient's body. The suture is then released into and out of the tissue. Finally, a knot is tied along the length of the suture in order to hold the suture in place. The knot is then fused by applying energy by mechanically connecting the first and second suture threads forming the knot. According to a preferred modality, the term “fusing” refers to any technique by which the suture and / or lashing element is joined in a way in which its material components are fixedly connected.

According to the preferred embodiments of the present invention, knot tying is achieved in a number of ways, where the first and second threads are tangled in order to keep the threads relative to each other. As such, those skilled in the art will appreciate that a variety of mooring techniques can be used in accordance with the present invention. For example, a traditional tying technique can be used in which the first and second sutures are tied in a mechanical knot which is subsequently fused.

According to a preferred embodiment, and with reference to Fig. 62, a suture hook device 2710 is described for tying the first and second threads 2730, 2732 of a suture. The hook device 2710 uses two parts to lock the closed suture together, the advantage of this method is that the cover 2712 has two extension arms 2714, 2716 that allow it to be twisted around its geometric axis by wrapping the intermediate lengths suture 2718 on its axis. The cap 2712 would then be broken into the outer collar 2720 locking the ends of the suture 2718. This would allow fine tensioning just before the locking of the suture.

More particularly, the suture hook device 2710 includes an outer collar 2720 and a cap 2712 shaped and sized to fit within the outer collar 2720. The outer collar 2720 is generally cylindrical and includes an open top edge 2722 and a closed base 30 of 2724 The cover 2712 includes an upper disk 2726 and a downwardly pending central axis 2728. The upper disk 2726 is shaped and sized to fit within the open upper edge 2722 of the outer collar.

2720 so that it is retained by friction within it, the central axis 2728 is smaller and acts as a guide for the suture 2718 wrapped around it.

The cap 2712 additionally includes extension arms extending downwardly opposing 2714, 2716. These arms 2714, 2716 provide wrapping of suture 2718 around cap 2712 by rotating cap 2712. Since suture 2718 is wrapped around of the cover 2712, the disk 2726 is fixed inside the external collar 2720, securing suture 2718 in a “knotted” arrangement.

Although several mechanical knot tying techniques are described above, it is contemplated that other fastening techniques can be used without departing from the spirit of the present invention. For example, and with reference to figure 63, the fusion of the tied suture is preferably achieved by RF, ultrasound or electro cauterization for fusion of the 2810 suture knot to improve the knot retention capacity. This method would allow a normal endoscopic knot to be tied adjacent to the area of ​​tight tissue. But since it would have a tendency to loosen, a source of energy (cauterization, ultrasound, RF or other heat source) will then be applied to the knot to fuse it.

The loop pattern, the method of tightening, and the means of anchoring the suture all contribute a lot to facilitate the use of the device. With that in mind, several suturing techniques have been developed. The present description should detail at least the preferred loop method and an alternative anchoring method for tightening both ends simultaneously.

According to the various loop techniques described below, the present method is achieved by providing a suture with a needle attached to it. The suture includes a first thread and a second thread. The needle and suture are then inserted into an organ via a passage. A single stitch is looped through a first element of fabric and a single stitch is looped through a second element of opposite and spaced fabric. The stitching step is repeated at least once and the first and second tissue elements are brought into contact by tensioning the suture, where suture dredging is minimized during tensioning and substantially homogeneous tissue compression is achieved. Finally, the suture is attached and positioned with the first and second tissue elements in position.

According to a first embodiment illustrated in figure 52, the resistance to tightening of a stitched suture 4212 is achieved through a loop inversion pin technique. The technique is initiated using traditional sewing techniques. That is, the needle and suture 4212 are inserted and alternating stitches are thrown along the opposing fabric elements 4274, 4276. The stitches are thrown consistently in the direction from proximal to distal, that is, the stitch is initiated by inserting the needle through the tissue proximally to the point at which the stitch of the needle is completed by re-entering the tissue. Although the terms distal and proximal are used in the present description, those skilled in the art will appreciate that these terms are relative and ultimately the specific direction of the point can be inverted without departing from the spirit of the present invention.

