END-5417

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

APPUCATION FOR LETTERS PATENT

INVENTORS:

MarkS. Ortiz, William J. Kraimer, Dave B. Griff ith & Lynetta S. Freeman

TITLE:

GASTRIC INSTRUMENT SLEEVE WITH FIXATION MEANS

BACKGROUND OF TFE INVENTION

1. Field of the Invention

The present invention relates to an apparatus for facilitating transgastric surgery.

More particularly, the invention relates to a procedure and apparatus for the insertion

and placement of a guide tube used in providing a sterile and repeatable pathway for

the passage of endoscopic instruments to and through the gastric wall.

2. Description of the Prior Art

Endoscopic procedures have been rapidly developing over the past decade.

These procedures often allow for the performance of surgical procedures with minimal

trauma, when compared to prior techniques requiring large external openings to

expose the internal organs or tissue requiring repair.

In addition to the many areas in which endoscopic procedures have found use,

endoscopic procedures have recently been developed for surgical procedures relating

to the stomach. Among the endoscopic procedures relating to the stomach are

transgastric procedures in which the exterior surface of the stomach is accessed via the

esophagus.

However, the passage of endoscopic instruments through the esophagus, into

the stomach and through an otomy formed in the gastric wall is replete with

complications. For example, otomy creation is difficult and abrasions, tears, from the

endoscope rubbing against the esophagus may cause trauma. In addition, the gastric

contents may contaminate the peritoneum. The creation of a repeatable path for

endoscopic instruments is also difficult and fixation of endoscopic instruments is

problematic. Finally, the need occasionally arises for blind insertion of instruments

endoscopically. In such cases, the risk of trauma to the esophagus or of inserting the

instrument down the trachea is very high.

As such, a need exists for an apparatus and method facilitating transgastric

procedures. The present invention provides such a method and apparatus employing a

guide tube for the creation of a sterile barrier as an endoscope is passed from the

patients' mouth to the peritoneum.

SUMMARY OF TEiE INVENTION

It is, therefore, an object of the present invention to provide a transgastric

instrument providing a sterile and repeatable pathway to and through a gastric wall for

the purpose of facilitating endoscopic transgastric procedures. The instrument

includes at least one guide tube having a proximal end and a distal end, the distal end

being shaped and dimensioned for positioning adjacent a desired location along the

gastric wall. The instrument also includes a fixation mechanism at the distal end of the

guide tube for selectively securing the distal end of the guide tube at a desired location

along the gastric wall. An otomy creation device circumferentially smaller than the

guide tube extends through the guide tube, the otomy creation device including a distal

end shaped and dimensioned for cutting and dilating the gastric wall.

It is also an object of the present invention to provide a transgastric instrument

wherein the otomy creation device is an inner tube designed to cut through the gastric

wall.

It is another object of the present invention to provide a transgastric instrument

wherein the inner tube is positioned within the guide tube and the inner tube includes

a distal end shaped and dimensioned to penetrate the gastric wall.

It is a further object of the present invention to provide a transgastric

instrument wherein the distal end of the inner tube includes a bevel cut, sharpened tip

which appears as an oval in a front view.

It is also another object of the present invention to provide a transgastric

instrument wherein the distal end of the inner tube includes a bevel cut with a tip

which comes to a sharp tip at its most distal point.

It is still another object of the present invention to provide a transgastric

instrument wherein the distal end of the inner tube includes a hot wire.

It is yet another object of the present invention to provide a transgastric

instrument wherein the fixation mechanism is composed of a plurality of shape

memory rods.

It is also an object of the present invention to provide a transgastric instrument

wherein the rods curl as they are distally moved into the gastric wall to create a fixation

point within the gastric wall.

It is a further object of the present invention to provide a transgastric

instrument wherein the rods extend to a proximal end of the guide tube where they are

manually actuated.

It is also a further object of the present invention to provide a transgastric

instrument wherein the fixation mechanism is composed of opposed circumferential

balloons secured at the distal end of the guide tube.

It is also another object of the present invention to provide a transgastric

instrument wherein the fixation mechanism includes a distal fixation arm and a

proximal fixation arm.

It is a further object of the present invention to provide a transgastric

instrument wherein the distal fixation arm selectively pivots from a wall of the guide

tube.

It is still a further object of the present invention to provide a transgastric

instrument wherein the distal fixation arm is an elongated substantially rigid rod

extending along the length of the guide tube.

It is yet a further object of the present invention to provide a transgastric

instrument wherein the distal fixation arm includes an outwardly oriented protrusion

formed at a distal end of the distal fixation arm, and the protrusion is shaped and

dimensioned for engaging an exterior surface of the gastric wall upon deployment.

