Retention hinge for plug-in physiological monitor syringe tool

Abstract

The invention provides a plug-in type physiological monitor syringe tool. The elongated handle includes a recess formed along a longitudinal axis and has an opening at a distal end. An insertion tube has a hollow elongate shape that is movably positioned within the elongate handle in the groove. The holding hinge is cut from the surface of the insertion tube and is formed as a curved surface inside the tube. A stationary shaft is proximally secured to the proximal end of the elongate handle and extends through the insertion tube when the insertion tube is in the retracted position. A protrusion is secured to the insertion tube, wherein the protrusion is capable of locking the insertion tube in an extended position.

Description

[0001] Priority claims and cross-references to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 357,445, filed on June 30, 2023, entitled "Retaining Hinge for Insertable Physiological Monitor Syringe Tool," the entire contents of which are incorporated herein by reference and incorporated by reference. Technical Field

[0003] The present application relates generally to medical tools, and more particularly to retaining hinges for insertable physiological monitor syringe tools. Background Art

[0004] Medical diagnosis involves the assessment of patient physiology, which describes the vital functions of the patient's anatomy (i.e., the living organism and its organs). The patient's physiological condition is determined through medical diagnostic procedures, including performing medical tests and reviewing patient data collected through monitoring when available, but first the data should be correlated with the patient's symptoms to have relevant diagnostic value.

[0005] Episodic conditions present a special challenge because a diagnostic test performed in a physician’s office may not be valid if the episodic condition fails to present when the test is performed. Episodic conditions may be due to chronic or acute causes and may include transient signs such as irregular heartbeats, muscle or nerve spasms, or hypoglycemia (or hyperglycemia) that may be accompanied by discernible symptoms. The unpredictable nature of episodic conditions often makes capturing physiological data a question of good timing. If the episodic condition does not present during the course of a medical test, no physiological data will be obtained, and therefore no diagnostic insights will be obtained.

[0006] In response, physicians have turned to mobile monitoring, which utilizes sensors placed on the patient's skin or implanted in the patient's body that are attached to recorders to provide physiological data capture as the patient goes about his or her daily life.

[0007] Ambulatory monitors that are fully implanted in the patient or that use implanted sensors generally provide clearer physiological data that is relatively free from environmental noise and influences, especially when compared to data captured by the skin. However, tools or other devices are required to perform the implantation of the ambulatory monitor. Implantation can be somewhat invasive and carry greater risks than skin or external forms of ambulatory monitoring. Typically, when an implantable medical device is inserted into a patient, some kind of insertion tube is required to guide the device through an incision into a subcutaneous pocket. Once the tube with the device inside is within the pocket, the tube can be retracted to place the device therein. The tube must be easily inserted through the incision, and the end of the tube must have some type of retaining feature so that the device does not fall out of the insertion tube before being guided to the proper insertion position.

[0008] Current implant tools may include a distal retention tab extending from a side wall of a cannula with one end attached to the side wall and an opposite end of the tab detached from and extending from the side wall to releasably retain an object in the cannula. However, while the tab serves to retain the object until it is ready for insertion, the tab prevents loading the object into the cannula from the same end from which the object is to be released.

[0009] U.S. Patent No. 2018 / 0168686 describes another implantation tool, which includes a housing member having a pair of opposing extending grooves to accommodate retaining elements. Each retaining element is coupled to the housing member.

[0010] As mentioned above, both implantation tools may prevent accidental release of the object.

[0011] Therefore, there remains a need for an implantation tool that safely and quickly injects a medical implant into a patient's body while allowing the medical implant to be inserted and released into a certain location of the patient through the same end of the implantation tool while preventing accidental release of the medical implant. Summary of the invention

[0012] The insertable physiological monitor syringe tool includes a handle, and the shaft and insertion tube are located in the handle. The insertion tube can have a hollow cylindrical shape and be sized to accommodate the shaft. A button can be located on the outer surface of the handle to retract the insertion tube when pressed or pulled back. During the retraction of the insertion tube, the shaft remains fixed. The insertion tube extends and is preloaded with an insertable physiological monitor (IPM) so that one end of the IPM is adjacent to the distal end of the shaft. Examples of IPMs can include heart, oxygen, blood pressure and blood glucose monitors and other types of monitors.

