WO2011067779A1

WO2011067779A1 - A safe and improved ostomy device adaptable to patients having colostomy or ileostomy

Info

Publication number: WO2011067779A1
Application number: PCT/IN2010/000733
Authority: WO
Inventors: Dineshbhai Purohit Hitendra; Pradipkumar Chinagi Sarvesh; Chandrakant Aradhye Charudatta
Original assignee: Johnson And Johnson Ltd.
Priority date: 2009-12-02
Filing date: 2010-11-10
Publication date: 2011-06-09

Abstract

The invention relates to a safe and improved ostomy device adaptable to patients undergone abdomino period resection, the device comprising a first component (1) having an extendable flexible tube (Ia) at a distal end to direct flow of fecal materials, a proximal end of the first component (1) being releasably fixed to the resected location, the flexible tube (Ia) internally accommodating a bellow portion (Ib), a disc-shaped part (1C) attached to the flexible tube (Ia) through a first face of a groove (Ie) dimensioned substantially in the center of the disc (Ic) in correspondence with the diameter of the flexible tube (Ia); a second component (2) having means for (2a) belt attachment and including a corresponding hole (2b) to match the groove (Ie), and further acting as a casing for a third component (3), the first and second components (1, 2) are joinable together through one of the processes comprising biocompatatible adhesive, ultrasonic welding, and molding to form a single component; and a third component (3) constituting a membrane module assembly having a membrane module (3A), a semi-permeable membrane (3B), and odor filter (3C), and an odor filter module (3D), the third component (3) being insertable on the second component along the hole (2b) which second component (2) being joinable with the first component (1).

Description

FIELD OF INVENTION

The invention relates to external collection appliances for disposal of fecal matter adaptable to patients. More particularly, the invention relates to a safe and improved ostomy device adaptable to patients having colostomy or Ileostomy.

BACKGROUND OF INVENTION

When Patients having colorectal cancer, they undergo APR (Abdomino perineal resection) surgery. An external opening on abdominal wall of the patient is created for such surgery which is known as "colostomy".

Patients having ulcerative colitis, Crohn's disease, toxic mega colon cancer or familial polyposis has to undergo surgery and the large intestine is removed, due to which an external opening is created on abdominal wall and that is known as "Ileostomy".

Accordingly, the patients have to use external collection appliance/device to collect fecal matter as their rectum is inactive now. W

With the removal of rectum the natural sphincter is also removed and on abdominal opening there is no control over fecal matter and gases produced during digestion. The existing devices do not provide any control over the fecal matter including the gases, which leads to leakage causing skin infection problems due to adhesive weakening or due to longer wear time.

OBJECTS OF INVENTION

It is therefore an object of the invention to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy which is enabled to exercise better control over fecal matter and gases produced during digestion.

Another object of the invention is to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy which eliminates the necessity of using collection bags by the patients.

A still another object of the invention is to propose a safe and improved ostomy device adaptable to patients having colostomy or Ileostomy which provides optional means for attaching collection bags if desired by a patient. Yet another object of the invention is to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy, which enhances the emptying process of the fecal matters produced during digestation.

A further object of the invention is to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy, which prevents leakage of fecal matters through the device, and thus, reduces the possibility of skin infection to the patient.

A still further object of the invention is to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy, which is enabled to communicate externally to achieve safety, comfort, and easiness in adaptation/deadaption to the patients.

Yet further object of the invention is to propose a safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy which additionally provides means to act as a deodorizer.

SUMMARY OF INVENTION

Accordingly, there is provided a safe and improved ostomy device adaptable to patients having colostomy or Ileostomy, the device comprising a first component having an extendable flexible tube at a distal end to direct flow of fecal materials, a proximal end of the first component being releasably fixed to the resected location, the flexible tube internally accommodating a bellow portion , a disc-shaped part attached to the flexible tube through a first face of a groove dimensioned substantially in the center of the disc in correspondence with the diameter of the flexible tube ; a second component having means for belt attachment and including a corresponding hole to match the groove , and further acting as a casing for a third component , the first and second components are joinable together through one of the processes comprising biocompatatible adhesive, ultrasonic welding, and molding to form a single component; and a third component constituting a membrane module assembly having a membrane module , a semi-permeable membrane , an odor filter , an odor filter module , the third component being insertable on the second component along the hole which second component being joinable with the first component . BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Figure 1- shows an exploded view of colostomy and ileostomy device of the invention in a disassembled condition.

Figure 2- shows two isometric views from left direction of the first component (inner barrier) of the device of Fig. 1.

Figure 3- shows respectively isometric views of the second component (outer barrier) and a subassembly of the first and second component of the device (left side view) during its construction.

Figure 4- shows a front-side isometric view of a sub-assembly of the first and second components during forming of the device of the invention.

Figure 5- shows respectively the intra-components forming the third component (Membrane module assembly) of the device; the third component in assembled condition; a sub-assembly of the first and second component; and a complete assembly of the first, second, and third components forming a first embodiment of the device of the invention.

Figure 6- shows a variation in the third component; and an alternative (second) embodiment of the device incorporating the alternatively configured third component.

Figure 7- shows a third embodiment of the device having an integrated outer barrier with bellow bag and odor filter.

Figure 8- shows a fourth embodiment of the invention in which the bellow bag is replaced with a membrane module. This membrane module comprises of foam and odor filter fabric to absorb more liquid portion of fecal matter and thereby reducing no of emptying of fecal matter in day.

DETAIL DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

As shown in fig-1 the device comprises three basic components attachable to each other in a sequence and manner to combinedly operate to produce an improved physical effect. The first component (1) constitutes an inner barrier which is attached to the second component (2) acting as an outer barrier. The first and second components (1,2) are attached to each other by skin-safe adhesive, or by ultrasonic welding, or by heat sealing. The third component (3) is inserted into the second component (2) such that the second component (2) acts as a casing for the third component (3). All the three components are formed out of silicon elastomer material.

