WO2008156353A1 - Cryosonde, procédé permettant de former une cryosonde - Google Patents

Cryosonde, procédé permettant de former une cryosonde Download PDF

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Publication number
WO2008156353A1
WO2008156353A1 PCT/NL2007/050293 NL2007050293W WO2008156353A1 WO 2008156353 A1 WO2008156353 A1 WO 2008156353A1 NL 2007050293 W NL2007050293 W NL 2007050293W WO 2008156353 A1 WO2008156353 A1 WO 2008156353A1
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WO
WIPO (PCT)
Prior art keywords
tip
probe
cryo
tissue
approximately
Prior art date
Application number
PCT/NL2007/050293
Other languages
English (en)
Inventor
Cornelis Hendrikus Anna Wittens
Original Assignee
Wittens Cornelis Hendrikus Ann
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 Wittens Cornelis Hendrikus Ann filed Critical Wittens Cornelis Hendrikus Ann
Priority to PCT/NL2007/050293 priority Critical patent/WO2008156353A1/fr
Publication of WO2008156353A1 publication Critical patent/WO2008156353A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid

Definitions

  • the invention relates to a cryo probe, configured to be entered in a body for minimal invasive cryosurgery, having at least one internal channel for connection to a cryogenic fluid supply such that cryogenic fluid can be supplied to an end portion of the probe, wherein the end portion of the probe has an elongated cooling tip, comprising thermally conductive material for freezing tissue.
  • the invention also relates to a method for shaping a cryo probe that is configured to be entered in a body, which probe has an elongated tip for freezing tissue to the tip, wherein the tip has a diameter of approximately 3 mm or smaller, preferably approximately 1.6 mm or smaller.
  • the invention relates to a method for performing cryosurgery.
  • Venous ulcers account for a large morbidity and high treatment costs, mainly because of the slow healing and high recurrence rate.
  • Several methods are used to treat chronic venous insufficiencies in patients.
  • treatment of the superficial venous system in combination with dissection of Incompetent Perforating Veins (ICPV) is perceived to be a relatively successful method for treating for patients with chronic venous leg ulceration.
  • ICPV Incompetent Perforating Veins
  • dissection of ICPV is to decrease venous reflux and reduce ambulatory venous hypertension.
  • Dissection of ICPV can for example be treated by Subfascial Endoscopic Perforating vein Surgery (SEPS), open perforantectomy (Linton procedure) and ultrasound-guided sclerotherapy.
  • SEPS Subfascial Endoscopic Perforating vein Surgery
  • Linton procedure open perforantectomy
  • ultrasound-guided sclerotherapy ultrasound-guided sclerotherapy.
  • SEPS is currently the surgical technique of choice in treating ICPV.
  • This technique is mainly suitable for the treatment of ICPV on the medial aspect of the lower leg.
  • a deflated balloon is inserted through a cut in the calf. Thereafter the balloon is inflated such that a space is created and the surgeon can access the perforating veins that are causing the problem.
  • the perforating vein is then sealed or clipped so that blood cannot go through the vein at all, stopping the reflux. Due to compartmental tapering at the ankle, the narrow confines have proven challenging for SEPS.
  • CPS Cryo Perforator Surgery
  • the incompetent perforating veins were identified using duplex ultrasound (ATL 5000) and ink-marked on the skin. Using local anaesthesia, the perforating veins were approached percutaneously, placing a 14 GA Venflon canule at the fascia defect under ultrasound guidance. The Venflon canule could be placed intra or extraluminal near the ICPV.
  • a goal is to improve the rate of successful treatments for CPS (Cryo Perforator Surgery), at least on ICPV (Incompetent Perforating Veins), while maintaining most of the current advantages of CPS.
  • a minimal invasive cryosurgery instrument comprising a cryo probe that is configured to be entered in a body, the probe having at least one internal channel for connection to a cryogenic fluid supply such that cryogenic fluid can be supplied to the probe, wherein an end portion of the probe has an elongated cooling tip, comprising thermally conductive material, for freezing tissue to the tip, which tip has a roughened surface for attachment of frozen tissue to the tip.
  • the ICPV After introduction, and when the probe tip is brought to a cryogenic temperature, the ICPV is frozen and attached to the tip and when the probe is pulled back the concerning ICPV is dissected. During entry the vein may be somewhat damaged by the roughened tip, however since the vein is dissected when pulling back the probe, damage that might have occurred will not affect the patient.
  • the tip is entered through tissue that is less sensitive to the roughened surface of the tip. For example, the tip may be entered through subcutaneous fat, to which no harmful damage will be caused by the roughened tip.
  • the tip or at least a part of it is initially covered by a cover and the tip is at least partially uncovered and brought into contact with the ICPV before said tip is brought to said temperature.
  • a suitable cover is a tubular sheath or a cap.
  • the tip is entered with the cover until it reaches the desired location, after which the cover is removed, e.g. pulled back or destructed, or the tip is pushed through the cover, and the tissue concerned is frozen to tip. Thereafter the cryo probe is pulled back and the tissue dissected.
