WO2024020624A1 - Dispositif d'accès à l'os - Google Patents

Dispositif d'accès à l'os Download PDF

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Publication number
WO2024020624A1
WO2024020624A1 PCT/AU2023/050661 AU2023050661W WO2024020624A1 WO 2024020624 A1 WO2024020624 A1 WO 2024020624A1 AU 2023050661 W AU2023050661 W AU 2023050661W WO 2024020624 A1 WO2024020624 A1 WO 2024020624A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
tubular member
cuff
distal end
adjacent
Prior art date
Application number
PCT/AU2023/050661
Other languages
English (en)
Inventor
Ralph MOBBS
Original Assignee
Jasper Medtech Pty Ltd
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
Priority claimed from AU2022902134A external-priority patent/AU2022902134A0/en
Application filed by Jasper Medtech Pty Ltd filed Critical Jasper Medtech Pty Ltd
Publication of WO2024020624A1 publication Critical patent/WO2024020624A1/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
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/317—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for bones or joints, e.g. osteoscopes, arthroscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3486—Balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0279—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing medical instruments into the body, e.g. endoscope, surgical tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0291—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body method or device for implanting it in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0297—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body at least part of it being inflatable, e.g. for anchoring, sealing or removing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/02—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1003—Spinal column
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the technology relates to minimally invasive surgical devices and methods for providing access to bones, particularly the spine.
  • Surgical procedures invariably involve trauma to tissues around the surgical site. Smaller skin incision and decreased disruption of surrounding tissue during the surgical approach reduces postsurgical healing time, and pain. Thus, there is increasing demand for minimally invasive surgical (MIS) techniques to perform surgical procedures, through smaller incisions with less disruption of the surrounding soft tissues, with the goal of decreased recovery times, lessened morbidity, and cost savings.
  • MIS minimally invasive surgical
  • Minimally invasive surgical access to bones, including bones in the spine typically involves a tubular retractor to decrease the collateral damage to spinal muscles compared to a conventional open posterior approach.
  • Muscle splitting serial tube dilators and retractors were designed to minimize disruption of the paraspinal musculature and provide direct and focal access to the diseased anatomy.
  • a tubular retractor system has the advantage of viewing the surgical images directly under the microscope. Though the primary indication for which the tubular retractor system was developed is lumbar disc herniation but over time and with certain modifications, tubular retractors have been used to carry out multilevel interbody fusions using multiple ports and augmented by percutaneous screws and rods as well as minimally invasive anterior approaches. The use of tubular retractors preserves stability provided by the envelope of paraspinal muscles.
  • tubular retractors can impinge on the spinous process or lamina thereby limiting the depth of insertion and consequently compromising visualisation due to muscle creep around the end of the retractor.
  • use of tubular retractors requires initial serial dilation before the tubular retractor is placed over the last dilator. With this approach the there is a risk that the dilators can migrate into the interlaminar space and cause an unintended durotomy or damage the spinal nerves or spinal cord.
  • the present inventor has developed a minimally invasive surgical device and method allowing for stable access to bones, with distal stabilization with an inflatable cuff, with the additional benefit of reducing muscle creep into the surgical corridor.
  • the device provides access for one or more endoscopes and provides additional working space at the bone surface compared to existing methods and devices.
  • the device can be incorporated into either a single, biportal or multiportal surgical techniques.
  • a device for accessing a bone of a subject comprising a tubular member having a proximal end, a distal end and a lumen extending therebetween, wherein the proximal end of the tubular member comprises an inflation port in fluid communication with an inflatable cuff at or adjacent to the distal end, and wherein in use the inflatable cuff draws tissue away from the bone, and/or reduce muscle creep into the surgical corridor adjacent the distal end of the tubular member and the bone.
  • the bone access device may further comprise: a) a hub having a proximal end and a distal end and a lumen extending therebetween; b) wherein the tubular member comprises a proximal end body connected to the distal end of the hub, a distal end and a lumen extending between the two ends, the tubular member comprises a collar adjacent the proximal end body and an inflatable cuff adjacent the distal end; and wherein the lumen of the tubular member is in communication with the lumen of the hub; and c) the proximal end of the hub is detachably connected to a cap, wherein, in use the inflatable cuff and the collar co-operate to draw tissue away from the bone and/or reduce muscle creep into the surgical corridor adjacent the distal end of the tubular member and the bone.
