WO2009082376A1 - Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme - Google Patents

Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme Download PDF

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Publication number
WO2009082376A1
WO2009082376A1 PCT/US2007/026305 US2007026305W WO2009082376A1 WO 2009082376 A1 WO2009082376 A1 WO 2009082376A1 US 2007026305 W US2007026305 W US 2007026305W WO 2009082376 A1 WO2009082376 A1 WO 2009082376A1
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WO
WIPO (PCT)
Prior art keywords
heat transfer
transfer medium
tool
article
energy probe
Prior art date
Application number
PCT/US2007/026305
Other languages
English (en)
Inventor
Shawn T. Huxel
Alan B. Miller
Original Assignee
Core Essence Orthopaedics, Llc.
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 Core Essence Orthopaedics, Llc. filed Critical Core Essence Orthopaedics, Llc.
Priority to PCT/US2007/026305 priority Critical patent/WO2009082376A1/fr
Publication of WO2009082376A1 publication Critical patent/WO2009082376A1/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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00137—Details of operation mode
    • A61B2017/00154—Details of operation mode pulsed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00734—Aspects not otherwise provided for battery operated
    • 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

  • the present invention relates to a method and apparatus for heating a shape memory article to a predetermined transformation temperature.
  • Shape memory articles comprised, for instance, substantially of NiTinol alloy, are used in many surgical applications, including use as staples for re-attaching tissue or bone.
  • external heat is applied to the shape memory article in order to transition it from a first shape in a martensitic, softer, morphology to a second shape in an austentitic, stiffer, morphology.
  • NiTinol a Nickel-Titanium alloy
  • the thermo-mechanical characteristics of the material and its biocompatibility have allowed its use across many medical and surgical specialties both for diagnostic and therapeutic applications.
  • shape memory alloys can display various types of shape memory.
  • the type of shape memory that has probably found the most use in commercial applications is commonly referred to as one-way shape memory.
  • one-way shape memory an article formed of a shape memory alloy in an original shape can be substantially plastically deformed into a shape while it is in the soft, martensitic phase and it will remain in that shape, (hereinafter the deformed shape). Then, upon heating above a first temperature, the material returns to it original (prior to deformation) shape while transitioning from the soft, martensitic phase to a much stiffer austentitic phase.
  • the article is much stiffer in the austentitic phase, it usually is still somewhat deformable, but primarily elastically, as opposed to plastically, deformable.
  • the material transitions back to the softer, martensitic phase, but maintains the shape it took during the transformation to the austentitic phase (i.e., its original shape) until it is acted upon by an external force or stress.
  • the material is less stiff (i.e., more pliable) in its martensitic phase, it is much easier to bend (back to the deformed shape or any other shape) and it will maintain that new shape up to and until it is heated once more above its transformation temperature.
  • the strength and transition temperatures of SMAs can be greatly varied by changing the exact composition of the alloy and/or the thermal history of the article.
  • shape memory staples in surgical skeletal repair enables a staple to be installed in bone or tissue in one shape while in its martensitic phase and then be heated to cause it to transition to the much stiffer austentitic phase while shifting to another shape that, for instance, draws the tissue or bone closer together.
  • Many medical applications use SMAs having a transition temperature for complete martensitic to austentitic transformation of about 55 0 C.
  • other medical applications utilize alloys having a complete transition temperature of about the human body temperature of 37 0 C.
  • SMA staples shape memory alloys
  • These SMA staples are smaller and less bulky than other fixation devices, such as plates, screws, and nails. They permit smaller incisions, which cause less trauma and scarring and lead to faster post-operative recovery. Also, since fewer holes need to be drilled and no screws are needed, more rapid surgical procedures are possible.
  • FIG. 1 is a graph showing a dynamic scanning calorimetry (DSC) for one particular NiTinol composition.
  • DSC dynamic scanning calorimetry
  • FIG. 1 is a graph showing a dynamic scanning calorimetry (DSC) for one particular NiTinol composition.
  • DSC is useful for determining the temperatures at which various substances undergo phase changes.
  • DSC is utilized to understand the temperatures required for transitioning from the martensitic phase to the austentitic phase and back again.
  • DSC measures the heat flow necessary to maintain the article at a certain temperature.
  • the bottom portion of the scan represents the state of the article at -5O 0 C as it is subjected to increasing temperature over time.
