US20210196248A1 - Device and method for aspirating bone marrow - Google Patents
Device and method for aspirating bone marrow Download PDFInfo
- Publication number
- US20210196248A1 US20210196248A1 US17/201,648 US202117201648A US2021196248A1 US 20210196248 A1 US20210196248 A1 US 20210196248A1 US 202117201648 A US202117201648 A US 202117201648A US 2021196248 A1 US2021196248 A1 US 2021196248A1
- Authority
- US
- United States
- Prior art keywords
- syringe
- needle
- aspiration
- target area
- bone marrow
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- 210000001185 bone marrow Anatomy 0.000 title claims abstract description 72
- 238000000034 method Methods 0.000 title claims abstract description 54
- 239000012530 fluid Substances 0.000 claims abstract description 61
- 239000007924 injection Substances 0.000 claims description 50
- 238000002347 injection Methods 0.000 claims description 50
- 210000001519 tissue Anatomy 0.000 claims description 27
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 239000011780 sodium chloride Substances 0.000 claims description 4
- 230000003444 anaesthetic effect Effects 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 3
- 230000003115 biocidal effect Effects 0.000 claims description 2
- 239000008174 sterile solution Substances 0.000 claims description 2
- 210000000988 bone and bone Anatomy 0.000 abstract description 9
- 238000000605 extraction Methods 0.000 description 9
- 230000007246 mechanism Effects 0.000 description 7
- 230000037361 pathway Effects 0.000 description 6
- 208000019901 Anxiety disease Diseases 0.000 description 4
- 230000036506 anxiety Effects 0.000 description 4
- 239000000284 extract Substances 0.000 description 2
- 230000002452 interceptive effect Effects 0.000 description 2
- 239000003589 local anesthetic agent Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 206010018910 Haemolysis Diseases 0.000 description 1
- 206010033372 Pain and discomfort Diseases 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 238000001574 biopsy Methods 0.000 description 1
- 238000009583 bone marrow aspiration Methods 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000002660 stem cell treatment Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
-
- A61M1/007—
-
- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
-
- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/80—Suction pumps
- A61M1/81—Piston pumps, e.g. syringes
- A61M1/815—Piston pumps, e.g. syringes the barrel serving as aspiration container, e.g. in a breast pump
-
- 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
- A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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
-
- A61M1/008—
-
- 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/10—Bone-marrow
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
Definitions
- This disclosure relates to aspiration methods and devices and, in particular, to an improved device and method for aspirating bone marrow.
- Extraction of bone marrow has many medical uses, and employment of treatments that make use of bone marrow concentrate are increasingly being used in physician office settings under local anesthetic.
- extraction procedures produce some discomfort and anxiety in patients, which may lead to limited use even in cases when it would be advantageous to the patient.
- physicians For example, more recently it has become increasingly common for physicians to perform aspirations of bone marrow in office settings, where patients are awake and under only local anesthetic.
- a high amount of anxiety can accompany this procedure, which results from the patient anticipating pain.
- the expectation of pain can lead to patients opting not to elect care that could prevent the necessity for more severe interventions in the future, such as surgical repair of joints.
- a device for aspirating bone marrow includes a double syringe assembly including a distal syringe with a barrel having a chamber and a proximal syringe coupled to the distal syringe, the proximal syringe having a barrel with a chamber.
- a single plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe.
- a needle assembly is coupled to the double syringe assembly.
- the needle assembly includes a needle with an outer tube and an inner tube disposed within the outer tube, a housing surrounding a portion of the needle, and a connector extending from the housing.
- the connector is attached to the distal syringe.
- the distal syringe extracts bone marrow from a target area through the outer tube of the needle and into the chamber of the distal syringe and the proximal syringe injects fluid into the target area through the inner tube of the needle at the same time and the same rate in which the bone marrow is extracted, the plunger controlling the flow volume of each syringe chamber such that the fluid volume ejected by the chamber of the proximal syringe is equal to the bone marrow volume received by the chamber of the distal syringe.
- a double syringe assembly for aspirating bone marrow includes a distal syringe having a barrel with a chamber and a proximal syringe coupled to the distal syringe, the proximal syringe having a barrel with a chamber.
- a plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe.
- the distal syringe Upon actuation of the plunger in a direction toward the proximal syringe, the distal syringe receives bone marrow in the chamber of the distal syringe and the proximal syringe ejects fluid disposed within the chamber of the proximal syringe one of before or simultaneous to the bone marrow being received in the chamber of the distal syringe.
- the plunger controls the flow volume of each chamber such that the fluid volume ejected by the chamber of the proximal syringe is equal to the bone marrow volume received by the chamber of the distal syringe.
- a method of aspirating bone marrow comprises extracting bone marrow from a target area through one of a first needle or an outer tube of a needle of a needle assembly and into a chamber of a distal syringe.
- the method further comprise injecting fluid from a chamber of a proximal syringe through one of a second needle separate from the first needle or an inner tube of the needle of the needle assembly and into the target area one of before or simultaneous to extracting the bone marrow, preventing negative pressure during aspiration.
- a method of aspirating bone marrow comprises extracting tissue from an aspiration hole in a target area and injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue.
- FIG. 1 is a top perspective view of a device for aspirating bone marrow according to one aspect of the present disclosure
- FIG. 2 is a side perspective view of a double syringe assembly according to another aspect of the present disclosure
- FIG. 3A is perspective view of a portion of the device of FIG. 1 ;
- FIG. 3B is a cross-section view of a needle of the device of FIG. 3A , taken along the lines A-A of FIG. 3A ;
- FIG. 4 is another perspective view of another portion of the device of FIG. 1 ;
- FIG. 5A is another perspective view of the device for aspirating bone marrow according to one aspect of the present disclosure
- FIG. 5B is a perspective view of a portion of the device of FIG. 5A ;
- FIG. 5C is a perspective view of another portion of the device of FIG. 5A
- FIG. 6 is a perspective view of an aspiration needle coupled to an aspiration syringe according to another aspect of the present disclosure.
- FIG. 7 is a perspective view of an injection needle coupled to an injection syringe according to another aspect of the present disclosure.
- a device and methods for aspirating bone marrow are disclosed.
- the device and methods mitigate patient pain caused by negative pressure of conventional aspiration devices and methods.
- the device and methods of the present disclosure significantly reduce or eliminate negative pressure by replacing fluid in the bone marrow target area being aspirated before or during aspiration of the bone marrow.
- the device comprises a double syringe assembly including a distal syringe with a barrel having a chamber and a proximal syringe coupled to the distal syringe.
- the proximal syringe includes a barrel with a chamber, and a single plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe.
- the distal syringe is for aspirating bone marrow and the proximal syringe for inserting fluid.
- a needle assembly is coupled to the double syringe assembly and includes a needle with an outer tube and an inner tube disposed within and separate from the outer tube.
- the distal syringe Upon actuation of the plunger in a direction toward the proximal syringe, the distal syringe aspirates bone marrow from a target area, such as a bone, through the outer tube of the needle and into the chamber of the distal syringe.