[0013] The insertion tube is inserted into the patient's skin at an angle, and the syringe tool is rotated to lie flat against the skin to lift the skin while performing the tunneling operation. Once the insertion tube reaches the desired position for the IPM, a button is pressed to retract the insertion tube. The fixed shaft ensures that the IPM remains in place in the patient by preventing the IPM from moving with the insertion tube as it is retracted. The syringe tool is then removed from the patient.

[0014] One embodiment provides an insertable physiological monitor syringe tool. An elongated handle includes a groove formed along a longitudinal axis and has an opening at a distal end. An insertion tube has a hollow elongated shape and is movably positioned within the elongated handle in the groove. A fixed shaft is fixed to the proximal end of the elongated handle on a proximal end, and when the insertion tube is in a retracted position, the fixed shaft extends through the insertion tube. A protrusion is fixed to the insertion tube, wherein the protrusion is capable of locking the insertion tube in an extended position.

[0015] Another embodiment provides an insertable physiological monitor syringe tool having structure by which a monitor housed therein is rechargeable.

[0016] In view of the disclosure described herein and without limiting the disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect or portion thereof, an insertable physiological monitor syringe tool includes: a structure by which a monitor housed in the structure is rechargeable; and a retaining hinge cut from a surface of the structure and formed as a curved surface inside the structure.

[0017] In a second aspect of the disclosure, which may be combined with any other aspect or portion thereof, the structure comprises an insertion tube having a hollow elongated shape.

[0018] In a third aspect of the present disclosure that may be combined with any other aspect or portion thereof, the tool further comprises at least one of an elongated handle, a fixed shaft, and a protrusion. The elongated handle has a groove formed therein along the longitudinal axis and includes an opening at the distal end. The structure is accommodated in the groove. The fixed shaft is fixed to the proximal end of the elongated handle at the proximal end, and when the insertion tube is in the retracted position, the fixed shaft extends through the insertion tube. The protrusion is fixed to the insertion tube, wherein the protrusion is capable of locking the insertion tube in the extended position.

[0019] In a fourth aspect of the present disclosure that may be combined with any other aspect or portion thereof, an insertable physiological monitor syringe also includes an elongated handle, an insertion tube, a fixed shaft, and a protrusion. A groove is formed in the elongated handle along the longitudinal axis and includes an opening at the distal end. The insertion tube includes a hollow elongated shape that is movably positioned in the elongated handle in the groove. The fixed shaft is fixed to the proximal end of the elongated handle on the proximal end, and when the insertion tube is in the retracted position, the fixed shaft extends through the insertion tube. The protrusion is fixed to the insertion tube, wherein the protrusion is capable of locking the insertion tube in the extended position.

[0020] In a fifth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, further comprising an implantable physiological monitor, the implantable physiological monitor being placed within the insertion tube when the insertion tube is in the extended position.

[0021] In a sixth aspect of the present disclosure which may be combined with any other aspect or portion thereof, a channel is formed in a proximal portion of the handle to allow movement of the projection.

[0022] In a seventh aspect of the present disclosure which may be combined with any other aspect or portion thereof, the insertion tube is configured to retract into the handle via the groove when the projection moves in the channel toward the proximal end of the handle.

[0023] In an eighth aspect of the present disclosure which may be combined with any other aspect or portion thereof, the insertion tube is made of plastic.

[0024] In a ninth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the proximal end of the insertion tube is sharpened.

[0025] In a tenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, further comprising one or more sets of guides formed on an inner surface of the insertion tube and shaped to surround at least a portion of the insertion tube in the groove.

[0026] In an eleventh aspect of the present disclosure which may be combined with any other aspect or portion thereof, further comprising a tip formed on a distal end of the insertion tube.

[0027] In a twelfth aspect of the present disclosure which may be combined with any other aspect or portion thereof, further comprising a notch formed on a proximal end of the insertion tube.

[0028] In a thirteenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, a button is secured to a recess of the insertion tube.

