WO2013117970A1

WO2013117970A1 - Movable balloon prosthesis for endoscopes

Info

Publication number: WO2013117970A1
Application number: PCT/IB2012/055014
Authority: WO
Inventors: Abeyratne Herath Mudiyanselage Pradeep ANURUDDHA
Original assignee: HIROYUKI Gomi
Current assignee: HIROYUKI Gomi
Priority date: 2012-02-06
Filing date: 2012-09-21
Publication date: 2013-08-15
Anticipated expiration: 2014-08-06

Description

Movable balloon prosthesis for endoscopes

Technical Field

This invention is a disposable or permanently fixed device to stabilize the distal segment of the endoscope (Working end) during Upper Gastrointestinal or Lower Gastrointestinal endoscopic interventions and to develop new techniques for endovascular intervention.

Background Art

Endoscopy is a vital part of medical diagnostic process and is an every day tool in current medical environment.

The evolutions of endoscopic technologies were driven by the desire to gain information on the patient's medical status from the optical appearance of body cavities.

Maneuvering of the endoscope along the gastrointestinal track is a challenge to the endoscopist due to different angulations of the gastrointestinal track. Complications associated with endoscopic procedures are not uncommon due to this difficulty.

Single balloon endoscopes and double balloon endoscopes were introduced to overcome this issue to some extent.

At present therapeutic applications of the endoscope has become popular in especially managing early gastrointestinal cancers. Endoscopic Submucosal Dissection( ESD) and Endoscopic Mucosal Resections (EMR) have shown good prognosis in early gastrointestinal cancers. Having the terminal part of the endoscope stabilized is very important and helpful to the endoscopist to do a proper resection.

Pathological conditions associated with vessels, which is associated with stenosis of it, is currently managed my balloon angioplasty, stenting and open surgery.

Application of endoscopes in treating endovascular procedures as in the gastro intestinal tract can be developed.

Technical Problem

Existing balloon systems for endoscopy have technical problems in different aspects. Permanently fixed balloon can be damaged during the endoscopic procedures and repair may be needed frequently.

A spherical or an ellipsoid shaped balloon does not facilitate proper 'open up' at the front region after inflation, hence more air insufflations is required during an endoscopic procedure which leads to complications.

The currently available balloon systems do not offer proper visualization of the gastrointestinal tract during the withdrawal phase. A partially inflated balloon does not facilitate proper stretching of the mucosa and it's folds hence, early lesions could be missed. Miss rate of these early lesions should be minimized.

In the existing balloon system, once it has been stabilized and air and water seal achieved, the working end cannot be progressed forwards or withdrawn.

Endovascular interventions can not be done by using endoscope with currently available balloon system as this restriction effect after balloon inflation.

Suggested balloon system also has certain technical problems which need improvements.

Retaining particles within the grooves after deflation may cause difficulty in cleaning process of endoscope.

Additional channel in the endoscope is needed for air insufflations to balloon and sleeves with different modulus of elasticity make the balloon system more complex and may have certain difficulty in manufacturing the suggested balloon system for endoscopy.

Technical Solution

This new invention describes a solution for above mentioned technical problems which is a disposable or permanently fixed unit to the endoscope according to the requirement. Shape of the balloon system after inflation provides maximum 'open up' at the front region of the working end of the endoscope when compared to the existing balloon system. The partially deflated system also facilitates stretching of the mucosa and folds in the gastro intestinal tract thus minimizing the missing rate of early lesions.

Air and water tight sealing and fixation of balloon system to the inner wall are essential in case of endovascular intervention. The possibility of limited to and fro movement within the vessel lumen once stabilized is essential at the working end. All these characteristics are entertained by this invention due to it's sleeves with different modulus of elasticity and movable ring.

Advantageous Effects

This balloon system can be used as a disposable unit, which has the ability to 'open up' the front region of the working end of the endoscope, without restricting forwards and backwards movement.