- the proximal syringe injects fluid, such as one or more of saline or other salt balanced fluid, antibiotics or anesthetic, into the target area through the inner tube of the needle at the same rate in which the bone marrow is aspirated, eliminating negative pressure during aspiration.
- fluid such as one or more of saline or other salt balanced fluid, antibiotics or anesthetic
- the method includes injecting fluid into the target area before aspiration of the bone marrow. In yet another example, the method includes injecting fluid into an injection bore or hole in the target area that is different from an aspiration bore or hole in the target area. In another example, the method includes injecting fluid into the aspiration bore or hole in the target area, which is also used to aspirate the bone marrow from the target area.
- the device 10 comprises a double syringe assembly 12 and a needle assembly 14 coupled to the double syringe assembly 12 .
- the double syringe assembly 12 includes a distal syringe 16 with a barrel 18 having a chamber 20 .
- a proximal syringe 22 is coupled to the distal syringe 16 and also includes a barrel 24 having a chamber 26 .
- a single plunger 28 has a distal end 30 disposed within the barrel 18 of the distal syringe 16 and a proximal end 32 ( FIG. 2 ) disposed within the barrel 24 of the proximal syringe 22 , as depicted in FIG. 2 .
- the double syringe assembly 12 further includes a securing mechanism 34 for coupling the distal syringe 16 to the proximal syringe 22 , such that the distal syringe 16 is stationary relative to the proximal syringe 22 .
- each of the distal syringe 16 and the proximal syringe 22 include a base portion 36 , 38 , respectively, attached to each of the barrel 18 of the distal syringe 16 and the barrel 24 of the proximal syringe 22 , respectively.
- each base portion 36 , 38 includes at least one aperture 46 , 47 or a plurality of apertures 48 , 49 for receiving the securing mechanism 34 , as described more below.
- the securing mechanism 34 comprises a plurality of rods 50 .
- Each rod 52 includes a first end 54 disposed within the at least one aperture 46 or an aperture from the plurality of apertures 48 of the base portion 36 of the distal syringe 16 .
- Each rod 52 further includes a second end 56 disposed within the at least one aperture 47 or an aperture from the plurality of apertures 49 of the base portion 38 of the proximal syringe 22 .
- each of the first and second ends 54 , 56 of each rod 52 extends through the at least one aperture 46 , 47 of the base portions 36 , 38 of the distal and proximal syringes 16 , 22 , respectively.
- first and second ends 54 , 56 are adapted to receive or receive a fastener 58 to secure the first and second ends 54 , 56 of the rods 52 to the base portions 36 , 38 of the distal and proximal syringes 16 , 22 , respectively.
- the fastener 58 may include one or more of a bolt, a screw, or a threaded part capable of securing the rod 52 to the base portions 36 , 38 of the distal and proximal syringes 16 , 22 .
- the securing mechanism 34 may additionally and/or alternatively be used and still fall within the scope of the present disclosure.
- the securing mechanism 34 may include a plate, such as a cylindrical plate, disposed between the distal syringe 16 and the proximal syringe 22 .
- any other securing mechanism capable of securing the distal and proximal syringes 16 , 22 together may be used.
- two rods 52 are depicted in FIG.
- the two rods 52 are equidistantly disposed from each other on the bases of the distal and proximal syringes 16 , 22 .
- the distal syringe 16 may further include a nozzle 60 disposed on a distal end 61 of the distal syringe 16 .
- the nozzle 60 may be coupled to a portion of the needle assembly 14 ( FIG. 1 ), as explained more below relative to FIGS. 3 and 4 .
- the proximal syringe 22 may further include a nozzle 62 disposed on a proximal end 63 of the proximal syringe 22 .
- the nozzle 62 may also be coupled to the needle assembly 14 , as further explained below.
- the plunger 28 is depicted in an unactuated state, in which the distal end 30 of the plunger 28 is adjacent to the nozzle 60 of the distal syringe 16 , and the proximal end 32 of the plunger 28 is adjacent the base portion 38 of the proximal syringe 22 .
- the plunger 28 is moveable from and between the unactuated state and an extended state.
- the extended state which is partially depicted in FIG. 1
- the proximal end 32 of the plunger 28 is adjacent to the nozzle 62 of the proximal syringe 22 and the distal end 30 of the plunger 28 is adjacent to the base portion 36 of the distal syringe 16 (not shown).
- the needle assembly 14 includes a needle 66 .
- the needle 66 includes an outer tube 68 and an inner tube 70 disposed within and concentric to the outer tube 68 , as depicted in FIG. 3B .
- the needle assembly 14 further includes a housing or housing portion 72 surrounding a portion of the needle 66 and having a body 74 and a connector 76 extending from the body 74 , for example.
- the connector 76 may be a Y-shaped connector, as depicted in FIG.
- the connector 76 is one or more of attached to or coupled to the nozzle 60 of the distal syringe 16 .
- the connector 76 couples the outer tube 68 of the needle 66 to the nozzle 60 of the distal syringe 16 to form a flow pathway between the outer tube 68 of the needle 66 and the chamber 20 of the distal syringe 16 .
- the nozzle 62 of the proximal syringe 22 may be coupled to another connector or tube, as explained more below relative to FIG. 5A .
- This connector may be attached to the inner tube 70 of the needle 66 to form a second flow pathway, such as a fluid flow pathway.
- the second flow pathway extends between the inner tube 70 of the needle 66 and the chamber 26 of the proximal syringe 22 .
- the inner tube 70 of the needle 66 is separate and sealed from the outer tube 68 of the needle 66 .
- any tissue, such as bone marrow, being extracted through the outer tube 68 is prevented from mixing or interfering with any fluid being injected or inserted from the proximal syringe 22 into the inner tube 70 , for example, as one of ordinary skill in the art understands.
- the distal syringe 16 aspirates, such as extracts, bone marrow from a target area TA ( FIG. 4 ) through the outer tube 68 of the needle 66 and into the chamber 20 of the distal syringe 16 .
- the proximal syringe 22 injects fluid into the target area TA through the inner tube 70 of the needle 66 at the same rate in which the bone marrow is aspirated.
- the plunger 28 controls the flow volume of each chamber 20 , 26 of the distal syringe 16 and the proximal syringe 22 , respectively.
- the fluid volume ejected from the chamber 26 of the proximal syringe 22 is equal to the bone marrow volume received in the chamber 20 of the distal syringe 16 .
- the target area TA through which bone marrow is extracted is depicted.
- the target area TA is coupled to the needle assembly 14 , for example, during aspiration.
- a cannula 78 of the needle assembly 14 is coupled to the needle 66 and inserted into an aspiration bore 80 of the target area TA to begin aspiration or extraction, for example.
- a needle separate from the needle 66 may alternatively be used to inject the fluid into the target area TA before or simultaneous to the extraction of the bone marrow from the target area TA.
- the target area TA is a lumen of a bone, such as a bone disposed in a posterior superior iliac spine area, which is a common point of entry for a marrow space in the lumen of the bone.
- the target area TA may alternatively include any other area of a subject, such as the human body, in which bone marrow is desired to be extracted, for example.