  • a catheter is used to guide the cryo probe through the body.
  • the catheter is entered in the body of a patient and the cryo probe is guided through the catheter.
  • the tip is uncovered by moving the tip and catheter relative to each other, e.g. for a couple of mm's or em's, such that the cryo tip is exposed and tissue can be frozen to the tip. Then the tissue is frozen and pulled back together with the cryo probe and/or the catheter.
  • a cover or catheter e.g. as an aid for the roughened cryo tip and/or protection for the tissue, may be advantageous or redundant, depending on the application.
  • the contact surface between frozen ICPV tissue and the roughened tip is increased such that the frozen tissue remains better attached when the probe is pulled back.
  • An improved grip of the tip on the surrounding frozen substance is obtained, such that the rate of successful treatment can be improved.
  • the roughened surface comprises diamond particles, i.e. a diamond dust, that are attached to the tip.
  • diamond particles i.e. a diamond dust
  • the tip is advantageous because they may remain relatively unaffected when the probe is applied at cryogenic temperatures for multiple times.
  • a method for shaping a cryo probe that is configured to be entered in a body, which probe has an elongated tip for freezing tissue to the tip, wherein the tip has a diameter of approximately 3 mm or smaller, preferably approximately 1.6 mm or smaller, wherein the tip is roughened by creating recesses and/or projections in the tip.
  • a cryo probe having an elongated cooling tip with a roughened surface for attachment of frozen tissue to the tip, wherein the probe is entered in a body and the tip is brought in proximity to a target tissue, wherein the tip is brought to a temperature under approximately -75°C such that said target tissue is frozen and attached to said tip and wherein the probe is withdrawn to dissect said target tissue.
  • figure 1 shows a schematic illustration of a minimal invasive cryosurgery instrument
  • figure 2 shows a cryo probe
  • figure 3 shows a cryo probe accompanied by an enlarged view of the tip of the probe.
  • cryo refers to low temperatures, for example approximately - 75° C or below, approximately -85°C or even approximately — 180°C or lower temperatures.
  • cryo should be understood as referring to temperatures that are used for freezing and attaching surrounding tissue, and should not be used in a limitative manner, as the skilled person will understand. While in other fields certain low temperatures may be referred to, e.g. below -150°C, these or any other convention known in that field concerning the use of the words "cryo”, “cryogenic”, or the like should not be construed as being limiting to the invention.
  • FIG. 1 A schematic illustration of an example of a minimal invasive cryosurgery instrument 1 is shown in figure 1.
  • the instrument 1 has a cryo probe 2 comprising the end of the instrument 1 that is to be brought into the body of a patient.
  • the cryo probe 2 has a tip 3 that is made of thermally conductive material to be able to locally freeze the environment.
  • a shaft 4 is constructed to conduct cryogenic fluid, for example liquid nitrogen, from a cryogenic fluid vessel 5 to the tip 3, wherein the cryogenic fluid circulates from the vessel 5 to the tip 3 and back, e.g. via channels 8, 9 of a cooling circuit.
  • the cooling circuit at least comprises a fluid inlet 8 and a fluid outlet
  • the inlet 8 conducts a liquid nitrogen to the tip 3, where it evaporates and is conducted back to the vessel 5 through the outlet 9.
  • the shaft 4 comprises thermally insulating material up to the tip 3.
  • cryo probe 2 is illustrated in figure 2.
  • the shaft 4 and the tip 3 have a diameter d of approximately 1.6 mm.
  • Other diameters of suitable cryo probes 2, suited for use in the field of minimal invasive surgery, are for example 2 mm, 2,4 mm, or 3 mm.
  • the tip 3 may be made of a metal, for example titanium and/or surgical steel.
  • the tip 3 has an elongate, cylindrical shape with a rounded end
  • the rounded end 10 may allow convenient passage through and/or along body tissue without unnecessarily damaging tissue.
  • the shaft 4 is preferably flexible to be able to extend through a bended canal within a patient's body and has a length such that the probe 2 may reach almost any desired location within the body.
  • cryosurgery instruments 1 and techniques that may be used according to the invention are for example disclosed in GB 1 482 424 and WO 2006/034295.
  • the probe 2 when performing cryosurgery, the probe 2 is entered in a body and the tip 3 is brought in proximity to a target tissue, wherein the tip is brought to a temperature under approximately -75°C, e.g. -89°C, such that said target tissue is frozen and attached to said tip and wherein the probe is withdrawn to dissect said target tissue.
  • cryo perforator surgery which may concern dissection of incompetent perforating veins (ICPV).
  • ICPV incompetent perforating veins
  • a scenario for use of a cryo probe 2 according to the invention may be the same as known from CPS, or CPS studies.
  • the tip 3 is guided to the ICPV, such that the tip 3 of the probe 2 touches, or nearly touches, the ICPV.
  • the tip 3 touches, or is at least close enough to the ICPV concerned, the tip 3 is brought to the desired temperature, e.g. -89°C, such that the incompetent perforating vein freezes.
  • the probe 2 is then pulled back such that the vein is torn off and the vein will no longer cause undesirable venous reflux.
