WO2019054867A1 - Instrument pour opérations chirurgicales minimalement invasives, comprenant une tige ou un cathéter et une pointe montée sur la tige ou le cathéter avec un élément élastiquement déformable - Google Patents

Instrument pour opérations chirurgicales minimalement invasives, comprenant une tige ou un cathéter et une pointe montée sur la tige ou le cathéter avec un élément élastiquement déformable Download PDF

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Publication number
WO2019054867A1
WO2019054867A1 PCT/NL2018/050603 NL2018050603W WO2019054867A1 WO 2019054867 A1 WO2019054867 A1 WO 2019054867A1 NL 2018050603 W NL2018050603 W NL 2018050603W WO 2019054867 A1 WO2019054867 A1 WO 2019054867A1
Authority
WO
WIPO (PCT)
Prior art keywords
tape loop
catheter
loop spring
rod
tip
Prior art date
Application number
PCT/NL2018/050603
Other languages
English (en)
Inventor
Giuseppe RADAELLI
Werner Wilhelmus Petrus Johann VAN DE SANDE
Awaz ALI
Original Assignee
Technische Universiteit Delft
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 Technische Universiteit Delft filed Critical Technische Universiteit Delft
Publication of WO2019054867A1 publication Critical patent/WO2019054867A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • A61B2018/00357Endocardium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Definitions

