DEVICE FOR RAPID ASPIRATION AND COLLECTION OF BODY TISSUE FROM WITHIN AN ENCLOSED BODY SPACE
20180200481 ยท 2018-07-19
Assignee
Inventors
Cpc classification
A61B17/1615
HUMAN NECESSITIES
A61B17/3423
HUMAN NECESSITIES
A61M1/85
HUMAN NECESSITIES
A61B2017/00292
HUMAN NECESSITIES
A61B2017/320032
HUMAN NECESSITIES
A61B10/025
HUMAN NECESSITIES
A61B17/2202
HUMAN NECESSITIES
A61B10/0283
HUMAN NECESSITIES
A61B17/3415
HUMAN NECESSITIES
International classification
A61B10/02
HUMAN NECESSITIES
A61B17/16
HUMAN NECESSITIES
Abstract
Device and method for rapid extraction of body tissue from an enclosed body cavity. Hollow entry cannula with optional core element provides entry into body tissue space such as bone marrow. Aspiration cannula is inserted through the hollow entry cannula into the body tissue and is manipulated to advance directionally through the body cavity. Optional stylet within the aspiration cannula aids in advancing the aspiration cannula through the body tissue and is removed to facilitate extraction of the body tissue through the aspiration cannula. Inlet openings near distal tip of the aspiration cannula allow tissue aspiration, with negative pressure source at the proximal end of the aspiration cannula providing controlled negative pressure. The aspiration cannula may be withdrawn and its path adjusted for multiple entries through a same entry point, following different paths through the body tissue space for subsequent aspiration of more tissue.
Claims
1. (canceled)
2. A system for bone marrow aspiration, comprising: an aspiration cannula having a flexible length coupled at a proximal end to a handle and attached at a distal end to a drill tip shaped to break up bone marrow, wherein the flexible length is configured to allow the aspiration cannula to follow a path whereby the drill tip is deflectable, wherein the distal end defines one or more openings which are configured to aspirate the bone marrow when the cannula is placed within the bone marrow and the drill tip is rotated relative to the handle when advanced through the bone marrow, and wherein the drill tip comprises a proximal portion and a distal portion having a rounded blunt tip, where the drill tip terminates at the rounded blunt tip such that the drill tip moves sideways upon encountering a surface of a cortical bone within the cavity without causing trauma to the surface.
3. The system of claim 1 further comprising a stylet slidably removable from a lumen defined through the aspiration cannula.
4. The system of claim 1 further comprising an entry cannula having a needle tip adapted to create an entry port through the cortical bone.
5. The system of claim 1 further comprising a control mechanism coupled to the distal end of the flexible length for directing a path of the drill tip through the bone marrow.
6. The system of claim 1 wherein at least one of the openings near the distal end defines an injection port in fluid communication with an anticoagulant.
7. The system of claim 1 further comprising an anticoagulant lining or coating along an inner surface of the aspiration cannula.
8. A system for bone marrow aspiration, comprising: an aspiration cannula having a flexible length coupled at a proximal end to a handle and attached at a distal end to a distal tip shaped to break up bone marrow, wherein the flexible length is configured to follow a path such that the distal tip is deflected when contacted with cortical bone and inhibited from puncturing through the cortical bone layer; wherein the distal end defines one or more openings which are configured to aspirate bone marrow when the cannula is placed within the bone marrow and the distal tip is rotated relative to the handle and advanced through the bone marrow, wherein the distal tip comprises a rotatable drill tip having a proximal fluted tapered portion which is tapered in a distal direction from a proximal end of the drill tip, and a distal portion having a rounded blunt tip, and wherein the distal tip terminates at the rounded blunt tip and wherein the distal tip is shaped to pass through the bone marrow while also shaped to be inhibited from puncturing through the cortical layer of bone such that the aspiration cannula is retained within the bone marrow cavity and the distal tip is configured to move sideways directly in contact along the layer of cortical bone upon encountering the cortical bone while rotating and without puncturing out of the bone marrow cavity.
9. The system of claim 8 further comprising an entry cannula having a needle tip adapted to create an entry port through the cortical bone layer.
10. The system of claim 8 further comprising a control mechanism coupled to the distal end of the length for directing a path of the drill tip through the bone marrow.
11. The system of claim 8 wherein at least one of the one or more openings are in fluid communication with an anticoagulant.
12. The system of claim 8 further comprising an anticoagulant lining or coating along an inner surface of the aspiration cannula.
