WO2002039913A1 - Dispositif memoire de forme pour etrangler des polypes pedicules lors d'une endoscopie - Google Patents

Dispositif memoire de forme pour etrangler des polypes pedicules lors d'une endoscopie Download PDF

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Publication number
WO2002039913A1
WO2002039913A1 PCT/IT2001/000571 IT0100571W WO0239913A1 WO 2002039913 A1 WO2002039913 A1 WO 2002039913A1 IT 0100571 W IT0100571 W IT 0100571W WO 0239913 A1 WO0239913 A1 WO 0239913A1
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WO
WIPO (PCT)
Prior art keywords
filament
shape memory
memory device
strangulating
loop
Prior art date
Application number
PCT/IT2001/000571
Other languages
English (en)
Inventor
Mario Immacolato Paternuosto
Original Assignee
Mario Immacolato Paternuosto
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mario Immacolato Paternuosto filed Critical Mario Immacolato Paternuosto
Priority to AU2002222519A priority Critical patent/AU2002222519A1/en
Publication of WO2002039913A1 publication Critical patent/WO2002039913A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • Shape memory device for strangulating pedunculated polyps during endoscopy
  • the present invention relates to the field of the digestive system endoscopy. More specifically, it concerns an auxiliary device to be used in particular endoscopy techniques such as polypectomy of pedunculated polyps by a metal loop.
  • endoscopy techniques such as polypectomy of pedunculated polyps by a metal loop.
  • a metal loop with a more or less varied circular shape is basically passed under open condition across the head of the polyp until its peduncle is reached. In such position, the loop is tightened round the ' peduncle and then an electrical current is passed in the metal loop. The final effect is the resection of the polyp peduncle.
  • the polyp peduncle is provided with a number of arterial, venous, lymphatic vases and nervous filaments.
  • the vases Upon resection of the peduncle by electrical current having mostly a coagulant effect to the tissues or after combined actions, i.e. resection and coagulation, the vases undergo an occlusion due to the necrosis induced by the current.
  • the current should be kept at a suitable intensity for a long enough time. If such effects are not suitable enough to occlude the arterial vas, the most dangerous consequence is the haemorrhage. Haemorrhage is mainly due to arterial blood and, if it is outstanding, makes the field of endoscopy inaccessible in a very short time.
  • the emergency endoscopy operations are partially the same as used for preventing haemorrhages due to polypectomy.
  • the most used ones are adrenaline injection, endoloops, and endoclips.
  • the big problem of blood and coagula still remains, thus making such techniques extremely difficult or even impossible to be carried out, especially with the passing of time and the haemorrhage in progress, if the amount of blood accumulated in the lumen of viscera is even more considerable and the function of the suction channel of the endoscope is reduced because of the presence of coagula which could occlude it upon suction.
  • Another technique used with bleeding due to polypectomy in progress is to seize again the blood spouting stump by the same loop which has been used for polypectomy and to hold it tight for five minutes.
  • Nitinol As known, some alloys such as a nickel-titanium alloy known under the trade name of Nitinol are provided with a thermal memory, i.e. they are able to take on a programmed shape when exposed to a predetermined temperature .
  • a filament of Nitinol which is programmed to take on the shape of an alpha loop at the temperature in the colon can take on a straight shape if it is brought to low temperature, i.e. about zero degree, while it recovers the shape of a loop or a letter (alpha) when it is removed from its rigid, straight support sheath in the intestine at the peduncle to be s rangulated.
  • the filament of Nitinol is included in a tubular closed sheath which is able to follow the shape changes in the same filament and can be blown up pneumatically by inflating air through a sclerosis needle to allow the operator to hold the peduncle tighter when the latter is restrained by the loop in order to ensure a perfect strangling.
  • the modality of use provides that the inflatable tubular sheath containing the filament of Nitinol is inserted into the channel of the endoscope through the distal ostium so as to be applied to the sclerosis needle after having been extracted from its rigid sheath when the endoscope is still outside the human body. This allows tearing of sheath of elastic material to be avoided notwithstanding its insertion along the whole length of the endoscope channel .
  • the tubular sheath can be extracted outside the channel by the sclerosis needle so that the filament of Nitinol being free of any obstacle in the environment at the temperature of the colon takes on the original programmed alpha shape again going round the peduncle .