  • Instrument for minimal invasive surgical operations comprising a rod or catheter and a tip mounted on the rod or catheter with an elastically deformable element
  • the invention relates to an instrument for minimal invasive surgical operations, comprising a rod or catheter and a tip mounted on the rod or catheter with an elastically deformable element, wherein the elastically deformable element is arranged to apply a contact force with the tip on a tissue that is subjected to the surgical operations.
  • a heart ablation procedure is a relatively long procedure ⁇ taking more than 4h) wherein a flexible catheter is fed through a vein inside the heart. The catheter tip approaches the inner side of the heart wall. Ideally, a path of scarred tissue is
  • US2005/0267332 discloses a spring tip flexible electrode, and a method for using that electrode for tissue abla- tion in the heart.
  • the spring tip flexible electrode comprises an enshrouded flexible electrode for applying ablation energy to target the tissue for the formation of spots or continuous linear lesions.
  • the spring of the spring tip may comprise compressible coils, compressible mesh, or compressible bellows.
  • the spring provides axial suspension and is capable of axial compression and extension, and is flexible enough for deflection and bending.
  • the axial suspension of the spring tip facilitates the desired contact between the electrode and the tissue surface and facilitates enhanced tissue contact in dif- ficult environments.
  • a disadvantage is however is that due to the linear characteristics of the spring the contact force may exceed a maximum value, and that the contact force varies together with the movement of the heart so that contact between the electrodes and the heart tissue is not at all times guar- anteed.
  • the invention has as an object to address these concerns and proposes to that end an instrument for minimal invasive surgical operations, comprising a rod or catheter and a tip mounted on the rod or catheter with an elastically deform- able element, wherein the elastically deformable element is arranged to apply a contact force with the tip on tissue that is subjected to the surgical operations, wherein the elastically deformable element is designed to provide a substantially constant force to the tip when a distance between the tip and the rod or catheter that supports the tip is varied within a predefined range.
  • Preferable embodiments of the instrument of the invention are proposed according to the features of one or more of the appended dependent claims.
  • the elastically deform- able element is designed to provide a substantially constant force to the tip when a distance between the tip and the rod or catheter that supports the tip is varied, the deformable element provides the tip with zero-stiffness when moved in a range in a longitudinal direction of the rod or catheter.
  • the deformable element autonomously resists bending in a transverse direction. This avoids the necessity to apply auxiliary features for maintain- ing directional stability of the tip mounted on the deformable element .
  • the deformable element has a monolithic structure.
  • the elastically deformable element is an endless tape loop spring with predefined parameters relating to at least its material, combination of materials, or positions in the tape loop spring where such material is missing, the tape loop spring width, the tape loop spring material thickness, and the tape loop spring's traverse curvature, wherein the tape loop spring is embodied with two elongated parts in or parallel to a longitudinal direction of the rod or catheter, which elongated parts convert into each other by bends at opposite sides of the elongated parts, and wherein each bend connects the elongated parts to each other, and wherein at least one of the said parameters of the endless tape loop spring is varied along the circumference of the tape loop spring, so that variation of the distance between the tip and the rod or catheter causes a circumferential round going motion of the endless tape loop spring which causes that the bends travel along the circumference of the endless loop while maintaining their position in or parallel to the longitudinal direction of the rod or catheter.
  • the said variation of at least one of the parameters of the endless tape loop spring along the circumference of the tape loop spring is essential to provide a substantially constant force to the tip when (within a predefined range) a distance between the tip and the rod or catheter that supports the tip is varied.
  • the motion of the endless loop is prefera- bly self-constrained to avoid the need of any additional guid ⁇ ing mechanism. This is preferably achieved by providing that the material of the endless tape loop spring has a transverse curvature in the direction of its width.
  • the parameters in the circumference of the endless tape loop spring notably one or more of the tape loop spring' s material, combination of materials, or positions in the tape loop spring where such material is missing, the tape loop spring width, the tape loop spring material thickness, and/or the tape loop spring's transverse curvature.
  • the width of the tape loop spring is varied in the circumferential direction of the tape loop spring, which from a constructional point of view is most easy to realize.
  • the construction of the instrument is then preferably such that the tape loop spring has an unloaded position wherein respective parts of the tape loop spring occupy a preferential position with respect to each other, and wherein then at or near the location of the bends the width of the tape loop spring is smaller than at the two elongated parts between the bends.
  • the endless tape loop spring has a width with tapered portions. This is relatively easy to implement and causes that the tapered por- tions have their smallest width at or near the bends when the tape loop spring is in the unloaded position, which corresponds with the lowest amount of potential energy in the tape loop spring.
  • a broader part of the tapered portions are at the bends of the endless tape loop spring when the tape loop spring is in a predefined loaded position. Then the potential energy in the tape loop spring is at a slightly higher value than in the unloaded position.
  • a further preferable feature is that in a transverse direction of the endless tape loop spring, the spring has a curvature with a predefined radius of curvature. This is a simple measure to provide the spring with a high stiffness in the transverse direction so as to resist bending in said direction and to provide directional stability to the tip.
  • the predefined radius of curvature is preferably selected at a value corresponding to the rod or catheter diameter.
  • the elongated parts of the endless tape loop spring are then always at an approximate distance from each other corresponding to the diameter of the rod or cathe- ter that supports the tip and the endless tape loop spring.
  • -figure 1 shows schematically a heart in which an instrument according to the invention is applied to provide an ablation procedure to certain tissue of the heart;