  • the surface of the tip 3 is roughened, which provides for better attachment of the tissue to the tip 3.
  • the tip 3 will not unnecessarily damage tissue while being entered into the body.
  • diamond particles 6, i.e. diamond dust may be attached to the tip 3, providing for a diamond coating 7 on the tip 3.
  • Figure 3 shows an enlargement of a tip 3 with a diamond coating 7 comprising diamond particles 6.
  • the diamond particles 6 have an average diameter of about 20 micron, but of course this may vary substantially and higher or lower average diameters may also be advantageously applied. For example different diameters varying from 5 micron to 50 micron, or even 100 micron, could be applied.
  • the diamond particles 6 may be secured to and/or embedded in the tip 3 by any suitable method.
  • a diamond coating 7 may be particularly suitable for use of the invention because it will not degrade when used multiple times at cryogenic temperatures. Also, it is relatively biocompatible and durable material. With these advantages, the small particle size allows the tip 3 to be entered into tissue without damaging it, while maintaining a relatively strong adhesion properties to ice, i.e. under cryogenic temperatures.
  • a catheter may be used as an aid in guiding the roughened tip 3.
  • the catheter is entered in the body, e.g. up to a location near to the tissue that is intended to be dissected. Then, the tip 3 is guided to the tissue and the catheter is pulled back such that the tip 3 is exposed, after which said tissue can be frozen and pulled back by the probe 2.
  • a cover can be used that covers the tip 3, or at least a part of it.
  • the cover can be retracted or destructed when the tip 3 has reached the tissue that is aimed for dissection. Then, the tissue can be frozen to the tip 3 and the whole is pulled back.
  • tissue that might be attached is removed and the roughened tip 3 is sterilised such that it can be re-used.
  • Diamond dust i.e. diamond particles 6, has been proven to be suitable for re-sterilisation.
  • suitable particles may include carbon and/or silicium, as these materials may also allow micron sized recesses and projections to be created on the tip 3. Other materials that are suitable may be recognised by the skilled person.
  • recesses and/or projections can be shaped in the tip 3, by shaping and/or treating the surface, e.g. without adding particles. In this case, also a roughened surface with good attachment properties can be obtained. For example, scratches, cuts, or the like, may be applied to the surface of the tip 3.
  • the projections and/or recesses that are formed may have heights and/or depths, respectively, approximately equal to one of said diameters of said diamond particles 6 mentioned above.
  • the relatively small size of the recesses and/or projections of the roughened surface of the tip 3 may provide for a strong grip on the ice while showing advantageously minimal friction or damage to surrounding tissue.
  • recesses are created in the tip 3, for example by removing material from the tip 3. In this case, care should be taken that the tip 3 maintains protected against leakage of nitrogen fluid.
  • a coating is applied on the tip 3 and/or projections are shaped in or on the tip 3, such that a certain solidness and/or thickness of the material of the tip 3 is upheld, e.g. to prevent that cryogenic fluid leaks from the probe 2.
  • Diamond particles 6, or other suitable particles and/or coatings can for example be attached to the tip 3 with the aid of chemical vapour deposition (CVD) and/or a plasma assisted surface treatment method, e.g. plasma CVD, although the particles 6 may for example also be mechanically embedded or adhesively secured.
  • CVD chemical vapour deposition
  • plasma assisted surface treatment method e.g. plasma CVD
  • CVD and/or plasma assisted surface treatment methods are able to apply a micron sized thin coating in a relatively controlled way, while the surface of, in this case, the tip 3 remains relatively unaffected. Furthermore, by use of such methods the diamond coating 7 is suited to remain secured to the tip 3 surface under cryogenic temperatures and for multiple uses. Other advantages of such methods are known in the art.
  • the conventional cryo probe showed an average pulling force of 2.95 kg, a median of 2.90 kg, and had a 95% confidence interval between 2.65 and 3.25 kg.
  • the diamond coated cryo probe 2 showed an average pulling force of 10.67 kg, a median of 10.95 kg, and had a 95% confidence interval between 9.87 and 11.48 kg.
  • the test showed that for the cryo probe 2 having a roughened surface the pulling force was much higher before the probe 2 would loose grip on the ice.
  • the pulling force needed to pull the cryo probe 2 with a roughened surface out of the ice was 3.6 times higher than the pulling force that was needed for a conventional cryo probe. Therefore, it is assumed that the cryo probe 2 according to the invention has a stronger grip on ice, i.e. frozen tissue, than the conventional probe.
  • the invention is not limited in any way to the embodiments that are represented in the description and the drawings. Many variations and combinations are possible within the framework of the invention as outlined by the claims. Combinations of one or more aspects of the embodiments or combinations of different embodiments are possible within the framework of the invention. All comparable variations are understood to fall within the framework of the invention as outlined by the claims.