[0029] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, an insertable physiological monitor syringe tool system comprises an elongated handle, an insertion tube, a retaining hinge, a fixed shaft, a protrusion, an insertable physiological monitor, and a charging device. A groove is formed in the elongated handle along the longitudinal axis. The insertion tube comprises a hollow elongated shape, which is movably positioned in the elongated handle, in the groove. The retaining hinge is cut from the surface of the insertion tube and formed as a curved surface inside the structure. The fixed shaft is fixed to the proximal end of the elongated handle at the proximal end, and when the insertion tube is in a retracted position, the fixed shaft extends through the insertion tube. The protrusion is fixed to the insertion tube, wherein the protrusion is capable of locking the insertion tube in an extended position. When the insertion tube is in the extended position, the insertable physiological monitor is placed in the insertion tube. When located in the insertion tube, the charging device recharges the battery of the insertable physiological monitor.

[0030] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, there is further included an incision tool comprising a handle and a blade fixed to a distal end of the handle.

[0031] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof, there is further included a tunneling tool comprising a handle and a rod fixed to a distal end of the handle.

[0032] In a seventeenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, the insertion tube is plastic.

[0033] In an eighteenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, further comprising a tip formed on a distal end of the insertion tube.

[0034] In a nineteenth aspect of the present disclosure which may be combined with any other aspect or portion thereof, further comprising a notch formed on a proximal end of the insertion tube.

[0035] In a twentieth aspect of the present disclosure which may be combined with any other aspect or portion thereof, a button is secured to a recess of the insertion tube.

[0036] Other embodiments will be readily apparent to those skilled in the art from the following detailed description, wherein the embodiments are described by way of illustration of the best mode contemplated. It will be appreciated that other different embodiments are possible, and that several details of the embodiments may be modified in various obvious respects, including time and event clustering, all without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1A perspective view of an insertable physiological monitor syringe tool is shown according to an exemplary embodiment of the present disclosure.

[0038] Figure 2 The exemplary embodiment according to the present disclosure is shown Figure 1 An internal view of a cross-section of the handle of an insertable physiological monitor syringe tool.

[0039] Figure 3 The exemplary embodiment according to the present disclosure is shown Figure 1 A perspective view of the insertion tube of an insertable physiological monitor syringe tool.

[0040] Figure 4 A perspective view of a notching tool according to an exemplary embodiment of the present disclosure is shown.

[0041] Figure 5 A perspective view of a tunneling tool according to an exemplary embodiment of the present disclosure is shown.

[0042] Figure 6 A perspective view of an insertable physiological monitor syringe tool loaded with an insertable physiological monitor is shown according to an exemplary embodiment of the present disclosure.

[0043] Figure 7 A perspective view of an insertable physiological monitor syringe tool is shown in a partially retracted position according to an exemplary embodiment of the present disclosure.

[0044] Figure 8 A perspective view of an insertable physiological monitor syringe tool in a fully retracted position is shown according to an exemplary embodiment of the present disclosure.

[0045] Fig. 9 A side view of an insertable physiological monitor syringe tool in a fully retracted position is shown according to an exemplary embodiment of the present disclosure.

[0046] Fig.10 A top view of an insertable physiological monitor syringe tool is shown in a fully retracted position according to an exemplary embodiment of the present disclosure.

[0047] Fig.11 A side view of an insertable physiological monitor syringe tool in a fully retracted position is shown according to an exemplary embodiment of the present disclosure.

[0048] Fig.12 The exemplary embodiment according to the present disclosure is shown Figure 1 Top views of different embodiments of insertable physiological monitor syringe tools.

[0049] Fig.13The exemplary embodiment according to the present disclosure is shown Fig.12 A side view of the distal end of an insertion tube of an embodiment of an insertable physiological monitor syringe.

[0050] Fig.14 The exemplary embodiment according to the present disclosure is shown Figure 8 A perspective view of an insertable physiological monitor syringe tool.

[0051] Fig.15A A perspective view of an insertable physiological monitor syringe tool having a channel is shown according to an exemplary embodiment of the present disclosure.

[0052] Fig. 15B A perspective view of an insertable physiological monitor syringe tool having a protrusion in a channel stem is shown according to an exemplary embodiment of the present disclosure.

[0053] Fig. 15C A perspective view of an insertable physiological monitor syringe tool having a protrusion at the distal end of a channel is shown according to an exemplary embodiment of the present disclosure.