  • a first drawback relates to the strangling function: this is bound to the formation of an air chamber round the filament of Nitinol which should compress the peduncle.
  • a third drawback consists in that the loop of Nitinol of the preceding Patent Application should be wound first round the polyp peduncle and then the pneumatic air chamber is inflated to strangulate the peduncle. This is, therefore, a two-step operation.
  • a fourth drawback consists in that the operator has to put the needle in the pneumatic sheath surrounding the filament of Nitinol and to position the whole at the distal end of the endoscope before the latter is put into the human body.
  • the inflatable sheath does not give any sufficient guarantee of providing a valid, effective electrical insulation for the filament of Nitinol in case of an accidental contact with the metal loop in the step of the peduncle resection.
  • the present invention seeks to overcome all of the problems described above by using a shape memory device having the following peculiar characteristics: a) the device consists of a filament of Nitinol provided with electrically insulated means able to avoid the danger that the same filament can transmit the current flowing in the metal loop during polypectomy to the wall of the intestine when the resection of the peduncle is carried out; b) said device can be put into the endoscope after having found the position of the peduncle to be cut without the need to extract the endoscope from the body of the patient because of the combination of a guide tube put into said endoscope up to its distal end and a means controlled by the operator and able to push the shape memory device from the proximal to distal ends of said guide tube causing the latter to protrude from the endoscope; c) the use of said guide tube and said means allows even more than one shape memory device to be positioned after one another near the distal end; d) a means for controlling the loop formation speed and grading the
  • the device consists of a filament of Nitinol which is coated by a non-inflatable tight latex sheath having only an insulation function to avoid the danger that the same filament can accidentally transmit the current flowing in the metal loop performing the resection to the wall of the intestine during polypectomy; said sheath may also be provided with microholes for an easier heat exchange.
  • Nitinol filament having only the insulating sheath; filament having only beads; filament having the insulating sheath and the beads; and two preferred expelling systems-, using common biopsy pincers seizing the proximal end of the shape memory device and controlling its protrusion from the guide tube; or using a thrust tube when the devices placed in the guide tube are more than one .
  • Fig. 1 is a general view of the shape memory loop in the original shape, i.e. in the form of a loop, according to a first embodiment consisting of a filament of Nitinol carrying a sphere at each end within a tubular sheath;
  • Fig. 2 shows the same loop of Fig. 1 in straight shape ;
  • Fig. 3 shows a portion of the loop of Fig. 2 in enlarged scale, with the sheath provided with microholes;
  • Figs . 4 and 5 show a second embodiment in the original loop structure and straight structure, respectively, where microspheres or beads of glass or similar material are threaded by the filament without sheath;
  • Figs. 6 and 7 show a third embodiment still in the original loop structure and straight structure, respectively, with the filament provided both with the sheath and microspheres or beads;
  • Fig. 8 shows schematically a first thrust means to be used when several loops are present in the endoscope after one another;
  • Fig. 9 shows a second embodiment of the thrust means to be used in case only one loop is employed;
  • Fig. 10 shows the filament of Nitinol at the beginning of the loop formation round the polyp peduncle
  • Fig. 11 shows the filament of Nitinol with an already closed loop.
  • the shape memory device consists of a filament 2 of Nitinol fastened at its ends to a couple of beads or bulges 1 placed within a sheath 3 preferably of rubber latex having only the function of insulating electrically such filament.
  • Figs. 3 and 4 show a second embodiment.
  • a plurality of microspheres or beads 10 of insulating material having a much larger diameter than the filament but lower than the lumen of the guide tube sliding in the channel of the colonoscope are threaded by filament 2.
  • microspheres 10 are of glass, a material having the advantage of being non- conductive .
  • FIG. 6 A third embodiment collecting the characteristics of the preceding embodiments is shown in Figs . 6 and 7. As can be seen in such Figures, the microspheres or beads are threaded by the sheath surrounding the filament of Nitinol.