  • This graph shows a stable structure (martensitic morphology) during temperatures up to an austentitic start temperature (A s ) of approximately 29 0 C, where phase transformation to the austentitic phase theoretically begins.
  • a s austentitic start temperature
  • Af austentitic finish temperature
  • the top portion of this scan represents cooling of the austentitic NiTinol article starting at 100 0 C.
  • Ms martensitic start temperature
  • NiTinol shape memory alloy This is only an example of one form of NiTinol shape memory alloy. Other transition temperatures are achievable with different chemical compositions and thermo-mechanical treatments. [0010] Using the exemplary material above, one can see that the device is geometrically stable in its martensitic phase up to room temperature, can be transformed to an austentitic phase via heating it to around 55 0 C and that it stays in a stable austentitic phase down to temperatures well below body temperature.
  • Tissue cautery and coagulation devices typically are available in an operating theater and are commonly used to provide heat to shape memory articles. Examples of these devices include a resistance wire driven by a voltage that essentially uncontrollably heats the wire to a temperature in excess of 600 0 C, sometimes reaching 1200 0 C. The wire is touched to the staple to heat it above the transition temperature. Other forms of cautery devices use radio frequency (RF) energy to directly heat either a monopolar or bipolar probe.
  • RF radio frequency
  • the monopolar form of cautery often referred to as a "bovie"
  • a pen-like device as the other conductor.
  • the circuit from the device through the patient and back to circuit ground is closed and heat is generated, preferably locally at the tip of the pen-like device, thus cauterizing or coagulating tissue.
  • heat is generated, preferably locally at the tip of the pen-like device, thus cauterizing or coagulating tissue.
  • arcing or sparking often occurs and the energy, transformed to heating the staple, is often uncontrollable.
  • the bipolar form of a cautery tool utilizes a handpiece that has two conductors separated or shielded from one another. When the device is energized and touches tissue, the circuit from one conductor to the other is closed through the tissue (which is conductive) and local heating at the tip of the device is used to cauterize and coagulate the tissue. When bipolar tools are used to heat shape memory staples, arcing and sparking also has been observed and the heating of the staple often is uncontrollable.
  • Another disadvantage with the mono- and bi-polar direct heating systems of the prior art is that they require significant power (between 40 and 100 Watts) to be useful since the body and the staple comprise very large electrical resistances. In order to generate the necessary heat by means of the joule effect, a significant amount of energy is required and the temperature is uncontrollable as it is a function of the staple resistance, the patient resistance, the power setting and the time of application.
  • a method for heating an article formed of a shape memory alloy comprising providing a tool having an energy probe, disposing a portion of a heat transfer medium adjacent the energy probe, placing the heat transfer medium in close proximity to the article, and activating the energy probe to heat the heat transfer medium, which heat transfer medium, in turn, conductively transfers the heat to the article.
  • a surgical tool for heating an article formed of a shape memory alloy comprising a body, an energy probe, a holder adjacent the energy probe, and an energy source for activating the energy probe.
  • Figure 1 is a graphical representation of a dynamic scanning calorimetry for one particular NiTinol composition.
  • Figure 2 is a schematic diagram of an exemplary heating apparatus in accordance with the principles of the present invention.
  • Figure 3 is an cross-sectional view of the hand tool shown in Figure 2.
  • Figure 4A illustrates an exemplary surgical staple formed of a shape memory alloy in its pre-surgical, martensitic phase.
  • Figure 4B illustrates the same staple in its post-surgical, austentitic phase after heajing above its martensitic-to-austentitic transformation temperature.
  • Figures 5-7 illustrate stages in a surgical procedure in accordance with one particular embodiment of the present invention.
  • Figure 8 is a perspective view of a tool in accordance with another embodiment of the invention.
  • Figure 9 is a flow diagram illustrating the steps involved in an exemplary application of the present invention for heating a surgical staple formed of a shape memory alloy.
  • the present invention solves the aforementioned problems associated with the conventional art of heating an article formed of a shape memory alloy above its transition temperature by using an intermediate heat transfer medium to transfer the heat to the article.
  • the invention is particularly suited to medical applications that utilize articles comprising shape memory alloys (hereinafter shape memory articles).
  • shape memory articles The invention is even more particularly suitable for medical applications that use shape memory articles inside the body, such as tissue and bone staples (hereinafter surgical staples).
  • the technique is low cost, simple, and fast, using primarily equipment that is already available in most operating rooms.