- the fluid disposed within the chamber 26 of the proximal syringe 22 may be one or more of saline, a salt-balanced sterile solution, an antibiotic or an anesthetic.
- a positive pressure for example, into the target area to one or more of reduce, neutralize, or zero-out the negative pressure produced during extracting of the bone marrow, may alternatively be used and still fall within the scope of the present disclosure.
- FIG. 5A another perspective view of the device 10 for aspirating bone marrow is depicted.
- the nozzle 60 of the distal syringe 16 is coupled to the needle assembly 14 and the nozzle 62 of the proximal syringe 22 is coupled to an injection tube 84 that receives fluid ejected from the proximal syringe 22 during operation of the device 10 .
- the fluid flows through the injection tube 84 and into the needle assembly 14 , as depicted.
- the injection tube 84 includes first end 85 that is coupled to the nozzle 62 of the proximal syringe 22 and a second end 86 that is coupled to the connector 76 of the needle assembly 14 .
- a second flow pathway 87 such as a fluid flow pathway, is formed between the nozzle 62 of the proximal syringe 22 and the needle assembly 14 coupled to the distal syringe 16 .
- the injection tube 84 is coupled to the inner tube 70 of the needle 66 of the needle assembly 14 , allowing injection of the fluid from the injection tube 84 and into the needle 66 during operation.
- the inner tube 70 of the needle 66 is separate and sealed from the outer tube 68 of the needle 66 .
- any tissue being extracted through the outer tube 68 of the needle 66 is prevented from mixing or interfering with any fluid being injected or inserted from the proximal syringe 22 , through the injection tube 84 , and into the inner tube 70 of the needle, for example.
- the second end 86 of the injection tube 84 is coupled to a portion of the connector 76 .
- the connector 76 includes a first leg 89 having a longitudinal axis parallel to a longitudinal axis of the housing 72 of the needle assembly 14 .
- the connector 76 further includes a second leg 90 that extends from the first leg 89 at an angle from the longitudinal axis of the first leg 89 , such that the second leg 90 of the connector 76 is not parallel to the longitudinal axis of the first leg 89 and the housing 72 .
- the second end 86 of the injection tube 84 is coupled to the second leg 90 of the connector 76 , allowing the injection tube 84 to be coupled to the inner tube 70 of the needle 66 .
- FIG. 5C another portion of the device 10 of FIG. 5A is depicted. More specifically, a close-up view of the nozzle 62 of the proximal syringe 22 is depicted.
- the first end 85 of the injection tube 84 further includes a connecting portion 91 that fits around the nozzle 62 to couple the injection tube 84 to the proximal syringe 22 .
- fluid disposed within the proximal syringe 22 may be ejected through the nozzle 62 and into the injection tube 84 for insertion into the inner tube 70 of the needle 66 .
- an aspiration needle 67 may be directly coupled to the nozzle 60 of the distal syringe 16 and an injection needle 88 ( FIG. 7 ) may be directly coupled to the nozzle 62 of the proximal syringe 22 .
- each of the aspiration needle 67 and the injection needle 88 may alternatively be directly coupled to a body portion of a needle assembly, which is directly coupled to the nozzles 60 , 62 or another portion of the distal and proximal syringes 16 , 22 , respectively.
- the aspiration needle 67 may be coupled to an aspiration syringe 90 , as depicted in FIG. 6 .
- the aspiration syringe 90 includes essentially all of the same components as the distal syringe 16 , except the aspiration syringe 90 is not coupled to any other syringe.
- FIG. 6 The aspiration syringe 90 includes essentially all of the same components as the distal syringe 16 , except the aspiration syringe 90 is not coupled to any other syringe.
- the injection needle 88 may be coupled to an injection syringe 92 , which is completely separate from, e.g., not assembled to, the aspiration syringe 90 .
- the injection syringe 92 includes essentially all of the same components as the proximal syringe 22 , except the injection syringe 92 is not coupled to any other syringe.
- the fluid from one of the proximal syringe 22 or the injection syringe 92 may be first injected into the target area TA (see, e.g., FIG. 4 ) using the injection needle 88 .
- the proximal syringe 22 may be a stand-alone device that is not coupled to the distal syringe 16 .
- tissue may then be extracted or aspirated from the same part of the target area TA using the needle 67 coupled to one of the distal syringe 16 , which may be a stand-alone device separate from the proximal syringe 22 in this example, or the aspiration syringe 90 of FIG. 6 .
- fluid may be first inserted into the target area TA using the injection needle 88 before any tissue is extracted using the aspiration needle 67 , as explained more below.
- injection and aspiration syringes 92 , 90 may alternatively be referred as first and second syringes and still fall within the scope of the present disclosure.
- fluid may be added and then tissue extracted in sequence, such as incrementally, for one or more additional times.
- tissue may be extracted in sequence, such as incrementally, for one or more additional times.
- 5 ml of saline fluid may be added and then 5 ml bone marrow may be extracted.
- various other amount of fluid and tissue may be injected and extracted, respectively, and still fall within the scope of the present disclosure.
- the fluid added or injected may be more or less than the tissue extracted.
- creating positive pressure with the injection syringe 92 before extracting may be more advantageous than maintaining a pressure equilibrium, depending upon the tissue or bone being extracted, for example.
- the fluid may be injected and tissue then extracted in sequence for any one of two through twenty additional times.
- the sequence may occur for more than twenty times, for example, and still fall within the scope of the present disclosure.
- one method includes the device 10 extracting bone marrow from one of a first needle or the outer tube 68 of the needle 66 of the needle assembly 14 and into the chamber 20 of the distal syringe 16 .
- the method further includes ejecting fluid from within the chamber 26 of the proximal syringe 22 through one of a second needle or the inner tube 70 of the needle 66 of the needle assembly 14 one of before or simultaneous to extracting the bone marrow, preventing negative pressure during aspiration.
- extracting the bone marrow is extracting the bone marrow through the outer tube 68 of the needle 66 of the needle assembly 14
- ejecting fluid is ejecting fluid disposed within the chamber 26 of the proximal syringe 22 through the inner tube 70 of the needle 66 of the needle assembly 14
- the method may further include controlling via the plunger 28 , for example, a flow volume in each chamber 20 , 26 of the distal syringe 16 and the proximal syringe 22 , respectively.
- a volume of fluid ejected from the chamber 26 of the proximal syringe 22 is equal to a volume of bone marrow being extracted into the chamber 20 of the distal syringe 16 .
- the method may include actuating the plunger 28 toward the proximal syringe 22 to initiate aspiration.
- the method may alternatively include ejecting fluid disposed within the chamber 26 of the proximal syringe 22 or the injection syringe 92 through a second needle different from a first needle.
- the fluid may be injected from the injection syringe 92 through the injection needle 88 ( FIG. 7 ) different from the aspiration needle 67 ( FIG. 6 ), which is used to extract the bone marrow from the target area TA.
- the method further comprises extracting the bone marrow through the extraction hole 80 , such as a bore or other aperture, in the target area TA and injecting the fluid from the proximal syringe 22 or the injection syringe 92 into the same extraction hole 80 .