[0054] Fig.15D A perspective view of an insertable physiological monitor syringe tool having a protrusion at the proximal end of a channel is shown according to an exemplary embodiment of the present disclosure.

[0055] Fig.15E A side view of an insertable physiological monitor syringe tool having a protrusion is shown according to an exemplary embodiment of the present disclosure.

[0056] Fig.16 Shown is a peripheral view of an insertion tube having a retaining hinge according to an exemplary embodiment of the present disclosure.

[0057] Fig.17 A side view of the interior of an insertion tube with a retaining hinge is shown in accordance with an exemplary embodiment of the present disclosure.

[0058] Fig.18 A side view of a retention hinge inserted into a tube opening is shown according to an exemplary embodiment of the present disclosure.

[0059] Fig.19 A top view of an insertion tube with a retaining hinge in an opening is shown according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION

[0060] Implantable devices can provide benefits to patients, such as continuous monitoring of physiological signals, which can help detect incident events and facilitate diagnosis by medical professionals. However, injectable implantable devices can be invasive and pose some risks to patients, such as infection or adverse reactions due to puncturing the patient's skin during the injection process. Minimally invasive injection tools (e.g., requiring only a small incision) can be implanted quickly and efficiently, helping to reduce risks to patients.

[0061] A minimally invasive injector tool may include an insertion tube, a handle, and a shaft. Figure 1 Illustrated is a perspective view of an insertable physiological monitor syringe tool 10 Fig.10 The syringe tool 10 may include a handle 11 with a groove formed inside the handle along the longitudinal axis. The handle 11 may have a cylindrical semicircular or rectangular shape, among other types of shapes. In one embodiment, the shape of the handle may be based on the shape of an implantable physiological monitor (IPM) that is injected into a patient using the injection tool. The proximal end 19 of the handle may be closed, while the distal end 21 of the handle may be open to allow access to the groove.

[0062] The insertion tube 16 is located in the recess of the handle, which may have a different shape or the same shape as the handle. The insertion tube 16 may have a hollow interior 17 and be sized to fit in the recess 12 of the handle. The length of the insertion tube 16 should extend at least through the opening beyond the distal end 21 of the handle. The distal end of the insertion tube may include a beveled edge or a straight edge and may be sharpened or unsharpened. In another embodiment, the tip may be attached to the distal end of the syringe barrel, as described below with respect to Fig.12 and 13 Further described.

[0063] A button or protrusion 18 is fixed to the insertion tube 16 to allow the user to move the insertion tube 16 within the groove. The button or protrusion 18 is positioned on the outer surface of the handle 11 through a channel 22 formed by a notch in the handle 11. The button can slide back and forth in the channel 22 to move the insertion tube 16 back and forth in the groove of the handle 11.

[0064] The shaft 15 is mounted within the insertion tube 16 and is fixed at one end to the proximal end 19 of the handle 11, or to a separate end piece 13 that is attached to the proximal end of the handle. In one embodiment, the proximal end of the shaft 15 is fixed to a support seat 14, which is then fixed to the proximal end of the handle or the separate end piece 13. The shaft 15 can be shaped as a circle, square, rectangle, oval, cross or other shape and is sized to fit within the insertion tube 16. The length of the shaft 15 can depend on the length of the handle and should extend slightly beyond the distal end of the handle 11. The shaft 15 remains in a fixed position while the insertion tube 16 slides back and forth on the shaft 15.

[0065] To ensure smooth movement of the insertion tube 16 within the handle 11, the handle may be adapted to fit securely around the insertion tube 16, leaving a slight gap between the inner surface of the handle 11 and the outside of the insertion tube 16. When the shape of the handle 11 is different from that of the insertion tube 16, the interior of the handle 11 may include a guide to allow the insertion tube 16 to move smoothly. Figure 2 An example is given Figure 1 25 is an internal view of a cross-section of a handle of an insertable physiological monitor syringe tool. The handle 11 can be formed from a single piece of material or two or more pieces of material. The material can include plastic, metal, or stainless steel, among other types of materials. Inside the handle 11, a guide 26 can be formed along the groove 12 to guide the insertion tube (not shown) to move along the longitudinal axis of the groove 12. The guide can be formed as a protrusion of material such as plastic, metal, or stainless steel extending from the inner surface of the handle 11. The guide can extend around or partially around the insertion tube (not shown). One or more groups of guides can be provided in the handle, each group can include two guides, each of which is formed on either side of the insertion tube.

