System and methods for clearance of obstructions

The present invention is a system and methods to clear obstructions including foreign objects and food boluses during an EGD procedure. The medical device according to the present invention includes a flexible tubular housing, power transfer device, clamp, tool element, power source, and optional hood. The present invention drills through the obstruction to rupture it into pieces. Displaced obstructions, and/or pieces thereof, can be collected within the housing. The remainder of the obstruction can then be passed into the stomach where it can be digested, safely excreted, or actively removed by an endoscopist.

FIELD OF THE INVENTION

The present invention generally relates to a medical system and methods and, more particularly, to a system and methods to clear obstructions within the upper gastrointestinal tract.

BACKGROUND OF THE INVENTION

Foreign object ingestion and food bolus impactions are a common occurrence. Urgent intervention is required to prevent aspiration and perforation. Foreign object ingestion or food bolus impaction creates an obstruction. Obstruction is anything that is obstructs, blocks, or closes off a bodily cavity. Food bolus impactions occur in the upper gastrointestinal tract (GI tract), with the most common site of impaction at the stomach-esophagus (gastro-esophageal) junction, or at other regions of narrowing within the esophagus. The upper GI tract consists of the mouth, pharynx, esophagus, stomach and duodenum terminating at the ligament of Treitz.

Typically, an initial endoscopic examination verifies, locates and identifies the obstruction. An endoscope is shaped as a long tube, which is inserted through the mouth into the esophagus and stomach to identify the foreign object or food bolus. Once the foreign object or food bolus has been identified with the endoscope, various instruments can be passed through the endoscope to grasp and remove or displace the obstruction. An endoscopist is a person trained to use an endoscope.

The foreign object or food bolus can usually be removed en bloc or in a piecemeal fashion with the instruments. Instruments include forceps, which come in varying shapes, sizes and grips, snares, and oval loops that can be retracted from outside the endoscope to lasso objects, as well as baskets, or mesh nets that can be closed to trap small objects, and magnets placed at the end of the scope. Some techniques have been described that use catheters to trap objects, or use two snares to orient foreign bodies.

These current instruments are not ideal in that they each are limited to specific uses. Furthermore, a “pull” and “push” technique is required. This technique requires the instrument to be manipulated by pulling it back and then pushing it gently to displace the obstruction into the stomach. This is not desirable for objects that cannot be digested or that cannot be safely excreted. Nor is this technique desirable to perform on obstructions that are firmly impacted with the upper GI tract including the walls of the esophagus.

As an alternative to the endoscopic clearance described, a food bolus impaction can be cleared passively through the use of medication, such as Glucagon. This approach is often not successful.

The currently available instruments for foreign object ingestion and food impaction clearance are not ideal. Likewise, medication does not offer consistent success to passively clearing a food impaction. Thus, there is a strong need for improvement in the clearance of obstructions in the upper gastrointestinal tract.

SUMMARY OF THE INVENTION

The present invention clears obstructions including foreign objects and food boluses by drilling through the obstruction to rupture or displace the obstruction in order to clear it. The obstruction is cleared by passing into the stomach where it can be digested or safely excreted. The obstruction can also be cleared by actively removing it from the human cavity by an endoscopist. The present invention is applicable to anything that can be swallowed and subsequently obstructs the upper GI tract.

The present invention includes a flexible tubular housing, such as a catheter device. The flexible tubular housing can further include one or more retainers therein. The retainers can be any size or shape that allows displaced obstructions, and/or pieces thereof, to be collected, for example, pockets, chambers, or compartments. The housing can be inserted into a human cavity, typically via an endoscope. The housing can be any material that is flexible, for example metal or plastic such as stainless steel, aluminum, titanium, silicone, or polyurethane. Although the tubular housing is flexible, it must maintain a tensile strength to stabilize the other components of the medical device, such as the clamp and tool element, throughout the procedure.

A power transfer device, for example drive shaft, catheter or laser, is positioned within the tubular housing, extending therethrough. The power transfer device may rotate as well as vacillate, or move in and out of the housing. It is also contemplated certain embodiments of the present invention do not include a power transfer device such that the housing itself rotates as well as vacillates, or move in and out of the human cavity. In one embodiment, a drive shaft power transfer device includes a clamp that is rotated by a power source that provides electrical output, mechanical or manual output, or power. The power transfer device and clamp can be any material for example metal or plastic such as stainless steel, aluminum, titanium, silicone, or polyurethane. It is further contemplated the power transfer device, or the housing itself, can function as a retainer to collect displaced obstructions. A laser power transfer device includes a coherent beam of light.