- the method alternatively comprises extracting the bone marrow through the extraction hole 80 in the target area TA and injecting the fluid from one of the proximal syringe 22 or the injection syringe 92 into the injection hole 82 of the target area TA one or more of simultaneous to or before extracting the bone marrow.
- the device 10 and other devices and needles may implement the following method of aspirating bone marrow.
- the method includes extracting bone marrow from the aspiration hole 80 in the target area TA and injecting fluid through one or more of the aspiration hole 80 or the injection hole 82 in the target area TA one or more of simultaneous to or before extracting the bone marrow.
- extracting the bone marrow from the aspiration hole 80 includes extracting the bone marrow through one of an aspiration needle 67 coupled to the aspiration syringe 90 ( FIG. 6 ) or the outer tube 68 of the needle 66 of the needle assembly 14 .
- injecting fluid through one or more of the aspiration hole 80 or the separate injection hole 82 comprises injecting fluid through one of the injection needle 88 ( FIG. 7 ) separate from the aspiration needle 67 or the inner tube 70 of the needle 66 of the needle assembly 14 .
- extracting bone marrow from the aspiration hole 80 in the target area TA comprises extracting the bone marrow into one of the chamber 20 of the distal syringe 16 or the aspiration syringe 90 .
- injecting fluid through one or more of the aspiration hole 80 or the separation injection hole 82 in the target area TA one or more of simultaneous to or before extracting the bone marrow comprises injecting fluid disposed within one of the chamber 26 of the proximal syringe 22 coupled to the distal syringe 16 or the injection syringe 92 , a stand-alone device not coupled to any other syringe.
- the device 10 and methods may be used to eliminate negative pressure during extraction of tissue, such as during a biopsy procedure, in any other part of the subject, such as a human body, including but not limited to bone in any other part of the subject outside of the spine, a breast area, or any other area of the subject.
- the device 10 and methods mitigate patient pain caused by negative pressure in conventional bone marrow aspiration devices and methods by replacing fluid in the bone marrow space before or during aspiration of bone marrow.
- the rate of bone marrow withdrawal may be increased and the risk of damaging the bone marrow sample may be reduced.
- each of the foregoing methods ensures that negative pressure is not experienced by the patient during aspiration at least because the volume of fluid within the marrow space in each method is controlled. Said another way, the fluid volume is never less than it was at the beginning of the procedure during aspiration, ensuring negative pressure does not occur during aspiration.
- the new device 10 and methods mitigate and/or completely eliminate patient pain, but also patient anxiety is reduced.
- patient anxiety is reduced.
- Coupled along with its derivatives.
- some implementations may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact.
- the term “coupled,” however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. The implementations are not limited in this context.
- the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion.
- a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
- “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Pathology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Immunology (AREA)
- Pulmonology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
A device and method for aspirating bone barrow. The device includes a double syringe assembly having a distal syringe and a proximal syringe coupled to the distal syringe. A plunger includes a distal end disposed within a barrel of the distal syringe and a proximal end disposed within a barrel of the proximal syringe. A needle assembly is coupled to the double syringe assembly and includes a needle having an outer tube and an inner tube disposed within the outer tube. Upon actuation of the plunger, the distal syringe aspirates bone marrow through the outer tube of the needle and into a chamber of the distal syringe. At the same time, the proximal syringe injects fluid through the inner tube of the needle at the same rate in which the bone marrow is aspirated.
Description
- This application claims priority to U.S. Provisional Patent Application No. 62/514,579 filed Jun. 2, 2017, entitled “Device and Method for Aspirating Bone Marrow” the entire disclosure of which is hereby incorporated by reference.
- This disclosure relates to aspiration methods and devices and, in particular, to an improved device and method for aspirating bone marrow.
- Extraction of bone marrow has many medical uses, and employment of treatments that make use of bone marrow concentrate are increasingly being used in physician office settings under local anesthetic. Typically, such extraction procedures produce some discomfort and anxiety in patients, which may lead to limited use even in cases when it would be advantageous to the patient. For example, more recently it has become increasingly common for physicians to perform aspirations of bone marrow in office settings, where patients are awake and under only local anesthetic. A high amount of anxiety can accompany this procedure, which results from the patient anticipating pain. The expectation of pain can lead to patients opting not to elect care that could prevent the necessity for more severe interventions in the future, such as surgical repair of joints.
- More specifically, the majority of pain and discomfort is experienced while the marrow is being aspirated. When aspiration occurs, negative pressure is created in a lumen of the bone. The negative pressure acts against the force of the aspiration device. As a result, many patients experience peak discomfort during this period. For example, patients often report a sensation of cramping, which in the case of aspiration from the posterior superior iliac spine (a very common point of entry to the marrow space) can happen anywhere and everywhere from the gluteus muscle, down the leg, and into the feet.
- In addition to causing patient discomfort, negative pressure during aspiration slows the rate at which the physician can withdraw the bone marrow. Furthermore, application of excessive aspiration force when aspirating can cause damage, such as hemolysis, to the bone marrow sample via sheer stress or other forces.
- A device for aspirating bone marrow includes a double syringe assembly including a distal syringe with a barrel having a chamber and a proximal syringe coupled to the distal syringe, the proximal syringe having a barrel with a chamber. A single plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe. A needle assembly is coupled to the double syringe assembly. The needle assembly includes a needle with an outer tube and an inner tube disposed within the outer tube, a housing surrounding a portion of the needle, and a connector extending from the housing. The connector is attached to the distal syringe. Upon actuation of the plunger in a direction toward the proximal syringe, the distal syringe extracts bone marrow from a target area through the outer tube of the needle and into the chamber of the distal syringe and the proximal syringe injects fluid into the target area through the inner tube of the needle at the same time and the same rate in which the bone marrow is extracted, the plunger controlling the flow volume of each syringe chamber such that the fluid volume ejected by the chamber of the proximal syringe is equal to the bone marrow volume received by the chamber of the distal syringe.
- In yet another example, a double syringe assembly for aspirating bone marrow includes a distal syringe having a barrel with a chamber and a proximal syringe coupled to the distal syringe, the proximal syringe having a barrel with a chamber. A plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe. Upon actuation of the plunger in a direction toward the proximal syringe, the distal syringe receives bone marrow in the chamber of the distal syringe and the proximal syringe ejects fluid disposed within the chamber of the proximal syringe one of before or simultaneous to the bone marrow being received in the chamber of the distal syringe. The plunger controls the flow volume of each chamber such that the fluid volume ejected by the chamber of the proximal syringe is equal to the bone marrow volume received by the chamber of the distal syringe.
- In another example, a method of aspirating bone marrow comprises extracting bone marrow from a target area through one of a first needle or an outer tube of a needle of a needle assembly and into a chamber of a distal syringe. The method further comprise injecting fluid from a chamber of a proximal syringe through one of a second needle separate from the first needle or an inner tube of the needle of the needle assembly and into the target area one of before or simultaneous to extracting the bone marrow, preventing negative pressure during aspiration.
- In yet another example, a method of aspirating bone marrow comprises extracting tissue from an aspiration hole in a target area and injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue.
