Methods for diagnosing and delivering therapeutic interventions in the peritoneal cavity

• US 10,238,392 B2
• Filed: 02/09/2015
• Issued: 03/26/2019
• Est. Priority Date: 12/29/2009
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Sr., Jose A.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US14/617,066
• Publication Number:
  US 20150150559A1
• Time in Patent Office: 1,506 Days
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

A device and system are described that are capable of isolating at least one targeted tissue and forming an anastomosis between two internal body structures though a completely endoscopic procedure. Further, the device and system described generally comprise two tubular members that are capable of moving in a telescopic fashion relative to one another. Additionally, a method is described for using the device and/or system to bypass the duodenum from digestion.

Claims

1. A method for performing an endoscopic procedure, comprising:

inserting an endoscopic device through an aperture in a body of a patient, the endoscopic device comprising;

an outer tubular member and an inner tubular member, the outer tubular member and the inner tubular member each comprising a proximal end, a distal open end, a vacuum channel in communication with a suction port, and a compartment, the vacuum channel disposed around the circumference of the tubular member such that the compartment is wholly surrounded by the vacuum channel, and the vacuum channels extend to the distal open end;

wherein the distal open ends of the outer and inner tubular members share a concentric linear axis, the inner tubular member is slidably disposed within the compartment of the outer tubular member such that the distal open end of the inner tubular member can advance through the distal open end of the outer tubular member, and the compartment of the inner tubular member is configured to slidably receive at least two instruments concurrently therein;

engaging the distal open end of the outer tubular member with a first targeted tissue;

supplying suction through the vacuum channel of the outer tubular member to form a reversible seal under vacuum between the suction port of the outer tubular member and the first targeted tissue;

penetrating the first targeted tissue with a catheter slidably disposed within the compartment of the inner tubular member such that a first opening is formed in the first targeted tissue;

advancing the inner tubular member through the first opening in the first targeted tissue;

supplying suction through the vacuum channel of the inner tubular member to form a reversible seal under vacuum between the suction port of the inner tubular member and a second targeted tissue;

penetrating the second targeted tissue with the catheter such that a second opening is formed in the second targeted tissue;

retracting the inner tubular member through the distal open end of the outer tubular member to pull the second opening in the second targeted tissue into close proximity and substantially concentric alignment with the first opening in the first targeted tissue using suction through the vacuum channel of the inner tubular member to maintain engagement with the second targeted tissue;

positioning a first stent at least partially within the first and second openings of the targeted tissues through operation of a stent delivery device slidably disposed within the compartment of the inner tubular member, wherein the first stent comprises a ring having a first end, a second end, and a plurality of hooks extending from both the first end and the second end; and

forming a sealed anastomosis between the first and second openings by deploying the first stent.

2. The method of claim 1, wherein the outer tubular member further comprises a first vacuum port in communication with at least one of the vacuum channel and compartment of the outer tubular member and the inner tubular member further comprises a second vacuum port in communication with at least one of the vacuum channel and compartment of the inner tubular member and supplying suction through the vacuum channel of the outer tubular member and supplying suction through the vacuum channel of the inner tubular member further comprises operatively connecting at least one vacuum source to the first and second vacuum ports.

3. The method of claim 1, further comprising:

cleaning and sterilizing the first targeted tissue prior to penetrating the first targeted tissue with the catheter, and

cleaning and sterilizing the second targeted tissue prior to penetrating the second targeted tissue with the catheter.

4. The method of claim 1, wherein the first targeted tissue comprises an interior wall of a stomach in a location proximal to a greater curvature of the stomach, and the second targeted tissue comprises an exterior wall of a small intestine in a location proximal to a proximal jejunum.

5. The method of claim 4, further comprising:

endoscopically inserting a second stent into the pylorus of the stomach such that the pylorus is occluded and digested matter is prevented from flowing therethrough; and

wherein the first stent is moveable between a first position where the plurality of hooks extend in a direction substantially parallel to an axis of the ring and a second position where the plurality of hooks extend in a direction substantially perpendicular to the axis of the ring.

6. The method of claim 1, further comprising:

an optic system instrument slidably disposed directly within the compartment of the inner tubular member such that the optic system can be inserted and withdrawn from the inner tubular independent of both the catheter and the stent delivery device concurrently positioned within the compartment of the inner tubular member, and further comprising using the optic system instrument to visually locate the first targeted tissue and the second targeted tissue.

7. The method of claim 1, wherein the catheter further comprises a dilation implement.

8. The method of claim 7, wherein the dilation implement of the catheter comprises a balloon adapted to move between a first deflated position and a second inflated position and further comprising the steps of:

advancing the balloon in the first deflated position into the first opening of the first targeted tissue;

dilating the balloon into the second inflated position such that the first opening increases in diameter;

deflating and advancing the balloon into the second opening of the second targeted tissue; and

dilating the balloon into the second inflated position such that the second opening increases in diameter.

