Cutting heads for tissue collection devices

Abstract

A device for collecting tissue from a body cavity includes a hollow tubular body. The tubular body has a tubular wall extending between a proximal end and a distal end of the tubular body. The tubular wall surrounds a passage extending to the distal portion of the tubular body. The tubular body can be a non-bent shaft or a shaft having an articulated section that allows a portion of the tubular body to be articulated relative to the proximal portion. The distal portion includes a coring drill having a cutting tip. The cutting tip defines a first orifice, a second orifice opposite the first orifice, and a web extending between the first and second orifices. The web tapers toward a drill tip located at the distal end of the tubular body.

Description

Technical Field

[0001] The present disclosure relates generally to instruments for collecting tissue from a body cavity, and more particularly to a cutting head for collecting tissue in a preserved state from a bone. Background Art

[0002] Bone marrow, produced and stored inside bones, can be collected and used for various purposes, including treatment of congenital defects and diseases and bone reconstruction. Bone marrow contains useful components, including hematopoietic stem cells and blood cells. Historically, conventional methods for collecting bone marrow have relied on the use of a needle. The needle is advanced through the patient's skin and bone wall until the needle tip enters the bone cavity that holds the bone marrow. Typically, the needle is advanced into the donor's pelvis, but the needle can also be inserted into other bones. Once the needle has penetrated the bone cavity, it is advanced along a linear path and the marrow is collected by suction.

[0003] Because the concentration of stem cells at a specific location is low, the bone marrow collection performed by aspiration usually produces a relatively small amount of stem cells. In order to collect a sufficient amount of marrow and stem cells, the doctor must extract a large amount of marrow that is greater than the amount that can be extracted by a single aspiration at one location. Therefore, in order to collect a sufficient amount of marrow and stem cells, a needle must be inserted into the bone at multiple locations within the bone cavity to extract marrow from different areas. This requires multiple punctures through the outer cortical area and into the bone cavity to collect the required amount of marrow. Multiple punctures may be time-consuming and laborious for the doctor performing the collection. In addition, multiple punctures can cause a lot of pain to the donor and require a long recovery time after the patient is released from general anesthesia.

[0004] Daniel Kraft and James Hole's U.S. Patent No. 7,462,181 (hereinafter referred to as the "'181 patent") describes an alternative device for aspirating bone marrow or tissue from a bone cavity. Rather than using a rigid needle that advances linearly through the bone, the device includes a thin, hollow needle that is flexible enough to move through the bone marrow cavity in a nonlinear manner. By advancing the needle along a nonlinear path, the needle can access different locations in the bone from a single entry point.

[0005] While the flexible needle of the '181 patent could theoretically allow for more bone marrow to be collected from a single entry point, collection can only be accomplished through aspiration. The flexible needle does not allow for the collection of bone marrow or tissue by "coring," in which a core of marrow is removed from the bone cavity in an undisturbed state. Aspiration tends to mix stem cells with blood and other components because the material is collected under suction. This mixing dilutes the concentration of stem cells at the collection point.

[0006] Flexible needles are also prone to breakage during surgery due to their very small diameter. This tendency to break often requires the use of accessories to reinforce the needle during the collection procedure. For example, the '181 patent describes an embodiment that uses a stylet located inside the flexible needle while advancing the needle into the bone marrow. The stylet provides additional strength and rigidity to the aspiration needle during advancement through the bone marrow space. The need for a stylet and other accessories increases the number of items that must be sterilized and handled along with the aspiration needle during the collection procedure.

[0007] Furthermore, flexible hollow needles offer few options for controlling the amount of bending or pivoting motion along the length of the needle. A flexible needle having a consistent cross-section is generally flexible along its entire length. This may be undesirable in applications where only a portion of the shaft needs to bend while the remainder of the shaft should remain rigid. Flexible needles also lack features that aid in cutting through dense cortical bone or shaving bone.

[0008] U.S. Patent No. 8,852,119 to Kortney Wawrziniak et al. (hereinafter referred to as the "'119 patent") describes another device for collecting bone marrow from a bone cavity. The device includes a flexible needle and a trocar having a cylindrical shaft. The cylindrical shaft of the trocar can be driven into the bone to provide an access path to the bone. The cylindrical shaft is also configured to receive the flexible needle after being driven into the bone. Once the needle is advanced into the target bone, a receiving portion is coupled to the needle to aspirate bone marrow through the needle. The needle can have a rigid section and a flexible portion extending distally from the rigid section. The flexible portion of the needle is defined by a continuous groove extending along a spiral path.

[0009] The needle described in the '119 patent offers some benefits over other needles that are flexible along their entire length. However, the needle of the '119 patent collects bone marrow only by aspiration and does not allow for the collection of bone marrow or tissue by coring. In fact, the channel inside the needle terminates short of the distal end, where it is aligned with an intake port on the side of the needle. Furthermore, the intake port on the side of the needle is recessed to prevent material other than the aspirate from entering the needle. In this arrangement, the needle channel cannot receive a core of material because the channel is essentially closed. Thus, the needle is limited in how it can collect bone marrow and collect material from the interior of the bone.

[0010] Applicants have previously developed a collection device, assembly, and procedure for more efficiently collecting tissue from a body cavity. The collection device is a versatile instrument for removing bone marrow material by either coring or aspiration. In some cases, the instrument functions as an auger-type tool for removing solid material from the body in a preserved state, while in other cases, it functions as a needle-type tool for removing liquid or fluid material by aspiration. An example of the collection device is described in U.S. Publication No. 2018 / 0049727 A1, the entire contents of which are incorporated herein by reference.

[0011] Despite advances in the field of tissue harvesting, there remains a need for improved harvesting devices that effectively harvest tissue, particularly from bone. Summary of the Invention

[0012] The shortcomings of conventional devices and techniques for collecting tissue and harvesting bone marrow are addressed by the cutting tip and shaft incorporating the cutting tip according to the present disclosure.

[0013] In one advantageous aspect of the present disclosure, an apparatus for collecting tissue from a body cavity includes a hollow tubular body defining a longitudinal axis. The tubular body may include a proximal portion terminating at a proximal-most end, a distal portion terminating at a distal-most end, and an intermediate section extending between the proximal and distal portions. The intermediate section may have a first end adjacent to and in close proximity with the proximal portion and a second end adjacent to and in close proximity with the distal portion. The tubular body may include a tubular wall extending between the proximal-most end and the distal-most end. The tubular wall may define an outer wall surface and an inner wall surface. The tubular wall may surround a passage extending to the distal portion of the tubular body. The distal portion may include a coring drill having a cutting tip. The cutting tip may define a first orifice, a second orifice opposite the first orifice, and a web extending between the first and second orifices. The web may taper toward a drill tip located at the distal-most end of the tubular body.

[0014] In another beneficial aspect of the present disclosure, the first aperture and the second aperture may each include a profile defined by a first linear edge, a second linear edge, and a third linear edge and a fourth curved edge.

[0015] In another beneficial aspect of the present disclosure, the first linear edge and the second linear edge may lie in a first plane transverse to the longitudinal axis.

[0016] In another beneficial aspect of the present disclosure, the third linear edge and the fourth curved edge may lie in a second plane transverse to the longitudinal axis and the first plane.

[0017] In another advantageous aspect of the present disclosure, the first plane and the second plane may intersect at a vertex line.

[0018] In another advantageous aspect of the present disclosure, the first linear edge, the second linear edge, and the vertex line may form a triangle.

[0019] In another advantageous aspect of the present disclosure, the third linear edge, the fourth curved edge, and the vertex line may form a pie shape bounded by two straight sides and one curved edge.

[0020] In another beneficial aspect of the present disclosure, the first aperture may be defined by a first cutout having a first cutout angle, and the second aperture may be defined by a second cutout having a second cutout angle.

[0021] In another beneficial aspect of the present disclosure, the first and second cutout angles may each be 30 degrees relative to the longitudinal axis.

[0022] In another advantageous aspect of the present disclosure, the first cut may be defined by a first cut sweep angle, and the second cut may be defined by a second cut sweep angle.

[0023] In another beneficial aspect of the present disclosure, the first kerf sweep angle and the second kerf sweep angle may each be 125 degrees relative to the longitudinal axis.

[0024] In another beneficial aspect of the present disclosure, the first aperture may be defined by a first edge having a first edge relief, and the second aperture may be defined by a second edge having a second edge relief.

[0025] In another beneficial aspect of the present disclosure, the first edge relief and the second edge relief may each be 15 degrees.

[0026] In another beneficial aspect of the present disclosure, the web may include an inner web surface, an outer web surface, and a web thickness between the inner web surface and the outer web surface.

[0027] In another beneficial aspect of the present disclosure, the web thickness at the drill tip may be 0.035 inches.

[0028] In another beneficial aspect of the present disclosure, the cutting tip may define an outer drill point angle and an inner core angle.

[0029] In another advantageous aspect of the present disclosure, the outer drill point angle and the inner core angle may be equal.

[0030] In another beneficial aspect of the present disclosure, the outer drill point angle and the inner core angle may be 118 degrees.

[0031] In another beneficial aspect of the present disclosure, the drill tip may include a linear edge.

[0032] In another beneficial aspect of the present disclosure, the linear edge may be 0.015 inches in length.

[0033] In another beneficial aspect of the present disclosure, the channel may terminate at a proximal end to define a proximal opening in the tubular body, and the channel may terminate at a distal end to define a first aperture and a second aperture.

[0034] In another beneficial aspect of the present disclosure, the tubular body may include an articulation section that allows a portion of the tubular body to articulate relative to the proximal portion.

[0035] In another beneficial aspect of the present disclosure, the articulating section may include a plurality of interlocking sections.

[0036] In another beneficial aspect of the present disclosure, the hinge section may include a first interlocking section and a second interlocking section.

[0037] In another advantageous aspect of the present disclosure, the first interlocking section and the second interlocking section may each have at least one pin and at least one socket.

[0038] In another advantageous aspect of the present disclosure, the at least one pin may be generally triangular in shape, and the at least one socket may be generally triangular in shape.

[0039] In another beneficial aspect of the present disclosure, the circumferential width of the at least one pin on the first interlocking segment can increase as the at least one pin on the first interlocking segment extends from the outer surface of the shaft to the inner surface of the shaft, so that the at least one pin on the first interlocking segment gradually widens toward the inner surface.

[0040] In another beneficial aspect of the present disclosure, the circumferential width of the at least one pin on the second interlocking segment can decrease as the at least one pin on the second interlocking segment extends from the outer surface of the shaft to the inner surface of the shaft, so that the at least one pin on the second interlocking segment gradually narrows toward the inner surface.

[0041] In another beneficial aspect of the present disclosure, the first interlocking segment and the second interlocking segment can be cut at relative angles to produce at least one inwardly angled surface and at least one outwardly angled surface, wherein the at least one inwardly angled surface is adjacent to the at least one outwardly angled surface.

[0042] In another beneficial aspect of the present disclosure, the tubular body can have a consistent outer diameter along the entire length of the tubular body, such that the outer diameter of the proximal portion, the outer diameter of the middle section, and the outer diameter of the distal portion are equal.

[0043] In another beneficial aspect of the present disclosure, the tubular body may be a one-piece body having a unitary structure.

[0044] In another advantageous aspect of the present disclosure, the one-piece body having a unitary structure may be bendable.

[0045] In another advantageous aspect of the present disclosure, the one-piece body having a unitary structure may be inflexible.

[0046] In another beneficial aspect of the present disclosure, the passageway may extend from a proximal portion of the tubular body to a distal portion of the tubular body.

[0047] In another advantageous aspect of the present disclosure, the web may include a first web section and a second web section.

[0048] In another beneficial aspect of the present disclosure, the first web section and the second web section may each have a pie wedge shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The Summary and Detailed Description sections will be better understood when viewed in conjunction with the accompanying drawings. The following drawings illustrate exemplary and non-limiting embodiments of the present disclosure and depict elements that may be combined and arranged as shown or in other combinations and arrangements conceived by those skilled in the art.

[0050] Figure 1 is a perspective view of a tissue collection device according to an example;

[0051] Figure 2 is a perspective view of a tissue collection instrument having a handle attached to the instrument according to another example;

[0052] Figure 3 yes Figure 1 A side view of a tissue collection device;

[0053] Figure 4 yes Figure 1 Another side view of the tissue collection device;

[0054] Figure 5 yes Figure 1 Along the tissue collection device Figure 4 A side cross-sectional view taken along line 5-5 in FIG.

[0055] Figure 6 yes Figure 1 Along the tissue collection device Figure 3 A side cross-sectional view taken along line 6-6 in FIG.

[0056] Figure 7 yes Figure 1 an enlarged cutaway view of a distal portion of a tissue collection device;

[0057] Figure 8 yes Figure 1 End view of a tissue collection device;

[0058] Figure 9 yes Figure 1 An enlarged cutaway perspective view of a tissue collection device;

[0059] Figure 10 yes Figure 1 an enlarged cutaway cross-sectional view of a distal portion of a tissue collection device;

[0060] Figure 11 yes Figure 1 Another enlarged cutaway view of the distal portion of the tissue collection instrument of FIG, wherein dashed lines illustrate certain features not visible from the side; and

[0061] Figure 12 is a block diagram illustrating steps of a tissue collection procedure according to one example. DETAILED DESCRIPTION

[0062] As used herein, the term "proximal end" refers to a point on an object that is positioned proximal compared to all other points on the object, or, in the case of multiple points that are positioned proximal compared to all other points on the object, the term refers to an edge or surface consisting of those multiple points.

[0063] As used herein, the term "distal-most end" refers to a point on an object that is positioned most distally compared to all other points on the object, or, in the case of multiple points that are positioned most distally compared to all other points on the object, the term refers to an edge or surface consisting of those multiple points.

[0064] For purposes of this description, the collection device and cutting tip will be described as they will be used to collect bone marrow from a bone. When used to collect bone marrow, the bone marrow can be collected for biopsy purposes, for use as a medium for bone regeneration, or for harvesting stem cells to be processed and used for subsequent treatment of a congenital defect, disease, or other condition.

[0065] The collection device has a cylindrical shaft that allows entry into the bone from a single entry point for safe and efficient bone marrow collection. The shaft can be a rigid (i.e., non-bending) shaft, such as a hard shaft with a one-piece, integral structure. Alternatively, the shaft can be a flexible shaft with at least one section that can be bent. The flexible shaft can include a rigid component that includes a rigid interlocking section that together forms a flexible section. The rigid section allows the shaft to advance through the bone marrow without the need for a stylet or other type of structural reinforcement located in or around the shaft. The flexible zone section allows the shaft to yield and bend when the shaft advances through the bone marrow, thereby following the path of least resistance. Therefore, after puncturing through the outer cortical area, the flexible shaft can bend and advance along the inner portion of the bone, where a higher concentration of stem cells can be found.

[0066] Providing flexibility in the shaft can also prevent the front end of the shaft from penetrating through the bone wall opposite the entry point because the flexible section causes the front end to flex in response to contact with the bone wall. This provides a safer alternative to rigid needles, particularly when used in long bones or other areas where the lumen is relatively narrow or restricted.

[0067] Both the flexible and non-bending shafts can include a distal shaving tip with a bone shaving feature not present on conventional needles. The shaving feature helps cut bone and displace bone from the outer cortical region during the initial penetration into the bone. The shaving feature can also allow the shaft to cleanly remove a core of bone marrow material as it advances into an area containing a high concentration of stem cells. As the distal shaving tip moves through the material, the core of the material can be cleanly cut from the surrounding material, resulting in a core with a high concentration of stem cells that is preserved internally. By allowing the bone marrow core to be removed, the stem cells are not diluted or mixed with blood and other substances. This avoids the need for subsequent processing such as centrifugation to separate the stem cells from other materials.

[0068] Now refer to Figure 1 , a collection instrument 100 for collecting tissue from a body cavity will be described according to one embodiment. The collection instrument 100 has a hollow tubular body in the form of a hollow shaft 110. The shaft 110 can be formed from any suitable medical grade material approved for use in surgical instruments, including but not limited to stainless steel. The shaft 110 includes a proximal portion 111 terminating at a proximal-most end 112. The proximal-most end 112 can be attached to a handle or other structure for operating the collection instrument 100, which can be operated manually and / or with an attached power tool. Figure 2 A similar shaft 110 is shown attached to a T-bar 200. Various other handle configurations may also be used.

[0069] The shaft 110 includes a distal portion 113 terminating at a distal-most end 114. The shaft 110 also includes an intermediate section 116 extending between the proximal portion 111 and the distal portion 113. The intermediate section 116 includes a first end 116a adjacent to and proximal to the proximal portion 111 and a second end 116b adjacent to and proximal to the distal portion 113. The shaft 110 also has a tubular wall 118 extending between the proximal-most end 112 and the distal-most end 114. The tubular wall 118 defines an outer wall surface 118a and an inner wall surface 118b. In addition, the tubular wall 118 defines and surrounds a channel 119 having a circular cross-section. The channel 119 extends from the proximal-most end 112 of the shaft 110 to the distal-most end 114 of the shaft.

[0070] The lengths of the shaft 110, proximal portion 111, intermediate section 116, and distal portion 113 are not shown to scale. Therefore, it will be understood that the relative lengths of each section, as well as the length of the entire shaft, are not necessarily represented by the relative dimensions shown in the figures. For example, the relative length of the proximal portion 111 relative to the intermediate section 116 and distal portion 113 may be much longer than appears in the figures.

[0071] Reference Figure 3 and Figure 4 , the middle section 116 of the shaft 110 includes an articulating section 120 that allows the distal portion 113 and a portion of the middle section to articulate or bend relative to the proximal portion 111. The articulating section according to the present disclosure can have various structures that allow the shaft 110 to articulate or bend. In a preferred embodiment, the articulating section includes a plurality of interlocking sections or interlocking elements, such as interlocking sections of the type and arrangement described in U.S. Patent No. 8,366,559, entitled "Cannulated Flexible Drive Shaft," the entire contents of which are incorporated herein by reference and for all purposes. For example, the articulating section may include a cannulated flexible drive shaft sold by Lenkbar, LLC of Naples, Florida, USA. Brand of flexible surgical shafts.

[0072] The hinge section 120 includes a first interlocking section 130 and a second interlocking section 140. The first interlocking section 130 has at least one pin 132 and at least one socket 134. Similarly, the second interlocking section 140 has at least one pin 142 and at least one socket 144. Each pin is generally triangular or trapezoidal in shape, and each socket is generally triangular or trapezoidal in shape, thereby having the same overall shape as the corresponding pin. The circumferential width of the pin 132 on the first interlocking section 130 increases uniformly (i.e., at a constant rate) from the outer wall surface 118a to the inner wall surface 118b, so that the pin gradually widens as the pin extends radially inward toward the longitudinal axis L of the shaft 110, which is Figure 5 The circumferential width of the pin 142 on the second interlocking section 140 decreases uniformly (i.e., at a constant rate) from the outer wall surface 118a to the inner wall surface 118b, such that the pin gradually narrows as it extends radially inward toward the longitudinal axis L of the shaft 110. The first interlocking section 130 and the second interlocking section 140 are cut at opposing angles to form at least one inwardly angled surface and at least one outwardly angled surface, the inwardly angled surface being adjacent to the outwardly angled surface.

[0073] The shaft according to the present disclosure may be cylindrical having a channel defined in various configurations. Figure 5 and Figure 6 , the channel 119 terminates at the proximal end 112 to define a proximal opening 122 in the shaft 110. It should be noted that although the proximal end 112 is shown as a smooth cylindrical end, the proximal end 112 can have a variety of internal and / or external geometries for coupling to handles, power tools, and other accessories. For example, the proximal end 112 can have one or more flat portions on the exterior that are configured to fit into a hexagonal or polygonal shaped socket formed in the handle shaft.

[0074] Reference Figure 7 and Figure 8 , channel 119 terminates at distal-most end 114, thereby forming first and second orifices 192, 194. First and second orifices 192, 194 are configured to receive bone marrow and other material through distal-most end 114 as shaft 110 is advanced into the bone. Inner wall surface 118b forms a smooth, continuous, and uninterrupted annular surface surrounding channel 119 and adjacent to first and second orifices 192, 194. This smooth surface slidingly receives material entering first and second orifices 192, 194 while minimizing friction and shear stresses, allowing the material to be removed cleanly and in a preserved state.

[0075] The distal portion 113 and the first and second orifices 192, 194 form a coring drill 150 that shaves the bone and smoothly cuts through the bone marrow. The coring drill 150 has a cylindrical outer wall 152 that is consistent with and coextensive with the outer wall surface 118a of the shaft. Therefore, the outer diameter of the coring drill 150 is equal to the outer diameter of the shaft 110. The shaft 110 can be used to remove bone marrow material using a coring technique. In addition, the shaft 110 can be used to remove bone marrow by suction. In this way, the shaft 110 is used as an auger-type tool for removing solid materials in a preserved state from the body in some cases, and as a needle-type tool for removing liquid or fluid materials by suction in other cases. When suction is performed, the first and second orifices 192, 194 can be used as suction ports to remove fluid materials from the bone cavity under negative pressure.

[0076] The coring drill 150 has a cutting tip 160. The cutting tip 160 is a distal shaving tip with a bone shaving feature that helps cut bone and displace bone from the outer cortical area during initial penetration into the bone. The shaving feature also allows the shaft to cleanly remove a core of bone marrow material as it advances into an area containing a high concentration of stem cells. As the distal shaving tip moves through the material, the core of the material can be cleanly cut away from the surrounding material, resulting in a core with a high concentration of stem cells that is preserved within the interior of the shaft 110.

[0077] Cutting tip 160 defines a drill tip 162 at distal-most end 114 of shaft 110. Drill tip 162 has a linear edge 163 extending perpendicular to longitudinal axis L. Edge 163 has an edge length 163a. ​​A first gash 164 is formed in cutting tip 160, and a second gash 166 is formed on an opposite side of the cutting tip. First gash 164 is defined by a first gash sweep angle 176, and second gash 166 is defined by a second gash sweep angle 178 that is equal to first gash sweep angle 176. A web 168 extends between first gash 164 and second gash 166, thereby forming a section of solid material located between first aperture 192 and second aperture 194. Web 168 extends radially outward and terminates at outer wall 152 of coring drill 150.

[0078] Reference Figure 9 , first cutout 164 defines a first lip 172. First lip 172 has an inner lip end 172a that terminates at tip 162 and an outer lip end 172b that terminates at outer wall 152. Similarly, second cutout 166 defines a second lip 174. Second lip 174 has an inner lip end 174a that terminates at drill tip 162 and an outer lip end 174b that terminates at outer wall 152. First lip 172 and second lip 174 form first and second cutting edges 172c and 174c, respectively, extending outward from drill tip 162 to outer wall 152.

[0079] The web 168 has an end profile 170 having a centrally located narrow section 170a and two wider ends 170b, thereby forming a bow tie or hourglass shape. The bow tie shape includes a first web section 168a and a second web section 168b. The first web section 168a and the second web section 168b converge toward each other as they extend toward the drill tip 162. In addition, the first web section 168a and the second web section 168b each define a pie wedge shape. The first edge 172 and the second edge 174 are coplanar and coincide with a plane P passing through the drill tip 162, as shown in FIG. Figure 8 As shown in .

[0080] Reference Figure 10 and Figure 11 , the web 168 has an inner web surface 182 and an outer web surface 184. The shaft material between the inner web surface 182 and the outer web surface 184 defines a web thickness 186. The web thickness 186 at the drill tip 162 defines a tip thickness 187. The tip thickness 187 is greater than the edge length 163a, which is greater than the edge length 163a. Figure 8. The distal-most portion 114 defines a drill point angle 183, which is the outer tip angle of the drill tip 162. This is the taper angle between the first web section 168a and the second web section 168b. The distal-most portion 114 also defines a core angle 185, which is the total angle or included angle between the first edge 172 and the second edge 174. The drill point angle 183 and the core angle 185 may be the same or slightly different.

[0081] First edge 172 has a first edge relief angle 173, and second edge 174 has a second edge relief angle 175. First edge relief angle 173 is equal to second edge relief angle 175. First cutout 164 defines a first cutout angle 165, and second cutout 166 defines a second cutout angle 167. First cutout angle 165 is the angle ground to form first aperture 192, and second cutout angle 167 is the angle ground to form second aperture 194.

[0082] Cutting tips according to the present disclosure can have various sizes, blade relief angles, cut sweep angles, and other geometric specifications. Table 1 lists a set of specifications that can be implemented in examples of cutting tips according to the present disclosure.

[0083] Table 1 - Examples of Cutting Tips

[0084]

[0085]

[0086] Return to reference Figure 7 First orifice 192 and second orifice 194 each have a profile 195 defined by four edges. Specifically, each profile 195 includes a first linear edge 195a, a second linear edge 195b, a third linear edge 195c, and a fourth curved edge 195d. First linear edge 195a and second linear edge 195b lie in a first plane 196. Third linear edge 195c and fourth curved edge 195d lie in a second plane 197, which intersects first plane 196 at an apex line 198. The portion of apex line 198 that passes through orifice 192 is shown in phantom. First plane 196 extends transversely relative to longitudinal axis L. Second plane 197 extends transversely relative to longitudinal axis L and first plane 196. Specifically, first plane 196 intersects second plane 197 at an obtuse angle, thereby forming a V-shaped end profile 198a. Thus, the orifice 192 and the corresponding edges of the orifice 192 form a V-shaped notch 192a, and the orifice 194 and the corresponding edges of the orifice 194 form a V-shaped notch 194a, as shown in FIG. Figure 2 and Figure 9 As shown in . The V-shaped notches 192a, 194a intersect at their apex.

[0087] First linear edge 195a, second linear edge 195b, and apex line 198 define triangle 199a. Third linear edge 195c, fourth curved edge 195d, and apex line 198 define pie shape 199b, bounded by two straight sides and one curved side. Triangle 199a and pie shape 199b intersect along apex line 198, the portion of apex line 198 passing through the aperture being shown in phantom. This geometry of first aperture 192 and second aperture 194 has been found to be effective for collecting bone marrow.

[0088] As previously mentioned, the tissue collection instrument according to the present disclosure can have various handle configurations for the physician to grasp. The handle portion according to the present disclosure can be connected to the shaft using any suitable connection method, such as a pin connection, a molded connection, or other alternatives. In a preferred embodiment, the handle portion is arranged at the proximal end of the tissue collection instrument. The preferred handle is ergonomically configured to allow the physician to comfortably grasp the instrument and manually apply different types of forces to the shaft via the handle. These forces can include thrust and pull forces that advance and retract the shaft, respectively, and torsion forces that rotate the shaft. A specific combination of thrust and torsion forces can also cause the shaft 110 to bend at the articulated section 120 during the shaft's advancement through the bone cavity.

[0089] The collection device according to the present disclosure may also include one or more features that assist the physician in visually monitoring the insertion depth of the shaft within the body. Figure 4 In FIG, the shaft 110 includes a plurality of markings 101 disposed along the outer wall surface 118a. The markings 101 can be manufactured by any suitable process, including but not limited to laser cutting, laser marking, etching, or other methods. Various types of markings can be provided according to the present disclosure. For example, the markings 101 include a first marking in the form of hash marks or lines 102 spaced apart at increasing intervals. The lines 102 extend circumferentially around the outer wall surface 118a. The markings 101 also include a second marking in the form of numbers 104. Each number 104 is positioned adjacent to and corresponds to one of the lines 102. The value of each number 104 represents the insertion depth in centimeters. Each number 104 is an integer representing the distance between its corresponding line 102 and the distal-most end 114 of the shaft 110. When the shaft 110 is advanced into the incision and the lines 102 are aligned with the patient's skin surface, the number 104 corresponding to that line at the skin surface indicates the depth to which the distal-most end 114 has been advanced into the body.

[0090] A shaft according to the present disclosure can have an articulation section that spans a small portion of the total length of the shaft or a large portion of the total length of the shaft to provide a desired degree of bending, i.e., a desired "pivot core." For example, the longitudinal length of the articulation section 120 can be one-quarter or 25% of the total length of the shaft 110. Thus, 25% of the shaft length is comprised of interlocking sections that allow the distal-most end 114 to bend and pivot relative to the proximal-most end 112. The remaining three-quarters or 75% of the total length of the shaft 110 is a solid, one-piece section 117 that remains fixed in its orientation. Thus, the proximal portion 111 and most of the middle section 116 can be fixed in orientation, thereby providing structural reinforcement that allows the shaft to be advanced through bone and tissue and maintain track without buckling.

[0091] In other embodiments, the length of the flexible section can certainly be different from the length of the solid, one-piece section. For example, a larger percentage of the length can be used for the articulated section to allow for a greater degree of bending and pivoting motion. Alternatively, a smaller percentage of the length can be used for the articulated section to allow for a lesser degree of bending and pivoting motion. Thus, the length of the articulated section can be any percentage of the total length of the shaft, including but not limited to 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 80% of the total length of the shaft. Percentages less than 5% or greater than 80% can also be used. Selecting a specific percentage allows for precise control of the flexibility and pivot taper of the shaft, which is different from conventional flexible needles that are flexible along their entire length.

[0092] Example – Bone Marrow Harvesting Procedure

[0093] Reference Figure 12 , a block diagram illustrating a possible tissue collection procedure according to the present disclosure. In this example, the procedure is a bone marrow harvesting procedure for collecting bone marrow and stem cells from the patient's anterior or posterior iliac crest. When describing the various steps, reference will be made to the previously described collection apparatus. Other devices may also be used to implement the methods according to the present disclosure. Furthermore, these steps may be performed with or without additional steps known to physicians and medical professionals of ordinary skill in the art.

[0094] In step 1000, tissue collection instrument 100 is inserted into the incision and tissue collection instrument 100 is advanced to the exposed bone surface of ilium. Before this step, the doctor can apply anticoagulant to the surface on tissue collection instrument 100 to prevent material coagulation, particularly coagulation on the inside of collection instrument. The doctor can also use perforating instrument to prepare small holes in the bone surface. Once tissue collection instrument 100 is inserted, the drill point 162 of cutting tip 160 is placed on the desired entry point through the bone. Then, the doctor firmly presses their hand or palm against the proximal end 112, which can have a handle, knob, palm rest or other structure in order to receive power from the doctor's hand or palm. Then, the doctor applies axial pressure to proximal end 112 and simultaneously rotates this proximal end in a clockwise direction. While maintaining axial pressure, tissue collection instrument 100 is rotated to manually drive cutting tip 160 and shaft 110 through cortical bone. In step 2000, the simultaneous application of axial pressure and rotation continues until the cutting tip 160 completely penetrates the cortical bone and enters the cavity. The moment of entry into the cavity can be felt by touch, as the resistance to axial advancement decreases when the cortical bone is completely penetrated and no longer offers resistance. Imaging can also be used to confirm entry into the bone cavity.

[0095] Once the cutting tip 160 enters the bone cavity, a tissue collection instrument is used in a coring mode to collect a bone marrow core in step 3000. The handle is simultaneously twisted and advanced to collect the bone marrow. The shaft 110 has a moderate degree of freedom in bending. However, the degree of flexibility of the articulated section 120 is limited, so that the shaft 110 can advance through the bone marrow even if it is not along a straight path. The limited flexibility of the articulated section 120 causes the distal portion 113 to yield under resistance when the distal portion 113 advances through the bone marrow and / or contacts the inner portion of the bone. This results in a bending motion that changes the direction of advance as the collection instrument 100 advances, which prevents unintentional puncture beyond the bone marrow space, thereby increasing the safety advantage of the process.

[0096] The tissue collection device 100 is advanced and rotated through the bone like an auger at the same time, until the bone marrow core in the motion path is collected in the passage 119 inside the shaft 110. The shaft 110 is advanced into the ilium and reaches the desired depth corresponding to the amount of bone marrow to be taken out. For example, the shaft 110 can be inserted to a depth of 3cm to 4cm. Once the rod 110 arrives at the desired depth, further advancement is stopped in step 4000 and the tissue collection device 100 is withdrawn from the patient's body. Then in step 5000, the bone marrow core inside the shaft 110 is carefully taken out from the shaft. Suitable instruments, such as perforating instruments or other instruments that can remove the bone marrow core from passage 119 can be used to take out the bone marrow from the shaft.

[0097] Removing bone marrow from a bone may leave a void in the bone cavity. During the removal of the collection instrument 100 from the bone cavity, the bone marrow in and around the void is agitated. This agitation can cause fluid dispersion of the stem cells and blood in the void. At this stage, the collection instrument 100 can be attached to a negative pressure source, such as a syringe, and operated in suction mode to collect the stem cells dispersed in and around the void. The collection instrument 100 is reinserted through the same incision and bone entry point and reinserted into the void to collect the dispersed stem cells.

[0098] Although this disclosure describes and illustrates specific embodiments, it is not intended that the disclosure be limited to the details shown. Rather, various modifications, combinations, substitutions, and / or rearrangements may be made to the components and features shown herein, wherein any such modifications, combinations, substitutions, and / or rearrangements are deemed to fall within the scope and range of equivalents of the claims and do not depart from the disclosure.

[0099] For example, a collection device according to the present disclosure need not have a flexible shaft as previously described, but may also have a non-bending shaft, such as a rigid shaft having a one-piece, unitary structure. An example of a rigid shaft having a one-piece, unitary structure would look the same as the shaft 110 shown in the accompanying drawings, but would lack the cut lines defining the interlocking segments and would be replaced with a solid wall.

[0100] The collecting device according to the present disclosure does not have to have only two apertures, but may also have fewer or more apertures. For example, the collecting device according to the present disclosure may have three, four, five, six or more apertures arranged circumferentially around the coring drill 150.

Claims

1. An apparatus for collecting tissue from a body cavity, the collecting apparatus comprising a hollow tubular body defining a longitudinal axis, the tubular body comprising a proximal portion terminating at a proximal-most end, a distal portion terminating at a distal-most end, and an intermediate section extending between the proximal and distal portions, the intermediate section having a first end adjacent to and proximate to the proximal portion and a second end adjacent to and proximate to the distal portion, the tubular body comprising a tubular wall extending between the proximal-most end and the distal-most end, the tubular wall defining an outer wall surface and an inner wall surface, the tubular wall surrounding a passage extending to the distal portion of the tubular body, wherein The distal portion includes a coring drill having a cutting tip defining a first aperture, a second aperture opposite the first aperture, and a web extending between the first aperture and the second aperture, the web tapering toward a drill tip located at the distal-most end of the tubular body, The first aperture and the second aperture each include a respective profile defined by a first linear edge, a second linear edge, a third linear edge, and a fourth curved edge, wherein The first linear edge and the second linear edge lie in a first plane, and the fourth curved edge of the first aperture extends along the longitudinal axis from a first intersection with the first linear edge of the first aperture to a second intersection with the third linear edge of the first aperture at a first cut angle relative to the longitudinal axis, and the fourth curved edge of the second aperture extends along the longitudinal axis from a third intersection with the first linear edge of the second aperture to a fourth intersection with the third linear edge of the second aperture at a second cut angle relative to the longitudinal axis, and The third linear edge and the fourth curved edge are located in a second plane transverse to the first plane.

2. The apparatus according to claim 1, wherein The first plane is transverse to the longitudinal axis.

3. The apparatus according to claim 1, wherein The first plane and the second plane intersect at a vertex line.

4. The apparatus according to claim 3, wherein The first linear edge, the second linear edge, and the vertex line form a triangle.

5. The apparatus according to claim 3, wherein: The third linear edge, the fourth curved edge, and the vertex line form a pie shape enclosed by two straight sides and one curved side.

6. The apparatus according to any one of claims 1 to 5, wherein The first cutout angle and the second cutout angle are each 30 degrees relative to the longitudinal axis.

7. The apparatus according to any one of claims 1 to 5, wherein: The cutting tip includes an outer wall, and the second linear edge of each of the first and second apertures extends from the outer wall of the cutting tip to the drill tip at half a drill tip angle relative to the longitudinal axis.

8. The apparatus according to claim 7, wherein The drill point angle is 118 degrees.

9. The apparatus according to claim 7, wherein: The second linear edge of each of the first and second orifices has a length of 0.015 inches.

10. The apparatus according to any one of claims 1 to 5, 8 to 9, wherein The passageway terminates at the proximal end to define a proximal opening in the tubular body, and the passageway terminates at the distal end to define the first and second apertures.

11. The apparatus according to any one of claims 1 to 5, 8 to 9, wherein The tubular body includes an articulation section that allows a portion of the tubular body to articulate relative to the proximal portion.

12. The apparatus according to claim 11, wherein The hinge section includes a plurality of interlocking sections.

13. The apparatus according to claim 11, wherein The hinge section includes a first interlocking section and a second interlocking section, and each of the first interlocking section and the second interlocking section has at least one pin and at least one socket.

14. The apparatus according to claim 13, wherein The at least one pin has a trapezoidal shape, and the at least one socket has a trapezoidal shape.

15. The apparatus according to claim 14, wherein The circumferential width of the at least one pin on the first interlocking section increases as the at least one pin on the first interlocking section extends from the outer surface of the shaft to the inner surface of the shaft, such that the at least one pin on the first interlocking section gradually widens toward the inner surface.

16. The apparatus of claim 14, wherein: The circumferential width of the at least one pin on the second interlocking section decreases as the at least one pin on the second interlocking section extends from the outer surface of the shaft to the inner surface of the shaft, such that the at least one pin on the second interlocking section gradually narrows toward the inner surface.

17. The apparatus of claim 13, wherein: The first and second interlocking sections are cut at opposing angles to create at least one inwardly angled surface and at least one outwardly angled surface, the at least one inwardly angled surface being adjacent to the at least one outwardly angled surface.

18. The apparatus of any one of claims 1 to 5, 8 to 9, 12 to 17, wherein The tubular body has a consistent outer diameter along the entire length of the tubular body such that the outer diameter of the proximal portion, the outer diameter of the intermediate section, and the outer diameter of the distal portion are equal.

19. The apparatus of any one of claims 1 to 5, 8 to 9, 12 to 17, wherein The web includes a first web section and a second web section, each having a pie wedge shape.

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