The output from the power source can be automatic, manual, and even computer controlled. The power source can further include a regulator for adjusting the power, for example by a knob or foot pedal. Likewise, the output applied to the power transfer device can be variable or fixed. Output is in the form of rotational speed, or revolutions per minute (rpm). Examples of power sources include electrical power supplies, mechanical or manual power supplies, linear power supplies and computer power supplies.

The clamp securely holds removable parts and includes a receiving unit to accept tool elements. Clamps can include collets and chucks such as pin chuck, drill chuck, magnetic chuck, three or more-jaw chuck, snap-fit configuration to name a few. It is also contemplated that the clamp is universal such that it receives all shaped and sized tool elements.

A tool element is received within the receiving unit of the clamp. Tool elements come in a variety of shapes and sizes such that the appropriate tool element is used for the procedure. It is contemplated that the tool elements may be disposable or re-used upon sterilization.

Tool elements include bits. Bits are cutting tools to create cylindrical-shaped holes, although bits are also available for non-cylindrical-shaped holes. Bits can be of any material that displaces and clears the obstruction, for example metal such as stainless carbide steel or carbine tungsten steel. Bits include a cutter and a shank. Shanks are received within the receiving unit of the clamp. Shanks include brace shanks, straight shanks, hex shanks, SDS shanks, triangle shanks, and morse taper shanks, for example. Different styles of shank/clamp combinations deliver different performance, such as allowing higher torque or greater centering accuracy.

Tool elements may also include lasers that vaporize, or burn, the obstruction. The laser can be a solid state laser such as yttrium aluminum garnet (YAG) or any other type including gas lasers, chemical lasers and excimer lasers.

Tool elements also include a hole saw, or hole saw-type device, which may be manufactured from plastic or steel. A hole saw-type device uses teeth to displace and clear the obstruction.

The present invention may further include a hood, such as a shield, guidepost, or guard. The hood surrounds the tool element to protect the human cavity and walls of the cavity from injury. The hood can be of any flexible material, for example metal or plastic such as stainless steel, aluminum, titanium, silicone, or polyurethane.

It is an object of the present to provide a system and method that can be mechanical-based, water-based, cautery-based, or laser-based. A mechanical-based system and method utilizes machine parts, whereas a water-based system and method utilizes a device to deliver water to the obstruction during the procedure. A cautery-based system and method utilizes a caustic device, such as a hot iron, electric current, or fire to burn the obstruction. A laser-based system and method utilizes a coherent beam of light to clear the obstruction.

It is an object of the present invention to provide a system and method that provides a rapid and safe removal of an obstruction from the upper GI tract of a patient.

Another object of the present invention is to improve patient safety. The present invention decreases the amount of anesthetic needed for anesthetic as well as decreases the risk for damaging the upper GI tract during the procedure.

An object of the present invention is to reduce the time it takes to clear an obstruction.

The present invention and its attributes and advantages will be further understood and appreciated with reference to the detailed description below of presently contemplated embodiments, taken in conjunction with the accompanying drawings.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention is applicable to anything that can be swallowed and subsequently obstructs the upper GI tract. The present invention clears obstructions, including foreign objects and food boluses, to be passed into the stomach for digestion or safe excretion or actively removed from the human cavity by an endoscopist.

As shown inFIGS. 1 and 2the mechanical-based medical device100according to the present invention includes a flexible tubular housing110, power transfer device130, clamp150, tool element170, hood190and power source200.

The housing110includes a distal end112and proximal end114. The housing110includes an inner diameter116and outer diameter118extending from the distal end112to the proximal end114. Housing110further includes one or more retainers140positioned within the inner diameter116of the housing110. Retainers140collect displaced obstructions, and/or pieces thereof, for removal.

A power transfer device130includes a first end132and a second end134with a clamp150positioned at the first end132. Clamp150includes a receiving unit152to receive tool elements170. Hood190surrounds the tool element170to protect the human cavity from injury during the procedure.