It is also an object of the present invention to provide a transgastric instrument

wherein the proximal fixation arm selectively pivots from a wall of the guide tube.

It is also another object of the present invention to provide a transgastric

instrument wherein the proximal fixation arm is an elongated substantially rigid rod

extending along the length of the guide tube.

It is another object of the present invention to provide a transgastric instrument

wherein the proximal fixation arm includes an outwardly oriented protrusion formed

at a distal end of the proximal fixation arm, and the protrusion is shaped and

dimensioned for engaging an interior surface of the gastric wall upon deployment.

Other objects and advantages of the present invention will become apparent

from the following detailed description when viewed in conjunction with the

accompanying drawings, which set forth certain embodiments of the invention.

Figure 1 is a cross-sectional view of the stomach with the present gastric

instrument sleeve in use.

Figure 2 is a detailed perspective view of a first embodiment of a fixation

mechanism in accordance with the present invention.

Figure 3 is a detailed view of the embodiment shown in Figure 2 with the

fixation arms extended.

Figure 4 is a detailed perspective view of the fixation mechanism employed in

accordance with a second embodiment of the present guide tube.

Figure 5 is yet another embodiment of the fixation mechanism utilized in

conjunction with the present gastric instrument sleeve.

Figures 6, 7 and 8 disclose a seal mechanism for use in conjunction with the

present gastric instrument sleeve.

Figure 9 shows a further embodiment of a seal mechanism that maybe utilized

in conjunction with the present gastric instrument sleeve.

Figures 10 and 11 disclose yet another embodiment of a seal mechanism which

maybe used in conjunction with the present invention.

Figures 12, 13 and 14 show various lumen constructions that maybe employed

in accordance with the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed embodiments of the present invention are disclosed herein. It

should be understood, however, that the disclosed embodiments are merely exemplary

of the invention, which maybe embodied in various forms. Therefore, the details

disclosed herein are not to be interpreted as limiting, but merely as the basis for the

claims and as a basis for teaching one skilled in the art how to make and/or use the

invention.

With reference to the various figures and the embodiments presented herein, a

procedure and apparatus for the insertion and placement of a guide tube(s) 10, 110,

210 is disclosed. The guide tubes 10, 110, 210 are used in providing a sterile and

repeatable pathway to and through the gastric wall 12 for the purpose of facilitating

endoscopic transgastric procedures. The guide tube(s) 10, 110, 210 includes a

proximal end 14, 114, 214 and a distal end 16, 116, 216. The distal end 16, 116, 216 is

positioned adjacent a desired location along the internal surface 18 of the gastric wall

12 in a manner described below in greater detail. Thereafter, various fixation

mechanisms 20, 120, 220 are employed in securing the distal end 16, 116, 216 of the

guide tube 10, 110, 210 at the desired location along the gastric wall 12.

As will be discussed below in greater detail, the fixation mechanism 20, 120, 220

may take a variety of forms. The figures presented herein disclose an apparatus

employing different fixation mechanisms within the same apparatus. However, the

apparatus used in practice maybe constructed with any combination of fixation

mechanisms without departing from the spirit of the present invention.

For example, and as will be discussed below in greater detail, the guide tube 10,

110 maybe formed with a plurality of radial extruded pathways 22, 122 containing

small diameter rods 24, 124, or splines, that are advanced distally out of the guide tube

10, 110 and inserted into the gastric wall 12 or other tissue in a controlled depth

manner. The rods 24, 124 can come out of the guide tube 10, 110 in a variety of

configurations including a shape memory alloy rod 124 which is straight in the

retracted state and when advanced distally curls into a loop while penetrating through

the mucosal layer of the stomach with its sharpened point (see guide tube 110). It is

further contemplated the rod 24 maybe constructed to pivot once it has penetrated

the gastric wall 12 in a manner preventing the rod 24 from coming back through the

gastric wall 12. While some rod designs will advance and penetrate into the mucosal

layer, and others will puncture through the gastric wall, the objective of the rod-based

coupling design is to provide fixation and to provide counter- traction when inserting

a dilating trocar inner tube through the gastric wall.

As will be discussed below in greater detail, fixation may also be achieved

through the utilization of opposed circumferential balloons 224 shaped and

dimensioned to trap the gastric wall 12 therebetween in a manner securing the distal

end 216 of the guide tube 210 to the gastric wall 12. In addition, and as those skilled

in the art will certainly appreciate, other fixation techniques may also be used without

departing from the spirit of the present invention.