  • -figure 2 shows a top part of the instrument of the invention providing a view at its rod or catheter, at an elas- tically deformable element supported by the rod or catheter, and at a tip supported by the elastically deformable element;
  • -figure 3 shows a force - distance diagram of the tip that is moved with reference to the rod or catheter.
  • FIG 1 a heart is schematically shown, as well as its inferior vena cava through which an instrument 1 ac- cording to the invention is guided, in particular in this case an ablation catheter.
  • the instrument 1 of figure 1 comprises a rod or catheter 2 and a tip 3 mounted on the rod or catheter 2 with an intermediate elastically de- formable element 4, wherein the elastically deformable element 4 is arranged to control a contact force applied with the tip 3 on the tissue of the heart shown in figure 1 that will be subjected to an ablation procedure.
  • the elastically deformable element 4 as shown in figure 2 is designed to provide a substantially constant force to the tip 3 when a distance is varied between the tip 3 and the rod or catheter 2 that indirectly (via the intermediate elas- tically deformable element 4) supports the tip 3. This variation of distance can of course only be done within a predefined range.
  • the tip 3 and the rod or catheter 2 are approximately at their closest position wherein the elastically deformable element 4 practically completely fills in the space between the rod or catheter 2 and the tip 3.
  • the elastically deformable element 4 is embodied as an endless tape loop spring 5.
  • This endless tape loop spring 5 has predefined parameters relating to at least its material (steel or other suitable material), combination of materials (steel and plastic or other combina ⁇ tions) , or positions in the tape loop spring where such material is missing (for instance in the middle part - not shown in figure 2 ) , the tape loop spring width 6, the tape loop spring material thickness (usually less than a millimetre) , and the tape loop spring's transverse curvature 7. It is essential that at least one of said parameters of the endless tape loop spring 5 is varied along the circumference of the tape loop spring 5.
  • the tape loop spring 5 is embodied with two elongated parts 8, 9 in or parallel to a longitudinal direction 10 of the rod or catheter 2, which elongated parts 8, 9 convert into each other by bends 11, 12 at opposite sides of the elongated parts 8, 9 so that each bend 11, 12 connects the elongated parts 8, 9 to each other.
  • Variation of the distance between the tip 3 and the rod or catheter 2 causes a circumferential round going motion of the endless tape loop spring 5 which causes that the bends 11, 12 travel along the circumference of the endless tape loop spring 5 while maintaining their position in or parallel to the longitudinal direction 10 of the rod or catheter 2. Since the tip 3 is mounted on a first part 15 of the tape loop spring 5, and the rod or catheter 2 connects to the tape loop spring 5 at a second part 16 of the tape . loop spring 5, the circumferential round going motion of the endless tape loop spring 5 results in a corresponding change of distance between the tip 3 and the rod or catheter 2 of the instrument 1.
  • the force F applied by the tip 3 on a tissue that is in contact with the tip 3 will during this varying distance between the tip 3 and the rod or catheter 2 be maintained at a relatively constant value which hardly varies with the changing distance between the tip 3 and the rod or catheter 2.
  • FIG 2 a preferred embodiment is shown in which the width 6 of the tape loop spring is varied in the circumferential direction of the tape loop spring 5.
  • Figure 2 particularly shows an embodiment wherein the endless tape loop spring 5 has a width 6 with tapered portions that extend along the length of the elongated parts 8, 9 and also in the bends 11, 12. It is however also possible to restrict the tapered portions to extend over a limited circumferential range of the tape loop spring 5.
  • the tape loop spring 5 also has an unloaded position wherein the respective parts of the tape loop spring 5 occupy a preferential position with respect to each other, and wherein then at or near the location of the bends 11, 12 the width 6 of the tape loop spring 5 will be at its smallest possible value which is in any case smaller than at the two elongated parts 8, 9 between the bends 11, 12.
  • the tapered portions are provided with an imaginary top angle, or also called sub- tended angle, which lies in the range of 95 - 135°.
  • Figure 2 further shows that in a transverse direction of the endless tape loop spring 5 that defines the width 6, the spring 5 has a curvature 7 with a predefined radius of curvature.
  • the traverse curvature 7 in trig dirgction of thQ width of the spring 5 supports that the motion of the endless loop is self-constrained and does not need any additional guiding mechanism.
  • the predefined radius of curvature 7 is preferably selected at a value corresponding to the diameter of the rod or catheter 2, which causes that the distance between the elongated portions 8, 9 of the endless tape loop spring 5 will approximately equate with the diameter of the rod or catheter 2.
  • Figure 3 shows the simulated results of an instrument design as shown in figure 2, wherein the relation is shown between the force F applied with the tip 3 on a tissue treated with the tip, which force is indicated along the y-axis, and the distance D shown along the x-axis which is the distance travelled by the tip 3 with reference to the rod or catheter 2.
  • the graph of figure 3 shows that the force at the tip 3 of the instrument is substantially constant and independent from the distance between the tip 3 and the rod or catheter 2.
  • the tip (3 ⁇ exhibits zero-stiffness or substantially zero-stiff ess when moved in a range in a longitudinal direction of the rod or catheter 2.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un instrument pour des opérations chirurgicales minimalement invasives, comprenant une tige ou un cathéter et une pointe montée sur la tige ou le cathéter avec un élément élastiquement déformable, l'élément élastiquement déformable étant agencé pour commander une force de contact appliquée avec la pointe sur un tissu qui est soumis aux opérations chirurgicales, et l'élément élastiquement déformable étant conçu pour fournir une force sensiblement constante à la pointe lorsqu'une distance entre la pointe et la tige ou le cathéter qui supporte la pointe varie dans une plage prédéfinie.
PCT/NL2018/050603 2017-09-14 2018-09-14 Instrument pour opérations chirurgicales minimalement invasives, comprenant une tige ou un cathéter et une pointe montée sur la tige ou le cathéter avec un élément élastiquement déformable WO2019054867A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL2019545 2017-09-14
NL2019545A NL2019545B1 (en) 2017-09-14 2017-09-14 Instrument for minimal invasive surgical operations, comprising a rod or catheter and a tip mounted on the rod or catheter with an elastically deformable element