13. A system for tissue bone marrow aspiration, comprising: an aspiration cannula having a flexible length and a distal end which is deflectable in all directions relative to a proximal end of the length which is coupled to a handle, wherein the aspiration cannula defines one or more openings near the distal end which are in fluid communication with a lumen defined through the length, the one or more openings being configured to aspirate disrupted bone marrow; and, a drill tip which is rotatable relative to the handle and attached at the distal end of the flexible length, wherein the drill tip comprises a proximal fluted portion having a shape which narrows distally from a proximal end of the drill tip to a distal portion having a rounded blunt tip, wherein the drill tip terminates at the rounded blunt tip and whereby the rounded blunt tip comprises a surface which is shaped to inhibit the drill tip from puncturing through a cortical layer of bone while rotating against the cortical layer of bone.
14. The system of claim 13 further comprising an entry cannula having a needle tip adapted to create an entry port through the cortical bone.
15. The system of claim 13 further comprising a control mechanism coupled to the distal end of the length for directing a path of the drill tip through the bone marrow.
16. The system of claim 13 wherein at least one of the one or more openings are in fluid communication with an anticoagulant.
17. The system of claim 13 further comprising an anticoagulant lining or coating along an inner surface of the lumen.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
[0046] Overview
[0047] An apparatus is provided to aspirate bone marrow and/or tissue rapidly and for large volumes of bone marrow from the ileac, femur, or other marrow containing bone marrow cavities. The apparatus includes a lumen adapted to receive an elongated aspiration cannula. Following entry through the bone wall, the aspiration cannula may be controlled to move in a non-linear fashion within the marrow cavity so that it can access a majority of bone marrow space through a single point of entry. Suction may be applied to the aspiration cannula to harvest the bone marrow or other aspiratable substances. If it is determined that a threshold amount of aspiratable substance has not been obtained, the aspiration cannula may be adjusted to enable further harvesting from the same bone wall entry or from an alternative bone wall entry.
[0048] Device and method for rapid, minimally invasive, aspiration and collection of body tissue from within an enclosed body space, as described herein, provide following advantages over the existing harvest systems:
[0049] Efficacytraditional extraction accesses only a small volume of marrow with each needle insertion and negative pressure draws blood from surrounding capillaries and dilutes the extract. Invention described herein moves to directly contact more of the marrow space and aspirates a more concentrated, less diluted extract. The extracted bone marrow is more concentrated in stem cells because the device penetrates the pelvic cavity more broadly and thus the extracted material is less diluted with blood drawn into the void created by the extraction. The decreased numbers of contaminating T-cells will likely lead to less Graft vs. Host Disease (GVHD) in allogeneic bone marrow recipients. Less total volume of bone marrow will need to be removed (as it is more concentrated).
[0050] Efficiencythe harvest performed with the invention described herein proceeds faster than conventional trocar harvest because only one access point into the marrow cavity is needed on each side of the body and less total volume of material is extracted (as it is more concentrated). One possible marrow access point is the easily accessible anterior ileac crest access site, which is easier to find and access on a broad array of patients (from thin to obese) and utilizing this entry site will also reduce harvest time.
[0051] Costthe procedure described herein will be considerably less expensive than the conventional procedure because described invention requires no operating room time, reduced support personnel, and no anesthesiologist. In terms of peripheral blood hematopoietic stem cell aspiration via apheresisthe $6,000-$10,000 cost for GCSF cytokine treatments and several lengthy (4-20+ hours each) apheresis procedures will be negated.
[0052] Convenience: There is no significant lead or preparative time required to perform a bone marrow harvest, as the procedure can be performed without an operating room, or general anesthesia by a single operator. Critically ill, or bone marrow donors who could not readily tolerate traditional harvest methods would benefit. Marrow and or stem cells derived from marrow could be obtained rapidly for use in follow-on therapeutic interventions.
[0053] Qualities & Benefits:
[0054] This device and method could be applied to a range of soft tissue extractions. Specific uses include, but are not limited to, the aspiration of bone marrow, removal of fat, aspiration of blood and muscle. We consider the bone marrow harvest application further for the sake of illustration.
[0055] To provide a bone marrow aspiration device for the rapid extraction of small or large volumes of bone marrow from the ileac, femur or other marrow containing bone marrow cavities or spaces.
[0056] To aspirate tissue such as marrow through a single skin and bone puncture site into the marrow cavity.