As briefly mentioned above, the present apparatus also includes an otomy

creation device 26, 126, 226, for example, an inner tube designed to cut through the

gastric wall 12 for otomy creation. As with the disclosed fixation mechanisms, the

figures presented herein disclose a preferred apparatus, although those skilled in the art

will appreciate any combination of otomy reaction devices within the spirit of the

present invention. Regardless of the chosen embodiment, the inner tube 26, 126, 226

is circumferentially smaller than the guide tube 10, 110, 210 and includes a proximal

end and a distal end. The distal end is designed for penetrating the gastric wall 12 and

maybe provided with a variety of constructions. For example, it is contemplated the

distal end may have a bevel cut 28 with a modified tip which comes to a sharp tip at its

most distal point, a bevel cut, sharpened tip 128 which appears as an oval in a front

view, a tip construction which uses a hot wire 228 to cut the tissue (see Figure 4) or a

veress needle 222a embodiment (see Figure 1).

In addition to cutting through the gastric wall 12, the otomy creation device 26,

126, 226 dilates the otomy 30 as it passes through the gastric wall 12. This creates a

sterile pathway to pass an endoscopic instrument through the gastric wall 12 to the

peritoneum without contamination from gastric contents when used in conjunction

with the guide tube 10, 110, 210.

Referring to Figures 1 to 14, a preferred embodiment of the present invention is

disclosed. The present transgastric instrument includes a tubular main body 32 having

a plurality of lumens, that is, guide tubes 10, 110, 210, extending therethrough.

Referring to Figures 12 to 14, those skilled in the art will appreciate a variety of

different lumen shapes and structures maybe used within the spirit of the present

invention. The guide tubes 10, 110, 210 are ultimately coupled to the gastric wall 12

for the performance of transgastric procedures. In particular, the main body 32

includes a proximal end 34 and a distal end 36. At the proximal end 34 of the main

body 32, the plurality of lumens are maintained in a cohesive unit. The lumens,

however, ultimately diverge to define a plurality of separate guide tubes 10, 110, 210 as

the main body 32 extends toward its distal end 36. The guide tubes 10, 110, 210

ultimately are used in providing a sterile and repeatable pathway to the transgastric

sites. Although three guide tubes are disclosed in accordance with a preferred

embodiment of the present invention, the transgastric instrument maybe constructed

with fewer or greater guide tubes if desired.

Each of the guide tubes 10, 110, 210 which diverge from the primary main body

32, are adapted for coupling along the gastric wall 12 such that a penetrating obturator,

or other gastrotomy creation device, may extend therethrough and cut through the

gastric wall 12 for the purpose of permitting transgastric procedures to take place.

With this in mind, each of the guide tubes 10, 110, 210 includes a distal end 16, 116,

216 at which a fixation mechanism 20, 120, 220 is provided.

The fixation mechanism 20, 120, 220 is provided for securing the distal end 16,

116, 216 of the respective guide tubes 10, 110, 210 to the gastric wall 12 for the

creation of a seal and a repeatable pathway for performing transgastric procedures.

Referring to the fixation mechanism 20 disclosed with reference to Figures 1, 2 and 3,

the fixation mechanism 20 includes distal and proximal fixation arms 24, 25 adapted to

pivot slightly from the wall of the guide tube 10 as they are positioned on opposite

sides of the gastric wall for securing the distal end 16 of the guide tube 10 at a

predetermined location along the gastric wall 12. The distal and proximal fixation

arms 24, 25 also move longitudinally relative to the guide tube 10. In accordance with

a preferred embodiment, the fixation arms 24, 25 extend to the handle (not shown)

where they are manually actuated.

More particular, each of the distal fixation arms 24 (two are provided in

accordance with a preferred embodiment) is an elongated substantially rigid rod

extending along the length of the guide tube 10 for actuation from the proximal end

34 of the main body 32. An outwardly oriented protrusion 38 is formed at the distal

end of the distal fixation arm 24 and is shaped and dimensioned for engaging the

exterior surface 40 of the gastric wall 12 upon deployment.

The distal fixation members 24 are deployed by slightly rotating them to bring

the protrusion 38 out of alignment with the exterior surface of the guide tube 10 and

unlocking the distal fixation member 24 for further distal movement. Thereafter, the

distal fixation member 24 is pushed distally through the gastric wall 12 until the

protrusion 38 is beyond the exterior surface 40 of the gastric wall 12. At this point,

the protrusion 38 is rotated out of alignment with its passageway and is drawn

proximally, trapping the gastric wall 12 between the protrusion 38 and the protrusion

42 of the proximal fixation arm 25 (two are provided in accordance with a preferred

embodiment of the present invention), which is similarly rotated outwardly from the

guide tube 10 wall.

