Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1637—Hollow drills or saws producing a curved cut, e.g. cylindrical
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B2010/0225—Instruments for taking cell samples or for biopsy for taking multiple samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
  • A61B2010/0258—Marrow samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
  • A61B2017/00561—Surgical instruments, devices or methods pneumatically or hydraulically operated creating a vacuum

Definitions

• the present invention is generally directed to devices for medical procedures, and more particularly, for bone marrow access.
• Bone marrow aspirations and trephine biopsies are often performed or directed by interventional radiologists and hematopathologists, while bone marrow enhanced tissue repair procedures are often performed by orthopedic surgeons.
• a hole is created at the biopsy site, a needle is inserted, and liquid blood and bone marrow are withdrawn. Blood and bone marrow cells are examined and checked for blood disorders, chromosome problems, and infection.
• Bone marrow aspirations and bone marrow trephines are most often performed together, with the aspiration first, followed by the trephine extraction.
• the second popular example use of the present invention is stimulating bone marrow in subchondral bone to repair cartilage.
• Bone marrow is rich in stem cells, which have great healing and regenerative properties.
• Other examples include the stimulation of healing in areas of tendinosis such as elbow lateral epicondylitis, patella tendinopathy, hip gluteus medius tendinopathy, and ankle Achilles tendinitis; to stimulate ligament healing such as in knee medial collateral ligament sprains; to enhance soft tissue to bone healing such as in the repair of the shoulder rotator cuff tendon to bone; for the enhancement of bony healing in fractures; and in the preparation of bone for improved healing to prosthetic implants
• Bone marrow and its associated cells are known to have regenerative properties which makes it valuable medicinally in areas of wear, damage, or impairment. In many cases, soft tissue and bone healing can benefit from improved access to bone marrow, typically through small holes in bone.
• One area of benefit is in articular cartilage repair.
• Articular cartilage is a smooth, low-friction tissue which covers the ends of bones and enables healthy joint function. Articular cartilage is prone to damage from excessive wear or traumatic injuries, as are common in sports. When articular cartilage is damaged, it can result in pain and reduced mobility for the patient, and in some cases subsequent arthritis. Articular cartilage has extremely limited ability to repair itself spontaneously due to absent blood flow.
• Microfracture surgery exists as a method to assist in the repair of articular cartilage in order to improve joint function.
• Microfracture creates a pathway for cartilage-building cells in blood and bone marrow to travel from the underlying cancellous bone to the articular surface by producing small holes in the cortical bone.
• Microfracture procedures are typically performed using an awl or a pick that is hit with a hammer.
• Other conditions where healing is often limited or impaired occurs in degenerative conditions where soft tissue attaches to bone, such as in rotator cuff tears and various insertional tendinopathies such as elbow lateral epicondylitis, patella tendinopathy, and Achilles tendinitis. In these situations, there is again limited or absent blood flow, and therefore healing is impaired without access to the necessary cells and growth factors.
• Drilling or perforation of the bone is performed to allow bone marrow and blood to access the area of damage.
• drill holes are often made to allow bone marrow and blood to reach the area of relatively poor circulation.
• Some marrow access devices for example U.S. Pat. No. 9,510,840 (“the '840 patent), are utilized via driving a wire with a hammer through an angled cannula. Like the hammer and awl method, this method requires a minimum of three hands to operate and delivers inconsistent results due to its subjective and uncontrolled external force delivery, which is a problem in microfracture procedures.
• the typical method of performing microfracture involves holding a longitudinal awl with an angled tip, and a hammer for impacting the proximal end of the handle of said awl.
• a surgical scope must be held and positioned in a manner which allows the surgeon to see the tip alignment, the depth of penetration, and the subsequent blood flow from each hole produced.
• a problem exists in that at least three hands are required to perform such a procedure using the historically accepted method. While each tool must be operated with careful precision, and the feedback from each tool is interdependent, coordinating a microfracture procedure with a minimum of two operators presents a challenge.
• the depth of penetration must be sufficient to adequately access the bone marrow elements underneath the relatively avascular subchondral bone.
• the holes must be of sufficient width to allow bone marrow and blood to reach the surface of the bone, while not being so large as to significantly affect the load-bearing characteristics of the bone. Holes must be adequately spaced apart to allow for adequate flow to cover the surface, but not collapse into each other. Ideally, the holes should be perpendicular to the surface so that minimal tissue is perforated to allow access to the bone surface.
• the standard technique uses a hammer manually impacting the back end of the awl. This can result in a highly variable amount of force being applied, resulting in unpredictable hole size and depth. In addition, excessive load can cause significant bone edema, pain and loss of function in patients. Furthermore, the direction of force applied by the hammer is not substantially aligned with the orientation of the tip, and the tip may not be perpendicular to the bone surface. This often results in substantial undesired damage to the subchondral bone, since an oblique hole or trough may be created. In many cases, the lateral force transmitted to the awl tip causes the tip to break into an adjacent hole, significantly disrupting the subchondral bone.
• the individual holes created may be much wider than what is necessary, leading to complications and prolonged recovery time.
• the majority of these instruments are multiple-use, and tend to dull or blunt over time, resulting in a need for increased force application to create the holes.
• Another example application of the present invention is to improve access to bone marrow and blood to enhance soft tissue or bony healing, including fracture union, fusion, or healing to prosthetic implants.
• Insufficient access to bone marrow in said procedures can result in reduced progenitor cells and growth factors, and ultimately substandard clinical outcomes.
• this access is achieved either with the use of an awl, with the previously described deficiencies; or by drilling into the bone.
• Drilling of the bone has several limitations: typically, this is performed through an open and not minimally invasive surgical technique.
• the angle of drilling is usually limited by use of a straight drill bit. Larger holes can weaken the underlying bony tissue, while smaller drill bits are prone to breakage due to the often awkward positioning and unbalanced size of the power drill. Drilling has also been implicated in thermal necrosis (death) of the bone, which is counterproductive in the healing environment. This can be exacerbated by the typical reuse of many drill bits which become duller with continued use.
• drilling with the typical size drill and bit is usually a two-handed procedure requiring an assistant to retract adjacent tissue.
• the present invention introduces a novel instrument for use in microfracture procedures and other bone marrow access procedures which solves the multiple issues mentioned above.
• the novel instrument can be operated using one hand, emulating both the hammer and the awl of the historically accepted microfracture procedure, or the stabilized drill and bit. In such form, one operator may coordinate each essential surgical element simultaneously with precision.
• the device can have variable angles to access the bone, unlike a straight awl or drill bit.
• the present invention demonstrates a means of transmitting power to a force in a direction better aligned with the orientation of the tip. This device can deliver a precise load and direction to the tip, resulting in much better controlled hole size, shape, and depth.
• Another advantage is a disposable tip, which can also increase the average sharpness of the instrument when used.
• the present invention comprises a one-handed solution for creating holes in tissue.
• the entire device is disposable, so as to ensure a safe and sterile procedure administered by the device.
• the tip is removable, and can be cleaned by standard reprocessing methods.
• the present invention includes a handheld surgical instrument having an energy storage element, wherein the energy storage element is a spring coupled to the impacting mechanism, the impacting mechanism having a tip configured to impact a bone, wherein the tip includes a tapered point, a power transmission mechanism is configured to transmit energy from the energy storage element to the impacting mechanism, wherein the power transmission mechanism includes a semi flexible metal wire guided by a hollow shaft, wherein the hollow shaft includes a distal end, wherein the semi-flexible metal wire includes a bend toward the distal end.
• a trigger mechanism is configured to release energy from the energy storage element, wherein the bend includes an angle, wherein the trigger mechanism includes a manual lever which, when actuated, simultaneously retracts the tip and charges the energy storage element.
• the invention includes a method of performing surgery that includes the use of a handheld surgical instrument comprising an energy storage element, wherein the energy storage element is a spring coupled to the impacting mechanism.
• An impacting mechanism has a tip configured to impact a bone, wherein the tip includes a tapered point.
• a power transmission mechanism is configured to transmit energy from the energy storage element to the impacting mechanism, wherein the power transmission mechanism includes a semi-flexible metal wire guided by a hollow shaft, wherein the hollow shaft includes a distal end.
• the semi-flexible metal wire includes a bend toward the distal end.
• a trigger mechanism is configured to release energy from the energy storage element, wherein the bend includes an angle, wherein the trigger mechanism includes a manual lever which, when actuated, simultaneously retracts the tip and charges the energy storage element.
• the present invention is an automated tissue coring device which comprises a handle, a hollow shaft, a biasing element, a first actuator, and a hollow penetrating needle with an elongate portion and a sharp tip.
• the distal portion of the hollow shaft is optionally curved for increased access in minimally invasive procedures.
• the handle houses a biasing element, optionally configured to an impactor and an indexing mechanism, which enables a user to apply a known force and / or advance a known distance, the penetrating needle tip upon triggering a first actuator.
• Biasing element may be coupled with one or more linear advancement mechanisms, such as the following list, for example and not limitation: a linear indexing Geneva mechanism, a rack and pinion, a slider crank, a barrel cam and follower, a slotted bar quick return mechanism, a Whitworth mechanism, a vibrating penetrator, an oscillating swash plate mechanism.
• linear advancement mechanisms such as the following list, for example and not limitation: a linear indexing Geneva mechanism, a rack and pinion, a slider crank, a barrel cam and follower, a slotted bar quick return mechanism, a Whitworth mechanism, a vibrating penetrator, an oscillating swash plate mechanism.
• the penetrating needle tip may be retracted through the use of an optional second actuator, an optional toggle, a secondary mode of the first actuator, or some combination thereof.
• a secondary mode of the first actuator may be enabled by pushing the first actuator forward, thereby mating an internal catch between the first actuator and the hollow needle as made by one with ordinary skill in the art, and then pulled back to retract the needle.
• Hollow shaft and its internal components are optionally removable from the handle and exchangeable with other attachments.
• system includes a first configuration for aspiration comprising a hollow tube with a port for suction and housing a solid removable elongate slider with cutting tip; and a second configuration for coring, comprising a hollow needle and a second elongated slider for column support.
• the hole in the cortical bone layer is created with first elongate slider, elongate slider is removed from hole and suction is applied to extract liquid blood and bone marrow, first elongate slider is removed from the handle out of the proximal side and replaced with a hollow needle and second elongate slider while keeping the hollow shaft in place, and then the needle tip is advanced beyond the bone surface to achieve sufficient depth for retrieving a core sample.
• the present invention includes an automated tissue coring device which may be utilized for bone marrow biopsies.
• a bone marrow biopsy is performed with the following steps: Place the distal tip at the site of interest; second charge the internal spring or biasing element by squeezing the lever or first actuator. Apply tip pressure to the bone surface and actuate the first impact or advancement by squeezing the trigger or second actuator. Trigger impact or advancement again if desired depth is not yet achieved. Depth may be indicated by markings on the needle or via a window in the handle which shows how far the needle has moved from its starting position. Repeat triggering impact or advancement until desired depth is achieved. With the hollow shaft tip in place, pull back on the handle toggle to retract the needle from the bone.
• the automated tissue coring device of the present invention may be utilized for bone marrow enhanced tissue repair.
• Bone marrow stimulation is achieved by performing the following detailed steps: Place the distal tip at the site of interest; second charge the internal spring (biasing element) by squeezing the lever (first actuator).
• Trigger impact or advancement again if desired depth is not yet achieved. Depth may be indicated by markings on the needle or via a window in the handle which shows how far the needle has moved from its starting position. Repeat triggering impact or advancement until desired depth is achieved. Once desired depth is achieved, engage the toggle on the handle to activate a retraction mode, and then squeeze the second actuator to retract the needle. When the actuator reaches the end of its stroke the toggle is pushed back into forward mode. Repeat from step until desired number of holes are created in bone. Each new hole will drive cores from previous holes further proximally into the hollow penetrating needle.
• an elongated slider is used after each coring operation to press out and dispose of the core in order to provide an unobstructed needle opening for the next coring operation.
• FIG. 1 depicts a side view of the automated tissue coring device.
• FIG. 2 depicts a cross-section of a hollow needle inside a hollow shaft positioned at a bone surface.
• FIG. 3 depicts a hollow needle tip as advanced a known distance with respect to a hollow shaft.
• FIG. 4 depicts a hollow needle tip as advanced a known distance twice with respect to a hollow shaft.
• FIG. 5 depicts a method of automated tissue transfer whereby both solid bone and liquid bone marrow are obtained from a site for removal or transfer.
• FIG. 6 depicts a hollow penetrating needle cross-section with a core retention element.
• FIG. 7 depicts a blood or bone marrow aspiration device whereby a hole is created and negative pressure is utilized to draw out fluid.
• FIG. 8 depicts a suction mechanism for drawing regenerative cells out of bone with a multi -lumen tube.
• FIG. 9 depicts a block diagram illustrating a biopsy method using the present invention.
• FIG. 10 depicts a block diagram illustrating a marrow stimulation method using the present invention.
• an automated tissue coring device 1 comprises a handle 11, a hollow shaft 12, a biasing element 13, a first actuator 14, and a hollow penetrating needle with an elongate portion and a sharp tip 152.
• the distal portion 122 of the hollow shaft is optionally curved for increased access in minimally invasive procedures.
• the handle houses a biasing element 13, optionally configured to an impactor and an indexing mechanism 131, which enables a user to apply a known force and / or advance a known distance, the penetrating needle tip upon triggering a first actuator 14.
• Biasing element may be coupled with one or more linear advancement mechanisms, such as the following list, for example and not limitation: a linear indexing geneva mechanism, a rack and pinion, a slider crank, a barrel cam and follower, a slotted bar quick return mechanism, a whitworth mechanism, a vibrating penetrator, an oscillating swash plate mechanism.
• the penetrating needle tip may be retracted through the use of an optional second actuator 16, an optional toggle 132, a secondary mode of the first actuator, or some combination thereof.
• a secondary mode of the first actuator may be enabled by pushing the first actuator forward, thereby mating an internal catch between the first actuator and the hollow needle as made by one with ordinary skill in the art, and then pulled back to retract the needle.
• Hollow shaft and its internal components are optionally removable from the handle and exchangeable with other attachments.
• system includes a first configuration for aspiration comprising a hollow tube with a port for suction and housing a solid removable elongate slider with cutting tip; and a second configuration for coring, comprising a hollow needle and a second elongated slider for column support.
• the hole in the cortical bone layer is created with first elongate slider, elongate slider is removed from hole and suction is applied to extract liquid blood and bone marrow, first elongate slider is removed from the handle out of the proximal side and replaced with a hollow needle and second elongate slider while keeping the hollow shaft in place, and then the needle tip is advanced beyond the bone surface to achieve sufficient depth for retrieving a core sample.
• the distal tip of the device is positioned against the bone surface 2 at the site of interest.
• the sharp tip 152 is located at or proximal to the bone surface 22 in the primary embodiment.
• the distal tip of the device is positioned against the bone surface 22 at the site of interest.
• the sharp tip is advanced a known distance, 1311, past the surface of the bone 22, and into the underlying bone 2, which contains blood and bone marrow.
• the needle tip may be advanced with a known force, and at a visibly measurable distance.
• said known force could be adjusted by the user if needed.
• known force may start relatively small, and if denser than normal bone is encountered, a user may adjust a dial on the handle housing, resulting in greater spring deformation, and more force output.
• the distal tip of the device is positioned against the bone surface 22 at the site of interest.
• the sharp tip is advanced twice a known distance 1311, past the surface of the bone 22, and into the underlying bone 2, which contains blood and bone marrow.
• Actuation of needle tip advancement may be repeated until desired depth is reached for core 21 extraction.
• Advancing the needle tip in an incremental fashion allows the user to precisely control the outcome, gathering feedback after each actuation.
• the needle tip may be advanced to a predetermined final depth upon first actuation, leveraging momentum and force delivered from the biasing element.
• a hollow needle 15 is positioned within a hollow shaft 12 and around an elongate slider 17.
• the elongate slider and the hollow shaft together support the hollow penetrating needle.
• the needle may comprise additional openings 153 for liquid blood and bone marrow flow.