This system also facilitates the development of new endovascular techniques in the treatment vessel related pathologies.

This invention can be made to be disposable, as after the initial workup, the materials which have been used are less expensive, production cost can be kept comparatively low.

Description of Drawings

Fig. 1 is to show the longitudinal section of the balloon system for endoscopy.

Fig. 2A is to show the all the stretchable components of balloon system and attachment to the movable ring.

Fig 2B is to show the inner cylinder with movable ring.

Fig. 3 is to show the balloon system after partially inflation.

Fig 4 is to show the appearance of the periphery of the balloon system when it inflate within a lumen of a tubule.

Fig 5 is to show with modification without the middle sleeve.

Fig 6A and Fig 6B is to show the way of creating blood less field at the intervening site of a major blood vessel.

Fig 6C is to show a another modification to the balloon system with new suction channel, middle layer without holes and central part of the anterior sheet with

multiple large holes.

Fig 7 is to show the application in Endoscopic Retrograde Cholangio Pancreaticography.

Fig 8 is to show the possibility of negotiation at the angulated site of colon.

Fig 9 is to show the withdrawing phase with pulling the scope with partially inflated balloon to prevent undetected lesions.

Fig 10 is to show the possibility of straighten the bowel loop in endoscopy.

Fig 11 is to show using this balloon system in Endoscopic Submucosal Dissection and Endoscopic Mucosal resection.

Fig 12 is to show the air moving channel in the inserting part of the endoscope and air pump with pressure monitor.

Mode for Invention

This invention can be used as a permanently fixed system or as a disposable system for endoscope and it comprises with mainly inner cylinder , sleeves ,a anterior sheet and a conical shape cylinder with property of elasticity, and a cylindrical rim that can move along the axis of the inner cylinder.

The inner cylinder and the movable cylindrical ring are made out of substance such as polymers which are non toxic and the consistency of ring and the inner cylinder are firm. However the inner cylinder has an ability to follow the movements and the limited bending of the shaft of the endoscope where it is mounted.

This inner cylinder can have various cross sectional inner diameter which mainly depends on the cross sectional external diameter of the insertion part of the

endoscope and the aim is to have adequate size of the lumen to mount on to the endoscope when it is used as a disposable system. Outer surface of the inner cylinder has three ridges, proximal end, 2cm distal to the proximal end and distal end in relation to the proximal end of the endoscope where it has controlling wheels.

The cross sectional inner diameter of the movable ring is larger than the cross sectional outer diameter of the inner cylinder, so that it can move easily on the surface of the inner cylinder. Sleeves have been mounted on the inner cylinder in three layers and proximally outer most sleeve is attached to the proximal ridge circumferentially whereas deeper sleeve and the middle sleeve to the ridge 2cm distal to the proximal ridge and on to the surface in between the proximal two ridges respectively.

Outermost sleeve has three segments continuously with different modulus of elasticity (young s modulus) and the distal segment has the least modulus of elasticity whereas the proximal has the highest. The total length of the middle sleeve is shorter than the outer most sleeve and the length, between the movable ring and the ridge 2cm distal to the proximal ridge when the balloon system is totally deflated.

A circular anterior sheet with two segments, a peripheral and a central, has been merged to the most distal part of the outermost sleeve at its peripheral edge, to the distal part of the middle sleeve at its junction between central and peripheral segment and to the movable ring at the center of the circular sheet.

The peripheral segment of the circular sheet has the least modulus of the elasticity out of all in this balloon system. With this arrangement, there are three different compartments. Outer compartment is in between outermost sleeve and the middle sleeve, middle compartment is situated between deep sleeve and the middle sleeve whereas deep compartment is situated between outer surface of inner cylinder and the deeper sleeve as it is attached circumferentially to the movable ring distally.