However, the final loop 4270 of suture 4212 (i.e., the final loop or last stitch of the suture through the tissue) is changed to reduce friction during the final tightening of suture 4212. More particularly, and according to a preferred embodiment of the present invention, dredging and friction is reduced by positioning a reversing pin 4272 between suture 4212 and the wall of fabric 4274 after the last stitch 4270 has been completed. This allows suture 4212 to be tightened without overlapping and twisting. Such an arrangement will significantly reduce the friction required to overcome and tighten close to the loop.

According to another embodiment, and with reference to figure 53, the resistance to tightening of a stitched suture 4312 is achieved through an inverted and overlapping loop technique. The technique is initiated using traditional sewing techniques. That is, the needle and the suture

4312 are inserted and alternating stitches are thrown along opposite tissue elements 4374, 4376. Stitches are thrown consistently in the proximal to distal direction, that is, the stitch is initiated by inserting the needle through the fabric proximally to the point at which the needle point is completed by re-entering the tissue. That is, the 4312 needle and suture are inserted and alternating stitches are thrown along opposite tissue elements. The stitches are thrown consistently in the direction from proximal to distal, that is, the stitch is initiated by inserting the needle through the fabric proximally to the point at which the stitch of the needle is completed by reentering the fabric. However, the final loop 4370 of suture 4312 is reversed to reduce friction during the final squeeze of the suture; that is, the final loop 4370 is completed by inserting the needle through the fabric in a direction distal to the point at which the needle point is completed by reentering the fabric.

More particularly, the end point 4370 is inverted in the direction in which it is looped so that it is directed to the position from which the surgeon will be pulling the suture line to tighten suture 4312. This allows the suture to be tightened without overlap and twist. Such a provision will significantly reduce the friction necessary to overcome and close the loop.

According to an alternative embodiment, and with reference to figure 54, an initial locking loop 4470 is employed to improve the ability to tighten suture 4412 after the seam is completed. In particular, a first thread 4412a of suture 4412 is anchored to the tissue along the first thread 4412a of the suture line rather than requiring that both ends be accessed by the user throughout the procedure. More particularly, the first thread, or front thread 4412a, of the suture line is sewn and a part of it is anchored in the fabric. After that the seam is completed, with the end point 4470 and the second thread, or rear thread, 4412b of the suture line being accessed to tighten them. However, in contrast to traditional tightening techniques, the second thread 4412b of the suture line needs to be pulled to tighten suture 4412. As illustrated in figures 52 and 53, such initial locking can be used with other loop techniques within the spirit of

I.

the present invention.

It is contemplated that each set of sutures can be tightened locally before the next set is unfolded from the suture apparatus. This minimizes, but does not eliminate, the need for the last sewing steps discussed above.

As illustrated in figures 55 to 61, the prior art for looping opposing fabric elements can be expanded in a number of ways. For example, and with reference to figure 55, suture 4512 can be applied to separate segments 4513 with the first and second ends 101212, 4512b of each segment 4513 anchored to the respective first and second fabric elements 4574, 4576. The first end 4512a of suture 4512 is subsequently tensioned and tied to tighten the suture. By using segments of stitches in this way (as discussed below according to other modalities), the local tightening of each segment of stitches can be performed in a way that can assist in perfecting the fabric union.

Referring to Figure 56, fabric 4612 can be applied to separate segments 4613 with the first and second ends 4612a, 4612b of suture 4612 coupled via a tie element20 per knot 4614. The first and second ends 4612a, 4612b are subsequently tensioned to tighten suture 4612 and the knot tie element 4614 and suture 4612 are fused to hold the suture in position.

With reference to figure 57, suture 4712 is again applied to separate segments 4713. The first end 4712a of suture 4712 is provided with a loop 4716 through which the remaining part of suture 4712 is passed to couple the first end 4712a from suture 4712 to a first fabric element 4774. As for the second end 4712b of suture 4712, it is secured via a knot tie element 4714 as discussed above. More particularly, the second end 4712b is attached to the knot anchoring element 4714 with a loop forming structure consisting of a first loop ί

4718 which is coupled to the knot anchoring element 4714, while a portion of the second end 4712b passes through the second fabric element 4776 to form a second loop 4720, the end of which is also coupled to the knot anchoring element 4714. Thereafter, the second end 4712b can be tensioned, in particular, the first loop 4718 can be pulled through the knot binding element 4714 and the knot binding element 4714 and suture 4710 are fused to hold suture 4710 in position.

