DEVICE AND METHODS FOR COMBINED MEDICAL PROCEDURES

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application Serial No. 61/894,648, filed October 23, 2013, the contents of which are incorporated by reference herein.

BACKGROUND INFORMATION

The evolution of modern technology has allowed for developments in medical devices which now make it possible to treat certain pathologies via minimally invasive pathways using a specialized compliment of endoscope and catheterization equipment. For example, natural orifice approaches are rapidly becoming the preferred method for accessing and treating these specific conditions of the pancreas, and can be performed safely and effectively with recovery rates in the ninety percent range when the patient is in the hands of a skilled endoscopist. However, even the most highly trained of these specialists has to deal with complex instrument exchanges during the procedures used to treat these patients which can prolong the process and increase the risk of patient injury.

Traditionally, diseases of the pancreas have traditionally been treated through open surgery. Disease conditions such as pancreatic pseudocysts and pancreatic duct strictures have high mortality rates if left untreated and surgical intervention has long and complex recovery with potential infection-related complications as a result of the nature of invasive treatment.

Several device manufacturers have attempted to improve upon these methods over time, adapting technologies from cardiac and urology devices to fit the needs of the endoscopist. However, so far no device has been able to combine access, biopsy, cannulation, dilation, and cauterization steps into one device. Current manufacturers offer at best two or three devices to achieve the same effect.

SUMMARY

Exemplary embodiments of the present disclosure allow the endoscopist to access and cannulate a mass (such as a pancreatic pseudocyst) or the pancreatic duct, aspirate tissue or fluid for biopsy, use diathermic energy to cauterize and/or seal any vessels or tissue required, and then advance the catheter slightly to help dilate the fistula. In specific embodiments, an attached balloon can allow the endoscopist to dilate the fistula in preparation for placement of a stent to aid in the drainage of the specific anatomy. The fact that this can be accomplished in a single step helps significantly reduce the risk of losing access to the anatomy during instrument exchanges and allows the endoscopist to confidently and quickly place the desired stent, ultimately resulting in a positive outcome for the patients.

Certain exemplary embodiments may include a device comprising: an elongated body comprising a tapered portion proximal to a distal end; a conduit extending through the elongated body; an expandable member coupled to the elongated body; and a radiopaque marker coupled to the elongated body. Particular embodiments may further comprise a diathermic element coupled to the elongated body. In certain embodiments, the diathermic element may be proximal to the distal end of the elongated body.

Specific embodiments may further comprise an electric conductor extending from the diathermic element through the elongated body. In particular embodiments the electric conductor may be coupled to an electrosurgical device. In certain embodiments the expandable member may be configured as an inflatable balloon. In specific embodiments the expandable member may be configured to expand to a diameter between 4.0 mm and 10.0 mm. In particular embodiments the expandable member may be between 2.0 cm and 5.5 cm long. In certain embodiments the expandable member may be coupled to the elongated body via a plurality of radiopaque metal rings and a biocompatible adhesive.

Specific embodiments may further comprise a lumen between the expandable member and the elongated body. In particular embodiments, the lumen may be configured to allow pressurized fluid or air to expand the expandable member. Certain embodiments may further comprise a needle inserted through the conduit of the elongated body. In specific embodiments, the needle may comprise a tapered end. In specific embodiments, the needle may be configured as a 19 gauge biopsy fine aspiration needle. Particular embodiments, may further comprise a depth gauge coupled to the needle. Certain embodiments may further comprise a sheath that extends over the expandable member.

Particular embodiments may also include a method of inserting a stent, where the method may comprise: inserting an endoscopic ultrasound scope into an anatomical passage; inserting a guidewire and a device as described above into the endoscopic ultrasound scope; creating a fistula with a needle extending through the conduit of the device; advancing the guide wire further into the fistula; advancing the elongated body of the device further into the fistula to expand the fistula; expanding the expandable member of the device to further expand the fistula; removing the device from the fistula; inserting a first stent over the guide wire to a first desired location; and deploying the first stent.