Deep compartment is filled with flimsy layer of lubricant, so that the friction between ring and the inner cylinder is in minimum level and holes in middle layer equalize the pressure within the outer and middle compartments. The conical shape cylinder is attached to the distal ring circumferentially by its narrow end and to the movable ring by its wider end.

At the proximal part in between distal ridge and the ridge 2cm distal to the proximal ridge, there is a channel to insufflate and deflate air through a connected channel in the inserting part of the endoscope.

Figure 1 shows a longitudinal section of the first embodiment (1). Inner cylinder (35) is made out of non toxic polymers and it is firm in consistency with a limited flexibility to follow the movement of the shaft of the endoscope (40)where it is mounted. The cylinder has ridges on its outer surface at the proximal end (21), 2cm distally from the proximal ridge ( 22) and at the distal end (20). The proximal ridge (21) gives attachment to the proximal part of the outer sleeve (4) and the proximal end of the deep sleeve (13) attach to the ridge 2 cm distal to the proximal ridge whereas the proximal end of the middle sleeve (14) attach in between these two ridges (21) and (22). The conical shape cylinder (24) has property of elasticity and attached to the distal ridge (20) by its narrow end and to the movable ring (23) through the other end. This stretchable cylinder (24) allow movements of the movable ring (23) on the axis of the inner cylinder (35) and getting back to its normal position, once the balloon system is deflated.

Fig 2A shows all the sleeves, anterior sheet and conical shape cylinder after detaching from the inner cylinder. Outermost sleeve consists with three segments, proximal (4), middle (5) and distal (6), and anterior sheet has two segments, peripheral (7) and central (8). Middle sleeve (14) has multiple holes (15) to communicate outer and middle compartment.

Fig 2B shows the inner cylinder. Air moving channel (29) is located at the proximal part in between proximal ridge (21) and ridge 2cm distal to the proximal ridge (22). Figure 4 is to show the inflated balloon system which is attached to the endoscope, within the tubular system such as arteries or intestine. Most outer part of the balloon system (31) which is formed by the distal segment of the outer sleeve (6) and the peripheral part of the anterior sheath (7), pushes the wall of the tubule (60) outward and the outward curvature of the most peripheral part of the balloon system (31) maintain the luminal opening (61) at the front region for considerable distance. After initial inflation to make the lumen patent, the shaft of the endoscope can be pushed forward with the aid of movement of the movable ring (23) and the changing shape of the balloon system. This movable distance of the endoscope can be increased by increasing the movable distance of the movable ring. This feature is helpful for performing procedures, negotiation the endoscope at certain difficult points such as angulated areas of tubules (80) especially intestine and distends the front region with minimum air insufflations.

Fig 6A and 6B describes a method that can be used to initiation of certain vascular procedures specially dissection of atheromatous plaques (75), to creation of lumen where in difficulties to do balloon angioplasty and to aspiration of clots due to deep vein thrombosis. Bloodless field (72) at the either side of the lesion within the vessel lumen can be created by an inflated balloon (73) and the invented balloon system (1) attached to endoscope. After aspiration of blood in that created space, without any deflation of the balloon system, the endoscope can be moved according to the requirement of the procedure. Endoscope can be inserted to the vessel through a flexible tube system (74), so that movements of the endoscope would not be affected.

Figure 6C shows another embodiment with modifications. This embodiment has an additional opening (78) at the middle compartment for aspiration, Middle sleeve does not contain any holes but the central part of the anterior sheet has larger holes (81). Middle compartment (87) of this embodiment is useful in vascular procedures, especially for collecting resected particles from atheromatous plaques and most of them can be aspirated through the aspirating channel (78). During the procedure, intermittent releasing of balloon is possible to minimize the possibility of reperfusion injury. One major step in Endoscopic Retrograde Pancreatico cholangiography is cannulating the duodenal papilla (90). Stabilizing the tip of the endoscope by mean of this invented balloon system at the targeted area is helpful to do easy cannulating (91) of duodenal papilla. It also helps, to minimize the trauma at the duodenal papilla, to keep the lumen patent with minimum air insufflations and to prevent air entry to the stomach.