With reference to figure 58, suture 4812 is applied to separate segments 4813 with the first and second ends 4812a, 4812b of suture 4812 coupled through a tie element by knot i 4814. However, the final loop 4870 of suture 4812 is reversed as discussed above with respect to figures 53 and 54. The first and second ends 4812a, 4812b are subsequently tensioned to tighten the seam 4812 and the knot binding element 4814 and suture 4812 are fused to hold suture 4812 in position.

With reference to figure 59, suture 4912 can be applied to separate segments 4913 with the first and second ends 4912a, 4912b of each segment 4913 anchored to respective first and second fabric elements 4974, 4976. However, each loop of suture 4912 it is inverted as discussed above with respect to figures 53 and 54, and extends in a distal to proximal direction as the suture is applied in the distal direction. The first end 4912a of suture 4912 is subsequently tensioned and tied to tighten suture 4912. With reference to figure 60, the same loop technique is applied with the exception of not being completed in the segments.

As illustrated in figure 61, an overhand knot 5022 can be used to secure the second end 5012b of suture 5012, while the first end 5012a of suture 5012 is anchored to the tissue.

According to the present invention, it is preferable to apply medical fluid / sealant to improve the ability of the suture lines to engage and retain the tissue. In particular, the suture line is subjected to substantial tension for a short period of time after its application, while the fabric applies substantial tension in its attempt to retain its original configuration. This usually takes 7 to 10 days after the surgery has been completed, and it is during that period of time that potential suture ruptures are most likely. With that in mind, and according to the description of the modalities, an adhesive, sealant, or medical fluid delivery mechanism can be used in conjunction with the present suture device to increase the short-term resistance of the stomach pouch by the joint by adhesive from the opposite fabric. A method of unfolding sealants or other medical fluids alters the rigidity properties of the tissue to improve the resistance of the gastroplasty suture by bonding the opposite tissue.

As such, and according to a preferred embodiment of the present invention illustrated in figure 69, adhesive 3210 is used to enhance the short-term strength of suture line 3213, that is, the tissue line held together through suture 3212 . A fluid unfolding mechanism is used to place a fluid sealant or adhesive line 3210 along suture line 3214 after suture line 3214 is completed to optimize the retention strength of the line. A thin layer adhesive or foamed adhesive (empty filler) or sealant 3210 can be used in conjunction with the 3212 suture.

According to an alternative embodiment, and with reference to figures 70, 71 and 72, suture 3312 is a hollow tube suture with periodic perforations 3314 along its length. Once suture line 3313 is finished, suture 3312 will be pumped in order to be filled with sealant or adhesive 3314 allowing it to be distributed along its length, increasing the effective suture diameter, minimizing suture migration beyond to provide a complementary bonding of the fabric in addition to the 3313 suture line.

With reference to figures 73 to 82, an additional embodiment is described. An extrusion with liquid polymer 3350 is used to form a sleeve 3352 around the inner bag 3353 formed, for example, in the stomach 3354. The entire interior of the small bag created by gastroplasty 3353 and some length of the intestines will be coated with polymer / adhesive 3350 . This not only improves the strength of the bag suture line, it also potentially creates some form of malabsorption supplement to the procedure that improves weight loss.

More particularly, and with reference to the various figures, a suction and delivery device 3356 is first inserted transorally into the stomach 3354. A vacuum is then created by joining opposite surfaces of tissue 3358, 3360 as illustrated in figures 73 and 74. Then Furthermore, the extrusion of liquid polymer 3350 is applied to the opposing tissue surfaces 3358, 3360 while the vacuum continues to be applied in order to keep the walls 3358, 3360 of the stomach 3354 in position. Eventually, the extrusion of liquid polymer 3350 will cure by keeping the tissue walls affixed 3358, 3360. Thereafter, and with reference to figures 9 and 80, the suction and application device 3356 according to the present invention can be removed and the internal stomach profile 3354 is reduced to a single passage that extends through it with a substantial part of the stomach closed against food absorption. Although the process described above does not employ sutures, the pouch can be certainly formed by suturing the opposite tissue with subsequent application of adhesives as described above.

While the preferred embodiments have been illustrated and described, it will be understood that there is no intention to limit the invention by such description, but instead it is intended to cover all modifications and alternative constructions that are within the spirit and scope of the invention. .

<img file="BRPI0704530A_D0007.tif" />