[0066] When the handle is formed from multiple pieces of material, screw holes or other fastening mechanisms 27 may be formed along the interior of the handle. The screw holes or other fastening mechanisms located on another piece of material of the handle should correspond to the screw holes on the first piece of material to secure the different pieces of material of the handle 11 together. At least one end of the handle is an opening 28, including the proximal end 21 of the handle, to allow an insertion tube (not shown) to be moved into and out of the handle 11.

[0067] The insertion tube slides in the groove via a button or a protrusion. Figure 3 A perspective view 30 of the insertion tube 16 is illustrated. The insertion tube 16 can be formed as a cylindrical tube with a hollow interior. However, other shapes are possible. Both ends of the insertion tube 16 can be openings 17 to allow the insertion tube 16 to move on an axis (not shown). The surface of the insertion tube 16 is formed with a notch 31 for fixing to a button (not shown). For example, the button (not shown) can include a protrusion inserted and fixed in the notch to allow the user to slide the button, thereby sliding the insertion tube 16.

[0068] The insertion tube 16 can be made of materials including metal, stainless steel, plastic, or other types of materials. When made of plastic, the IPM can be recharged while inserted into the insertable physiological monitor syringe tool 10, as described in further detail below. The length of the insertion tube can depend on the location of the implantation site where the IPM will be implanted. For example, an implantable cardiac monitor can be implanted between the skin and the ribs of the wearer. Therefore, the insertion tube 16 must be long enough to extend beyond the patient's skin, but not longer than the distance between the ribs and the skin. In addition, the shape of the insertion tube can depend on the IPM to be inserted into the wearer. For example, when the IPM is cylindrical, the insertion tube can be cylindrical.

[0069] The implantation of the IPM may utilize an incision tool, a tunneling tool, and an insertable physiological monitor injector tool. Figure 4 A perspective view 35 of an incision tool 36 is illustrated. The incision tool 36 includes a handle 37 and a blade 38. The blade may be triangular, rectangular, or other shapes. When shaped as a triangle, the base of the triangle may be fixed to the distal end of the handle 37, with the apex of the triangle facing the outside of the handle 37. The incision tool 36 is used to make an incision in the patient's skin after the incision area is cleaned and disinfected.

[0070] After the incision is made, a tunneling tool is used to clear a path through the patient's tissue for later insertion of the insertable physiological monitor injector tool. Figure 5 A perspective view 40 of a tunneling tool 41 is illustrated. The tunneling tool 41 includes a handle 42, a stopper or depth gauge 46, and a rod 43. The handle 42 includes a grip 45 for a user to hold while inserting the tunneler into a patient. The stopper or depth gauge 46 is fixed to the distal end of the handle to provide a specific length of the rod to be inserted into the patient, and the rod 43 extends from the stopper. The stopper or depth gauge 46 can be fixed or adjustable to adjust the length of the rod for insertion into different depths in the patient. The distal end of the rod can include a tip 44, which can be sharpened or unsharpened. The length of the rod 43 can depend on the location of the IPM to be placed.

[0071] The tip 44 of the rod is inserted into the incision formed by the incision tool. Once inserted, the user pushes the rod further into the patient's body via the handle 42 to clear a path in the tissue to place the IPM. The user can push the tunnel tool 41 into the patient's body until the stopper contacts or is close to the patient's skin. The user then removes the tunnel tool 41 from the patient's body.

[0072] Once the incision has been made and the path cleared for placement of the IPM, the insertable physiological monitor injector tool may be inserted into the patient. Figure 6 A perspective view 45 of an insertable physiological monitor syringe tool loaded with an IPM is illustrated. For injection, the insertion tube 16 may be in an extended position, outside of a recess in the handle 11. The ICM 26 is placed within the insertion tube 16 with the proximal end adjacent to the shaft (not shown).