- Additional optional aspects and features are disclosed, which may be arranged in any functionally appropriate manner, either alone or in any functionally viable combination, consistent with the teachings of the disclosure. Other aspects and advantages will become apparent upon consideration of the following detail description.
- It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the example embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily to scale.
-
FIG. 1 is a top perspective view of a device for aspirating bone marrow according to one aspect of the present disclosure; -
FIG. 2 is a side perspective view of a double syringe assembly according to another aspect of the present disclosure; -
FIG. 3A is perspective view of a portion of the device ofFIG. 1 ; -
FIG. 3B is a cross-section view of a needle of the device ofFIG. 3A , taken along the lines A-A ofFIG. 3A ; -
FIG. 4 is another perspective view of another portion of the device ofFIG. 1 ; -
FIG. 5A is another perspective view of the device for aspirating bone marrow according to one aspect of the present disclosure; -
FIG. 5B is a perspective view of a portion of the device ofFIG. 5A ; -
FIG. 5C is a perspective view of another portion of the device ofFIG. 5A -
FIG. 6 is a perspective view of an aspiration needle coupled to an aspiration syringe according to another aspect of the present disclosure; and -
FIG. 7 is a perspective view of an injection needle coupled to an injection syringe according to another aspect of the present disclosure. - Generally, a device and methods for aspirating bone marrow are disclosed. The device and methods mitigate patient pain caused by negative pressure of conventional aspiration devices and methods. For example, the device and methods of the present disclosure significantly reduce or eliminate negative pressure by replacing fluid in the bone marrow target area being aspirated before or during aspiration of the bone marrow. More specifically, and in one example, the device comprises a double syringe assembly including a distal syringe with a barrel having a chamber and a proximal syringe coupled to the distal syringe. The proximal syringe includes a barrel with a chamber, and a single plunger has a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe. The distal syringe is for aspirating bone marrow and the proximal syringe for inserting fluid. A needle assembly is coupled to the double syringe assembly and includes a needle with an outer tube and an inner tube disposed within and separate from the outer tube. Upon actuation of the plunger in a direction toward the proximal syringe, the distal syringe aspirates bone marrow from a target area, such as a bone, through the outer tube of the needle and into the chamber of the distal syringe. Simultaneously, the proximal syringe injects fluid, such as one or more of saline or other salt balanced fluid, antibiotics or anesthetic, into the target area through the inner tube of the needle at the same rate in which the bone marrow is aspirated, eliminating negative pressure during aspiration. As a result, the ease of bone marrow withdrawal is improved, the rate of withdrawal may be increased, and the risk of damaging the bone marrow sample may be reduced. Further, patient pain caused by negative pressure is significantly mitigated, if not eliminated, reducing patient anxiety.
- In other examples, which are explained more below, the method includes injecting fluid into the target area before aspiration of the bone marrow. In yet another example, the method includes injecting fluid into an injection bore or hole in the target area that is different from an aspiration bore or hole in the target area. In another example, the method includes injecting fluid into the aspiration bore or hole in the target area, which is also used to aspirate the bone marrow from the target area.
- Referring now to
FIG. 1 , adevice 10 for aspirating bone marrow according to one aspect of the present disclosure is depicted. Thedevice 10 comprises adouble syringe assembly 12 and aneedle assembly 14 coupled to thedouble syringe assembly 12. Thedouble syringe assembly 12 includes adistal syringe 16 with abarrel 18 having achamber 20. Aproximal syringe 22 is coupled to thedistal syringe 16 and also includes abarrel 24 having achamber 26. Asingle plunger 28 has adistal end 30 disposed within thebarrel 18 of thedistal syringe 16 and a proximal end 32 (FIG. 2 ) disposed within thebarrel 24 of theproximal syringe 22, as depicted inFIG. 2 . - Referring now to
FIG. 2 , another view of thedouble syringe assembly 12 is depicted. In one example, thedouble syringe assembly 12 further includes a securing mechanism 34 for coupling thedistal syringe 16 to theproximal syringe 22, such that thedistal syringe 16 is stationary relative to theproximal syringe 22. In a further example, each of thedistal syringe 16 and theproximal syringe 22 include abase portion barrel 18 of thedistal syringe 16 and thebarrel 24 of theproximal syringe 22, respectively. For example, thebase portion 36 is attached to aproximal end 40 of thedistal syringe 16, and thebase portion 38 is attached to adistal end 44 of theproximal syringe 22. In addition, eachbase portion aperture apertures - In one example, the securing mechanism 34 comprises a plurality of
rods 50. Eachrod 52 includes afirst end 54 disposed within the at least oneaperture 46 or an aperture from the plurality ofapertures 48 of thebase portion 36 of thedistal syringe 16. Eachrod 52 further includes asecond end 56 disposed within the at least oneaperture 47 or an aperture from the plurality ofapertures 49 of thebase portion 38 of theproximal syringe 22. In addition, each of the first and second ends 54, 56 of eachrod 52 extends through the at least oneaperture base portions proximal syringes fastener 58 to secure the first and second ends 54, 56 of therods 52 to thebase portions proximal syringes fastener 58 may include one or more of a bolt, a screw, or a threaded part capable of securing therod 52 to thebase portions proximal syringes - While the aforementioned describes the securing mechanism 34 as the plurality of
rods 50 or the at least onerod 52, one of ordinary skill in the art will appreciate that various other securing mechanisms 34 may additionally and/or alternatively be used and still fall within the scope of the present disclosure. For example, and optionally, the securing mechanism 34 may include a plate, such as a cylindrical plate, disposed between thedistal syringe 16 and theproximal syringe 22. Alternatively, any other securing mechanism capable of securing the distal andproximal syringes rods 52 are depicted inFIG. 2 , for example, one of ordinary skill in the art will further appreciate that three, four, five, six, or any additional number of rods capable of being disposed within thebase portions FIG. 2 , the tworods 52 are equidistantly disposed from each other on the bases of the distal andproximal syringes - Still referring to
FIG. 2 , thedistal syringe 16 may further include anozzle 60 disposed on adistal end 61 of thedistal syringe 16. Thenozzle 60 may be coupled to a portion of the needle assembly 14 (FIG. 1 ), as explained more below relative toFIGS. 3 and 4 . In a similar manner, theproximal syringe 22 may further include anozzle 62 disposed on aproximal end 63 of theproximal syringe 22. Thenozzle 62 may also be coupled to theneedle assembly 14, as further explained below. - In
FIG. 2 , theplunger 28 is depicted in an unactuated state, in which thedistal end 30 of theplunger 28 is adjacent to thenozzle 60 of thedistal syringe 16, and theproximal end 32 of theplunger 28 is adjacent thebase portion 38 of theproximal syringe 22. Theplunger 28 is moveable from and between the unactuated state and an extended state. In the extended state, which is partially depicted inFIG. 1 , theproximal end 32 of theplunger 28 is adjacent to thenozzle 62 of theproximal syringe 22 and thedistal end 30 of theplunger 28 is adjacent to thebase portion 36 of the distal syringe 16 (not shown). - Referring now to