Abstract

La présente invention concerne une cryosonde, conçue afin de pénétrer dans un corps pour une cryochirurgie à invasion minimale, ayant au moins un canal intérieur destiné à être relié à une alimentation en fluide cryogénique de telle sorte que le fluide cryogénique peut être fourni au niveau d'une partie d'extrémité de la sonde présentant une pointe de refroidissement allongée et comprenant un matériau thermiquement conducteur permettant de congeler un tissu, une telle pointe présentant une surface rugueuse permettant le rattachement du tissu congelé à la pointe.
PCT/NL2007/050293 2007-06-18 2007-06-18 Cryosonde, procédé permettant de former une cryosonde WO2008156353A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/NL2007/050293 WO2008156353A1 (fr) 2007-06-18 2007-06-18 Cryosonde, procédé permettant de former une cryosonde

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/NL2007/050293 WO2008156353A1 (fr) 2007-06-18 2007-06-18 Cryosonde, procédé permettant de former une cryosonde

Publications (1)

Publication Number Publication Date
WO2008156353A1 true WO2008156353A1 (fr) 2008-12-24

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009018291A1 (de) * 2009-04-21 2010-10-28 Erbe Elektromedizin Gmbh Kryochirurgisches Instrument
WO2016030707A1 (fr) 2014-08-26 2016-03-03 Laboratoires Urgo Dispositif destiné à être fixé sur la peau
US10610280B1 (en) 2019-02-02 2020-04-07 Ayad K. M. Agha Surgical method and apparatus for destruction and removal of intraperitoneal, visceral, and subcutaneous fat

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997041784A1 (fr) * 1996-05-09 1997-11-13 Lehrer, Aharon Procede et systeme destines a la chirurgie de la cataracte
US6551309B1 (en) * 2000-09-14 2003-04-22 Cryoflex, Inc. Dual action cryoprobe and methods of using the same
US20040078033A1 (en) * 2002-08-26 2004-04-22 Alexander Levin Cryosurgical instrument and its accessory system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997041784A1 (fr) * 1996-05-09 1997-11-13 Lehrer, Aharon Procede et systeme destines a la chirurgie de la cataracte
US6551309B1 (en) * 2000-09-14 2003-04-22 Cryoflex, Inc. Dual action cryoprobe and methods of using the same
US20040078033A1 (en) * 2002-08-26 2004-04-22 Alexander Levin Cryosurgical instrument and its accessory system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009018291A1 (de) * 2009-04-21 2010-10-28 Erbe Elektromedizin Gmbh Kryochirurgisches Instrument
US11229476B2 (en) 2009-04-21 2022-01-25 Erbe Elektromedizin Gmbh Cryosurgical instrument
WO2016030707A1 (fr) 2014-08-26 2016-03-03 Laboratoires Urgo Dispositif destiné à être fixé sur la peau
US10610280B1 (en) 2019-02-02 2020-04-07 Ayad K. M. Agha Surgical method and apparatus for destruction and removal of intraperitoneal, visceral, and subcutaneous fat

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