[0073] The distal end of the extended insertion tube 16 is inserted into the incision of the patient, and the user moves the insertable physiological monitor syringe tool into the patient's tissue using the path formed by the tunnel tool. In one embodiment, the user can press or push the button 18 distally to prevent the insertion tube 16 from retracting through the groove 12 toward the proximal end of the handle 11. However, in another embodiment, the button can be in a locked position to prevent the retraction of the insertion tube 16.

[0074] Once the distal end of the insertion tube 16 reaches the desired location, Figure 7 A perspective view 50 of an insertable physiological monitor syringe tool 10 in a partially retracted position is illustrated. The insertable physiological monitor syringe tool 10 can be inserted into the patient until the distal end of the housing contacts or adheres to the outward surface of the patient's skin. Once reached, the button 18 can be pressed or released from a spring-loaded or locked position, depending on the type of safety mechanism, and the button 18 is slowly moved along the channel 12 toward the proximal end of the handle 11. As the button moves proximally, the insertion tube 16 slides over the IPM 26, which is fixed and begins to be exposed to the patient's tissue as the insertion tube is retracted.

[0075] Once the insertion tube is fully retracted, the IPM is located outside of the insertion tube and completely within the patient's tissue. Figure 8 A perspective view 55 of an insertable physiological monitor syringe tool 10 in a fully retracted position is illustrated. To obtain the retracted position, the user should slide the button 18 the length of the channel 22 formed in the handle 11 to move the insertion tube 16 along the groove 12 to the interior of the handle 11. As the insertion tube is retracted, more of the IPM 26 is exposed and introduced into the patient's tissue. The fixed shaft 15 in the insertion tube is close to the proximal end of the IPM 26 and prevents the IPM 26 from retracting with the insertable tube 16. Therefore, the IPM 26 remains in the patient's tissue, and after the insertion tube 16 is fully retracted, the insertable physiological monitor syringe tool 10 is moved away from the patient.

[0076] Fig. 9 A side view 60 of the insertable physiological monitor injector 10 in a fully retracted position is illustrated. In the fully retracted position, the button 18 is located at the proximal end of the handle 11, the insertion tube 16 is fully retracted, and a portion of the insertion tube 16 may extend slightly beyond the distal end of the handle. The shaft remains fixed and also extends slightly beyond the distal end of the handle, while the IPM 26 is no longer contained by the insertion tube 16 and remains at the desired implantation location in the patient's tissue.

[0077] Fig.10 A top view 65 of the insertable physiological monitor syringe tool 10 in a fully retracted position is illustrated. When the insertion tube 16 is fully retracted, the button 18 is located at the proximal end of the handle and the IPM 26 is no longer located in the insertable physiological monitor syringe tool 10. The IPM 26 is located in the patient's tissue and remains in the patient's tissue when the insertable physiological monitor syringe tool is removed from the patient's tissue. During the retraction and removal of the insertable physiological monitor syringe tool 10, the shaft 15 prevents the IPM 26 from retracting along the groove of the handle along with the insertion tube 16.

[0078] When in the fully retracted position, the shaft is located within the insertion tube and the insertion tube is located within the recess of the handle. Fig.11 A side view 70 of the insertable physiological monitor syringe tool 10 in a fully retracted position is illustrated. In the fully retracted position, the button 18 is located at the proximal end of the insertable physiological monitor syringe tool 10. The insertion tube 16 is located in a recess in the handle and the shaft 15 is located within the insertion tube 16.

[0079] The above-mentioned insertable physiological monitor syringe tool can have different embodiments. For example, Fig.12 An example is given Figure 1 75 is a top view of a different embodiment of an insertable physiological monitor injector 10. A tip 76 may be formed on at least a portion of the distal end of the insertion tube 16. The tip 76 may be thermoformed to prevent an IPM (not shown) from falling out of the insertion tube 16 during insertion into a patient. Fig.13 An example is given Fig.12 80 of the distal end of the insertion tube 16 of the insertable physiological monitor syringe embodiment. The distal end 81 of the insertion tube 16 may include a tip 83 for preventing the IPM placed in the interior 84 of the insertion tube 16 from falling out, especially when the syringe tool is inserted into the patient's body at a certain angle.