  • the energy probe instead of contacting the shape memory article directly with an energy probe, which typically reaches unsafe temperatures well in excess of the temperature necessary to transform the article from its martensitic phase to its austentitic phase, the energy probe energizes an intermediate heat transfer medium to heat the medium, which, in turn, is in contact with the shape memory article.
  • the heat travels from the heat transfer medium to the article, thereby heating the article more evenly, and with much lower power and temperatures.
  • the heat transfer medium preferably has a steady state temperature above the martensitic-to-austentitic transition temperature of the article, but well below a temperature that may cause tissue damage.
  • a water-based heat transfer medium such as saline solution
  • saline solution will have a steady state temperature of about 100°C (the boiling point of water), which is well above the 37 0 C or 55°C needed to transition most, if not all, shape memory articles used in medical procedures, yet well below the dangerous 600°C-1200°C range of conventional techniques.
  • Figure 2 is a schematic diagram illustrating an exemplary embodiment of an apparatus 200 for heating a shape memory article in accordance with the present invention.
  • Figure 3 is a cross-sectional view of the hand tool of Figure 2.
  • a hand-held device In accordance with the invention, a hand-held
  • O tool 201 comprising a body 203 and a energy probe 205 is provided for generating localized heating.
  • the tool 201 can be a purpose-built tool for use in the present invention.
  • the tool can be a multi-purpose tool with other uses such as tissue cautery or ultrasonic probing.
  • the tool uses a bipolar probe as the energy probe 205.
  • This type of energy probe comprises two conductive elements, e.g., concentric tubes, 209, 210 having distal ends 209a, 210a, respectively, separated from each other by an insulator, which insulator is a electrically nonconductive polymer in the illustrated embodiment.
  • Each concentric tube is coupled to a wire 212, 213, respectively, passing through the body 203 to an electrical connector 217a, 217b, respectively.
  • a removable electrical cable 215 bearing a connector 216 for connecting to the instrument connectors 217a, 217b is connected to the instrument.
  • the cable 215 is coupled via a second connector 217 to a power source 218 for generating a suitable signal to cause current to run through the conductive elements when the open circuit between the spaced ends 209a, 210a of the two conductive elements 209, 210 is closed by a conductive medium therebetween.
  • a foot switch 208 may be provided for permitting the physician to activate the power supply 218 to provide the electrical signal through the cable 215 to the probe 205.
  • the signal may be a DC voltage or an alternating current.
  • the bipolar electrical probe described above and illustrated in the Figures is merely exemplary and that the energy probe (and the accompanying power supply) may be any reasonable means of generating energy to heat a heat transfer medium, including monopolar electrical probes and ultrasonic probes that heats by vibrating at ultrasonic frequency.
  • the energy probe may be a laser light source or an infrared light source that produces an intense beam of light when activated, which beam strikes a heat transfer medium with a matched wavelength that absorbs the light energy and transforms it to heat.
  • a tube 219 is attached to the end of the instrument 201 that closely surrounds the energy probe.
  • the tube 219 is permanently affixed to the instrument 201.
  • the tube is removable.
  • the tube 219 is formed of a resilient material, such a silicone, having an unbiased inner diameter, d, slightly smaller than the diameter of the shoulder 221 formed in the body 203 of the energy probe 205 so that the tube 219 can be forced over the shoulder 221 whereupon it will expand to accept the shoulder and become attached to the instrument via friction.
  • the tool body 203 may include a flange 222 defining a stop for the hole 219 so that the removable tube is always inserted to the same position.
  • the distal end 219a of the tube 219 extends slightly beyond the distal ends 209a, 21 Oa of the energy probe so that the energy probe 205 is completely within the tube 219, but close to the distal end 219a of the tube. In this manner, the energy probe 205 cannot directly contact anything, such as tissue or the shape memory article, that is not inside of tube 219. On the other hand, a bolus of heat transfer medium adhered to the end of the tube 219 will be in contact with or in close proximity to the energy probe 205.
  • the instrument 201 is used to transfer heat to a shape memory article, such as a surgical staple 413, as illustrated in Figures 4A and 4B.
  • Figure 4A shows the staple in its pre-surgical, martensitic shape
  • Figure 4B shows the staple in its post-surgical, austentitic shape after it has been heated above its transformation temperature.