Referring to the Fig. 8 stabilizing the endoscope and positioning the terminal part at the center of the tubule system, particularly related to colonoscopy helps to negotiate the angulated points (80) easily. Insufflating air will retain beyond the balloon system and minimum air insufflations will be sufficient for easy intubation.

Referring to the Fig.10, balloon system can be used to straighten the endoscope in case of looping specially in colonoscopy and prevent discomfort to the patient. In withdrawing phase of colonoscopy, this invented balloon system can be used to minimize the missing of smaller lesions especially in angulated areas such as hepatic flexure.

Referring to the Fig. 9 withdrawing the endoscope with adequately inflated balloon system prevents missing lesions, due to stretching the mucosa (95) over the folds by its specially arrange curved peripheral area of the inflated balloon.

This balloon system can be used in endoscopic mucosal resections and endoscopic submucosal dissection of lesions at the colon, esophagus or pharynx as shown in Fig. 11. The balloon system helps, to stabilize the endoscope at the center of the lumen, to keep the lumen patent and minimize the requirement of air insufflations.

Referring to the Fig.12, there should be a separate channel (120) to air insufflations and deflation along the inserting part of the endoscope. Separate air pump (121) with pressure monitor (122) can be connected through a tubing system (123) to this particular channel.

Industrial Applicability

This movable balloon prosthesis can be mounted to the insertion part of the endoscope. Characteristic shape after inflation of this balloon helps to negotiation of insertion part of the endoscope through the gastrointestinal tract with minimal air insufflations. Partially inflated balloon at the withdrawal phase stretches the intestinal mucosa over the folds and this is useful to minimize the missing rate of lesions. Further more terminal bending segment of the insertion part of the endoscope can be stabilized at the center of the lumen by this movable balloon prosthesis. Endoscopic mucosal resection, Endoscopic Submucosal Dissection, Polypectomies and Endoscopic retrograde cholangio pancreaticography can be done with out much difficulty as this movable balloon system has this stabilizing ability. Limited to and fro movements are possible even after fully inflation of the balloon system with air tight fixation to the inner luminal wall. This property is also helpful for gastrointestinal endoscopic procedures and to develop new endovascular procedures by using endoscopes especially for vascular luminal narrowing due to various pathological conditions.

Claims

A movable balloon prosthesis for endoscopes has been invented to minimize the difficulties in inserting endoscope to a tubular structures of human or animal, to initiate a system with creating a blood less space within the vessel lumen for endovascular intervention as a treatment modality for vascular stenosis due to various pathology and deep vein thrombosis, to facilitate endoscopic sub mucosal dissection or endoscopic mucosal resection of colon, esophagus, pharynx or any other duct system in the body by stabilizing the scope end in place during the dissection, to prevent slippage specially at the angular point such as at hepatic flexure and to minimize the requirement of air insufflations during the procedure which comprises;

i) a cylinder (35 )which has a proximal end where it closure to the manipulating end with wheels and channels of the endoscope and a distal end where it closure to the distal

end or the camera end of the inserting part of the endoscope ;

ii) a outer surface with three circumferential ridges, at the proximal end , 2cm distal to the proximal end and at the distal end of the cylinder;

iii) a hole (29) at the proximal part of the cylinder in between proximal ridge and the ridge 2cm distal to the proximal ridge for air movement through the connecting channel of the endoscope;

iv) a cylindrical rim (23) which is able to move along the axis of the cylinder between distal

ridge and the ridge 2 cm distal to the proximal ridge;

v) three different sleeves with different modulus of elasticity of each as well as along the sleeves arranged along the axis of cylinder namely, outer most (4) , middle (13) and deeper (14) accordance with the positions in relation to the central cylinder and anterior sheet with property of elasticity;