[0080] In one embodiment, tip 81 may be formed on the upper surface of the insertion tube, closest to the button. Tip 83 may be formed inwardly, into hollow interior 84, to create interference between the insertion tube and the ICM. For example, material 82 of insertion tube 16 may be bent downwardly over the distal tip, into hollow interior 84. However, bending tip 83 too far into the interior of the insertion tube may prevent release of the IPM when the insertion tube is retracted. Therefore, tip 83 should be shaped to prevent the IPM from falling off, but allow the insertion tube to be retracted over the IPM, which is held in place by a shaft (not shown).

[0081] In another embodiment, the tip may include a piece of additional material secured to the upper interior surface of the insertion tube material 82. The additional material may extend down into the hollow interior of the insertion tube to prevent the IPM from falling out.

[0082] When the insertion tube 16 is fully extended, the button 18 is located at the distal end of the handle 11 and the groove 12 in the handle 11 is visible. In addition, the proximal end 77 of the insertion tube 16 can be seen through the passage. However, when in the fully retracted position, the groove 12 may not be visible because the outer surface of the insertion tube 16 may block the groove 12 from being seen through the passage 22.

[0083] Fig.14 An example is given Fig.121. A perspective view of an insertable physiological monitor syringe tool 10. In the extended position, the insertion tube 16 extends outward from the handle 11 and the button 18 is located at the distal end of the handle 11. The tip 76 extends from the distal end of the insertion tube 16 to the bottom surface of the opening. However, in another embodiment, the tip may extend from the top surface or completely surround the opening of the insertion tube 16 at the distal end. When the insertable physiological monitor syringe tool 10 is inserted into the patient's body, the tip prevents the IPM (not shown) from moving out of the insertion tube 16.

[0084] Fig.15A -E exemplifies Figure 1 Different embodiments of an insertable physiological monitor syringe. Fig.15A A perspective view 90 of an insertable physiological monitor syringe tool 10 having a passage 22 is illustrated. The housing 11 of the insertable physiological monitor syringe tool 10 has the passage 22 formed in a surface (e.g., a top surface). The passage 22 may extend along the longitudinal axis of the housing 11 and include a rod 91 formed on the distal end of the housing and extending outwardly along the longitudinal axis, away from the passage. The rod 91 may be used to lock the insertion tube 16 in an extended position by a protrusion (not shown).

[0085] Fig. 15B A perspective view 95 of an insertable physiological monitor syringe tool 10 having a protrusion 18 in a channel rod is illustrated. The protrusion (e.g., button 18) can be in a locked position when located in a rod (not shown) of a channel 22 formed in the handle 11. Specifically, when the button 18 is located in the rod, the button 18 is blocked from moving distally or proximally along the handle, which blocks movement of the insertion tube 16. Thus, when the button or protrusion 18 is locked, the insertion tube 16 is locked in the extended position.

[0086] Fig. 15C A perspective view 100 of an insertable physiological monitor syringe tool 10 having a protrusion 18 at the distal end of a channel 22 is illustrated. To unlock the insertion tube 16 of the insertable physiological monitor syringe tool 10 from the extended position, the user slides the protrusion (e.g., button 18) out of the rod (not shown) and into the channel 22. Specifically, the user moves the button or protrusion 18 along the longitudinal axis of the handle 11 and toward the channel 22.

[0087] Fig.15D A perspective view 110 of an insertable physiological monitor syringe tool 10 is illustrated having a protrusion 18 at the proximal end of the channel 22. To retract the insertion tube 16, the user slides the protrusion (e.g., button 18) from the channel rod 91 along the channel 22 toward the proximal end of the handle 11. When the button 18 is at the proximal end, the insertion tube 16 moves into the recess of the handle and completely or substantially clears the IPM 26, allowing the IPM to be implanted in the patient's tissue.

[0088] Fig.15E A side view 120 of an insertable physiological monitor syringe tool 10 having a protrusion 18 is illustrated. The protrusion may include a button, a knob, a pin, or other type of device that can be attached to the insertion tube 16 and moved by the user. At a minimum, the protrusion should be able to move from a locked position in the channel rod 91 into the channel 22 and then move along the channel 22. When the protrusion 18 moves proximally along the channel 22, the insertion tube is retracted into the interior of the housing 11, leaving the IPM 26 in the patient's tissue.