[0057] The ability to control directionality of described invention within the marrow cavity such that it can access majority of bone marrow space through a single point of entry.
[0058] To provide controlled aspiration suction through described invention of bone marrow or other aspiratable substance such as fat.
[0059] Described invention will significantly shorten bone marrow harvest time, not require general anesthesia, and result in cost reductions compared to traditional bone marrow harvest of peripheral blood stem cell collection.
[0060] To enable access to multiple diagnostic samples of bone marrow from disparate sites within the marrow cavity
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[0063] Core element 104 comprises a trocar or other element for breaking or piercing through the bone wall (or other tissue boundary) and creating an entry for subsequent aspiration. Optionally, entry cannula 101 is strong enough to break or pierce through the bone wall without the help of core element 104.
[0064] In an alternative embodiment, an entry in the bone wall is created using a tool other than entry cannula 101 and/or core element 104, such as a separate trocar or other sharp tool for breaking or piercing the bone wall, preparing the bone (or other tissue area) for the entry of aspiration cannula 105.
[0065] Once an entry is created into the bone marrow and entry cannula 101 enters the bone marrow (or other body tissue intended for aspiration), core element 104 is removed, leaving a hollow entry lumen with access to the medullary cavity.
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[0067] Aspiration cannula 105 optionally comprises a stylet 106 (aspiration stylet). When inserted into aspiration cannula 105, optional aspiration stylet 106 provides structural strength and aids in (for example the intramedullary bone marrow space of the ileac or femur bone) advance of aspiration cannula 105 through the marrow space (or other tissue area). Optionally, aspiration stylet 106 comprises a preset degree of curvature prior to and following entry into body cavity through entry cannula 101. Aspiration stylet 106 can be removed from aspiration cannula 105 to allow aspiration of marrow (or other body tissue) through aspiration cannula 105. Optionally, aspiration stylet 106 is used to remove and/or disrupt blockages within aspiration cannula 105, such as bone fragments, fat, coagulation, blood clots or other substance which may be blocking aspiration.
[0068] Optionally, aspiration cannula 105 is steerable and directable.
[0069] Optionally, as shown in
[0070] Optionally, as shown in
[0071] Optionally, as shown in
[0072] Optionally and as illustrated in
[0073] According to one embodiment of the present invention and as shown in
[0074] As shown in
[0075] Optionally and as shown in
[0076] Optionally, distal tip 130 is modified such that it cannot puncture out of the body space or cavity (such as bone marrow space or other body tissue area) but instead moves sideways along a wall or boundary upon encountering such wall or boundary.
[0077] Optionally, aspiration device 100 comprises a combination of radio-opaque and/or radio-transparent material for use in conjunction with an imaging device, such as an X-ray or ultrasound device, for visual location of the aspiration cannula 105. For example, aspiration cannula 105 and/or other parts may be radio-transparent, with aspiration cannula 105 comprising a radio-opaque visual guide (for example using X-Rays or other radiographic methods) along the length of aspiration cannula 105 (such as a strip with visual distance markings showing how far aspiration cannula 105 has advanced into bone marrow space or other body tissue area).
[0078] As shown in
[0079] Optionally, aspiration device 100 comprises a pain attenuating device for dampening pain and/or sensation during the aspiration procedure. For example, aspiration cannula 105 may comprise one or more sites for providing electrical nerve stimulation to the harvest area resulting in pain attenuation (see U.S. Pat. No. 6,159,163, Strauss et al., 5/1998).
[0080] Optionally, a lining of anticoagulant material (such as heparin) on the inside wall of entry cannula 101 and/or aspiration cannula 105 prevents blood and/or marrow from coagulating and hindering aspiration of marrow or body tissue. Optionally, entry cannula 101 and/or aspiration cannula 105 are flushed with anticoagulant solution to prevent and/or dissolve clots.
[0081] Optionally and as shown in
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[0083] The length and/or diameter and/or flexibility and/or curvature of entry cannula 101 and/or aspiration cannula 105 can be chosen to accommodate different anatomies (such as corresponding to different ages, bone sizes, amount of body fat, and other factors distinguishing patients) and for the harvest of a range of body tissues, such as bone marrow, fat (liposuction), fluid in the abdomen of a patient (with liver disease for example), or possibly for minimally invasive removal of a soft tissue mass such as a tumor. For example, a child may require a shorter, more flexible aspiration cannula 105. As another example, aspiration of bone through the lateral trocanter of the femur, or via the anterior ileac crest may require a shorter entry cannula 10I and/or aspiration cannula 105 than aspiration of bone marrow through the posterior ileac crest which may have more soft tissue above the bone.