  • filament of Nitinol 2 is programmed to take on the shape of the Greek small letter alpha at the temperature of colon, it can be formed before use, i.e. outside the human body, to a straight shape by submitting it to a low temperature . Under such conditions it is possible to insert the filament with the straight shape into a guide tube 7 with suitable diameter so as to allow it to pass easily through channel 12 of a colonoscope or another endoscope 14.
  • a suitable thrust means can be either common biopsy pincers 6 able to seize the proximal end of the loop, as can be seen in Fig. 9, or another tube 5 coaxial to channel 7 but with lower diameter, as shown in Fig. 8.
  • the loop in the intestine will take on the alpha shape to which it has been programmed, and will engage the polyp peduncle in such a movement so as to strangulate it (Fig. 10) .
  • tube 7 containing the loop of Nitinol with the straight shape in its distal length can include another tube 5 coaxial thereto and acting as pusher instead of pincers 6.
  • Such tube 5 which is empty is provided at its distal end with suitable means for pushing such shape memory device and is pushed together with tube 7 along channel 12 of the endoscope .
  • tube 5 as thrust means is necessary when the shape memory devices are more than one located after one another in the last few centimetres of length of tube 7, as can be seen in Fig. 8, in order to engage as many peduncles.
  • pincers allows only one device to be guided until it protrudes from guide tube 7.
  • such tube 5 also allows both the shape memory devices to be pushed and cold water to be injected so that the same shape memory devices do not bend in tube 7, thus avoiding problems due to the protrusion of the same guide tube 7. It should be noted to this purpose that such glass beads slow down the winding speed. Conversely, if there is only one shape memory device, even if the latter tends to bend in the guide tube containing the same, the thrust exerted by biopsy pincers is strong enough to bring it outside the tube toward the peduncle round which it will be wound automatically. Biopsy pincers are obviously inserted into the same guide tube and hold the end of the loop of Nitinol provided with beads in its straight shape tight between their arms.
  • the loop strangulating the peduncle has a variety of sizes.
  • the diameter of the loop varies relative to the size of the peduncle to be strangulated.
  • the minimum diameter of the loop is 3 mm because a peduncle smaller than 3 mm hardly bleeds when it is cut by a loop for polypectomy.
  • the desired size can however be reached by either shaping the Nitinol loop in that way or, if it is believed suitable for technical reasons, by shaping the loop in a larger manner and contracting it by using glass beads 1 which are compatible with the diameter of the channel containing the same.
  • glass microspheres 1 When a system of dual coaxial tubes 5-7 is used to push the shape memory device, glass microspheres 1, besides being stacked in the length of Nitinol filament which will then form the loop, should also be positioned in the minimum number of three along the two wings of the loop so that they are not expelled too quickly from the distal ostium of the endoscope, thus slowing down the winding speed. Conversely, when a thrust tube 5 is used, it is convenient that one of the two ends of the loop is longer than the other one so that it does not spring with excessive speed and get lost in the lumen of the intestine, since it is not held by pincers but only slowed down in its winding by a cold water flow.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un dispositif mémoire de forme conçu pour étrangler des polypes pédiculés lors d'une endoscopie afin d'empêcher le saignement lors de polypectomie. Ledit dispositif comporte un filament (2) de nitinol électriquement isolé contre des contacts accidentels avec la boucle métallique traversée par le courant effectuant la résection du fait d'une gaine (3) isolante étroite non gonflable en latex ou, autre possibilité, porte un certain nombre de microsphères à base de billes de verre judicieusement réparties sur toute la longueur du filament. Ces billes (10) ralentissent également la vitesse de formation de la boucle d'étranglement. Afin de réguler cette vitesse, on injecte de l'eau froide à l'intérieur du tube guidant le dispositif à l'intérieur du canal endoscopique de façon à le toucher avant protrusion, ce qui permet d'éviter que le même filament se détende violemment lorsqu'il est soumis à la température des viscères, ou soit retenu par l'extrémité distale du tube guide dans le cas où il se plie trop tôt. Le dispositif mémoire de forme est poussé par des tenailles ou par un second tube coaxial par rapport au tube guide dans lequel s'écoule l'eau de refroidissement.
PCT/IT2001/000571 2000-11-14 2001-11-13 Dispositif memoire de forme pour etrangler des polypes pedicules lors d'une endoscopie WO2002039913A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002222519A AU2002222519A1 (en) 2000-11-14 2001-11-13 Shape memory device for strangulating pedunculated polyps during endoscopy