Publications (1)

Publication Number Publication Date
WO2019054867A1 true WO2019054867A1 (fr) 2019-03-21

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PCT/NL2018/050603 WO2019054867A1 (fr) 2017-09-14 2018-09-14 Instrument pour opérations chirurgicales minimalement invasives, comprenant une tige ou un cathéter et une pointe montée sur la tige ou le cathéter avec un élément élastiquement déformable

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NL (1) NL2019545B1 (fr)
WO (1) WO2019054867A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11135398B2 (en) 2018-07-19 2021-10-05 Neptune Medical Inc. Dynamically rigidizing composite medical structures
WO2021250541A1 (fr) 2020-06-09 2021-12-16 Pfizer Inc. Composés spiro en tant qu'antagonistes du récepteur de la mélanocortine 4 et leurs utilisations
WO2023026180A1 (fr) 2021-08-26 2023-03-02 Pfizer Inc. Forme amorphe de (s)-2-(5-((3-éthoxypyridin-2-yl)oxy)pyridin-3-yl)-n-(tétrahydrofuran-3-yl)pyrimidine-5-carboxamide
US11744443B2 (en) 2020-03-30 2023-09-05 Neptune Medical Inc. Layered walls for rigidizing devices
US11793392B2 (en) 2019-04-17 2023-10-24 Neptune Medical Inc. External working channels
WO2023228023A1 (fr) 2022-05-23 2023-11-30 Pfizer Inc. Traitement du diabète de type 2 ou contrôle de la gestion du poids avec de l'acide 2-((4-((s)-2-(5-chloropyridin-2-yl)-2-méthylbenzo[d][1,3]dioxol-4-yl)pipéridin-1-yl)méthyl)-1-(((s)-oxétan-2-yl)méthyl)-1h-benzo[d]imidazole-6-carboxylique ou un sel pharmaceutique de celui-ci
US11937778B2 (en) 2022-04-27 2024-03-26 Neptune Medical Inc. Apparatuses and methods for determining if an endoscope is contaminated
WO2024084360A1 (fr) 2022-10-18 2024-04-25 Pfizer Inc. Modificateurs de la proteine 3 contenant le domaine phospholipase de type patatine (pnpla3)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6673290B1 (en) * 1998-11-12 2004-01-06 Scimed Life Systems, Inc. Electrode structure for heating and ablating tissue and method for making and assembling the same
US20050267332A1 (en) 2004-05-27 2005-12-01 Saurav Paul Spring-tip, flexible electrode catheter for tissue ablation
US20090093802A1 (en) * 2007-10-05 2009-04-09 Coaptus Medical Corporation Systems and Methods for Transeptal Cardiac Procedures, Including Tissue Penetrating Members and Associted Methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6673290B1 (en) * 1998-11-12 2004-01-06 Scimed Life Systems, Inc. Electrode structure for heating and ablating tissue and method for making and assembling the same
US20050267332A1 (en) 2004-05-27 2005-12-01 Saurav Paul Spring-tip, flexible electrode catheter for tissue ablation
US20090093802A1 (en) * 2007-10-05 2009-04-09 Coaptus Medical Corporation Systems and Methods for Transeptal Cardiac Procedures, Including Tissue Penetrating Members and Associted Methods

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11135398B2 (en) 2018-07-19 2021-10-05 Neptune Medical Inc. Dynamically rigidizing composite medical structures
US11478608B2 (en) 2018-07-19 2022-10-25 Neptune Medical Inc. Dynamically rigidizing composite medical structures
US11554248B1 (en) 2018-07-19 2023-01-17 Neptune Medical Inc. Rigidizing devices
US11724065B2 (en) 2018-07-19 2023-08-15 Neptune Medical Inc. Nested rigidizing devices
US11793392B2 (en) 2019-04-17 2023-10-24 Neptune Medical Inc. External working channels
US11744443B2 (en) 2020-03-30 2023-09-05 Neptune Medical Inc. Layered walls for rigidizing devices
WO2021250541A1 (fr) 2020-06-09 2021-12-16 Pfizer Inc. Composés spiro en tant qu'antagonistes du récepteur de la mélanocortine 4 et leurs utilisations
WO2023026180A1 (fr) 2021-08-26 2023-03-02 Pfizer Inc. Forme amorphe de (s)-2-(5-((3-éthoxypyridin-2-yl)oxy)pyridin-3-yl)-n-(tétrahydrofuran-3-yl)pyrimidine-5-carboxamide
US11937778B2 (en) 2022-04-27 2024-03-26 Neptune Medical Inc. Apparatuses and methods for determining if an endoscope is contaminated
WO2023228023A1 (fr) 2022-05-23 2023-11-30 Pfizer Inc. Traitement du diabète de type 2 ou contrôle de la gestion du poids avec de l'acide 2-((4-((s)-2-(5-chloropyridin-2-yl)-2-méthylbenzo[d][1,3]dioxol-4-yl)pipéridin-1-yl)méthyl)-1-(((s)-oxétan-2-yl)méthyl)-1h-benzo[d]imidazole-6-carboxylique ou un sel pharmaceutique de celui-ci
WO2024084360A1 (fr) 2022-10-18 2024-04-25 Pfizer Inc. Modificateurs de la proteine 3 contenant le domaine phospholipase de type patatine (pnpla3)

Also Published As

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