  • a staple can be installed into tissue or bone, with one tine 416 of the staple inserted in one bone fragment and the other tine 417 inserted in another bone fragment. Then, it can be heated to cause the martensitic-to-austentitic transformation, changing from the shape shown in Figure 4A to the shape shown in Figure 4B, while also becoming much stiffer. This shape transformation would draw the two bone fragments closer (if they are not already in contact) and/or apply a constant dynamic force urging the bone fragments together (if they are already in contact or reach contact prior to the staple 413 reaching its stress-free austentitic shape).
  • FIGs 5-7 help illustrate a method in accordance with the principle of the present invention.
  • the shape memory article is a surgical staple for joining two bone pieces together.
  • the staple has already been installed in the two bone pieces in its martensitic phase and awaits transformation to the austentitic phase with the accompanying change in shape to draw the two bone fragments closer together and/or apply a dynamic force urging the bone fragments together.
  • a portion of a heat transfer medium 227 is applied to the distal end 219a of the tube 219.
  • the heat transfer medium preferably is a substance with a high coefficient of thermal conductivity so that it can absorb and release (i.e., transfer) heat rapidly.
  • the heat transfer medium may be a liquid, such as water, or a viscous substance such as a gel.
  • the heat transfer medium must contain a substance, either in solution or in sufficient quantity, to render the medium excitable by the energy source embodied.
  • the heat transfer medium should be electrically conductive.
  • the heat transfer medium 227 may be a saline solution, wherein the salt in solution acts as an electrical conductor and the water in solution acts as the heat transfer medium.
  • the heat transfer medium may be partially or wholly solid or a gel.
  • the energy probe is an ultrasonic probe, then an acoustic medium having good acoustic absorption would be beneficial.
  • the energy probe is a light source, then a heat transfer medium having a pigment with matching absorption properties to the wavelength of the light source would be a beneficial property in order to most efficiently convert the light energy into heat when the light strikes the heat transfer medium.
  • the heat transfer medium may contain a pigment specifically added for this purpose.
  • the article to be heated may include the heat transfer medium.
  • the heat transfer medium may be provided in the form of a coating or surface treatment of the article. Alternately, it may be dispersed in the article itself.
  • simple activation with the energy probe of this invention will cause the heat transfer medium to heat and, in turn, heat the shape memory article to a predetermined temperature.
  • the heat transfer medium preferably has a steady state temperature (or maximum excitation temperature) above which it essentially cannot be heated that is at or above the martensitic-to-austentitic transformation temperature of the shape memory article, but below a temperature that might cause unnecessary tissue damage.
  • the heat transfer medium is a saline solution, which generally has a boiling point of about 100 0 C, thereby effectively defining a steady state excitation temperature above which it essentially cannot be heated.
  • the steady state temperature of this heat transfer medium is above the typical transformation temperature for a medical shape memory article, but much lower than the 600 0 C to 1200 0 C temperatures generated for heating shape memory articles in the prior art.
  • the boiling point of saline solution of about 100 0 C defines a steady state heating temperature.
  • the heat transfer medium 227 can be applied to the distal end of the tube in a number of ways.
  • Figure 5 illustrates one embodiment in which the heat transfer medium is applied to the end 219a of the tube 219 by dipping the tube 219 into a supply, such as a vial 225, of the heat transfer medium 227.
  • a bolus 228 of the medium 227 sticks to the end 219a of the tube 219 due to the surface adhesion properties of liquid and viscous materials.
  • the exact size of the bolus will depend on many factors, including the surface adhesion properties of the heat transfer medium and its viscosity, and various properties of the tube, such as its surface adhesion properties, size, wall thickness, inner diameter, outer diameter, surface roughness, etc. In fact, all of these properties of the heat transfer medium and/or tube can be engineered to help assure that a bolus of a particular size suitable to the SMA being heated is formed.
  • the instrument is moved to the article, which is shown as a staple 231 already installed in its open state into two bone fragments 233 and 235.
  • the distal end 219a of the tube 219 is brought to the article 231 so that the bolus 228 of heat transfer medium touches the article 231.
  • the bolus of heat transfer medium partially transfers to the article 231 via the same surface adhesion that caused it to adhere to the tube 219.
  • the tube is left in contact with the bolus and the energy probe is then activated to heat the bolus of heat transfer medium 235 via the conversion of energy absorbed by the heat transfer medium to heat.
  • the heat transfer medium which is in mutual contact with the tube 219 (and possibly the energy probe 205 itself), on the one hand, and the staple 231 , on the other, transfers the heat to the staple, thereby raising its temperature above the transition temperature that causes the article to transform from its martensitic phase to its austentitic phase and change shape.
