ES2436865A1 - Probe for a transcecal ileostomy - Google Patents

Abstract

The invention relates to a probe for a transcecal ileostomy, comprising a catheter (1) with a central conduit (3) comprising, on the distal end thereof, a single heart-shaped balloon (2) with a vertex (2a) oriented towards the proximal end of the probe, the distal end (2b) of the balloon extending beyond the distal end of the catheter (1). The catheter (1) comprises a conduit (6) which passes longitudinally through the main part of the wall, parallel to the axis thereof, to the balloon (2), where it communicates with the outside by means of an undercut (7) in the outer wall of the catheter (1), and a through-conduit (4) which runs parallel to the longitudinal axis of the probe, and has an outlet (5) in the distal end of the catheter (1).

Description

TRANSCECAL ILEOSTOMY PROBE

TECHNICAL FIELD

The present invention relates to a probe for the creation of a derived ileostomy by inserting the probe into the terminal ileum through the blind and the valve ileocecal

BACKGROUND OF THE INVENTION

10 Much of the morbidity and approximately one third of the mortality from colon surgery is due to anastomotic dehiscence (AD).

AD has been used as an indicator of the quality of surgery performed and has been the reason for numerous studies on the variables associated with this complication.

The dehiscence or disruption of the anastomosis is defined as that clinical manifestation that includes:

20 1) the outflow of intestinal contents or gases through a drain, from the main wound

or fistulization to a neighboring organ and / or,

2) the findings of a reintervention for a localized (collection) or generalized peritonitis secondary to an anastomosis leak.

25 In patients with a protective ileostomy, the outflow of fecaloid or purulent material with a debit greater than 50 ml / day was considered as dehiscence.

Specifically, suture line rupture is a frequent complication after two

30 surgical interventions commonly performed in the distal and rectum colon: segmental colectomy due to diverticulitis and anterior resection of the rectum (partial colectomy) due to carcinoma, with an anastomosis performed below the peritoneal reflection.

Transparientocecal probes allow drainage of intestinal contents before they enter the colon without the need for a proximal colostomy.

Patent ES 2342581 describes a transparietocecal probe that facilitates the anastomosis at rest. This probe consists of a catheter fitted with a spherical fixation balloon that is positioned in the colon and a spherical locking balloon that is positioned in the ileum, the catheter extending in front of the spherical locking balloon and positioned at the end of it. in a distal position, a perforation. This probe is placed in the cecum through the appendicular stump or the free cecal belt.

These double spherical balloon probes are of complex manufacture and use, by incorporating two spherical balloons, which make it difficult to place the probe, especially as it passes through the ileocecal valve in the retrograde direction. As for the design, the two balls involve the use of two ways and two inflation valves incorporated into the catheter. On the other hand, the fixation balloon must have a volume of about 400 cc so that a spherical structure guarantees the immobilization of the probe, but such a large volume complicates intestinal defunctionalization.

DESCRIPTION OF THE INVENTION

The present invention consists of a probe for transcecal ileostomy that improves the state of the art by presenting a constructive structure that improves surgery by reducing the risks of AD, minimizes manufacturing costs and simplifies its use, facilitating its placement and improves defunctionalization. intestinal.

At the same time, the new probe includes means to perform a wash of the ileum that allows the removal of intestinal debris that could accumulate before the probe, as well as the dosing of appropriate liquid drugs for the treatment of the area.

Specifically, the new probe is constituted by a PVC or silicone catheter, of circular section, which at its distal end presents a heart-shaped balloon with a vertex oriented towards the proximal end of the probe, extending the balloon in front of the catheter. once swollen This balloon is deployed introducing physiological serum inside reaching a volume of approximately 15cc.

The catheter basically has three ducts: a central duct for waste disposal, and two secondary ducts; a longitudinal conduit made in the thickness of the catheter wall through it in its entirety, and another conduit, also practiced in the thickness of the catheter wall, which crosses it longitudinally only to the position of the balloon, where it communicates with the outside. Both secondary routes are positioned in symmetrically facing sectors so that the valves associated with each are as spaced as possible, and that the behavior in terms of elasticity and flexibility of the catheter is homogeneous.