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT2000RM000593A IT1317934B1 (it) 2000-11-14 2000-11-14 Dispositivo a memoria di forma per il trattamento per via endoscopicadi polipi peduncolati.
ITRM2000A000593 2000-11-14

Publications (1)

Publication Number Publication Date
WO2002039913A1 true WO2002039913A1 (fr) 2002-05-23

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Application Number Title Priority Date Filing Date
PCT/IT2001/000571 WO2002039913A1 (fr) 2000-11-14 2001-11-13 Dispositif memoire de forme pour etrangler des polypes pedicules lors d'une endoscopie

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Country Link
AU (1) AU2002222519A1 (fr)
IT (1) IT1317934B1 (fr)
WO (1) WO2002039913A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005070309A1 (fr) * 2004-01-26 2005-08-04 Mario Immacolato Paternuosto Boucle pliable constituee de nitinol pour traitement perendoscopique de polypes pedoncules
DE102004030391A1 (de) * 2004-06-23 2006-01-26 Somatex Medical Technologies Gmbh Marker
WO2011058334A1 (fr) * 2009-11-13 2011-05-19 Btg International Limited Clamp et applicateur
US9186169B2 (en) 2005-10-14 2015-11-17 Boston Scientific Scimed, Inc. Snare with loop made of heat shrinkable shape memory material and method of use thereof
CN113662631A (zh) * 2021-07-21 2021-11-19 西安交通大学医学院第二附属医院 一种b超引导下肝段切除术用辅助装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997012553A1 (fr) * 1995-10-03 1997-04-10 Changus James E Appareil pour faciliter la tumorectomie, et methodes associees
US6080160A (en) * 1996-12-04 2000-06-27 Light Sciences Limited Partnership Use of shape memory alloy for internally fixing light emitting device at treatment site
WO2000053107A1 (fr) * 1999-03-09 2000-09-14 General Science & Technology Corporation Serre-noeud pour polypectomie

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997012553A1 (fr) * 1995-10-03 1997-04-10 Changus James E Appareil pour faciliter la tumorectomie, et methodes associees
US6080160A (en) * 1996-12-04 2000-06-27 Light Sciences Limited Partnership Use of shape memory alloy for internally fixing light emitting device at treatment site
WO2000053107A1 (fr) * 1999-03-09 2000-09-14 General Science & Technology Corporation Serre-noeud pour polypectomie

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005070309A1 (fr) * 2004-01-26 2005-08-04 Mario Immacolato Paternuosto Boucle pliable constituee de nitinol pour traitement perendoscopique de polypes pedoncules
DE102004030391A1 (de) * 2004-06-23 2006-01-26 Somatex Medical Technologies Gmbh Marker
US9186169B2 (en) 2005-10-14 2015-11-17 Boston Scientific Scimed, Inc. Snare with loop made of heat shrinkable shape memory material and method of use thereof
US9827008B2 (en) 2005-10-14 2017-11-28 Boston Scientific Scimed, Inc. Snare with loop made of heat shrinkable shape memory material and method of use thereof
WO2011058334A1 (fr) * 2009-11-13 2011-05-19 Btg International Limited Clamp et applicateur
AU2010317715B2 (en) * 2009-11-13 2013-11-07 Btg International Limited Clamp and applicator
US9955975B2 (en) 2009-11-13 2018-05-01 Btg International Limited Clamp and applicator
CN113662631A (zh) * 2021-07-21 2021-11-19 西安交通大学医学院第二附属医院 一种b超引导下肝段切除术用辅助装置

Also Published As

Publication number Publication date
IT1317934B1 (it) 2003-07-15
AU2002222519A1 (en) 2002-05-27
ITRM20000593A0 (it) 2000-11-14
ITRM20000593A1 (it) 2002-05-14

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