As shown in fig.-2, the first component comprises an extendable flexible tube (la), a bellow portion (lb) in the inner tube 1(a) allows the tube to extend longer so as to direct the flow of fecal matter, simultaneously ensuring that no spillage of fecal matter over the skin takes place. The conical shape at the end of the first component (1) facilitates locational placement of the device. The safe skin adhesive is pasted on the rear side of the first component (1) for an external attachment of the device. The first component (1) further comprises a disk- shaped component (lc) having a corresponding hole to accommodate the tubular structure (la).

As shown in fig. 3- the second component (2) acts as a casing for an interposed membrane module (3) and provides extra support to the device, and further having a belt attachment means (2a).

As shown in fig. 4, the first and second components (1&2) are joined together with biocompatible adhesive or by ultrasonic welding or by over molding so as to form a single part. The first component. (1) comprises a locating feature (Id) to align the second component (2). In this assembled condition of the first and second component (1&2), the device is inserted into location. The first and second components (1&2) can be molded as single part.

As shown in Fig. 5, the membrane module assembly (3) consists of :

a Membrane module (3A),

a Semi permeable membrane (3B),

an. Odor Filter (3C), and

an Odor filter module (3D).

The membrane module (3A) comprises a flexible slit 120°, which resists solid fecal matter and allows the liquid and gas to flow through the holes. The liquid and gas thereafter get separated by the semi permeable membrane (3B). The semi-permeable membrane (3B) is inserted into the membrane module (3A).

The odor filter (3C) is inserted into the odor filter module (3D) such that the gas separated from the liquid by the semi-permeable module (3B) comes in contact with the Odor filter, which then separate the odor from the gas.

Assembly of the membrane module (3A) and the semi-permeable module (3B) is then snap fitted with the assembly of the odor filter (3C) and odor filter module (3D). The final assembly of the third component (3A,3B,3C,3D) is then fitted with the assembly of the first and second components (1,2) to completely form the device of the invention.

Fig. -6 an alternative embodiment of the device in which the third component (3) is configurable as a disposable module and it is molded in a singe part unlike the part -3A and part 3D as shown in Fig. 6. Further, the membrane (3B) and the odor filter (3C) are combined in a single sandwich layer.

The device can be securely placed with an elastic belt.

The device has facility to accommodate customized bags supplied with package.

As shown in fig. - 7, an alternative arrangement is proposed which unlike the other disclosed embodiments of the invention, is enabled to communicate externally. The device comprises:

- a Face Plate (1); and

- an Outer Cover Assembly (2).

The outer cover assembly (2) comprises:-

-an Outer Cover (2)

-a Bellow Bag (2a)

-an Odor filter (2b).

As shown in fig.- 8 the bellow bag shown in fig. 7, can be replaced with a Membrane Module (4). The membrane module (4) shown here comprises an inner lining made of foam, and a fabric as outer lining, the foam absorbs a major portion of the liquid fecal matter collected into the module, and the fabric works as a deodorizer for the gas released out of the module. The module (4) has holes all over its open side to allow the fabric to evaporate the liquid collected from the foam, which in turn allows the module (4) to collect more amount of fecal matter and thereby improves quality of life of the user by reducing the number of times the fecal matter is to be emptied.

Claims

WE CLAIM:

1. A safe and improved ostomy device adaptable to patients having Colostomy and Ileostomy, the device comprising:

- a first component (1) having an extendable flexible tube (la) at a distal end to direct flow of fecal materials, a proximal end of the first component (1) being releasably fixed to the resected location, the flexible tube (la) internally accommodating a bellow portion (lb),

- a disc-shaped part (1C) attached to the flexible tube (la) through a first face of a groove (le) dimensioned substantially in the center of the disc (lc) in correspondence with the diameter of the flexible tube (la);

- a second component (2) having means for (2a) a belt attachment, and including a corresponding hole (2b) to match the groove (le), and further acting as a casing for a third component (3), the first and second components (1,2) are joinable together through one of the processes comprising biocompatatible adhesive, ultrasonic welding, and molding to form a single component; and - a third component (3) constituting a membrane module assembly having a membrane module (3A), a semi-permeable membrane (3B), odor filter (3C), and an odor filter module (3D), the third component (3) being insertable on the second component along the hole (2b) which second component (2) being joinable with the first component (1).

2. The device as claimed in claim 1, wherein the first component (1) comprises a locating feature (Id).

3. The device as claimed in claim 1, wherein the membrane module (3A) comprises a flexible slit disposed at an angle of 120°.

4. The device as claimed in claim 1, wherein the membrane module assembly (3) is formed in such a way that the assembly (3) acts as a disposable module, and wherein the third component (3) is molded as a single part.

5. A safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy, the device comprising :

- a face plate (1); and

- an outer cover assembly (2),

wherein the outer cover assembly (2) comprises an outer cover (2), a bellow bag (2a), and an odor filter (2b).

6. A safe and improved ostomy device adaptable to patients having colostomy or Ileostomy, the device comprising

- a face plate (1); and

- an outer cover assembly (2),

wherein the outer cover assembly (2) comprises an outer cover (2), a membrane module (4), and an odor filter (2b).

7. The device as claimed in claim 6, wherein the membrane module (4) comprises an inner lining made of foam material, an outer lining made of fabric material which further acts as a deodorizer for the released gas, wherein the module (4) having a plurality of holes all over its open side.

8. A safe and improved ostomy device adaptable to patients having Colostomy or Ileostomy, the device as substantially described and illustrated herein with reference to the accompanying drawings.