  • the proximal end body further comprises an inflation port in fluid communication with an inflation lumen extending between the inflation port and the inflatable cuff.
  • the inflatable cuff may further provide a fluid pocket adjacent the bone, for example to allow an endoscope tip advanced through the tubular member to be positioned within the fluid pocket to facilitate efficient surgical workflow.
  • the inflatable cuff provides pressure to a fluid in the fluid pocket.
  • a luer fitting, a valve assembly, or both may be attached to the inflation port.
  • the collar is moveable along the length of tubular member and may comprise a locking means.
  • the outer surface of the tubular member is threaded and the inner surface of the collar has a complementary thread.
  • the cuff is elastic and all or the major portion of the inner surface of the cuff in its deflated condition is closely adjacent to and may be in contact with the outer surface of the tubular member.
  • the cuff may be pre-shaped to have a bulbous, or flat, or any form when inflated.
  • the bone may be a spinal bone such as a vertebra, sacrum or coccyx.
  • a spinal bone such as a vertebra, sacrum or coccyx.
  • a spinous process, lamina, transverse process, facet or body of a vertebra for example a spinous process, lamina, transverse process, facet or body of a vertebra.
  • a method of providing bone access comprising a) advancing the device of the first aspect into an incision such that the distal end of the tubular member is adjacent to or abuts the bone; b) inflating the cuff to draw tissue away from the bone.
  • a method of providing bone access comprising c) advancing the tip of a guidewire to be adjacent a bone of a subject; d) advancing the device of the second aspect over the guidewire until the distal end of the tubular member is adjacent to or abuts the bone; e) inflating the cuff; and moving the collar along the tubular member to clamp the subject's tissues between the collar and the inflated cuff such that the inflatable cuff and the collar co-operate to draw tissue away from the bone.
  • Inflation of the cuff may further provide a fluid pocket adjacent the bone, for example to allow an endoscope tip advanced through the tubular member to be positioned within the fluid pocket to facilitate efficient surgical workflow.
  • the method further comprises providing a fluid to the fluid picket.
  • inflation of the cuff provides pressure to a fluid in the fluid pocket.
  • the method may further comprise removing the guidewire and removing the cap.
  • the bone is a spinal bone.
  • the spinal bone may be a vertebra, sacrum or coccyx.
  • a spinous process, lamina, transverse process, facet or body of a vertebra For example a spinous process, lamina, transverse process, facet or body of a vertebra.
  • the method may comprise using the distal end of the tubular member to bluntly dissect tissue to access the bone.
  • 'a' and 'an' are used to refer to one or more than one (ie, at least one) of the grammatical object of the article.
  • 'an element' means one element, or more than one element.
  • the term 'about' means that reference to a figure or value is not to be taken as an absolute figure or value, but includes margins of variation above or below the figure or value in line with what a skilled person would understand according to the art, including within typical margins of error or instrument limitation.
  • use of the term 'about' is understood to refer to a range or approximation that a person or skilled in the art would consider to be equivalent to a recited value in the context of achieving the same function or result.
  • Figure 1 illustrates one embodiment of the device 10.
  • Figure 2 illustrates the insertion of guidewire 100 into a subject.
  • Figure 3 illustrates the device described herein being advanced over the guidewire 100.
  • Figure 4 illustrates the distal end of the tubular member 50 adjacent to the spine and the removal of the guidewire 100.
  • Figure 5 illustrates removal of the cap 30 once the device 10 is inserted into a subject.
  • Figure 6 illustrates the distal end of the tubular member 50 abutting the spine and the collar 70 moved along the tubular member 50 to be in contact with the subject's skin.
  • Figure 7 illustrates inflation of the cuff 60.
  • Figure 8 illustrates that subject's tissues secured between the inflated cuff 70 and the collar 70 which is locked in place on the tubular member 50 thereby providing a clear surgical filed at the bone surface.