9. The method of claim 8, wherein the first deflated position comprises a first diameter and the second inflated position comprises a second diameter, wherein the first diameter is less than the second diameter.

10. The method of claim 7, wherein the catheter further comprises a needle extending distally from the catheter.

11. The method of claim 1, further comprising:

increasing the suction through the vacuum channel of the outer tubular member such that the first targeted tissue is temporarily displaced from its normal anatomical position in the body.

12. A method for performing a surgical operation on internal body tissues of a patient comprising:

inserting at least part of an endoscopic device of a system through an aperture of a body of the patient, the system comprising;

the endoscopic device comprising;

an outer tubular member for placement in a gastrointestinal tract, the outer tubular member comprising;

a first vacuum channel comprising a first vacuum port, a first suction port, and an interior, a vacuum source operatively connected to the first vacuum port, and the first suction port configured to removably attach to a first targeted tissue,

a first compartment comprising an interior,

a first proximal end, and

a second distal end in operative communication with the first suction port,

wherein the first vacuum channel is disposed around the circumference of the outer tubular member such that the first compartment is wholly surrounded by the first vacuum channel and the first vacuum channel extends to the second end; and

an inner tubular member slidably disposed within the interior of the first compartment of the outer tubular member, the inner tubular member comprising;

a second vacuum channel comprising a second vacuum port, a second suction port, and an interior, wherein the second vacuum port shares said vacuum source with the first vacuum port, and the second suction port is configured to removably attach to a second targeted tissue,

a second compartment wholly surrounded by the second vacuum channel and comprising an interior configured to slidably receive at least two instruments concurrently therein,

a first proximal end, and

a second distal end in operative communication with the second suction port,

wherein the second end of the inner tubular member is capable of extending through the second end of the outer tubular member and the second end of both the inner and outer tubular members share a concentric linear axis;

a catheter slidably disposed directly within the interior of the second compartment, the catheter comprising a first end and a second end and wherein the second end of the catheter comprises a means for penetrating the first and second targeted tissues and a means for dilation;

a stent delivery device slidably disposed directly within the interior of the second compartment such that the stent delivery device can be inserted and withdrawn from the interior of the second compartment independent of the catheter, the stent delivery device comprising a first end and a second end, wherein the second end is capable of removably coupling with a stent; and

a first stent removably coupled with the second end of the stent delivery device, the first stent comprising a ring having a first end, a second end, and a plurality of hooks extending from both the first end and the second end, wherein the first stent is capable of forming an anastomosis between the first and second tissues and;

supplying suction through the first vacuum port such that the first suction port of the outer tubular member forms a reversible seal with the first targeted tissue;

penetrating the first targeted tissue with the means for penetrating the first and second targeted tissues such that a first opening is formed in the first targeted tissue;

advancing the inner tubular member through the second end of the outer tubular member and through the first opening in the first targeted tissue;

supplying suction through the second vacuum port such that the second suction port of the inner tubular member forms a reversible seal with the second targeted tissue;

penetrating the second targeted tissue with the means for penetrating the first and second targeted tissues such that a second opening is formed in the second targeted tissue;

retracting the inner tubular member through the second end of the outer tubular member to pull the second opening into close proximity and substantially concentric alignment with the first opening in the first targeted tissue using suction through the second suction port to maintain engagement with the second targeted tissue;

slidably inserting the stent delivery device and the first stent into the interior of the inner tubular member;

positioning the first stent partially within the first and second openings; and

deploying the first stent to form a sealed anastomosis between the first and second openings.

13. The method of claim 12, wherein the first targeted tissue comprises an interior wall of a stomach in a location proximal to the greater curvature of the stomach, and the second targeted tissue comprises an exterior wall of a small intestine in a location proximal to the proximal jejunum.

14. The method of claim 13, further comprising endoscopically inserting a second stent into a pylorus of the stomach such that a portion of the pylorus is occluded and digested matter is prevented from flowing therethrough;

and

wherein the first stent is moveable between a first position where the plurality of hooks extend in a direction substantially parallel to an axis of the ring and a second position where the plurality of hooks extend in a direction substantially perpendicular to the axis of the ring.

15. The method of claim 12, wherein the system further comprises an optic system instrument slidably disposed directly within the second compartment of the inner tubular member such that the optic system may be inserted and withdrawn from the inner tubular member independent of both the catheter and the stent delivery device concurrently positioned within the compartment of the inner tubular member, and further comprising using the optic system instrument to visually locate the first targeted tissue and the second targeted tissue.