[0084] There is growing body of scientific evidence that bone marrow derived stem cells can be utilized to regenerate or improve function of damaged myocardium following a myocardial infarction (MI), and may be useful in treating and preventing congestive heart failure. The ability to rapidly and easily obtain bone marrow derived stem cells for use in cardiac regeneration and other regenerative stem cell based therapies may be crucial. For example; a patient who has recently been diagnosed with a significant myocardial infarction .is brought to the catheterization suite, where interventional cardiologists perform angioplasty to open up a blocked coronary artery. Before, during or after the angioplasty procedure, a significant volume of bone marrow would be harvested using aspiration device 100. The bone marrow could be rapidly processed to enrich for hematopoietic stem cells or other populations or fraction of cells contained within bone marrow. These cells would then be delivered via catheter of other delivery device to the region of the heart which has undergone infarction and injury or death secondary to acute cardiac ischemia or other acute or chronic insults to the myocardial tissue. The delivered bone marrow or stem cell component contributes to regeneration of the myocardium or otherwise acts to improve cardiac function in the area of the infarct and leads to improved cardiac function and patient functional status and mortality. Optionally, marrow could be harvested separately from the initial cardiac catheterization procedure (for example 7 days after the MI, and in a separate procedure, stem cells or marrow enriched for stem cells could be delivered by any number of delivery mechanisms, for example by intracoronary or intramuscular injection. Use of a minimally invasive harvest device 100 would facilitate ease of harvest in patients who may be critically ill and not able to easily tolerate traditional marrow harvest procedures.
[0085] Advantageously, aspiration device 100 considerably improves on existing bone marrow harvest procedures by enabling a single operator to harvest marrow through one bone entry point, as illustrated in
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[0087] As described above, aspiration cannula 105 will have a degree of flexibility and/or curvature allowing it to follow the cavity (for example the intramedullary bone marrow space of the ileac or femur bone), and an optional ultrasound transducer device at the distal tip 130 of the aspiration cannula 105 can aid movement and define width of the cavity.
[0088] Once the aspiration catheter is fully introduced into the body cavity, negative pressure is initiated 203, using for example a syringe or a powered negative pressure device as described above. As bone marrow is aspirated the aspiration cannula 105 is slowly withdrawn 204, with aspiration continuing as the aspiration cannula 105 is withdrawn. If 205 sufficient amount of bone marrow is aspirated 205, the aspiration process is complete 206. Otherwise 207, after withdrawal of aspiration cannula 105, the curvature and/or directionality of the aspiration cannula 105 is adjusted 208, and aspiration cannula 105 is redirected through the entry into the bone marrow space and manipulated to follow a different path through the space and aspirating more bone marrow. This process can be repeated for example 3-4 times, resulting in its aspiration of bone marrow from the majority of the bore marrow space (for example the ileac crest). This process can be repeated 011 both sides of the body as needed (
[0089] As described above, there is the option of utilizing one or more aspiration cannulae 105 with preset or modifiable degrees of curvature and/or length and/or diameter and/or flexibility to adapt to different individual patients' anatomy and degree of ileac or other bone anatomy. As described above, aspirated bone marrow will go directly into bone marrow reservoir or container through a closed system for initial storage and/or follow-on manipulation (such as filtering, stem cell enrichment, or other follow-on manipulation or treatment of bone marrow).
[0090] The apparatus and method shown herein provide many advantages for rapid aspiration and collection of body tissue from within an enclosed space. The directional control of the aspiration cannula by the operator enables the cannula to directly contact more of the marrow space and thereby aspirate a bone marrow that is more concentrated with stem cells than that available in the prior art. In addition, the harvest performed with the apparatus shown herein proceeds faster than prior art harvesting with a trocar since only one access point is required on each side of the body and less total volume of material is extracted. Finally, the procedure outlined above requires less time and reduced support personnel, thereby reducing costs for a procedure for harvesting bone marrow and/or tissue.
[0091] Foregoing described embodiments of the invention are provided as illustrations and descriptions. They are not intended to limit the invention to precise form described. Other variations and embodiments are possible in light of above teachings, and it is thus intended that the scope of invention not be limited by this Detailed Description, but rather by Claims following.