  • the energy probe is activated to heat the heat transfer medium prior to the heat transfer medium coming in contact with the shape memory article.
  • the energy probe is first activated and the heat transfer medium is brought into contact with the article.
  • the heat transfer medium may only be brought close to the article without even contacting it.
  • the heat transfer medium has a known steady state temperature. For instance, anything that is substantially water-based will have a boiling point of about 100 0 C and, therefore, the heat transfer medium essentially cannot be heated to a temperature greater than its boiling point, representing the steady state temperature. Hence, this provides extremely well-controlled heating of a shape memory article, which essentially cannot be heated to a temperature greater than the steady state excitation temperature of the heat transfer medium. Furthermore, the present invention provides more uniform heating than in the conventional art.
  • the same surface adhesion properties of liquids that causes the bolus to stick to the end of the tube 219 also causes the bolus to spread out over the surface area of the shape memory article, thereby potentially wetting a larger portion of the article than can be directly contacted by the energy probe itself in the prior art.
  • the heat transfers through the heat transfer medium, it is transferred more efficiently to the shape memory article than in the prior art. Accordingly, the heat reaches the segments of the article that are further away from the contact point of the tool more quickly than in the conventional art.
  • the article 231 can be provided with a surface treatment that enhances the wetting of the article by the bolus of heat transfer medium when the bolus is contacted to it.
  • a surface treatment may include coating the article with a surfactant or wetting agent that reduces the surface tension of a liquid, allowing it to spread across and/or penetrate the surface of the article.
  • a surfactant or wetting agent that reduces the surface tension of a liquid, allowing it to spread across and/or penetrate the surface of the article.
  • wicking materials, surfactants, and hydrophilic materials are widely available.
  • roughening of the surface or otherwise making the surface porous, or machining or otherwise forming grooves, divots, and/or pores in the surface of the article also can enhance wetting.
  • the article 231 may be directly coated with the heat transfer medium.
  • the object of the heat transfer medium is to be excited by the energy absorbed into the medium and convert it into heat.
  • the heat is conducted to the article, raising the temperature of the article above the transformation temperature.
  • the distal end 219a of the tube 219 is close enough to the distal end of the energy probe 205 so that, when a bolus of the heat transfer medium adheres to the tube, the bolus is in contact with the energy probe. This provides faster, more efficient heating of the bolus.
  • the tube can be sized, shaped, and positioned relative to the energy probe so that the energy probe is not in contact with the bolus, but heats the bolus through convective heating through the air.
  • the tool can be readily adapted as desired in this regard.
  • the tube 219 illustrated in the drawings also is merely exemplary.
  • Other means for holding a portion of heat transfer medium adjacent (including in contact with) the energy probe also are envisioned.
  • the end of the energy probe may be surrounded by or wrapped in a non-woven material, in the nature of a cotton swab.
  • the tube may be formed of a woven or porous material that absorbs and/or retains fluids well.
  • the end of the tube 219 may contain an absorbent material that will absorb the heat transfer medium.
  • the absorbent material may comprise a cylinder of cotton or other absorbent material having a proximal end in contact with the energy probe and a distal end extending slightly distally from the distal end 219a of the tube 219 for contacting the shape memory article.
  • the holding device need not comprise a tube and need not surround the energy probe at all.
  • a separate component of the system might be placed in close proximity to the energy probe of the tool and have a holding element at its end for holding the heat transfer medium.
  • the holding element may be a ball of woven or non- woven material, or simply a form having significant surface area for surface adhesion, such as a sphere or a flat waffle type configuration, preferably formed of a material having high surface adhesion properties.
  • This component will carry the heat transfer medium and, when placed in contact between the energy probe and the shape memory article, will wet the article as previously described.
  • the energy source for activating the energy probe, in one embodiment of the invention, can be programmed to provide heating in multiple bursts to help regulate the heating of the heat transfer medium.
  • the power source may provide a current through direct current (DC), alternating current (AC) or through high frequency means such as radio frequency (RF).
  • the present invention is extremely effective using commonly available saline solutions as the heat transfer medium.
  • operation of the invention can be improved by specifically engineering the heat transfer medium to have particularly beneficial properties.
  • the medium can be engineered to have a specific resistance or conductivity.
  • the energy probe is an ultrasonic probe
  • the medium can be selected or engineered to have particularly desirable acoustic properties.