  • Figure 9 illustrates a surgical instrument inserted through the lumens of the device and access the bone surface.
  • Figure 10 illustrates another embodiment of the device 10.
  • the device 10 comprises a hub 20, and a generally elongate tubular member 50 extending from one end of the hub 20.
  • the hub 20 includes a body 21 having a proximal end 22 and a distal end 23 and a central lumen extending therebetween.
  • a port 55 is provided in the side of the main body 21 of hub 20.
  • the port 55 formed in the main body 21 of the hub 20 is in fluid communication with an inflatable cuff 60.
  • the tubular member 50 has a central lumen extending between the proximal end 22 and the distal end 23 of the main body 21 of hub 20.
  • the tubular member 50 has a port 25 in fluid communication with the central lumen.
  • the port 25 may comprise a luer fitting or a valve assembly can be attached to the port 25 so that fluid can pass through the valve/luer and into the lumen 59 of the tubular member 50.
  • the central lumen comprises a first lumen portion and a second lumen portion.
  • the first lumen portion and the second lumen portion can have a common central axis. It will be appreciated by one skilled in the art that first lumen portion and second lumen portion are not required to have a common central axis.
  • the first lumen portion is proximate to the distal end 23 of the hub 20 while the second lumen portion is proximate to the proximal end 22 of the hub 20.
  • the device 10 comprises a cap 30 detachably connected the central lumen proximate to the proximal end 22 of the hub 20.
  • the surface of cap 30 is sized and configured to be received within the proximal end 22 of the hub 20.
  • the surface of the cap 30 forms a protrusion 32 to be received by the interior surface of the proximal end body 22 of the main body 21 of the hub 20, and the central lumen 59 of tubular member 50.
  • the proximal end 22 of the main body 21 of the hub 20 is configured to receive the protrusion 32.
  • the protrusion 32 of the cap 30 can have various other configurations and shapes as long as it is configured to cooperate with the proximal end 22 of the hub 20 and the central lumen 59 of tubular member 50.
  • proximal end 22 of the hub 20 and a portion the exterior surface 32 cooperate form a seal.
  • the cap 30 has a lumen extending through the protrusion 32 to enable advancement of the device 10 over guidewire 100.
  • the cap 30 has an opening 34 in a medial portion thereof that is sized to receive a guidewire 100.
  • the opening 34 extends through protrusion 32.
  • An exemplary embodiment of the cap 30 of the present invention is illustrated in FIGS 1 and 3-5.
  • the cap 30 is configured to cooperate the proximal end 22 of the hub 20.
  • the exterior surface of the cap 30 configured to receive the proximal end 22 of the hub 20.
  • the proximal end 22 of the hub 20 has an opening formed therein configured to receive the cap 30.
  • distal portion of the cap 30 and the opening in the proximal end 22 of the hub 20 can have various other configurations and shapes as long as they are configured to cooperate and have a sealing engagement.
  • distal portion of the cap 30 and the opening the proximal end 22 of the hub 20 could be U-shaped, round, rectangular square, oval, elliptical, tapered, or any combination thereof as long as they are configured to detachably cooperate.
  • the port 55 is in fluid communication with an inflation lumen extending between the port 55 and an inflatable cuff 60 at or adjacent the distal end of the tubular member 50.
  • the proximal end of the inflation lumen is connected in a fluid-tight connection with the inflation port 55.
  • the inflation lumen 55 is formed within the wall of the tubular member 50 or may be formed by a tube or conduit connecting the inflation port 55 and cuff 60.
  • the tube or conduit may be secured, such as by an adhesive, heat bonding or other suitable means, to the tube tubular member 50.
  • the port 55 may comprise a luer fitting or a valve assembly can be attached to the port 55 so that fluid can pass through the valve/luer and into the inflation lumen extending between the port 55 and an inflatable cuff 60.
  • the tubular member 50 comprises a grip 65.
  • the grip 65 may be integrally formed with the tubular member 50 or may be fastened to tubular member 50.
  • the grip 65 typically comprises a textured surface, for example a series or pattern of raised sections as illustrated in FIGS 1 and 3-8.