FIGS. 3A, 3B and 4 , portions of theneedle assembly 14 ofFIG. 1 are further depicted. As depicted inFIGS. 3A and 3B , theneedle assembly 14 includes aneedle 66. Theneedle 66 includes anouter tube 68 and aninner tube 70 disposed within and concentric to theouter tube 68, as depicted inFIG. 3B . Theneedle assembly 14 further includes a housing orhousing portion 72 surrounding a portion of theneedle 66 and having abody 74 and aconnector 76 extending from thebody 74, for example. Theconnector 76 may be a Y-shaped connector, as depicted inFIG. 3A , or any other type of connector known by persons having ordinary skill in the art and still fall within the scope of the present disclosure. In this example, theconnector 76 is one or more of attached to or coupled to thenozzle 60 of thedistal syringe 16. Theconnector 76 couples theouter tube 68 of theneedle 66 to thenozzle 60 of thedistal syringe 16 to form a flow pathway between theouter tube 68 of theneedle 66 and thechamber 20 of thedistal syringe 16. - In a similar manner, the
nozzle 62 of theproximal syringe 22 may be coupled to another connector or tube, as explained more below relative toFIG. 5A . This connector may be attached to theinner tube 70 of theneedle 66 to form a second flow pathway, such as a fluid flow pathway. The second flow pathway extends between theinner tube 70 of theneedle 66 and thechamber 26 of theproximal syringe 22. As one of ordinary skill in the art will appreciate, theinner tube 70 of theneedle 66 is separate and sealed from theouter tube 68 of theneedle 66. So constructed, any tissue, such as bone marrow, being extracted through theouter tube 68 is prevented from mixing or interfering with any fluid being injected or inserted from theproximal syringe 22 into theinner tube 70, for example, as one of ordinary skill in the art understands. - So configured, upon actuation of the
plunger 28 in a direction toward theproximal syringe 22, thedistal syringe 16 aspirates, such as extracts, bone marrow from a target area TA (FIG. 4 ) through theouter tube 68 of theneedle 66 and into thechamber 20 of thedistal syringe 16. Simultaneously, theproximal syringe 22 injects fluid into the target area TA through theinner tube 70 of theneedle 66 at the same rate in which the bone marrow is aspirated. In this way, theplunger 28 controls the flow volume of eachchamber distal syringe 16 and theproximal syringe 22, respectively. As a result, the fluid volume ejected from thechamber 26 of theproximal syringe 22 is equal to the bone marrow volume received in thechamber 20 of thedistal syringe 16. - Referring now to
FIG. 4 , the target area TA through which bone marrow is extracted is depicted. The target area TA is coupled to theneedle assembly 14, for example, during aspiration. Said another way, acannula 78 of theneedle assembly 14 is coupled to theneedle 66 and inserted into an aspiration bore 80 of the target area TA to begin aspiration or extraction, for example. In other example methods, as explained more below, a needle separate from theneedle 66 may alternatively be used to inject the fluid into the target area TA before or simultaneous to the extraction of the bone marrow from the target area TA. In this example, a needle separate from theneedle 66 may be inserted into theaspiration hole 80 before theneedle 66 is inserted for extraction or inserted into aninjection hole 82, separate from theaspiration hole 80, as depicted inFIG. 4 . In one example, the target area TA is a lumen of a bone, such as a bone disposed in a posterior superior iliac spine area, which is a common point of entry for a marrow space in the lumen of the bone. As one of ordinary skill in the art will appreciate, the target area TA may alternatively include any other area of a subject, such as the human body, in which bone marrow is desired to be extracted, for example. - The fluid disposed within the
chamber 26 of theproximal syringe 22 may be one or more of saline, a salt-balanced sterile solution, an antibiotic or an anesthetic. One of ordinary skill in the art will appreciate that any other fluid providing a positive pressure, for example, into the target area to one or more of reduce, neutralize, or zero-out the negative pressure produced during extracting of the bone marrow, may alternatively be used and still fall within the scope of the present disclosure. - Referring now to
FIG. 5A , another perspective view of thedevice 10 for aspirating bone marrow is depicted. In this view, thenozzle 60 of thedistal syringe 16 is coupled to theneedle assembly 14 and thenozzle 62 of theproximal syringe 22 is coupled to aninjection tube 84 that receives fluid ejected from theproximal syringe 22 during operation of thedevice 10. The fluid flows through theinjection tube 84 and into theneedle assembly 14, as depicted. More specifically, theinjection tube 84 includesfirst end 85 that is coupled to thenozzle 62 of theproximal syringe 22 and asecond end 86 that is coupled to theconnector 76 of theneedle assembly 14. - So configured, a
second flow pathway 87, such as a fluid flow pathway, is formed between thenozzle 62 of theproximal syringe 22 and theneedle assembly 14 coupled to thedistal syringe 16. In this way, theinjection tube 84 is coupled to theinner tube 70 of theneedle 66 of theneedle assembly 14, allowing injection of the fluid from theinjection tube 84 and into theneedle 66 during operation. As noted, theinner tube 70 of theneedle 66 is separate and sealed from theouter tube 68 of theneedle 66. So constructed, any tissue being extracted through theouter tube 68 of theneedle 66 is prevented from mixing or interfering with any fluid being injected or inserted from theproximal syringe 22, through theinjection tube 84, and into theinner tube 70 of the needle, for example. - As further depicted in
FIG. 5B , thesecond end 86 of theinjection tube 84 is coupled to a portion of theconnector 76. More specifically, theconnector 76 includes afirst leg 89 having a longitudinal axis parallel to a longitudinal axis of thehousing 72 of theneedle assembly 14. Theconnector 76 further includes asecond leg 90 that extends from thefirst leg 89 at an angle from the longitudinal axis of thefirst leg 89, such that thesecond leg 90 of theconnector 76 is not parallel to the longitudinal axis of thefirst leg 89 and thehousing 72. Thesecond end 86 of theinjection tube 84 is coupled to thesecond leg 90 of theconnector 76, allowing theinjection tube 84 to be coupled to theinner tube 70 of theneedle 66. - Referring now to
FIG. 5C , another portion of thedevice 10 ofFIG. 5A is depicted. More specifically, a close-up view of thenozzle 62 of theproximal syringe 22 is depicted. In one example, thefirst end 85 of theinjection tube 84 further includes a connectingportion 91 that fits around thenozzle 62 to couple theinjection tube 84 to theproximal syringe 22. In this way, fluid disposed within theproximal syringe 22 may be ejected through thenozzle 62 and into theinjection tube 84 for insertion into theinner tube 70 of theneedle 66. - In yet another example, and referring now to
FIGS. 6 and 7 , there alternatively may be two separate syringes, such as thedistal syringe 16 and theproximal syringe 22, that are not assembled together. In this example, an aspiration needle 67 (FIG. 6 ) may be directly coupled to thenozzle 60 of thedistal syringe 16 and an injection needle 88 (FIG. 7 ) may be directly coupled to thenozzle 62 of theproximal syringe 22. In another example, each of theaspiration needle 67 and theinjection needle 88 may alternatively be directly coupled to a body portion of a needle assembly, which is directly coupled to thenozzles proximal syringes aspiration needle 67 may be coupled to anaspiration syringe 90, as depicted inFIG. 6 . Theaspiration syringe 90 includes essentially all of the same components as thedistal syringe 16, except theaspiration syringe 90 is not coupled to any other syringe. In addition, and as depicted inFIG. 7 , theinjection needle 88 may be coupled to aninjection syringe 92, which is completely separate from, e.g., not assembled to, theaspiration syringe 90. In a similar manner, theinjection syringe 92 includes essentially all of the same components as theproximal syringe 22, except theinjection syringe 92 is not coupled to any other syringe. - So configured, the fluid from one of the