In particular embodiments, the method may further comprise: cauterizing an opening of the fistula after advancing the guide wire further into the fistula and prior to advancing the elongated body of the device further into the fistula to expand the fistula. In certain embodiments, the anatomical passage may be a pancreatic duct or a bile duct. In exemplary embodiments, the anatomical passage may be any pathophysiology for which the device may have application. Specific embodiments may further comprise inserting a second stent over the guide wire to a second desired location; and deploying the second stent. Particular embodiments may also comprise inserting additional stents over the guide wire to additional desired locations and deploying the stents.

In the following, the term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically.

The use of the word "a" or "an" when used in conjunction with the term "comprising" in the claims and/or the specification may mean "one," but it is also consistent with the meaning of "one or more" or "at least one." The term "about" means, in general, the stated value plus or minus 5%. The use of the term "or" in the claims is used to mean "and/or" unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and "and/or."

The terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has," "includes" or "contains" one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes" or "contains" one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will be apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present disclosure. The invention may be better understood by reference to one of these drawings in combination with the detailed description of specific embodiments presented herein.

FIG. 1 shows a side view of a device according to an exemplary embodiment of the present disclosure.

FIG. 2 shows a partial section view of the device of FIG. 1.

FIG. 3 shows a flowchart of steps in a method utilizing the device of FIG. 1.

FIG. 4 shows a flowchart of steps in a method utilizing prior art devices.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS Referring initially to FIGS. 1-2, an exemplary embodiment of a device 100 is shown comprising an elongated body 110 comprising a distal end 130 and a conduit 140 extending through elongated body 1 10. In the exemplary embodiment shown, a needle 150 with a tapered end 155 is inserted through conduit 140. In addition, elongated body 110 comprises a tapered portion 120 proximal to distal end 130 in this embodiment. It is understood that needle 150 is a separate component of device 100 and is shown in FIGS. 1 and 2 inserted in conduit 140 for illustrative purposes.

In the embodiment shown, device 100 further comprises an expandable member 170 coupled to elongated body 1 10. In this embodiment, expandable member 170 is configured as an inflatable balloon, and a fluid (e.g. gas or liquid) may be injected into a lumen 175 to inflate or dilate expandable member 170.

The exemplary embodiment shown also comprises a plurality of radiopaque markers 160 coupled to elongated body 1 10. In particular embodiments, radiopaque markers 160 may be located along tapered portion 120 to allow visibility on fluoroscopy during use of device 100.

In addition, the embodiment shown in FIGS. 1-2 also comprises a diathermic element 190 coupled to elongated body 1 10 and a sheath 180 that extends over expandable member 170. It is understood that other exemplary embodiments may not include all of the features shown and described in FIGS. 1-2, including for example sheath 180 and diathermic element 190,

In certain embodiments device 100 (and elongated body 110 in particular) may comprise a high performance medical grade thermoplastic and/or silicon. In particular embodiments, conduit 140 may comprise nickel titanium (also known as Nitinol) or another material configured to prevent a needle puncture in conduit 140. In specific embodiments, distal end 130 may be sized slightly larger than a 19 gauge needle (e.g. with an inner diameter larger than 0.0425 inches). Tapered portion 120 may extend approximately 20 to 30 mm from distal end 130 in certain embodiments. In particular embodiments, tapered portion 120 and elongated body 1 10 may have a maximum diameter of approximately 7 French and a length of approximately 250-400 cm.

Expandable member 130 may comprise a high performance medical grade thermoplastic, silicon, or nickel titanium in certain embodiments. In particular embodiments, expandable member 130 can be made of a material that is radiopaque or may be filled with radiopaque dye. In specific embodiments, expandable member 130 may be between approximately 2.0 cm and 5.5 cm long, and be configured to inflate to diameters of between approximately 4.0 and 10.0 mm. In certain embodiments, expandable member 130 may be coupled to elongated body 1 10 via radiopaque metal rings and biocompatible adhesive. For example, expandable member 130 may be folded over or under the rings and fastened securely to the elongated body 1 10. During use, expandable member 130 can be inflated to appropriate pressures to dilate the tissue without bursting. For example, fluid can be injected into lumen 175 (e.g. via a syringe or other pressure source coupled to a Luer lock or other coupling mechanism) to expand or dilate expandable member 170 and further expand a fistula. Device 100 can then be removed from the fistula and a stent inserted over the guide wire. The stent can then be moved to the desired location and deployed. In certain embodiments, lumen 175 may have multiple ports toward the distal end of elongated body 1 10 (e.g. under expandable member 130) for faster inflation. However, the incorporation of multiple ports should not compromise the overall the flexibility or structural rigidity of device 100. In particular embodiments, the maximum diameter of expandable member 130 will be approximately 8.0 French or less, and the distal end of expandable member 130 will be proximal to tapered section 120.