  • the cuff 60 is preferably elastic and sits 'tight-to-shaft' as shown. That is when disposed on the tubular member 50, all or the major portion of the inner surface of the cuff in its deflated condition is closely adjacent to and may be in contact with the outer surface of the tubular member 50 .
  • the cuff is preferably formed of an elastic material, such as natural or synthetic rubber, or a suitable elastomeric thermoplastic material. A latex or silicone rubber, for example, may be used.
  • the cuff 60 is secured to the tubular member 50 adjacent the distal end, which end is adapted to be inserted into a subject.
  • the cuff 60 is fixed in relation to the outer surface of tubular member 50, such as by an adhesive, solvent bonding, heat bonding or in any other suitable manner.
  • the inflatable or expansible portion of cuff 60 is, of course, able to move away from tubular member 50 when the cuff is inflated, the cuff assuming a bulbous or toroidal form as indicated in FIGS. 7 and 8.
  • the cuff 60 may be pre-shaped if desired to have a bulbous form when inflated under slight inflation pressures.
  • the cuff may be made of a plastic which is not elastic or mildly elastic, such as urethane, polyvinyl chloride or the like.
  • the elastomeric 'tight-to-shaft' cuff is capable of quickly and fully collapsing when deflated for easy removal of the tubular member 50 from the subject, it is preferred to the type which is preformed in the bulbous form and which generally becomes irregular in shape when deflated. Either type of cuff can be used.
  • the cuff 60 may be located at the very distal end of the tubular member 50, or just distal to the collar 70, or at any position therebetween.
  • the cuff 60 is depicted herein as a balloon, however various other embodiments can be used such as a deployable umbrella or cup, or other structural mechanism to keep the tubular member 50 in place.
  • the deployed shape of the umbrella or cup is substantially complimentary to the collar 70, such that when in use to draw tissue away from the bone cooperation between the cuff 60 and collar 70 is enhanced.
  • the tubular member 50 may be inserted into the subject, either by way of a previous surgical incision or as illustrated in FIGS 2-5 using a guide wire so that the cuff 60 is positioned internal to the subject's skin, subcutaneous fat and musculature.
  • the cuff 60 can then be inflated, for example by using an air or saline filled syringe attached to the inflation port 55.
  • the cuff 60 when inflated the cuff 60 draws tissue away from the bone. In some embodiments inflation of the cuff 60 reduces muscle creep into a surgical corridor adjacent the distal end of the device and the bone.
  • the inflatable cuff 60 provides a fluid pocket adjacent the bone. Creation of a fluid pocket allows endoscope tip, which may be advanced through the tubular member, to be positioned within the fluid pocket to facilitate efficient surgical workflow, that is the fluid pocket provides space for the surgeon to work and allows for clearance of any debris generated during surgery which can be removed when the fluid is removed or exchanged. Accordingly, in some embodiments a fluid such as sterile saline can be provided to the pocket through the device or separately, for example by injection.
  • the device further comprises a collar 70 positioned adjacent the proximal end of the tubular member 50.
  • the collar 70 is moveable along the length of tubular member 50 and comprises a locking means such the collar 70 can be fixed at a desired location on the tubular member 50.
  • Any suitable locking means may be used such as a set screw, pin, or other device, that can be used to tighten the collar 70 onto the tubular member 50.
  • the outer surface of the tubular member 50 is threaded and the inner surface of the collar 70 has a complementary thread such that the collar can be screwed along the axis of the tubular member 50.
  • FIGS. 1 and 9 depict exemplary embodiments of the tubular member 50.
  • the tubular member 50 includes a proximal end body 52 and a distal end 57 with a lumen extending between the two ends.
  • the distal end 57 of the tubular member 50 is adapted to dissect muscle from the bone using a back and forth scraping technique. This helps lift the muscle off the bone when inflating the cuff 60 and pulling it away from the bone.
  • the distal end 57 may have a narrow tip to assist with initial placement over a guidewire, and initial dissection of tissue attached to the bone.
  • the tubular member 50 is comprised of a durable material and is able to maintain the lumen 59 when in place and surrounded by the subject's tissue.
  • the proximal end body 52 of the tubular member 50 is configured to be received proximate to the distal end 23 of the hub 20 for example by being screwed into the distal end 23 or by the use of a retaining means comprising angular ridges or teeth-like features formed in the distal end the retainer configured to contact and engage the proximal end body 52 of the tubular member 50.
  • the retaining means may have various other configurations and perform the function thereof.
  • proximal end body 52 of the tubular member 50 is resiliently engaged in the lumen of the hub 20 by a snap-fit or frictional engagement
  • various other methods of attachment could be utilized, such as welding, adhesives, mechanical fasteners and the like.
  • proximal end body 52 of the tubular member 50 may have various other configurations.
  • the proximal end body 52 may be generally shaped as depicted in FIGS. 1 and 2-9.
  • the distal end 57 of the tubular member 50 can include a tapered portion depicted in FIG. 9A in which the diameter of the tubular member 50 is gradually reduced.
  • a tapered portion may be produced through known manufacturing methods such as drawing, sanding, grinding, heat forming or other similar processes.
  • the device or components thereof can be formed using one or more materials known in the art as suitable sterile medical grade biomaterials, synthetic materials or plastics for single, or multiple use.
  • Exemplary materials may include, but are not limited to, flexible PVC, polyurethane, silicone, liner low-density polyethylene (“LLDPE”), polyethylene, high density polyethylene, (“DHPE”), polyethylene-lined ethylvinyl acetate (“PE-EVA”), polypropylene, latex, thermoplastic rubber, polytetrafluoroethylene (PTFE), expandable polytetrafluoroethylene (ePTFE), fluoroethylene-propylene (FEP), perfluoroalkoxy (PFA), ethylene-tetrafluoroethylene-copolymer (ETFE), ethylene-chlorotrifluoroethylene (ECTFE), polychloro-trifluoroethylene (PCTFE), polyimide (PI), polyetherimide (PEI), polyetherketone (PEEK), polyamide-
  • Exemplary materials used in the device or the components thereof may also include elastomers or thermoplastic elastomers.
  • elastomers include, but are not limited to, natural rubber, silicone rubber, polyurethane rubber, polybutadiene, polyisoprene, chlorosulfonated polyethylene, polysulfide rubber, epichlorohydrin rubber, ethylene propylene rubber, and the like or any combination thereof. These materials provide the elasticity that enable the sheath to expand and/or contract to accommodate the removal/insertion of a medical device as required.
  • Other materials that can be used can include, but are not limited to, dip coated type silicones.
  • the materials suitable for use in an introducer sheath and the components thereof are configured to have chemical resistance, crack resistance, no toxicity, Food and Drug Administration (“FDA”) or other regulatory compliance, non- electrically conductive, dimensional stability, and/or be sterilized by ethylene oxide, gamma radiation, autoclave, UV light, ozone, and the like.
  • FDA Food and Drug Administration
  • the selection of materials for the device or its components can depend on a variety of factors that include, but are not limited to, a particular stiffness and/or flexibility of the device or any portion thereof, including the desired stiffness and strength to enable insertion of the tubular member, the ability to resist kinking, and the like.
  • one or more of the hub 20, the tubular member 50, the cap 30, and the proximal end body 52 may be constructed of materials such as acrylonitrile butadiene styrene (ABS), polyvinylchloride (PVC), polycarbonate.
  • ABS acrylonitrile butadiene styrene
  • PVC polyvinylchloride
  • the hub 20, the cap, and the proximal end body 52 are formed through injection molding.
  • the elongate tubular member 50 may be constructed of polytetrafluoroethylene, Teflon, or similar materials.
  • the tubular member 50 is fabricated by and may be constructed of a single material or may from more than one material.
  • any of the above identified materials may further include glass reinforcement particles mixed therewith.
  • the devices described herein can be used to effect percutaneous bone access, particularly to the spine.
  • a surgeon will initially identify the insertion point in a suitably anesthetized subject, either by using an anatomical landmark or with the aid of ultrasound or other imaging technique.
  • a guide wire is then inserted into the subject and the proximal end of the guidewire advanced using a translation motion with until the tip of the guidewire is adjacent to or abuts the bone (FIGS 2-4).
  • Alternative methods for placement of guidewires are known in the art and include the use of a needle or catheter.
  • the distal end of the tubular member 50 is advanced over the guidewire and the guidewire is fed through the opening 34 in cap 30 and protrusion 32.
  • the device is advanced over the guidewire 100 (FIGS 2-3) until the distal end of the tubular member 50 is adjacent to or abuts the bone (FIG 4).
  • the guidewire and cap are then removed (FIG 4 and 5) and the cuff 60 inflated (FIG 7).
  • Cuff inflation (FIG 7) prevents the device being withdrawn from the subject.
  • the collar 70 is then advanced distally along the tubular member 50 to clamp the device in place by as illustrated in FIG 8 thereby providing surgical access to the bone as illustrated in FIG 9.
  • the device can be inserted into an incision and advanced towards the bone.
  • the device can optionally be used to bluntly dissect tissue as it is advanced.
  • the cuff 60 is inflated and prevents the device being withdrawn from the subject and to withdraw the tissue from the adjacent bone, and/or reducing muscle creep into the surgical corridor at the distal end of the tubular access device.
  • one or more dilators is used to increase the size of the incisions before introducing the device into the incision and advancing it towards the bone.

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Abstract

Il est prévu un dispositif pour accéder à l'os d'un sujet, le dispositif ayant une extrémité proximale et une extrémité distale et une lumière s'étendant entre celles-ci, l'extrémité proximale de l'élément tubulaire comprenant un orifice de gonflage en communication fluidique avec un manchon gonflable au niveau ou au voisinage de l'extrémité distale, le manchon gonflable tirant un tissu dans un sens à l'opposé de l'os lors de son utilisation.
PCT/AU2023/050661 2022-07-29 2023-07-19 Dispositif d'accès à l'os WO2024020624A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2022902134 2022-07-29
AU2022902134A AU2022902134A0 (en) 2022-07-29 Bone Access Device

Publications (1)

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WO2024020624A1 true WO2024020624A1 (fr) 2024-02-01

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5924424A (en) * 1993-02-22 1999-07-20 Heartport, Inc. Method and apparatus for thoracoscopic intracardiac procedures
US20050165432A1 (en) * 2002-05-09 2005-07-28 Russell Heinrich Adjustable balloon anchoring trocar
US20060079918A1 (en) * 2004-10-12 2006-04-13 Brian Creston Balloon anchored surgical apparatus, its use and manufacture
US20060116658A1 (en) * 2004-11-30 2006-06-01 Kimberly-Clark Worldwide, Inc. Multi-lumen stoma measuring device and method for using same
US20170086880A1 (en) * 2012-02-22 2017-03-30 Tanam Medical Inc. Trans-endoscopic and laparoscopic surgery port
US20190314009A1 (en) * 2013-08-05 2019-10-17 Endo-Tagss, Llc Transabdominal Gastric Device and Method
US20210205589A1 (en) * 2020-01-07 2021-07-08 CRM Medical Devices, Inc. Catheter and click connector

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5924424A (en) * 1993-02-22 1999-07-20 Heartport, Inc. Method and apparatus for thoracoscopic intracardiac procedures
US20050165432A1 (en) * 2002-05-09 2005-07-28 Russell Heinrich Adjustable balloon anchoring trocar
US20060079918A1 (en) * 2004-10-12 2006-04-13 Brian Creston Balloon anchored surgical apparatus, its use and manufacture
US20060116658A1 (en) * 2004-11-30 2006-06-01 Kimberly-Clark Worldwide, Inc. Multi-lumen stoma measuring device and method for using same
US20170086880A1 (en) * 2012-02-22 2017-03-30 Tanam Medical Inc. Trans-endoscopic and laparoscopic surgery port
US20190314009A1 (en) * 2013-08-05 2019-10-17 Endo-Tagss, Llc Transabdominal Gastric Device and Method
US20210205589A1 (en) * 2020-01-07 2021-07-08 CRM Medical Devices, Inc. Catheter and click connector

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