  • the tube can be selected or engineered to provide certain acoustic properties, such as a certain acoustic resonance, or certain acoustic focusing.
  • the energy probe is not a physical probe, but rather a light beam, such as a laser light beam or an infrared light beam
  • contact between the energy probe, per se, and the bolus is not an issue.
  • the heat transfer medium may be adapted to contain pigment having a color that is highly absorbent of the light of the particular wavelength of the light source in order to efficiently excite the pigment, thus heating the heat transfer medium.
  • therapeutic agents such as antibiotics
  • the heat transfer medium may be encapsulated in a shell in the manner of gel capsule pills or actually wholly comprised of a solid.
  • the shell material preferably is selected so that it also will break down (thereby releasing the heat transfer medium) during heating.
  • the heat transfer medium is itself a solid ball of gel capsule material.
  • a solid ball of the heat transfer medium may be attached to the end of the tube or other holding device by an adhesive or by its inherent tackiness.
  • the heat transfer medium can be any substance, in solution, mixture or other form, that can be caused to be heated to a predetermined temperature by the energy delivered by an energy probe.
  • the heat transfer medium may start out as a gel or solid at room temperature and transform upon heating to a flowable substance for wetting the shape memory article.
  • the heat transfer medium may be supplied to the end of the tube by or through the instrument itself (rather than by dipping the end of the instrument into a supply of the medium).
  • a supply tube 801 may run along the side of the body 803 (alternately, it may run through the body of the instrument 800) with the distal end 801a of the tube positioned adjacent the end of the energy probe 805 and deliver a quantity of heat transfer medium 228 to the operative site.
  • the proximal end 801 b of the tube 801 may be coupled to a reservoir 850 of the heat transfer medium and supplied through the supply tube 801 to the distal tip 801 a of the tube.
  • the reservoir 850 is illustrated schematically as a block. However, it may be located directly in or on the hand-held tool 800. Alternately, it may be provided integral with the power supply, such as power supply 218 of Figure 2. Even further, the reservoir may be free-standing and/or remotely located from the hand-held portion of the tool, with the supply tube extending from the proximal end of the tool to the remote reservoir.
  • the heat transfer medium may be advanced through the supply tube via gravity feed. However, in other embodiments, it may be forced through the supply tube by a pump, such as a peristaltic pump. In other embodiments, the heat transfer medium may be provided through a spray nozzle near the end of the tube.
  • Figure 8 also illustrates that the tool 800 may be battery powered by self-contained batteries 811 because it requires relatively low power to operate, as previously mentioned. Particularly, Figure 8 illustrates an embodiment in which two batteries 811 (shown in phantom since they are inside the body) are contained within the body of the instrument 800. A switch 816 is provided for selectively energizing the probe from the battery power. If the tool is battery powered so that it operates without connection to a separate power source, signal processing also may be provided within the body of the tool for conditioning the power supplied to the probe.
  • an Application Specific Integrated Circuit ASIC
  • microcontroller microprocessor, analog circuit, digital signal processor or any combination thereof may be provided within the body 803 of the instrument for pulsing the power to the probe when the button is activated, turning the power off a certain time period after the button is activated, activating an LED to indicate when the probe is energized, etc.
  • ASIC Application Specific Integrated Circuit
  • the invention has many other advantages. For instance, it is small and handheld. It requires very low power to energize and heat the heat transfer medium. It also provides a highly controllable amount of heating of the shape memory article and the results are highly reproducible. Also, the heating is more uniform over the volume of the article.
  • FIG. 9 is a flow diagram illustrating one preferred implementation of a method in accordance with the present invention.
  • the procedure starts at step 901.
  • step 902 the surgeon places the staple or other shape memory article into the position where it is to be transformed.
  • step 903 the surgeon applies a portion of the heat transfer medium to the tip of the tube.
  • step 905 the surgeon touches the tip of the tube containing the heat transfer medium to the article.
  • step 907 the surgeon activates the energy probe and, in step 909, this causes the heat transfer medium to heat up. In turn, this causes the heat transfer medium to heat the article above its martensitic transformation temperature and transform in shape. If desired, steps 903- 91 1 may be repeated one or more times to assure transformation. The process ends at step 913.