As shown more specifically inFIGS. 1 and 2, housing110is a catheter111and power transfer device130is a drive shaft131. Catheter111includes retainers140that are cylindrical columns142. Drive shaft131is positioned within inner diameter116of catheter111. Clamp150, here a chuck151, is positioned at the first end132of drive shaft131. Upon positioning drive shaft131within inner diameter116, chuck151is positioned at distal end112of catheter111. Chuck151includes a receiving unit152for engagement with a tool element170, here a bit172. Bit172includes a cutter174and a shank176. Shank176is received with in receiving unit152.

An electrical power supply202is connected to the drive shaft131for rotation of the chuck151. Guidepost191protects the body cavity and walls of the body cavity from injury during the procedure.

Once a patient has been diagnosed with a foreign object ingestion and/or food bolus impaction, the patient is prepared for an esophago-gastro-duodenoscopy (EGD) procedure.

An endoscope is inserted into the esophagus to verify, locate and identify the obstruction. The end of the endoscope is placed at the obstruction and the medical device100according to the present invention is then passed through the endoscope. Thus, the distal end112of the catheter111is positioned at the obstruction.

Upon reaching the obstruction, the medical device100is powered by an electrical power supply202to rotate the drive shaft131and chuck151. Consequently, the bit172positioned with the chuck151rotates to drill through the obstruction causing it to rupture into pieces. Likewise, displaced obstructions, and/or pieces thereof, can be collected into the cylindrical columns142within the flexible catheter111. The medical device100can further include a guidepost191to protect the esophagus from injury, for example, caused by inadvertent misdirection of the bit172. The pieces of the obstruction are then passed into the stomach where the obstruction can be digested, safely excreted, or actively removed by an endoscopist.

A medical device300utilizing a mechanical power supply400is shown more specifically inFIG. 3. As shown inFIG. 3, the mechanical-based medical device300according to the present invention includes a flexible tubular housing310, power transfer device330, clamp350, tool element370, and mechanical power source400. It is contemplated the medical device300may further include a hood (not shown) to protect the human cavity from injury during the procedure.

The housing310includes a distal end312and proximal end314. The housing310includes an inner diameter316and outer diameter318extending from the distal end312to the proximal end314.

A power transfer device330, here a catheter331, includes a first end332and a second end334with a clamp350positioned at the first end332. Clamp350includes a receiving unit352to receive tool element370. It is also contemplated certain embodiments of the present invention do not include a power transfer device330such that the housing310includes a clamp350with a receiving unit352to receive a tool element370.

The catheter331further includes an inside diameter336and an outside diameter338. The space342defined by the inside diameter336of the catheter331acts as retainer340positioned therein. Retainers340collect displaced obstructions, and/or pieces thereof, for removal.

The mechanical power supply402is connected to catheter331. Although it is also contemplated the catheter331can be connected to an electrical power supply or a computer power supply. The mechanical power supply402is operated by manual hand crank404, but is also contemplated to be any structure, for example a rotating lever, to manually rotate the catheter331including tool element370. In certain embodiments of the present invention that do not include a power transfer device330, housing310includes a clamp350with a tool element370wherein the housing310may rotate as well as move in and out of the human cavity.

In one embodiment, the manual hand crank404includes a gear reduction system406to allow slow calculated rotations of the tool element370.

As shown inFIG. 3, housing310is a flexible plastic tube311that includes a catheter331. Upon positioning catheter331within inner diameter316of the tube311, clamp350is positioned at distal end312of the tube311as well as at the first end332of the catheter331. In one embodiment, clamp350is a snap-fit configuration which includes a receiving unit352for engagement with a tool element370, here a hole saw-type device372.

After diagnosis, the patient is prepared for an esophago-gastro-duodenoscopy (EGD) procedure. Subsequent to insertion of an endoscope into the esophagus, the medical device300is passed through the endoscope.

Thus, the distal end312of the tube311is positioned such that the hole saw-type device372is at the obstruction. Upon reaching the obstruction, the medical device300is powered by manipulating the hand crank404to rotate the catheter331including hole saw372. The catheter331can be manipulated to rotate as shown by arrow A inFIG. 3, as well as vacillate, or move in and out of the housing as shown by arrow B. Consequently, the hole saw372rotates to drill through the obstruction causing it to rupture into pieces.

Likewise, displaced obstructions, and/or pieces thereof, can be collected into space342defined by the inside diameter336of the catheter331. The pieces of the obstruction are then passed into the stomach where the obstruction can be digested, safely excreted, or actively removed by an endoscopist.