In specific embodiments, needle 150 can be configured as a standard 19 gauge biopsy (fine needle aspiration) needle to ensure appropriate flexibility. In exemplary embodiments, conduit 140 can be sized to can function as a sheath for needle 150. In specific embodiments, the internal lumen of needle 150 is configured to accommodate a 0.035" guide wire. In particular embodiments, needle 150 is flexible enough to perform a 180 degree turn typically found in endoscope positioning during pancreas and bile duct procedures.

In addition, needle 150 should be configured so that it is rigid enough to penetrate tissue of density of the gastrointestinal tract. In certain embodiments, needle 150 may comprise nickel titanium or other similar materials. As previously mentioned, needle 150 comprises tapered end 155 that is configured in such a manner as to minimize the possibility of puncture of conduit 140 during movement in and out of the channel.

In certain embodiments, needle 150 may be coupled to a depth gauge on the proximal end of device 100, which can allow an endoscopist to visualize the penetration depth of the tissue. In particular embodiments, needle 150 may comprise an aspiration or injection port (e.g. a Luer lock connector) which can be used with common syringes. In addition, needle 150 may comprise circumferential markers visible on fluoroscopy and ultrasound for biopsy and targeting purposes.

Certain embodiments of device 100 may comprise a diathermic element 190. In specific embodiments, diathermic element 190 is located proximal to distal end 130 of elongated body 110. In particular embodiments, a wire or other electrical conductor may be imbedded in elongated body 110 or pass through a separate channel in elongated body 1 10 to couple the distal and proximal ends of device (e.g. via a common "banana"-style connector). In exemplary embodiments, the connector can be coupled to an electrosurgical or diathermy device. In particular embodiments, the electrical conductor comprises stainless steel or other highly durable material that can withstand the temperatures required to achieve cauterization of the target tissue without failure.

Exemplary embodiments of device 100 are therefore capable of being pushed while advancing but flexible enough to travel through curves of an orifice or anatomical passage (e.g. a pancreatic duct) or be deflected by a boundary (e.g. the interior wall of a pancreatic pseudocyst) without puncturing adjacent tissue. Device 100 can be used to reduce the number of instruments and the number of steps needed to perform certain medical procedures. For example, device 100 can be used along with an endoscopic ultrasound scope to insert a stent. In certain exemplary embodiments, an endoscopic ultrasound scope can be inserted into an anatomical passage. A guidewire and device 100 can then be inserted into the endoscopic scope, and needle 150 can be extended through conduit 140 of device 100 to create a fistula. The guide wire and elongated body 110 can then be advanced further into the fistula so that tapered portion 120 expands the fistula. Device 100 can then be further advanced and expandable member 130 dilated. Device 100 can then be removed and a stent inserted over the guidewire to a desired location and then deployed. Additional stents can be deployed by repeating the process described above. Referring now to FIG. 3, a flowchart 300 of steps in one exemplary method used to deploy a stent utilizing device 100 is provided. As shown in FIG. 3, this method comprises eleven steps from the insertion of an endoscopic ultrasound scope to deployment and placement of a stent.

In comparison, FIG. 4 illustrates a flowchart 400 depicting the steps used with prior art devices to deploy a stent. As shown in FIG. 4, the prior art method comprises fourteen steps from the insertion of an endoscopic ultrasound scope to deployment and placement of a stent. Accordingly, the use of device 100 in the method outlined in FIG. 3 reduces the number of steps, as well as the number of components needed, to perform the stent deployment procedure. This reduction in steps and components can reduce the time and complexity of the procedure, thereby reducing the risks to the patient. It is understood that the above-described methods are merely examples of the procedures capable of being performed with exemplary embodiments of the devices disclosed herein.

All of the apparatus, devices, systems and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices, systems and methods of this invention have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices, systems and/or methods in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

REFERENCES

The contents of the following references are incorporated by reference herein:

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