Liquid (usually physiological serum) is introduced through the longitudinal longitudinal passage to wash the distal area of the balloon and catheter. This function is not possible in conventional double balloon probes, which, in a first application are also used for intraoperative washing of the colon by the central route, but once

10 placed the balloons respectively in the colon and in the ileum, it will no longer be suitable for the introduction of fluids in the opposite direction to drainage due to the risk of contamination with residual residues in the catheter.

The second secondary conduit (according to the explanatory order), has the function of

15 introduction of the physiological serum into the balloon, which presents a novel heart-shaped configuration extending in front of the catheter. In this way it performs a double function, catheter fixation, and ileum block.

Operationally, the new probe can incorporate a third secondary conduit, which is

20 develops in parallel to the previous two, extending through the catheter to the area before the ball, where it communicates with the outside. This duct is suitable for the introduction and application of liquid products directly in the area of the intestine where the anastomosis has been performed for treatment.

25 EXAMPLE DESCRIPTION

Figure 1 represents an elevation and profile of the new probe with the ball retracted. Figure 2 represents a sectional elevation and profile view of the probe with the balloon swollen.

30 Figure 3 consists of a representation of the probe inserted in a patient. Figure 4 consists of a view of the new probe in its four-duct version. Figure 5 consists of a detailed view of the area of the ball.

According to the drawings, the novel transcecal ileostomy tube has a catheter (1)

35 made of silicone, which at its distal end has a heart-shaped balloon (2) with a vertex (2a) oriented towards the proximal end of the probe, while its distal area (2b) extends in front of the distal end of the catheter (1) once swollen with 15cc of physiological serum.

The catheter (1) has a circular section of 12 mm radius with a wall 2 mm thick, and 5 in it there are three ducts:

A central duct for waste disposal (3) of 8mm radius.

A secondary secondary duct (4) of 1.5 mm in diameter, made in the thickness of the catheter wall (1) following a path parallel to the longitudinal axis of the catheter, which has the outlet opening (5) at the end catheter distal (1).

Another secondary duct (6) of 1mm in diameter, also practiced in the thickness of the catheter wall (1) but displaced 180º with respect to the through duct (4), which runs through the catheter longitudinally to the balloon (2), where communicates to the outside by means of a concave recess (7) practiced in the outer wall of the catheter (1).

The proximal end of the catheter has a three-way vial (8) of which two incorporate shut-off valves, a valve (9) for the balloon (2) and a valve (10) for the 20-through wash duct (4). ). The third path corresponding to the central duct (3) has a closure plug (11).

Operatively, the new probe is introduced into the terminal ileum (12) directed by a Fogarty probe, through the blind (14), and retrograde through the ileocecal valve 25 (12). The balloon (2) adjusts progressively from its vertex (2a) to its distal area (2b) against the inner wall of the ileum (12), obtaining it and preventing its backward movement towards the ileocecal valve (13), keeping the anastomosis (15). In this way, an extra immobilizer balloon lodged in the blind is not necessary (14), and since its volume is much lower than conventional retention balls, its intestinal defunctionalization is easier and

30 fast.

In a more developed embodiment, the catheter (1) incorporates a fourth conduit (16), provided with its corresponding valve (17) in the vial (8), which has an outlet (18) in an area prior to the balloon (2) . Through this duct can be washed the probe e

35 even, if required, administer liquid products for the direct treatment of anastomosis) (15).

List of references:

5

one Catheter

2

Ball (2nd) Vertex Balloon (2b) Distal end Balloon

3

Central duct

4

Washed duct

5

Exit hole

10

6 Duct Balloon

7

Rebate

8

Vial

9

Balloon Valve

10

Wash valve

fifteen

eleven Plug

12

Ileum

13

Ileocecal valve

14

Blind

fifteen

Anastomosis

twenty

16 Anastomosis duct

17

Anastomosis duct valve

18

Anastomosis duct outlet

Claims (2)

1ª.-PROBE FOR TRANSCECAL ILEOSTOMY of the type comprising a catheter (1) with a central duct (3) for draining the intestinal contents before entering the colon, essentially characterized in that the catheter (1) incorporates at its end distal a single heart-shaped balloon (2) with vertex (2a) oriented towards the proximal stretch of the catheter, while, when swollen reaching a volume approximately 15cc, its distal end (2b) extends past the end catheter distal (1). The catheter (1) in turn incorporates a duct (6), which passes through the thickness of its wall 10 longitudinally parallel to its axis, to the balloon (2), where it communicates with the outside by means of a recess (7) practiced in the external wall of the catheter (1). 2nd.-PROBE FOR TRANSCECAL ILEOSTOMY according to claim one characterized in that it incorporates a through passage (4), practiced in the thickness of the catheter wall 15 (1) following a path parallel to its longitudinal axis, which has the outlet opening (5) at the distal end of the catheter (1). 3rd PROBE FOR TRANSCECAL ILEOSTOMY according to claim one and two, characterized in that the through conduit (4) is 180 ° offset from the conduit 20 (6). 4th.-PROBE FOR TRANSCECAL ILEOSTOMY according to claim 1 and 2, characterized in that it has a third conduit (16), practiced in the thickness of the catheter wall (1) following a path parallel to the longitudinal axis, which has an outlet 25 (18) in a pre-ball zone (2). 5ª.-PROBE FOR TRANSCECAL ILEOSTOMY according to claim one, second and fourth, characterized in that the through conduit (4), the conduit (6) and the conduit (16) are displaced 120 °. 30 6th.-PROBE FOR TRANSCECAL ILEOSTOMY according to previous claims, characterized in that the proximal end of the catheter has a vial (8) with as many ways as ducts the catheter has, of which the one corresponding to the central duct (3) has a stopper shut-off (11), and the rest, shut-off valves (9) (10) and (17). SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201331308 SPAIN Date of submission of the application: 06.09.2013 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61F5 / 445 (2006.01) A61M25 / 10 (2013.01) RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

TO

US 2002173771 A1 (LA TAPACHULTECA II) 21.11.2002, 1.6

paragraphs [1], [8], [10-12], [23], [28-31], [33-38]; Figures 2-4.

TO

MX 2010011045 A (CONVATEC TECHNOLOGIES INC.) 01.11.2010, 1-6

page 1, lines 4-10; page 7, line 10 - page 11, line 15; page 12, line 24 - page 13,

line 14; Figure 1.

TO

WO 2011139498 A1 (CONVATEC TECHNOLOGIES INC.) 10.11.2011, 1.6

page 5, last paragraph - page 19, last paragraph; figures.

TO

EN 2337263 T3 (CEDARS-SINAI MEDICAL CENTER) 04.24.2010, 1.6

column 1, lines 20-25.52-64; column 2, lines 24-31.55-60; Figure 1.

TO

US 4344434 A (SANTA BARBARA MEDICAL FOUNDATION CLINIC) 17.08.1982, 1.6

column 5, line 47 - column 11, line 52; figures.

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 20.12.2013

Examiner J. Square Prados Page 1/5

REPORT OF THE STATE OF THE TECHNIQUE Application number: 201331308 Minimum documentation sought (classification system followed by classification symbols) A61F, A61M Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ. State of the Art Report Page 2/5  WRITTEN OPINION Application number: 201331308 Date of Written Opinion: 20.12.2013 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-6 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-6 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base.- This opinion has been made on the basis of the patent application as published. State of the Art Report Page 3/5  WRITTEN OPINION Application number: 201331308 1. Documents considered. The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

US 2002173771 A1 (LA TAPACHULTECA II) 21.11.2002

D02

MX 2010011045 A (CONVATEC TECHNOLOGIES INC.) 01.11.2010

D03

WO 2011139498 A1 (CONVATEC TECHNOLOGIES INC.) 10.11.2011

D04

ES 2337263 T3 (CEDARS-SINAI MEDICAL CENTER) 04/22/2010

D05

US 4344434 A (SANTA BARBARA MEDICAL FOUNDATION CLINIC) 17.08.1982

2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The request refers to a probe for the creation of an ileostomy derived by introducing the probe into the terminal ileum through the cecum and the ileocecal valve. The application aims to solve the problems that, according to the applicant, present the probes known in the state of the art, which allow draining the intestinal contents before entering the colon without the need to practice a proximal colostomy, which are double probes spherical balloon, and in which the double balloon "makes the placement of the probe difficult, ..., involves the use of two pathways and two inflation valves incorporated into the catheter, ..., and the fixation balloon (to the large intestine) requires a volume so large that complicates intestinal defunctionalization ”(see page 3, lines 8-14). The request proposes to solve these problems by means of a probe for transcecal ileostomy that presents a single balloon. In the state of the art there are antecedents in this field that show probes for transcecal ileostomy that bear similarities with the probe of the application under study. However, a probe like the one proposed in the application under study does not seem to be detached from the background of the prior art. Examples of the state of the art are documents D01 to D05 cited in the State of the Art (IET) Report. In the opinion of this Administration, these documents only show the general state of the art and are not considered of particular relevance. None of the documents cited in the EIT show or suggest the particular relationship of components that follows from the object of the main claim of the application. Document D01 can be considered the state of the art closest to the object of the main claim, and refers to a probe for transcecal ileostomy which, as in the application, incorporates a single balloon. The probe shown in D01 shares many of the features included in the main claim (see parts cited in the IET), specifically in D01 it is anticipated (references in brackets apply to D01) one:

-

Probe for transcecal ileostomy (paragraph 12, for example) of the type comprising a catheter (12) with a central duct (20-21) for draining the intestinal contents before entering the colon (paragraph 28), in which the catheter (12) incorporates at its distal end a single balloon (14). The catheter (12), in turn, incorporates a duct (26) through the thickness of its wall (paragraph 30) that crosses it longitudinally parallel to its axis (figures 3, 4), to the balloon (14), where communicates with the outside by means of a recess (paragraph 30) practiced in the external wall of the catheter (12).

However, in D01 some of the features included in the main claim of the application are not anticipated, mainly:

-

In D01, the balloon shown is not “heart-shaped with a vertex oriented towards the proximal end of the catheter, while, when swollen, reaching a volume of approximately 15 cc, its distal end is extended in front of the distal end of the catheter".

-

In D01 it is indicated that the volume of the swollen balloon is preferably 35 cc (paragraph 29), more than double that suggested in the application.

State of the Art Report Page 4/5  WRITTEN OPINION Application number: 201331308 These differential characteristics seem to be clear from the request that they pursue a specific purpose, since it is indicated that “the heart-shaped configuration extending in front of the catheter… performs a double function, the catheter fixation and the ileum block” (see page 4, lines 15-17), since “the ball adjusts progressively from its vertex to its distal area against the inner wall of the ileum, the anastomosis being preserved, so that an extra immobilizer balloon is not necessary. blind ”(see page 5, lines 25-30). Although it can be evidenced that there are similarities and characteristics shared between the transcecal ileostomy probe shown in D01 and that of the application, it is considered that in D01 the particular technical object derived from the main claim of the application is not anticipated or suggested. study, so it is not judged as a relevant document, but a mere reflection of the state of the art. The transcecal ileostomy probe of document D02 also provides for the possibility of incorporating a single distal fixation balloon in the ileum (see page 8, lines 4-5) but, as in D01, the particular configuration claimed for the shape of the ball None of the rest of the documents cited in the EIT show or suggest the particular relationship of technical, structural and constitutive characteristics that emerge from the object of the main claim of the application. These characteristics of the object of the main claim of the application give rise to a particular embodiment that is not considered obvious to a person skilled in the art. Thus, documents D01 to D05 cited in the EIT can be considered examples of the prior art, which only show the general state of the art, and are not considered of particular relevance. It would not be obvious for a person skilled in the art to apply the features included in the cited documents and arrive at the invention as disclosed in the claim of the application. Therefore, the object of this main claim meets the requirements of novelty and inventive activity. Dependent claims 2 to 6 delimit additional optional features and as the first general also meet the requirements regarding novelty and inventive activity. State of the Art Report Page 5/5