proximal syringe 22 or the injection syringe 92 (FIG. 7 ) may be first injected into the target area TA (see, e.g.,FIG. 4 ) using theinjection needle 88. In this example, theproximal syringe 22 may be a stand-alone device that is not coupled to thedistal syringe 16. After injection of the fluid in the target area TA is complete, tissue may then be extracted or aspirated from the same part of the target area TA using theneedle 67 coupled to one of thedistal syringe 16, which may be a stand-alone device separate from theproximal syringe 22 in this example, or theaspiration syringe 90 ofFIG. 6 . Said another way, fluid may be first inserted into the target area TA using theinjection needle 88 before any tissue is extracted using theaspiration needle 67, as explained more below. Still further, one of ordinary skill in the art will understand that the injection andaspiration syringes injection syringe 92 before extracting may be more advantageous than maintaining a pressure equilibrium, depending upon the tissue or bone being extracted, for example. In another example, the fluid may be injected and tissue then extracted in sequence for any one of two through twenty additional times. Of course, one of ordinary skill in the art will appreciate that the sequence may occur for more than twenty times, for example, and still fall within the scope of the present disclosure. - The
device 10 described in the foregoing examples may be operated according to one of more of the following methods. For example, one method includes thedevice 10 extracting bone marrow from one of a first needle or theouter tube 68 of theneedle 66 of theneedle assembly 14 and into thechamber 20 of thedistal syringe 16. In addition, the method further includes ejecting fluid from within thechamber 26 of theproximal syringe 22 through one of a second needle or theinner tube 70 of theneedle 66 of theneedle assembly 14 one of before or simultaneous to extracting the bone marrow, preventing negative pressure during aspiration. - In one example, extracting the bone marrow is extracting the bone marrow through the
outer tube 68 of theneedle 66 of theneedle assembly 14, and ejecting fluid is ejecting fluid disposed within thechamber 26 of theproximal syringe 22 through theinner tube 70 of theneedle 66 of theneedle assembly 14. The method may further include controlling via theplunger 28, for example, a flow volume in eachchamber distal syringe 16 and theproximal syringe 22, respectively. In this way, a volume of fluid ejected from thechamber 26 of theproximal syringe 22 is equal to a volume of bone marrow being extracted into thechamber 20 of thedistal syringe 16. Further, the method may include actuating theplunger 28 toward theproximal syringe 22 to initiate aspiration. - In another example, the method may alternatively include ejecting fluid disposed within the
chamber 26 of theproximal syringe 22 or theinjection syringe 92 through a second needle different from a first needle. For example, the fluid may be injected from theinjection syringe 92 through the injection needle 88 (FIG. 7 ) different from the aspiration needle 67 (FIG. 6 ), which is used to extract the bone marrow from the target area TA. In yet other examples, the method further comprises extracting the bone marrow through theextraction hole 80, such as a bore or other aperture, in the target area TA and injecting the fluid from theproximal syringe 22 or theinjection syringe 92 into thesame extraction hole 80. In yet another example, the method alternatively comprises extracting the bone marrow through theextraction hole 80 in the target area TA and injecting the fluid from one of theproximal syringe 22 or theinjection syringe 92 into theinjection hole 82 of the target area TA one or more of simultaneous to or before extracting the bone marrow. - In still another example, the
device 10 and other devices and needles, for example, may implement the following method of aspirating bone marrow. The method includes extracting bone marrow from theaspiration hole 80 in the target area TA and injecting fluid through one or more of theaspiration hole 80 or theinjection hole 82 in the target area TA one or more of simultaneous to or before extracting the bone marrow. In one example, extracting the bone marrow from theaspiration hole 80 includes extracting the bone marrow through one of anaspiration needle 67 coupled to the aspiration syringe 90 (FIG. 6 ) or theouter tube 68 of theneedle 66 of theneedle assembly 14. In addition, injecting fluid through one or more of theaspiration hole 80 or theseparate injection hole 82 comprises injecting fluid through one of the injection needle 88 (FIG. 7 ) separate from theaspiration needle 67 or theinner tube 70 of theneedle 66 of theneedle assembly 14. In another example, extracting bone marrow from theaspiration hole 80 in the target area TA comprises extracting the bone marrow into one of thechamber 20 of thedistal syringe 16 or theaspiration syringe 90. In addition, injecting fluid through one or more of theaspiration hole 80 or theseparation injection hole 82 in the target area TA one or more of simultaneous to or before extracting the bone marrow comprises injecting fluid disposed within one of thechamber 26 of theproximal syringe 22 coupled to thedistal syringe 16 or theinjection syringe 92, a stand-alone device not coupled to any other syringe. - While the foregoing description refers to bone marrow being extracted from the target area TA, such as a bone in the target area TA, one of ordinary skill in the art will appreciate that any tissue from a subject may alternatively and/or additionally be extracted according to the
device 10 and methods of the description and still fall within the scope of the present disclosure. More specifically, thedevice 10 and methods may be used to eliminate negative pressure during extraction of tissue, such as during a biopsy procedure, in any other part of the subject, such as a human body, including but not limited to bone in any other part of the subject outside of the spine, a breast area, or any other area of the subject. - One of ordinary skill in the art will appreciate the following advantages of the
device 10 and methods described above. For example, thedevice 10 and methods mitigate patient pain caused by negative pressure in conventional bone marrow aspiration devices and methods by replacing fluid in the bone marrow space before or during aspiration of bone marrow. By replacing fluid in the marrow space, the rate of bone marrow withdrawal may be increased and the risk of damaging the bone marrow sample may be reduced. In addition, each of the foregoing methods ensures that negative pressure is not experienced by the patient during aspiration at least because the volume of fluid within the marrow space in each method is controlled. Said another way, the fluid volume is never less than it was at the beginning of the procedure during aspiration, ensuring negative pressure does not occur during aspiration. Thus, not only do thenew device 10 and methods mitigate and/or completely eliminate patient pain, but also patient anxiety is reduced. As a result, there will be an increase in the number of patients opting to receive bone marrow and bone marrow stem cell treatments in an office, where they are safest and cheapest to perform. - The following additional considerations apply to the foregoing discussion. Throughout this specification, plural instances may implement components, operations, or structures described as a single instance. Although individual operations of one or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed concurrently, and nothing requires that the operations be performed in the order illustrated. Structures and functionality presented as separate components in example configurations may be implemented as a combined structure or component. Similarly, structures and functionality presented as a single component may be implemented as separate components. These and other variations, modifications, additions, and improvements fall within the scope of the subject matter herein.