• the hollow needle depicted is driven beneath the bone surface to desired depth for removing a core 21.
• Proximal end 172 of elongated slider may be configured with a cutting tip for penetrating cortical bone surface 22.
• needle and elongated slider are driven into bone together until the cortical layer is penetrated, and then separated such that the needle may be advanced further into bone 2 until sufficient depth is achieved. Suction may be applied proximally within the hollow shaft 15 using an internal plunger 173 or an external negative pressure element.
• the penetrating needle is configured as a multi-lumen tube such that one lumen captures a solid core, and another lumen captures liquid blood and bone marrow when negative pressure is applied.
• the elongated slider may be used to eject the core into a second site or outside the body by being pushed distally with respect to the hollow shaft.
• hollow needle 15 is configured with a sharp tip 152 and one or more internal protrusions 1521, configured to retain a solid bone core 21 upon retraction of the needle tip from the bone 2.
• Elongated slider 17 may be configured to move proximally as new core material enters the needle.
• proximal side of bone core 21 may push distal end of elongated slider 17 freely when the needle tip enters the bone, until a point at which user desires to remove core from needle by pushing the proximal side 171 of the elongated slider distally with respect to the needle 15.
• a hollow penetrating needle 15 may be driven into bone 2 containing bone marrow, blood, stem cells, or other desirable fluids. Negative pressure may be achieved by attaching a tube to luer fitting or other adapter 181 on the device handle 11 or on the hollow shaft 12, and actuating a pump, syringe or other negative pressure element.
• the adapter port is on the proximal portion 121 of the hollow shaft. Access points 153 for fluid to exit the bone and enter the hollow shaft may be located on the sides of the needle as shown in Fig 7, or embodied by a multi-lumen tube as depicted in Fig 8
• a hollow needle 15 comprising a multi-lumen 153 tube is inserted into bone 2.
• a negative pressure is then applied through an instrument 18 down a cannula 122 past the bone surface 22 and ultimately to the bone cavity.
• negative pressure 18 is applied to a first lumen to extract liquid blood and bone marrow, and a second lumen is utilized for core extraction.
• a pilot hole may be created using a removable metal penetrating attachment, and then a hard polymer multi-lumen tube may be inserted and advanced via biasing element for liquid blood, bone marrow, and bone extraction.
• the automated tissue coring device of the present invention may be utilized for bone marrow biopsies.
• a bone marrow biopsy is performed with the following steps: 31 Place the distal tip at the site of interest; second 32 charge the internal spring (biasing element) by squeezing the lever (first actuator). 33 Apply tip pressure to the bone surface and actuate 34 first impact or advancement by squeezing the trigger (second actuator). Trigger impact or advancement again if desired depth is not yet achieved. Depth may be indicated by markings on the needle or via a window in the handle which shows how far the needle has moved from its starting position. Repeat triggering impact or advancement until desired depth is achieved.
• the automated tissue coring device of the present invention may be utilized for bone marrow enhanced tissue repair.
• bone marrow stimulation is achieved by performing the following detailed steps: 31 Place the distal tip at the site of interest; second 32 charge the internal spring (biasing element) by squeezing the lever (first actuator). 33 Apply tip pressure to the bone surface and actuate 34 first impact or advancement by squeezing the trigger (second actuator). Trigger impact or advancement again if desired depth is not yet achieved. Depth may be indicated by markings on the needle or via a window in the handle which shows how far the needle has moved from its starting position. Repeat triggering impact or advancement until desired depth is achieved.

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• 2020
  • 2020-03-11 WO PCT/US2020/022184 patent/WO2020185961A1/en not_active Ceased
  • 2020-03-11 JP JP2021554996A patent/JP2022524622A/ja active Pending
  • 2020-03-11 CA CA3133240A patent/CA3133240A1/en active Pending
  • 2020-03-11 AU AU2020237491A patent/AU2020237491A1/en not_active Abandoned
  • 2020-03-11 EP EP20769835.8A patent/EP3937794A4/en not_active Withdrawn
  • 2020-03-11 US US16/815,908 patent/US20200289134A1/en active Pending

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