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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un procédé et sur un appareil pour chauffer un article (231, 413) formé d'un alliage à mémoire de forme, comprenant les étapes d'utilisation d'un outil (201) comportant une sonde d'énergie (205), de disposition d'une partie d'un milieu de transfert thermique (227) au voisinage de la sonde d'énergie, de mise en contact du milieu de transfert thermique avec un article à mémoire de forme, et d'activation de la sonde d'énergie pour chauffer le milieu de transfert thermique, lequel milieu de transfert thermique transfère par conduction de la chaleur à l'article.
PCT/US2007/026305 2007-12-26 2007-12-26 Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme WO2009082376A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2007/026305 WO2009082376A1 (fr) 2007-12-26 2007-12-26 Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/026305 WO2009082376A1 (fr) 2007-12-26 2007-12-26 Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme

Publications (1)

Publication Number Publication Date
WO2009082376A1 true WO2009082376A1 (fr) 2009-07-02

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PCT/US2007/026305 WO2009082376A1 (fr) 2007-12-26 2007-12-26 Procédé et appareil pour délivrer de la chaleur à un article à mémoire de forme

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111225626A (zh) * 2017-09-05 2020-06-02 艾达吉欧医疗公司 具有形状记忆探针的消融导管

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3868956A (en) * 1972-06-05 1975-03-04 Ralph J Alfidi Vessel implantable appliance and method of implanting it
US4485816A (en) * 1981-06-25 1984-12-04 Alchemia Shape-memory surgical staple apparatus and method for use in surgical suturing
FR2778549A1 (fr) * 1998-05-15 1999-11-19 Mba Sa Dispositif pour chauffer et fermer des agrafes a memoire de forme thermoretractables utilisees en chirurgie
WO2001062136A2 (fr) * 2000-02-24 2001-08-30 Stryker Instruments Plaques, elements de fixation et outils bioabsorbables et procede d'utilisation associe
WO2005065561A1 (fr) * 2003-12-18 2005-07-21 Boston Scientific Limited Systeme de traitement tissulaire utilisant l'irrigation tissulaire par servocommande
WO2007044951A2 (fr) * 2005-10-13 2007-04-19 Intelifuse, Inc. Système et dispositif destinés à chauffer ou a refroidir des dispositifs chirurgicaux à mémoire de forme
US20070093869A1 (en) * 2003-06-20 2007-04-26 Medtronic Vascular, Inc. Device, system, and method for contracting tissue in a mammalian body
WO2007078978A2 (fr) * 2005-12-28 2007-07-12 Intrinsic Therapeutics, Inc. Dispositifs et procedes pour ancrage osseux
WO2007106263A2 (fr) * 2006-03-10 2007-09-20 Board Of Trustees Of The University Of Arkansas Dispositif thermotherapeutique interstitiel a conduction selective

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3868956A (en) * 1972-06-05 1975-03-04 Ralph J Alfidi Vessel implantable appliance and method of implanting it
US4485816A (en) * 1981-06-25 1984-12-04 Alchemia Shape-memory surgical staple apparatus and method for use in surgical suturing
FR2778549A1 (fr) * 1998-05-15 1999-11-19 Mba Sa Dispositif pour chauffer et fermer des agrafes a memoire de forme thermoretractables utilisees en chirurgie
WO2001062136A2 (fr) * 2000-02-24 2001-08-30 Stryker Instruments Plaques, elements de fixation et outils bioabsorbables et procede d'utilisation associe
US20070093869A1 (en) * 2003-06-20 2007-04-26 Medtronic Vascular, Inc. Device, system, and method for contracting tissue in a mammalian body
WO2005065561A1 (fr) * 2003-12-18 2005-07-21 Boston Scientific Limited Systeme de traitement tissulaire utilisant l'irrigation tissulaire par servocommande
WO2007044951A2 (fr) * 2005-10-13 2007-04-19 Intelifuse, Inc. Système et dispositif destinés à chauffer ou a refroidir des dispositifs chirurgicaux à mémoire de forme
WO2007078978A2 (fr) * 2005-12-28 2007-07-12 Intrinsic Therapeutics, Inc. Dispositifs et procedes pour ancrage osseux
WO2007106263A2 (fr) * 2006-03-10 2007-09-20 Board Of Trustees Of The University Of Arkansas Dispositif thermotherapeutique interstitiel a conduction selective

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111225626A (zh) * 2017-09-05 2020-06-02 艾达吉欧医疗公司 具有形状记忆探针的消融导管
CN111225626B (zh) * 2017-09-05 2023-11-14 艾达吉欧医疗公司 具有形状记忆探针的消融导管

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