- Some implementations may be described using the expression “coupled” along with its derivatives. For example, some implementations may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact. The term “coupled,” however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. The implementations are not limited in this context.
- As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
- In addition, use of the “a” or “an” are employed to describe elements and components of the implementations herein. This is done merely for convenience and to give a general sense of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.
- Further, while particular implementations and applications have been illustrated and described, it is to be understood that the disclosed implementations are not limited to the precise construction and components disclosed herein. Various modifications, changes and variations, which will be apparent to those skilled in the art, may be made in the arrangement, operation and details of the method and apparatus disclosed herein without departing from the spirit and scope defined in the appended claims.
Claims (10)
1.-26. (canceled)
27. A method of aspirating bone marrow comprising:
extracting tissue from an aspiration hole in a target area;
injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue.
28. The method of claim 27 , wherein injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue comprises injecting one or more of a saline or other salt-balanced sterile solution, an antibiotic, or an anesthetic.
29. The method of claim 27 , wherein extracting bone marrow from an aspiration hole in a target area comprises extracting the tissue through one of an aspiration needle or an outer tube of a needle of a needle assembly.
30. The method of claim 27 , wherein injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue comprises injecting fluid through one of an injection needle separate from the aspiration needle or an inner tube of a needle of a needle assembly.
31. The method of claim 27 , wherein extracting tissue from the aspiration hole in a target area comprises extracting the tissue into one of a chamber of a distal syringe or an aspiration syringe.
32. The method of claim 31 , wherein injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue comprises injecting fluid disposed within one of a chamber of a proximal syringe coupled to a distal syringe or an injection syringe.
33. The method of claim 27 , wherein extracting tissue from an aspiration hole in a target area comprises extracting bone marrow from the aspiration hole in the target area.
34. The method of claim 27 , wherein injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area one or more of simultaneous to or before extracting the tissue comprises injecting fluid through one or more of the aspiration hole or a separate injection hole in the target area before extracting the tissue.
35. The method of claim 34 , wherein, after extracting tissue from the aspiration hole in the target area, the method further comprises again injecting the fluid through one or more of the aspiration hole or a separate injection hole in the target area before extracting the tissue and extracting tissue from the aspiration hole in the target area in sequence for one or more additional times.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/201,648 US20210196248A1 (en) | 2017-06-02 | 2021-03-15 | Device and method for aspirating bone marrow |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762514579P | 2017-06-02 | 2017-06-02 | |
US15/996,015 US10973500B2 (en) | 2017-06-02 | 2018-06-01 | Device and method for aspirating bone marrow |
US17/201,648 US20210196248A1 (en) | 2017-06-02 | 2021-03-15 | Device and method for aspirating bone marrow |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/996,015 Division US10973500B2 (en) | 2017-06-02 | 2018-06-01 | Device and method for aspirating bone marrow |
Publications (1)
Publication Number | Publication Date |
---|---|
US20210196248A1 true US20210196248A1 (en) | 2021-07-01 |
Family
ID=64458508
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/996,015 Active 2039-01-10 US10973500B2 (en) | 2017-06-02 | 2018-06-01 | Device and method for aspirating bone marrow |
US17/201,648 Abandoned US20210196248A1 (en) | 2017-06-02 | 2021-03-15 | Device and method for aspirating bone marrow |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/996,015 Active 2039-01-10 US10973500B2 (en) | 2017-06-02 | 2018-06-01 | Device and method for aspirating bone marrow |
Country Status (1)
Country | Link |
---|---|
US (2) | US10973500B2 (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2022533564A (en) * | 2019-05-07 | 2022-07-25 | イェール ユニバーシティー | Method for maximizing distribution and minimizing outflow of injectate in bone and enhanced aspiration extraction |
US20230096096A1 (en) * | 2021-09-27 | 2023-03-30 | Royal Biologics | Marrow aspiration device and method of use |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4969870A (en) * | 1989-06-07 | 1990-11-13 | The Regents Of The University Of California | Method and apparatus for intraosseous infusions |
US20120035501A1 (en) * | 2010-08-03 | 2012-02-09 | Biomet Biologics, Llc | Bone Marrow Aspiration Needle |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9468709B2 (en) * | 2012-11-12 | 2016-10-18 | Shippert Enterprises, Llc | Syringe fill method and apparatus |
PT3003449T (en) * | 2013-05-29 | 2018-06-08 | Speiser Paul | Three lumen balloon catheter apparatus |
-
2018
- 2018-06-01 US US15/996,015 patent/US10973500B2/en active Active
-
2021
- 2021-03-15 US US17/201,648 patent/US20210196248A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4969870A (en) * | 1989-06-07 | 1990-11-13 | The Regents Of The University Of California | Method and apparatus for intraosseous infusions |
US20120035501A1 (en) * | 2010-08-03 | 2012-02-09 | Biomet Biologics, Llc | Bone Marrow Aspiration Needle |
Also Published As
Publication number | Publication date |
---|---|
US20180344298A1 (en) | 2018-12-06 |
US10973500B2 (en) | 2021-04-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20210196248A1 (en) | Device and method for aspirating bone marrow | |
US7850656B2 (en) | Devices and methods for delivering medical agents | |
DE112010005064B4 (en) | Guide and flexible sleeve for use with catheters | |
US9498575B2 (en) | Substance delivery devices, systems and methods | |
US9572928B2 (en) | Substance delivery devices, systems and methods | |
US20110202014A1 (en) | Adapter device for application of small amounts of fat graft material by use of syringes | |
JP2016533848A (en) | Assembly and related methods for continuous delivery of drugs | |
KR101997372B1 (en) | Chemical ablation device and chemical ablation system | |
US9913949B2 (en) | Needle hub assembly for a syringe and a syringe comprising such needle hub assembly | |
US20170014569A1 (en) | Gel delivery catheters, systems, and methods | |
EP2076309A2 (en) | Needle assembly for use in delivering precise dosages of proteinaceous pharmaceutical compositions and methods for use of same | |
EP3380131A1 (en) | Implantable fluid pump system | |
CN209405474U (en) | A kind of novel cavity mirror medicament injection apparatus | |
KR101774231B1 (en) | Nerve blocking material injector set for regulating nerve pain | |
US20170128709A1 (en) | Venous Access Implantable Port | |
KR20140010776A (en) | Cannula structure for protecting damage on the skin | |
KR20160067277A (en) | Painless syringes | |
JP2014180570A (en) | Neural injection system and related method | |
CN105727401A (en) | Double-pipe and double-channel syringe and needle | |
KR102542271B1 (en) | injection equipment set | |
CN201239183Y (en) | Peripheral nerve block indwelling trocars | |
US20150151078A1 (en) | Catheter | |
KR102338495B1 (en) | Biopsy device with drug injection | |
KR20130061708A (en) | A medical needle assembly | |
CN213608677U (en) | Novel clinical treatment of department of neurology device |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |