Intraosseous access device and positioner assembly

Abstract

An intraosseous access device for accessing an intraosseous space of a patient includes a manual driver and a sternum positioner. A handle is connected to an inner penetrator sleeve, and an inner penetrator extends from the inner penetrator sleeve. An outer penetrator sleeve is releasably engaged to the inner penetrator sleeve. A protective cover is slidably connected to the handle. The protective cover is operable to move from an extended position covering the inner penetrator to a retracted position exposing the inner penetrator. The sternum positioner includes a base, a collar extending from a first surface of the base, and the collar is used to fix the intraosseous access device to limit the longitudinal separation of the intraosseous access device from the positioner. The positioner can be removed from the patient while the outer penetrator remains inserted into the intraosseous space of the patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 865,170, filed on June 22, 2019, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present application generally relates to medical devices for positioning and accessing intraosseous spaces of patients. More specifically, the present application relates to intraosseous access devices and positioner assemblies for placing a catheter into an intraosseous space within a patient's bone. Background Art

[0004] Many life-threatening emergencies (including shock, trauma, cardiac arrest, drug overdose, diabetic ketoacidosis, cardiac arrhythmias, burns, and status epilepticus, to name a few) often lead to death unnecessarily because intravenous (IV) access cannot be achieved in a timely manner. A key element in treating many life-threatening emergencies is the rapid establishment of an IV line to allow medications and fluids to be directly injected into the patient's vascular system. Whether treated by paramedics in an ambulance, by emergency medicine specialists in the emergency room, or by military doctors in the battlefield, the goal is the same - to quickly open an IV to inject life-saving medications and fluids. To a large extent, the ability to successfully treat most critical emergencies depends on the operator's skill and luck in achieving vascular access. Although veins on some patients are relatively easy to open, doctors, nurses, and paramedics often experience great difficulty in establishing IV access for certain patients. The success rate can be much lower on the battlefield, where these wounded soldiers are often repeatedly probed with sharp needles in an effort to quickly establish IV access.

[0005] In the case of patients with chronic diseases or the elderly, the possibility of easy access to veins may be reduced. Other patients may not have an available IV site due to insufficient anatomy of peripheral veins, obesity, extreme dehydration or previous IV drug use. For these patients, finding a suitable location for the implementation of life-saving treatment often becomes a difficult and frustrating task. Therefore, many patients suffering from life-threatening emergencies may die when access to the vascular system by life-saving IV treatment is delayed or simply impossible.

[0006] In many cases, it is necessary to introduce drugs or other liquids into the bone marrow of a subject's bones. For example, in the case of a subject suffering from severe trauma or cardiac arrest, it may be impractical to deliver liquids by means of intravenous (IV) infusion. Intraosseous infusion can also be used to deliver fluids to newborns and young children who have difficulty accessing suitable blood vessels. Intraosseous infusion can be used to deliver fluids to a subject's sternum, humerus, femur, tibia or other bones. The advantage of intraosseous infusion is that, with appropriate technology, an intraosseous infusion pathway can be established very quickly. This can save lives in critical situations. The entrance in the bone can also be used to extract or aspirate fluid from the bone.

[0007] The intraosseous (IO) space provides a direct conduit to the patient's vascular system and offers an attractive alternative route for the infusion of IV medications and fluids. Medication infused intraosseously enters the patient's circulatory system, so the bone marrow can function as a large, non-collapsible vein.

[0008] Proper placement of an intraosseous needle within a bone is critical. If a user attempts to insert a needle in the wrong place, the bone may be too thick and therefore difficult for the needle to penetrate. Alternatively, the bone may be too thin; in such a case, the needle may fully penetrate the anterior and posterior sides of the bone and completely miss the intraosseous area. Additionally, placing the needle at an angle that is not substantially perpendicular to the surface of the bone may result in needle breakage or other complications. Additionally, certain powered drivers are unable to successfully penetrate bone when their respective power sources are exhausted. Furthermore, conventional driver assemblies can be dangerous if the user accidentally mishandles the sharp penetrator tip prior to a planned insertion procedure. For example, without adequate sharps protection, a user could easily accidentally stab themselves or someone else with the penetrator.

[0009] Therefore, there is a need for an intraosseous access device and locator assembly that is operable to locate a suitable insertion site and provide quick and easy access to the intraosseous space within a patient's bone. Summary of the invention

[0010] According to the present invention, the aforementioned needs are met by embodiments of a device for entering an intraosseous space within a patient's bone. According to one aspect of the present invention, the device includes a penetrator assembly having a sharp penetrating end, the sharp penetrating end being configured to penetrate the bone and associated bone marrow; a manual driver connected to the penetrator assembly, the manual driver including a handle, the handle being operable to manually drive the penetrator assembly into the bone and associated bone marrow; a protective shield having a distal end and a proximal end, the protective shield being slidably connected to the handle and defining a longitudinal hollow passage extending between the distal end and the proximal end; wherein the protective shield is operable to move between an extended position and a retracted position, in which the sharp penetrating end of the penetrator assembly is disposed in the longitudinal hollow passage of the protective shield to provide sharps protection, and in which the sharp penetrating end of the penetrator assembly is disposed outside the longitudinal hollow passage of the protective shield to allow the penetrator assembly to penetrate into the intraosseous space.

[0011] According to another aspect of the invention, the distal end of the protective cover defines an opening sized to receive the penetrator assembly.

[0012] According to another aspect of the invention, the distal end of the protective cover includes a blunt surface operable to contact the patient's skin without cutting the skin.

[0013] According to another aspect of the invention, the protective cover is removably connected to the handle.

[0014] According to another aspect of the present invention, the driver further includes an internal recess configured to slidably receive the protective cover.

[0015] According to another aspect of the invention, the proximal end of the protective cover includes resilient fingers.

[0016] According to another aspect of the invention, at least two spaced apart resilient fingers are disposed along the circumference of the proximal end of the protective cover.

[0017] According to another aspect of the invention, each resilient finger includes an outwardly projecting ridge configured to provide a friction fit within an inner recess of the driver to retain the boot in a desired position.

[0018] According to another aspect of the present invention, the inner recess has a shape corresponding to that of the protective cover.

[0019] According to another aspect of the present invention, the protective cover is generally cylindrical, and the inner recessed portion is correspondingly annular.

[0020] According to another aspect of the present invention, the penetrator assembly further includes an outer penetrator and an inner penetrator, the outer penetrator defining a longitudinal hollow bore, the inner penetrator being slidably received within the hollow bore of the outer penetrator.

[0021] According to another aspect of the invention, the inner penetrator comprises a rigid stylet and the outer penetrator comprises a flexible cannula.

[0022] According to another aspect of the invention, an outer penetrator hub is connected to the outer penetrator, the outer penetrator hub being removably attached to the manual driver.

[0023] According to another aspect of the invention, the outer penetrator hub includes a proximal end including an externally threaded surface configured to releasably engage a corresponding internally threaded surface of the manual driver.

[0024] According to another aspect of the present invention, the manual driver further includes an inner penetrator hub connected to the inner penetrator.

[0025] According to another aspect of the invention, a skirt extends from the handle.

[0026] According to another aspect of the invention, the skirt includes a distal end having an outwardly extending flange.

[0027] According to another aspect of the invention, the handle has an ergonomic shape suitable for gripping during manual insertion of the penetrator assembly into a bone and associated bone marrow; and the handle is configured to allow application of manual force and simultaneous rotation of the handle.

[0028] According to another aspect of the present invention, the device also includes a sternum locator, which includes: a base having a first surface, a second surface, and a through hole extending through the base; and a collar extending from the first surface of the base, the collar being configured to fix the manual driver to limit the longitudinal separation of the manual driver from the locator, the collar surrounding the through hole and defining a channel, the channel being configured to receive the protective cover for guiding the penetrator assembly into the intrabone space during the insertion process without limiting the movement of the protective cover between its extended position and retracted position.

[0029] According to another aspect of the present invention, the collar further includes a collar contact surface configured to contact a distal end of a skirt extending from the manual driver to prevent further insertion of the penetrator assembly into the intrabone space.

[0030] According to another aspect of the present invention, the locator further includes a bone probe extending from the second surface of the base.

[0031] According to another aspect of the invention, the positioner is operable to be removed from a patient while an outer penetrator of the penetrator assembly remains inserted into an intraosseous space of the patient.

[0032] According to another aspect of the present invention, a method for accessing an intraosseous space in a patient's sternum includes: providing an intraosseous access device, the intraosseous access device including a penetrator assembly having a sharp penetrating end, a manual driver connected to the penetrator assembly, and a protective cover slidably connected to the driver and defining a longitudinal hollow channel; providing a sternum locator, the sternum locator including a base having a first surface and a second surface, a through hole extending through the first surface and the second surface of the base, a collar extending from the first surface of the base and surrounding the through hole, and a bone probe extending from the second surface of the base; positioning the through hole of the sternum locator on the sternum; inserting the bone probe into the patient's body until the bone probe contacts the sternum; introducing the protective cover of the intraosseous access device into the through hole of the base of the locator to guide the penetrator assembly into the sternum; and manually inserting the penetrator assembly into the intraosseous space of the sternum.

[0033] According to another aspect of the invention, manually inserting the penetrator assembly includes grasping an ergonomically shaped handle of the driver and manually applying force to an insertion location while manually rotating the handle.

[0034] According to another aspect of the invention, the distal end of the protective cover contacts the patient's skin during insertion of the penetrator assembly into the intraosseous space.

[0035] According to another aspect of the invention, the protective cover is moved from the extended position to the retracted position during insertion of the penetrator assembly into the intraosseous space.

[0036] According to another aspect of the present invention, the penetrator assembly includes an inner penetrator and an outer penetrator, wherein the inner penetrator is slidably disposed within a longitudinal hollow bore of the outer penetrator.

[0037] According to another aspect of the invention, the inner penetrator is withdrawn from the outer penetrator while the outer penetrator remains inserted into the intraosseous space.

[0038] According to another aspect of the invention, the positioner is withdrawn from the patient while the outer penetrator remains inserted into the intraosseous space.

[0039] According to another aspect of the present invention, during the withdrawal of the inner penetrator from the intrabone space, the protective cover is moved back from the retracted position to the extended position, thereby providing sharps protection for the inner penetrator.

[0040] Thus, certain aspects of the invention have been outlined in order that the detailed description thereof may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional embodiments of the invention which will be described hereinafter and which form the subject of the appended claims.

[0041] In this regard, before explaining in detail at least one aspect of the intraosseous access device, it should be understood that the device is not limited in its application to the structural details and arrangements of components set forth in the following description or shown in the accompanying drawings. In addition to those aspects described, the intraosseous access device can have other aspects and can be practiced and implemented in various ways. In addition, it should be understood that the phraseology and terminology used herein, as well as the abstract, are for descriptive purposes and should not be regarded as limiting.

[0042] Therefore, it should be appreciated by those skilled in the art that the concepts upon which the present invention is based can be readily used as the basis for designing other structures, methods and systems for achieving the multiple purposes of the present invention. Therefore, it is important that the claims be deemed to include such equivalent structures without departing from the spirit and scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] To facilitate understanding of the present invention, aspects of an intraosseous (IO) access device are shown by way of example in the accompanying drawings, wherein like parts are designated by like reference numerals throughout.

[0044] Figure 1 A schematic diagram of the human thoracic cavity is shown.

[0045] Figure 2 A cross-sectional view of the region of the human sternum is shown.

[0046] Figure 3 A partially exploded side view of an intrabone access device according to the present invention is shown.

[0047] Figure 4A A side view of an intrabone access device of the present invention is shown.

[0048] Figure 4B Shows Figure 4A Top view of the intraosseous access device.

[0049] Figure 4C Shows Figure 4ABottom view of the intraosseous access device.

[0050] Figure 4D Shows Figure 4A Cross-sectional side view of an intraosseous access device.

[0051] Figure 5 A perspective view of a shield of the intrabone access device of the present invention is shown.

[0052] ] Figure 6 A side view of an inner penetrator of an intrabone access device of the present invention is shown.

[0053] Fig. 7A A top perspective view of a sternum positioner of the intraosseous access device of the present invention is shown.

[0054] Figure 7B A bottom perspective view of a sternum localizer of the intraosseous access device of the present invention is shown.

[0055] Figure 7C A top view of the sternum locator of the present invention is shown.

[0056] Fig.7D A bottom view of the sternum locator of the present invention is shown.

[0057] Fig. 7E A side view of the sternum locator of the present invention is shown.

[0058] Figure 8 Shows Figure 7C Cross-sectional view of the sternum locator taken along line 8-8.

[0059] Fig. 9A A perspective view of a bone probe according to the present invention is shown.

[0060] Fig. 9B Shows Fig. 9A Side view of the bone probe.

[0061] Fig. 9C A perspective view of a bone probe according to another embodiment of the present invention is shown.

[0062] Fig.9D Shows Fig. 9C Side view of the bone probe.

[0063] Fig. 10A A perspective view of a stabilizer according to the invention is shown.

[0064] Fig. 10B A top view of an adhesive patch of a stabilizer according to the invention is shown.

[0065] Fig. 10CA perspective view of an adhesion stop of a stabilizer according to the invention is shown.

[0066] Fig.11 A perspective view of an intrabone access device and locator assembly according to the present invention is shown.

[0067] Fig.12 A side view of an intrabone access device and locator assembly according to the present invention is shown.

[0068] Fig.13 Shows Fig.12 A cross-sectional view of the intrabone access device and locator assembly taken along line 13-13.

[0069] Fig.14 A cross-sectional view of an intrabone access device and a locator assembly with a manual driver removed according to the present invention is shown. DETAILED DESCRIPTION

[0070] The present invention provides an intraosseous access device and locator assembly for locating a suitable insertion site and penetrating the underlying bone (e.g., the sternum of a human patient), and quickly and easily providing access to the intraosseous space within the bone for related medical procedures (including delivery of fluids and medications, aspiration and bone marrow biopsy, etc.).

[0071] Figure 1 A schematic diagram of a human thoracic cavity 10 is depicted. The sternum 2 is a flat, narrow bone between the ribs 6, and includes three parts: the manubrium, the body, and the xiphoid process. The sternum also includes a sternal notch 104 (also called a "suprasternal notch" or "jugular notch"), which is a U-shaped anatomical feature located above the sternum, below the throat, and between the clavicles. Figure 2 A cross-sectional view of a portion of a sternum 2 is shown. Skin 11 covers a layer of subcutaneous tissue 12, which in turn covers bone 14. Bone 14 includes an intraosseous space 16, which is bounded by anterior compact bone (i.e., anterior cortex) 15 and posterior compact bone (i.e., posterior cortex) 17. In other words, the intraosseous space 16 is the region in the bone between the anterior cortex and the posterior cortex. Bone marrow includes blood, hematopoietic cells, and connective tissue established within the intraosseous space.

[0072] In most adult patients, the anterior compact bone 15 and the posterior compact bone 17 are each approximately 2.0 millimeters (mm) thick, and the intraosseous space 16 is approximately 10.0 mm thick. Therefore, the total thickness of the bone 14 is approximately 14.0 mm. The target area within the intraosseous space 16 is the center, which in most adult patients is approximately 7.0 mm from the upper surface of the anterior compact bone 15.

[0073] The intraosseous space 16 can be entered by an IO device, which may include but is not limited to a hollow needle, a hollow drill, a bone penetrator, a catheter, a cannula, a trocar, a stylet, an inner penetrator, an outer penetrator, a needle or a trocar, or other devices operable to provide access to the intraosseous space or the interior of the bone. Such an IO access device may be formed at least in part by a metal alloy, such as 304 stainless steel and other biocompatible materials associated with a needle and similar medical devices. A variety of IO access devices may be formed according to one or more teachings of the present invention. For example, during insertion at a selected insertion position, a variety of trocars, spindles and / or shafts may be provided in the cannula. The inner penetrator may include such trocars, shafts and rods, etc. In addition, the inner penetrator may include various lengths, including but not limited to 20 to 50 mm (e.g., between 35 and 40 mm, 38.5 mm and / or the like). The outer penetrator may include a catheter, a cannula, a hollow needle and a hollow drill, etc. In some embodiments, the penetrator assembly may include a flexible outer penetrator and a rigid inner penetrator as disclosed in International Patent Application No. PCT / IB2019 / 053900, which is incorporated herein by reference in its entirety.

[0074] Figure 3 An embodiment of an IO access device 100 of the present invention and its components is shown, and the IO access device is configured for manual insertion into the intraosseous space of a subject. The intraosseous access device 100 includes a manual driver 101, which includes a handle or grip 110 connected to an inner penetrator sleeve 108, and the inner penetrator sleeve 108 is attached to a rigid inner penetrator 111. The inner penetrator 111 can, for example, take the form of any suitable stylet or trocar. The inner penetrator 111 includes a distal end having a tip 102, which is configured to penetrate bone and associated bone marrow. The inner penetrator 111 also includes a proximal end, which may have a notch 112 configured to facilitate connecting the inner penetrator sleeve 108 to the inner penetrator 111, such as Figure 4D and Figure 6For example, the inner penetrator 111 can be overmolded on the inner penetrator 111 so that material from the inner penetrator 111 can be molded to extend into the recess 112. The inner penetrator 111 is surrounded by an annular skirt 105 that is connected to and extends from the handle 110. The distal end 116 of the skirt 105 includes an annular flange 119 extending radially outward therefrom. In some embodiments, the inner penetrator 111 extends from the handle or grip 110 and further extends from the distal end 116 of the skirt 105.

[0075] IO access device 100 also includes an outer penetrator sleeve 106 connected to an outer penetrator 113. The outer penetrator 113 can take the form of, for example, a hollow tube, such as a cannula (e.g., a metal cannula) or a hollow drill bit, and the outer penetrator (e.g., in order to have sufficient rigidity) can be configured so that the outer penetrator 113 will not bend or be damaged when passing through the anterior dense bone together with the inner penetrator 111. In other embodiments, the outer penetrator 113 can be flexible so that it can be manipulated after being inserted into the intraosseous space (i.e., by bending a portion of the outer penetrator to fix it to the patient's skin together with the outer penetrator sleeve 106 to provide a lower profile). The outer penetrator sleeve 106 includes a proximal end 107 and a distal end 109. The outer penetrator 113 also includes a proximal end and a distal end 117, and the proximal end of the outer penetrator 113 is connected to the outer penetrator sleeve 106. The outer penetrator distal end 117 includes a cutting surface that is operable to penetrate the bone and the associated bone marrow. The outer penetrator 113 extends from the distal end 109 of the outer penetrator hub 106 .

[0076] Inner penetrator hub 108 is configured to be removably attached to outer penetrator hub 106. More specifically, proximal end 107 of outer penetrator hub 106 and inner penetrator hub 108 can be configured as complementary connectors (e.g., inner penetrator hub 108 includes a female Luer connector, while proximal end 107 of outer penetrator hub 106 is configured as a male Luer connector, but these configurations can be reversed in other embodiments) to allow manual driver 101 to be removably connected to outer penetrator 113. For example, outer penetrator hub 106 (and, more specifically, proximal end 107 of outer penetrator hub 106) can include an outer surface 114 that is threaded and proximate to a passageway that is in fluid communication with the passageway of outer penetrator 113. Inner penetrator hub 108 can include an inner surface 115 that is threaded to mate with outer threaded surface 114 at proximal end 107 of outer penetrator hub 106. The inner threaded surface 115 is adjacent to and surrounds a male projection that tapers to match an inwardly tapered recess in the proximal end 107 of the outer penetrator bushing 106 .

[0077] The outer penetrator 113 includes a longitudinal channel configured to slidably receive a portion of the inner penetrator 111 when the inner penetrator sleeve 108 is attached to the outer penetrator sleeve 106, thereby forming a penetrator assembly. The handle or handle 110 of the manual driver 101 is configured to manually drive the penetrator assembly into the bone intramedullary space, and the handle or handle has an ergonomic shape, such as a round or dome-shaped handle, suitable for grasping and manually applying force during the manual insertion of the inner and outer penetrators into the bone and the associated bone marrow. The handle or handle 110 is configured to allow the application of manual force and simultaneously allow the handle to rotate during the insertion of the penetrator assembly into the IO space.

[0078] When the driver 101 and the outer penetrator 113 are connected to each other, the inner penetrator 111 is disposed within the channel of the outer penetrator 113, and the inner penetrator tip 102 extends beyond the distal end 117 of the outer penetrator 113. Both the inner penetrator tip 102 and the outer penetrator distal end 117 are operable to penetrate bone and associated bone marrow. More specifically, the inner penetrator tip 102 and the outer penetrator distal end 117 are configured to cooperate with each other to form a penetrator assembly tip that is operable to penetrate bone and associated bone marrow when the inner penetrator bushing 108 is attached to the outer penetrator bushing 106.

[0079] like Figures 4A-4D and Figure 5 As shown, the IO access device 100 may also include a protective shield or cover 120. The cover 120 is configured to move between a first or extended position and a second or retracted position, the first or extended position being operable to provide sharp piece protection to the distal ends of the inner penetrator and the outer penetrator, and the second or retracted position being operable to guide the penetrator assembly to be inserted into the IO space of the insertion position when a positioner is used, which will be discussed in further detail below. The cover 120 includes a blunt (i.e., not sharp) distal end 121 having an opening 122. The cover 120 also includes a proximal end 124. The cover 120 may have a generally tubular shape and define a longitudinal hole extending from the distal end 121 to the proximal end 124. When the cover is in the first or extended position, the inner penetrator 111 and / or the outer penetrator 113 may be disposed within the opening 122 to protect the user or operator of the IO access device 10 (and the subject using the device) from being accidentally stabbed by the inner and / or outer penetrator tips.

[0080] The proximal end 124 of the cover 120 may include a plurality of elastic fingers 125 arranged annularly along its circumference, each finger including a corresponding ridge or nub 126 protruding radially outward from it. The proximal end 124 of the cover 120 may be slidably connected to the manual driver 101 by an internal groove or recess 118 of a corresponding shape, which is arranged between the inner penetrator bushing 108 and the handle 110. For example, in an embodiment in which the protective cover 120 has a generally tubular shape, the corresponding inner recess 118 is annularly arranged in the driver. More specifically, each ridge or nub 126 arranged on the elastic fingers 125 of the cover 120 is operable to provide a friction fit in the recess 118 of the driver to keep the cover in a desired position, such as in an extended position or in a retracted position. The cover 120 can be separated from the driver 101 so that the driver can be used to insert the periphery of the penetrator assembly into the intrabone space.

[0081] In some embodiments, handle 110 and inner penetrator sleeve 108 can be attached to each other by the binding piece made by ultraviolet light (UV) curing adhesive. In other embodiments, handle 110 and inner penetrator sleeve 108 can be one-piece (for example, by injection molding) with each other, thereby form a single integral structure. In other embodiments, handle 110 and inner penetrator sleeve 108 can be connected by force, or otherwise adhere to each other, and in other embodiments, handle 110 and inner penetrator sleeve 108 can be removably connected to each other, so that they can separate and do not destroy, damage or weaken the function of the two, for reuse. In other embodiments, handle 110 can be directly connected to outer penetrator sleeve 106, so that there is no inner penetrator sleeve 108 in between, and inner penetrator 111 is directly attached to handle 110.

[0082] The tip 102 of the inner penetrator 111 is sharpened and configured to allow the IO access device 100 to be driven into, for example, the intraosseous space 16 into the intraosseous space. The inner penetrator 111 fits tightly within the channel of the outer penetrator 113 so that the inner penetrator 111 prevents the outer penetrator 113 from being blocked by tissue (e.g., skin, bone, bone marrow) when the IO access device 100 is driven into the insertion site of the subject (e.g., patient). In some embodiments, the inner penetrator tip 102 and the outer penetrator distal end 117 can be ground together to form corresponding cutting surfaces, wherein the inner penetrator 111 and the outer penetrator 113 both include suitable metals. In other embodiments, the inner penetrator tip 102 and the outer penetrator distal end 117 can be ground separately to form corresponding cutting surfaces configured to penetrate the bone and the associated bone marrow. Once IO access device 100 is properly positioned at the insertion site, manual driver 101 can be disengaged from outer penetrator hub 106, exposing proximal end 107 (which can take the form of a male Luer lock) and forming a conduit from outer penetrator hub 106 through outer penetrator 113 to the intraosseous space. A fluid source can then be connected to proximal end 107 of outer penetrator hub 106 to deliver fluid through outer penetrator 113 and into the intraosseous space.

[0083] Figures 7A-7E Various views of a sternum locator 200 for use with an IO access device 100 are depicted. The locator 200 is operable to assist a user in locating an insertion site on a patient's sternum and facilitate insertion of the IO access device 100 into an intraosseous space. The locator 200 includes a rounded collar 210 and a base 230 protruding from the rounded collar 210. The base 230 includes a top surface 232 and an underside surface 236. The base 230 also includes an alignment feature 234, as will be discussed in detail below.

[0084] The round collar 210 includes a collar contact surface 212 and an annular through hole or channel 214 extending through the locator. The collar 210 also includes a plurality of longitudinally oriented elastic locking tabs 216 spaced apart from each other (i.e., spaced apart circumferentially at intervals of 120 degrees). In some embodiments, as shown, there may be three locking tabs 216. In other embodiments, there may be more or fewer locking tabs 216 (e.g., 1, 2, 3, 4, 5, 6, 7, 8 or more tabs). The through hole 214 extends from the collar contact surface 212 to the bottom surface 236 of the base. The collar contact surface 212 is configured to contact the annular flange 119 at the distal end 116 of the skirt 105 to prevent the penetrator assembly from being further inserted into the bone space, thereby providing a depth stop for the IO access device. The collar contact surface 212 is an example of a proximal-facing surface adjacent to the channel of the penetrator configured to receive the IO access device.

[0085] The collar 210 is configured to connect the locator 200 to the IO access device 100, and more specifically, one or more locking clips 216 of the collar 210 are configured to secure the locator 200 to the IO access device 100. For example, each clip 216 has an inwardly projecting portion 216i that includes a surface 216s that is configured to cover a portion of the inner penetrator bushing 108 of the IO access device 100 (and more specifically, the flange 119 at the distal end 116 of the skirt 105). At least a portion of each surface 216s can be oriented at a non-zero (e.g., perpendicular) angle relative to the insertion direction of the IO access device 100. More specifically, each surface 216s can be configured to be complementary to the shape of the portion of the flange 119 at the distal end 116 of the skirt 105 that will be contacted after the IO access device 100 is inserted into the intraosseous space, which portion can be on the proximally facing surface of the flange 119. Thus, surface 216s is configured to block or prevent removal of inner penetrator 111 after inner penetrator 111 and outer penetrator 113 are inserted into the intraosseous space.

[0086] Each locking clip 216 (and more specifically, each vertical member 216v of each clip 216) is configured to flex outwardly from the center of collar 210 when the inwardly tapered outer surface 216t of projection 216i contacts the distally facing surface of flange 119 at distal end 116 of skirt 105, and then snap inwardly as surface 216s passes over flange 119, thereby locking IO access device 100 in place. It should be understood that the number of clips used can be adjusted to best suit the shape of the IO access device being used.

[0087] The locking buckle 216 is configured to stabilize the IO access device by resisting any outward longitudinal movement of the IO device (meaning moving out of the bone space along the insertion direction) and any movement caused by the tilting of the IO device from side to side or other lateral movement. The collar 210 also includes a longitudinally oriented element 256 having an inwardly tapered surface 256t and a curved inner surface (shaped like the inner side of a cylinder) 256s. These elements are higher than the locking buckle 216 and are used to guide the IO device to a suitable position when the IO access device enters the space defined by the collar 210, which also helps to prevent damage to the buckle 216. The longitudinally oriented elements 256 also help to resist any lateral tilting or movement of the IO device. Each element 256 includes at least one longitudinally oriented rib 258, which is used to increase the rigidity of the element 256 (and tend to resist lateral bending). Each rib includes an enlarged portion that surrounds a portion of the bone probe 30.

[0088] The alignment feature or notch 234 of the locator 200 is an arcuate portion of the base 230. The alignment feature 234 is configured to approximate the shape of the sternal notch 4 of a human patient and is operable to indicate proper placement of the locator 200. When the locator is placed on the sternum, the locator is properly positioned on the patient's chest such that the sternal notch is visible and is at least partially (and preferably completely) defined by the alignment feature 234.

[0089] The most inwardly curved portion of the alignment feature 234 is spaced a distance D from the center of the through hole 214. A (i.e., D A is the shortest distance between the hole 214 and the alignment feature 234. In some embodiments, D A It may be approximately 21 mm. In other embodiments, D A It can be in the range of about 10 mm to about 35 mm. The outer edge of the base 230 can be about 7 mm from the closest position on the nearest locking buckle 216, so that the distance D F It may be about 7 mm. In other embodiments, D F It may be in the range of from about 0 mm to 15 mm. Some other embodiments of the present positioner 200 may not include the base 230 .

[0090] The retainer 200 includes a plurality of openings 238 in the bottom surface 236 of the base 230. For example, Figure 7B and 7D Six openings 238 are depicted, but other embodiments may have more or fewer openings (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more openings). A recess 239 extends from each opening 238 into a corresponding rib 258 of a corresponding longitudinally oriented element 256. Figure 8 As shown, each recess 239 is configured to receive a corresponding bone probe 30. Other embodiments may include more or fewer recesses (and associated openings) configured to receive more or fewer bone probes 30.

[0091] like Fig. 9A and 9BAs shown, each probe 30 includes a tip 32, a plurality of circumferential grooves or notches 34, and a proximal end 36, wherein the notches 34 are closer to the proximal end 36 than the tip 32. The probe 30 may include stainless steel, but other suitable sterile or biocompatible materials may be used (or materials that can be made sterile before use on a patient). The proximal end 36 is configured to be inserted into an opening 238 and a corresponding recess 239 of the locator 200. In some embodiments, the bone probe 30 may be fixed to the locator 200, for example, by bonding to the locator 200 using a UV-curable adhesive applied to the recess 239 and / or the notches 34 and / or the proximal end 36 of the probe. In other embodiments, the bone probe 30 may be pressed through the opening 238 and into the recess 239 so that the probe is held in place by friction between the probe and the material of the locator in contact with the probe, thereby forming an interference fit. In other embodiments, the probe 30 may be fixed to the locator 200 as part of an injection molding process or using an epoxy resin. Each probe 30 may comprise any of a variety of lengths, and the probe 30 may extend, for example, approximately 19 to 24 millimeters from a proximal-facing surface adjacent the channel (eg, from the collar contact surface 212).

[0092] Fig. 9C and 9D Another embodiment of a bone probe 30a suitable for use with a locator 200 is depicted. Each probe 30a includes a tip 32a, a circumferential groove or notch 34a, and a proximal end 36a, wherein the notch 34a is closer to the proximal end 36a than the tip 32a. Each probe 30a may include stainless steel, but other suitable sterile or biocompatible materials may be used (or materials that can be made sterile before use in a patient). The proximal end 36a is configured to be inserted into a corresponding recess 239 of the locator 200 through an opening 238. The probe 30a can be fixed to the locator 200, for example, by using a UV-curable adhesive applied to the recess 239 and / or the notch 34 and / or the proximal end 36 of the probe to bond to the locator 200. In other embodiments, the probe 30a can be pressed into the opening 238 and the recess 239 so that the probe is held in place by friction between the probe and the material of the locator in contact with the probe, thereby forming an interference fit. In other embodiments, the stylet 30 can be secured to the retainer 200 as part of an injection molding process or using epoxy. The stylet 30 can include any length and can extend, for example, approximately 19 to 24 millimeters from a proximal-facing surface adjacent the channel (e.g., from the collar contact surface 212).

[0093] FIG. 10 a shows a stabilizer 20 configured to be placed on a subject's (e.g., human patient's) chest near the sternum 14 and aligned with the sternal notch 4. The stabilizer 20 is also configured to ensure proper placement of the IO access device in the intraosseous space 16. The stabilizer 20 includes a locator 200, the base of which is located and connected between a stabilizer dressing, which includes a top sheet 40 and an adhesive stopper 50. In addition, the top sheet 40 and the adhesive stopper 50 are connected to each other. The adhesive stopper 50 includes an adhesive member configured to adhere the stabilizer 20 to the subject's (e.g., the skin on the chest of a human patient) during use.

[0094] The top sheet 40 may include a single-sided tape, such as 3M 1526 polyethylene single-coated tape. The top sheet 40 is oriented so that the adhesive side of the tape connects the top sheet 40 to the top surface 232 of the base 230 and the adhesive stopper. The adhesive stopper 50 may include any standard medical grade adhesive. For example, the adhesive stopper may include a double-sided tape, such as 3M 1522 transparent polyethylene double-coated tape. One side of the adhesive stopper 50 is connected to the bottom surface 236 of the base 230 and the top sheet 40, and the other side of the adhesive stopper 50 is connected to at least one liner (such as release paper).

[0095] As shown in Figs. 10b and 10c, the adhesive stopper 50 is connected to a removable first pad 62 and a removable second pad 64. The removable pads 62, 64 cover the bottom adhesive side of the adhesive stopper 50 (e.g., to prevent the stabilizer 20 from undesirably sticking). When the stabilizer 20 is ready for use, the user can remove the pads 62, 64 and the stabilizer 20 can be placed on the patient's chest.

[0096] Some embodiments of the stabilizer may not include the top sheet 40 or the adhesive stop 50. For example, the stabilizer 20 may not require any adhesive features for connecting the template to the patient's chest. In other embodiments, the bottom surface 236 of the base 230 can be coated with an adhesive that is applied directly to the locator 200 (i.e., without requiring a tape layer as described above). In such embodiments, one or more pads can be directly connected to the locator 200 to prevent unwanted adhesion. Embodiments of the stabilizer that include an adhesive, such as an adhesive applied directly to the bottom surface of the flange of the stabilizer or an adhesive on the bottom (distal) surface of the adhesive member, can be configured to adhere to the skin of a subject.

[0097] Fig.11Depicted is an intraosseous access assembly including an IO access device 100 and a locator 200 prior to use in a patient (top sheet 40 and adhesive stop 50 are omitted for clarity). The locator 200 is operable to locate the preferred position of the IO access device 100 for insertion (e.g., drive) into the patient's sternum, i.e., by using the alignment feature 234 as previously described in detail above. The locator 200 is also configured to guide the IO access device 100 into the intraosseous space, i.e., by using the cap 120 as a guide to allow the penetrator assembly of the IO access device to pass through the through hole 214 of the locator and enter the intraosseous space of the patient. Prior to use in a patient, the cap 120 is operable to provide sharp piece protection to the distal ends of the inner penetrator and the outer penetrator. The cap 120 is also operable to provide sharp piece protection to the distal end of the inner penetrator when the driver is separated from the outer penetrator after entering the intraosseous space.

[0098] Fig.12 and 13 An intrabone access assembly is depicted when used on a human patient, the intrabone access assembly comprising the IO access device 100 connected to the positioner 200 (the top sheet 40 and adhesive stop 50 are omitted for clarity). D1 is the distance from the collar contact surface 212 to the top surface 232 of the base 230. D2 includes the thickness of any adhesive or any 50 (not shown) on the base 230 and the bottom surface 236. D3 is the distance from the bottom surface 236 or any adhesive or any adhesive member attached to the bottom surface 236 to the tip 32 of the bone probe 30. D4 is the distance from the bone probe tip 302 to the tip 102 of the inner penetrator 111. Therefore, the entire exposed length of the penetrator assembly (the portion of the inner penetrator 111 and the outer penetrator 113 that extends beyond the outer penetrator bushing 106)) is D1+D2+D3+D4.

[0099] In some embodiments, D l2. D1 may be approximately 5.25 mm, D2 may be approximately 2.0 mm, D3 may be approximately 23.5 mm, and D4 may be approximately 7.75 mm; therefore, the penetrator assembly may be exposed or protrudes approximately 38.5 mm beyond the outer penetrator bushing 106. In addition, the bone probe 30 may be exposed or protrudes approximately 23.5 mm beyond the bottom surface 236 of the locator 200. In some embodiments, the inner penetrator 111 may protrude approximately 1.5 mm beyond the outer penetrator 113. When the IO access device 100 is connected to the locator 200 so that the buckle 216 is in the locked position (and the surface 216s is supported against the upper surface of the flange portion 119 of the distal end 116 of the skirt 105), the inner penetrator 111 may extend approximately 7.0 to 8.0 mm beyond each of the plurality of bone probes 30. Depending on the application, the exposed portions of the inner penetrator 111, the outer penetrator 113, and the bone probe 30 may be less or more than shown and described. For example, when sternum locator 200 and IO access device 100 are intended for use with infants or children, inner penetrator 111 and bone probe 30 may be shorter (and inner penetrator 111 may extend a shorter distance beyond probe 30). In addition, when sternum locator 200 and IO access device are intended for use with obese patients, tall patients, or patients with thicker than normal sternums, inner penetrator 111 and probe 30 may be longer (and inner penetrator 111 may extend a greater distance beyond probe 30). In other embodiments, D1 may be approximately 5.25 mm, D2 may be approximately 1.25 mm, D3 may be approximately 23.5 mm, and D4 may be approximately 6.0 mm; such that the penetrator assembly is exposed or protrudes approximately 32 mm beyond outer penetrator sleeve 106 and / or probe 30 protrudes approximately 19.5 mm beyond bottom surface 236 of locator 200. Any dimension listed herein as "approximately" may also be substantially (including exactly) equal to the given value.

[0100] In order to use the sternum locator 200, the user first locates the patient's sternum notch 4 by feeling the U-shaped cavity above the sternum, below the throat and between the clavicles. The user then aligns the alignment feature 234 of the locator with the sternum notch 4 to ensure the balance of the sternum locator on the patient's sternum. Along with the sternum locator 200 being properly aligned, the user then applies pressure to the sternum locator 10 so that the bone probe 30 penetrates the skin 11 and the muscle 12 until the bone probe contacts the front dense bone 15 (the upper surface of the sternum). Therefore, once the bone probe 30 contacts the bone, the bone probe 30 provides a depth stopper for the locator 200. The bone probe 30 can penetrate into a certain edge distance in the front dense bone 15, such as about 0.5mm to about 1.0mm, but does not penetrate into the bone intra-space 16. The user then removes the removable pads 62, 64 of the stabilizer dressing and presses the adhesive stopper 50 on the skin 11 to ensure that the adhesive stopper 50 adheres to the patient's skin.

[0101] The thickness of the skin 11 and the subcutaneous tissue 12 may be equal to the thickness of the exposed length D3 of the bone probe 30. However, the thickness of the skin 11 and the subcutaneous tissue 12 may vary widely depending on the patient. Therefore, in some patients, the length of the probe 30 may exceed the tissue thickness, so that the locator base 230 is not flush with the skin 11, and thus a portion of the probe 30 is exposed. In this case, the adhesive layer 50 provides additional stabilization by fixing the sternum locator 200 to the patient's chest.

[0102] Once the stabilizer 200 is securely secured to the patient's chest, the user then introduces the distal portion of the IO access device 100 (including the inner penetrator tip 102, the outer penetrator distal end 117, and the distal end of the cap 120) into the through hole 214 in the base 230 of the locator 200. The through hole 214 includes an annular shape that is complementary to the annular shape of the tubular cap 230 so that the cap is guided through the through hole during insertion. The user applies pressure and rotates, twists, or reciprocates the IO device 100 (possibly backwards and forwards, but not necessarily all the way, so that the driving movement can be characterized as reciprocating, twisting, or non-rotational motion (meaning that a full rotation is not utilized)) until the inner penetrator 111 and the outer penetrator 113 pierce the skin 11, subcutaneous tissue 12, and anterior dense bone 15. During this insertion process, the distal end 121 of the cap 120 contacts the skin 11 but does not penetrate it because the distal end is blunt (i.e., not sharp). When the inner penetrator and the outer penetrator are inserted into the intraosseous space, the cover 120 is then moved from the extended position to the retracted position. In some cases, the intraosseous access device 100 can be used in a peripheral insertion position, such as the humerus or tibia of a patient, without the positioner 200. During such a peripheral insertion process, since the distal end is blunt (i.e., not sharp), the distal end 121 of the cover 120 contacts the skin 11 but does not penetrate it. When the inner penetrator and the outer penetrator are inserted into the intraosseous space, the cover 120 is operable to move from the extended position to the retracted position.

[0103] As previously described, the collar 210, and more specifically one or more resilient locking clips 216 of the collar 210, are configured to connect (e.g., secure) the locator 200 to the IO access device 100. The IO access device 100 is properly positioned when the surface 216s of the locking clip 216 fully engages (or contacts) the flange 119 of the distal end 116 of the skirt 105. The rigidity of the resilient locking clip 216 serves to stabilize the IO access device with the sternal locator connected thereto by resisting any outward longitudinal movement of the IO access device (i.e., movement out of the intrabone space in the direction of insertion) as well as any movement caused by tilting of the IO access device from side to side or other lateral movement. The collar 210 also includes a longitudinally oriented element 256 that is higher than the buckle 216 and is operable to guide the IO access device to the proper position when the flange 119 of the distal end 116 of the inner penetrator bushing enters the space defined by the collar 210. The collar 210 also helps prevent damage to the buckle 216 and further helps resist any lateral tilting or movement of the IO access device during insertion. Each element 256 includes a pair of longitudinally oriented ribs 258 on opposite sides of the element, which are used to increase the rigidity of the element 256 (and tend to resist lateral fullness). Each rib 258 is hollow to receive and surround a portion of a corresponding bone probe 30.

[0104] In some aspects, an audible sound (e.g., a click) may be heard as the buckle 216 passes over the flange portion 119 of the distal end 116 of the skirt 105 and snaps into place. In addition, because the force required to advance the device is reduced, the user may feel the IO access device pass the buckle 216 (thus, the user may feel a tactile response of the IO access device "clicking" into place). Introducing the IO access device 100 into the patient in this manner may be described as non-surgically introducing (or inserting) the IO access device, or introducing (or inserting) the IO access device without previously making an incision using a different cutting tool (e.g., a scalpel). For most patients, the force required to drive the IO access device into locking engagement with the retainer may be greater than the force required to drive the stabilizer through the skin and subcutaneous tissue and into contact with the anterior dense bone.

[0105] like Fig.14 As shown, the driver 101 (including the handle 110, the inner penetrator sleeve 108 and the associated inner penetrator 111, and the cover 120) can then be removed from the outer penetrator sleeve 106. For example, the inner penetrator sleeve 108 can be separated from the outer penetrator sleeve 106 by rotating the handle 101 in a counterclockwise direction to disengage the threaded surface 114 of the corresponding outer penetrator and the threaded surface 115 of the inner penetrator. This allows the user to retract the inner penetrator 111 from the outer penetrator 113 while the outer penetrator remains disposed in the intraosseous space. Thus, a conduit is formed from the open proximal end 107 of the outer penetrator sleeve 106 through the opening of the outer penetrator distal end 117, which is in direct fluid communication with the intraosseous space 16. In some embodiments, a flexible outer penetrator can be used so that after removing the stabilizer assembly, the outer penetrator can be manipulated and fixed to the patient to provide a lower profile (i.e., by bending the outer penetrator downward to fix it on the skin).

[0106] A fluid source may then be connected to the proximal end 107 of the outer penetrator sleeve 106 for delivering a fluid (e.g., blood or a drug) to or aspirating a fluid from the intraosseous space 16. Additionally, upon removal of the driver 101 from the outer penetrator sleeve 106 and the positioner 200, the cap 120 is operable to move from the retracted position back to the extended position to provide sharps protection for the distal tip 102 of the inner penetrator 111.

[0107] The sternum locator 200 is also configured to be retracted from the patient's chest while the outer penetrator 113 remains disposed in the bone intraspace. In particular, when the locator is retracted from the patient, the through hole 214 passes through the outer penetrator sleeve 106 and the outer penetrator 113 is not removed from the bone intraspace. The diameter of the through hole 214 of the locator 200 is greater than the diameter of the outer penetrator sleeve 106 so that the locator can be freely lifted on the sleeve and not bumped into the sleeve. After the locator is retracted from the patient, the bone probe 30 can be inserted into the penetrable material of the sharps container.

[0108] A complete set of workpieces can be provided, comprising a package (e.g., a flexible package, e.g., a package that does not include a rigid plastic tray), the package comprising at least one of the sternum positioner of the present invention, one of the stabilizer of the present invention, one of the sharps container of the present invention, and one of the disclosed IO access devices, and instructions for use, which can be provided on the outside of the package, one of the above-mentioned components, and / or on the insert contained in the package. In addition, non-limiting examples of suitable materials for the positioner, handle, and sleeve of the present invention described above can include injection moldable plastics, such as polycarbonate. Non-limiting examples of suitable materials for the inner penetrator, outer penetrator, and probe of the present invention described above can include stainless steel, such as 304V stainless steel.

[0109] Although the intraosseous access device and the locator assembly are described using specific aspects, the present invention is not limited to the disclosed aspects. In addition, many features and advantages of the present invention are apparent from the detailed description, and therefore, the appended claims are intended to cover all such features and advantages of the present invention that fall within the spirit and scope of the present invention. In addition, the present invention is not limited to the exact construction and operation shown and described, and therefore, all suitable modifications and equivalent forms that can be adopted fall within the scope of the present invention. Therefore, the present invention should be considered illustrative rather than restrictive. Thus, the present invention is intended to cover various modifications and similar constructions included within the spirit and scope of the claims, which should be interpreted in the broadest sense to cover all such modifications and similar structures.

Claims

1. A device for accessing an intraosseous space in a patient's bone, the device comprising: a penetrator assembly having a sharp penetrating end configured to penetrate the bone and associated bone marrow; a manual driver coupled to the penetrator assembly, the manual driver including a handle operable to manually drive the penetrator assembly into the bone and associated marrow; a boot having a distal end and a proximal end, the boot slidably connected to the handle and defining a longitudinal hollow passage extending between the distal end and the proximal end, wherein the proximal end of the boot includes resilient fingers; and an inner recess in the handle, the inner recess configured to slidably receive the protective cover; wherein the protective cover is operable to move between an extended position and a retracted position, wherein in the extended position, the sharp penetrating end of the penetrator assembly is disposed in the longitudinal hollow channel of the protective cover to provide sharp member protection, and in the retracted position, the sharp penetrating end of the penetrator assembly is disposed outside the longitudinal hollow channel of the protective cover to allow the penetrator assembly to penetrate into the intrabone space, and Therein, each resilient finger includes an outwardly protruding ridge configured to provide a friction fit within an inner recess of the driver to retain the protective cover in a desired position.

2. The device according to claim 1, wherein: The distal end of the protective cover defines an opening sized to receive the penetrator assembly.

3. A device according to any one of the preceding claims, wherein: The distal end of the protective cover includes a blunt surface operable to contact the patient's skin without cutting the skin.

4. The device according to claim 1 or 2, wherein: The protective cover is removably connected to the handle.

5. The device of claim 1, further comprising at least two spaced apart resilient fingers disposed along a circumference of the proximal end of the boot.

6. The device according to claim 1, wherein: The inner recess has a shape corresponding to that of the protective cover.

7. The device according to claim 6, wherein: The protective cover is generally cylindrical, and the inner recessed portion is correspondingly annular.

8. The device according to claim 1 or 2, wherein: The penetrator assembly also includes an outer penetrator defining a longitudinal hollow bore, and an inner penetrator slidably received within the hollow bore of the outer penetrator.

9. The device according to claim 8, wherein: The inner penetrator comprises a rigid stylet and the outer penetrator comprises a flexible cannula.

10. The device of claim 8, further comprising an outer penetrator hub connected to the outer penetrator, the outer penetrator hub being removably attached to the manual driver.

11. The device according to claim 10, wherein: The outer penetrator hub includes a proximal end including an externally threaded surface configured to releasably engage a corresponding internally threaded surface of the manual driver.

12. The device according to claim 8, wherein: The manual driver also includes an inner penetrator hub connected to the inner penetrator.

13. The device of claim 12, further comprising a skirt extending from the handle.

14. The device according to claim 13, wherein: The skirt includes a distal end having an outwardly extending flange.

15. The device according to claim 1 or 2, wherein: The handle has an ergonomic shape suitable for gripping during manual insertion of the penetrator assembly into a bone and associated bone marrow; and wherein the handle is configured to allow application of manual force and simultaneous rotation of the handle.

16. The device according to claim 1 or 2, further comprising a sternum locator, the sternum locator comprising: a base having a first surface, a second surface, and a through hole extending through the base; as well as A collar extends from the first surface of the base, the collar being configured to secure the manual driver to limit longitudinal separation of the manual driver from the locator, the collar surrounding the through hole and defining a channel, the channel being configured to receive the protective cover for guiding the penetrator assembly into the intrabone space during insertion without restricting movement of the protective cover between its extended position and retracted position.

17. The device according to claim 16, wherein: The collar also includes a collar contact surface configured to contact a distal end of a skirt extending from the manual driver to prevent further insertion of the penetrator assembly into the intrabone space.

18. The device according to claim 16, wherein: The locator also includes a bone probe extending from the second surface of the base.

19. The device according to claim 16, wherein: The positioner is operable to be removed from a patient while an outer penetrator of the penetrator assembly remains inserted into the intraosseous space of the patient.

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