vi) and a conical elastic sleeve (24) ,at the distal part, attaching to the distal circumferential ridge by the narrow end and to the movable cylindrical rim by the wider end of it.
The movable balloon prosthesis for endoscopes of claim 1 wherein all components has been made out of non toxic materials.
The movable balloon prosthesis for endoscopes of claim 2 wherein the non toxic materials for inner cylinder and movable rim are made out of materials which has ability of limited bending along with the movement of endoscope such as polymers where as all the sleeves and the anterior sheath are made out of materials which are elastic such as natural rubber and silicon.
The movable balloon prosthesis for endoscopes of claim 1 wherein the outer most sleeve consist with continuous three segments ,proximal, middle and distal and they are made out of materials of different modulus of elasticity (young's modulus) with highest at the proximal segment and the least at the distal segment, whereas anterior sheet has two segments, peripheral and central with least modulus of elasticity at the periphery.
The movable balloon prosthesis for endoscopes of claim 1 wherein the elasticity of middle sleeve increases from the proximal to distal, having least at distally, whereas elasticity is constant along the deeper sleeve and conical elastic sleeve.
The movable balloon prosthesis for endoscopes of claim 1 wherein the proximal end of the outermost sleeve is mounted to the proximal ridge of the cylinder circumferentially and the deeper sleeve to the ridge 2 cm distally to the proximal ridge and the middle sleeve is mounted in between.
The movable balloon prosthesis for endoscopes of claim 1 wherein the outer most sleeve distally merge with most peripheral edge of the anterior sheet whereas middle sleeve merge with the junction of two segments of anterior sheet while deeper sleeve, central edge of the anterior sheet and proximal end of the conical sleeve have been attached to the movable cylindrical rim.
The movable balloon prosthesis for endoscopes of claim 1 wherein there are three different compartments namely ,outermost, middle and inner depend on the relation to the external surface and there are multiple holes in the middle sleeve to have equal pressure within outer and middle compartments and furthermore the deeper compartment can be filled with flimsy layer of lubricant to minimize the friction between movable ring and the inner cylinder.
The movable balloon prosthesis for endoscopes of claim 1 wherein the modulus of elasticity of the peripheral segment of the anterior sheet is lower than the distal segment of the outermost sleeve.
The movable balloon prosthesis for endoscopes of claim 1 can be permanently fixed to the inserting part of the endoscope or it can be a disposable part and when it is fixed to the endoscope the distal ridge of the cylinder is proximal to the origin of the movable segment of the endoscope which does not affect the manipulation of the endoscope.
The movable balloon prosthesis for endoscopes of claim 1 wherein the movable distance of the movable cylindrical rim is depend on the requirements accordance with the selected endoscope or tubular system of the body and by changing the length of the cylinder specially distance between distal ridge and ridge 2 cm distal to the proximal ridge, while movable distance can be changed.
The movable balloon prosthesis for endoscopes of claim 1 wherein by keeping the inner diameter of movable cylindrical rim more than the outer diameter of the inner cylinder, possible restriction to mobility of rim due to bending of endoscope can be avoided.
The movable balloon prosthesis for endoscopes of claim 1 wherein balloon system is mounted in a separate air channel and larger the channel the efficiency of the balloon system will be better specially when inserting the endoscope to the duct system by creating maximum negative pressure at the balloon system and prevent the retraction of sleeve and due to achieved maximum collapsing of balloon system, the added diameter to the endoscope will be minimum.
The movable balloon prosthesis for endoscopes of claim 13 wherein the air channel is connected to a separate syringe system that can inflate and deflate the air easily and a three way tap and another syringe is used to achieve a maximum negative pressure.
The movable balloon prosthesis for endoscopes of claim 13 wherein the air channel is connected to a pressure monitoring system ,so that developing pressure within the system is assessed and precautions are taken where necessary provided the maximum bursting pressure for the particular duct system is known.