With reference to Figure 1 and 5, the fixation mechanism 120 may take the

form of a plurality of shape memory (for example, Nitinol) rods 124 embedded within

the pathways 122 formed in the wall of the guide tube 110 for selective retrieval when

fixation is required. The rods 124 curl as they are distally moved into the gastric wall

12 and loop within the gastric wall 12 to create a fixation point within the gastric wall

12. In accordance with a preferred embodiment, the rods 124 extend to the handle

(not shown) where they are manually advanced.

An alternate embodiment is disclosed with reference to Figures 1 and 4. In

accordance with this alternate embodiment, opposed circumferential balloons 224 are

secured at the distal end 216 of the guide tube 210. The circumferential balloons 224

are selectively inflated on both sides of the gastric wall 12 to provide for fixation of the

guide tube 210 at the gastric wall 12. The balloons 224 are actuated in a conventional

manner using fluid supply lumens (not shown) extending along the length of the guide

tube 210.

As with the fixation mechanisms 20, 120, 220, a plurality of seal mechanisms

44, 144, 244 maybe employed along the length of the guide tube 10, 110, 210 for

preventing insufflation. For example and with reference to Figures 6, 7 and 8, a single

slit design 44 maybe utilized. Similarly, a tri-slit design 144 could be utilized as shown

in Figure 9 or a sphincter sleeve 244 maybe utilized as shown in Figures 10 and 11.

While a variety of seal structures are disclosed in accordance with a preferred

embodiment of the present invention, those skilled in the art will appreciate various

seal structures could be utilized without departing from the spirit of the present

invention. A preferred design employs two overlapping latex or silicone leaves shaped

and dimensioned for permitting the passage of an instrument therethrough.

In practice, and in accordance with a preferred embodiment of the present

invention, the main body 32 with the plurality of guide tubes 10, 110, 210 depending

therefrom is inserted down the esophagus and into the stomach. A gastroscope is

then inserted into one of the lumens of the main body 32. The gastroscope is moved

down the esophagus and into the stomach of the patient. Once the gastroscope is

inserted within the stomach, it is used to determine the proper sites for gastrotomies

for each of the guide tubes 10, 110, 210 and for the creation of various fixation points

at which the distal ends 16, 116, 216 of the guide tubes 10, 110, 210 will be secured.

In conjunction with the utilization of a gastroscope, a gastrotomy creation

device 26, 126, 226 is inserted down one of the other lumens. The gastrotomy

creation device maybe an RF needle knife, an obturator such as is used in existing

endopath devices or a beveled hollow needle. As those skilled in the art will

appreciate, a variety of gastrotomy creation devices maybe used without departing

from the spirit of the present invention. The gastroscope and gastrotomy creation

device are utilized to create a gastrotomy.

Once the gastrotomy is created, the gastrotomy creation device 26, 126, 226 is

extracted, the distal end 16, 116, 216 of the guide tube 10, 110, 210 is placed at the

gastric wall 12 adjacent the created gastrotomy and the fixation mechanism 20, 120,

220 is then deployed. It is also contemplated that the distal end of the guide tube may

be affixed to the gastric wall before the gastrotomy is created.

Where the pivoting rod fixation mechanism 20 is used, the proximal fixation

arm 25 is deployed first so that the depth of insertion of the guide tube 10 through the

gastrotomy maybe controlled. Once the proximal fixation arm 25 is deployed, the

distal end 16 of the guide tube 10 is pushed through the gastrotomy and the distal

fixation arm 24 is deployed such that the guide tube 10 is now fixed to the abdominal

wall. At this point, cross contamination of the stomach contents into the peritoneal

cavity is prevented.

In accordance with a preferred embodiment, an insufflation seal 44, 144, 244 is

employed. As discussed above, and in accordance with a preferred embodiment of the

present invention, the insufflation seal maybe an elastic band like sphincter valve 244

incorporated in the wall of the guide tube 10, 110, 210. The seal 10, 110, 210 dilates to

accommodate instruments that are inserted down the sleeve. This passive seal is

normally closed and also seals around the shaft of any device inserted down the tube

to thereby maintain insufflation.

The same procedure is repeated for each of the guide tubes that are to be fixed

along the gastric wall. As necessary, the gastroscope maybe moved to other lumens to

provide visualization as necessary. Additionally, it maybe desirable for the

gastroscope to be moved to the first deployed cannula immediately after deployment

so as to visualize gastrotomy creation of the additional cannulas and to ensure safe

otomy creation.

^" While the preferred embodiments have been shown and described, it will be

understood that there is no intent to limit the invention by such disclosure, but rather,

is intended to cover all modifications and alternate constructions falling within the

spirit and scope of the invention.