[0089] In one embodiment, the IPM can be packaged with an insertable physiological monitor syringe tool, such as by placing the IPM in an insertion tube. The syringe tube is in an extended position to provide space where the IPM can be placed at the distal end of a shaft, with a portion of the shaft also within the insertion tube in the extended position. Depending on the time that elapses from packaging the IPM with the syringe tool to injecting the IPM into a patient, the battery of the IPM may be low. Ideally, the IPM should be fully charged before insertion into a patient to ensure that all functions of the IPM are working. When the insertion tube is made of a conductive material that allows electromagnetic waves or energy to pass through, the battery of the IPM can be recharged while remaining in the insertable physiological monitor syringe tool before being placed in the patient. The material of the insertion tube may include plastic, metal, or other types of materials.

[0090] In one embodiment, the battery can be inductively charged by a wireless device placed on the sterile packaging of the insertable physiological monitor syringe tool. The wireless charging device can include a disk or stick or other type of device capable of wireless charging. The device wirelessly charges the battery until the battery is fully charged. The insertable physiological monitor syringe tool is then removed from the packaging and used to insert the IPM into the patient.

[0091] Insertion type physiological monitor syringe tool can be constructed by constructing elongated handle, and described elongated handle has the groove formed along the longitudinal axis inside handle.The insertion tube with hollow elongated shape can be positioned in the groove of elongated handle.One or more groups of guides are formed on the inner surface of handle, to surround and guide at least a part of the insertion tube in the groove.In one embodiment, can form notch on the proximal end of insertion tube, and this insertion tube can move in groove.The fixed shaft is placed in insertion tube, and is fixed to the proximal end of described elongated handle, inside.When described insertion tube is in retracted position, described fixed shaft extends through described insertion tube.Protrusion such as button or knob is fixed to described insertion tube through notch.Protrusion can be used for locking insertion tube in extended position.When insertion tube is in extended position, implantable physiological monitor is placed in insertion tube.Channel is formed in the proximal part of described handle, to allow button to move to retract insertion tube from extended position to retracted position.

[0092] The IPM can be inserted into the insertion tube 16 from the front or rear end. However, when inserted at the front or distal end, it may become more difficult to ensure that the IPM remains in the insertion tube. The retention hinge or tongue can allow the IPM to be moved in and out of the insertion tube while ensuring that the IPM is not accidentally released. Fig.16 A peripheral view of an insertion tube 16 with a retaining hinge 131 is shown. The insertion tube 16 can be cut at an angle at the distal end, and the retaining hinge or tongue 131 can be located on the longer exposed surface 130 of the insertion tube formed by the cut. In one embodiment, the angle of the cut can be about 35 degrees to the axis of the tube; however, other angles are possible, such as 25-45 degrees. The cut can be perpendicular to the axis of the tube.

[0093] The insertion tube 16 can be formed of a polyetheretherketone tube, but other materials are possible, such as other plastics or some metals, and can also be covered or coated with a friction reducing material. A U-shaped cutout can be formed on the surface of the insertion tube and bent to form a retaining hinge 131, which resembles a tongue in a mouth. For example, a rounded portion of the U is cut from the insertion tube 16 and attached to the attachment end of the insertion tube opposite the rounded end. Other shapes of the retaining hinge cutout are possible, including rectangular.

[0094] The curved surface of the U-shaped hinge can be formed inside the insertion tube to prevent the IPM from being accidentally released from the tube while also allowing a medical professional to insert the IPM into the tube. In one embodiment, the retaining hinge 131 is formed as a living hinge to accommodate an implantable monitor. The shape of the retaining hinge 131 can be similar to a mountain-shaped or bell-shaped curved surface, wherein the attached end of the U-shape is formed upward to the inside of the insertion tube 16 and then bent downward around the middle of the U-shape, so that the free end of the U-shape is slightly higher than or flush with the inner surface of the insertion tube 16. Since the rounded end is free, the retaining hinge 131 can be moved downward to create more space inside the insertion tube to allow the IPM to move in or out when pressure is applied to one side of the curved surface. Once the pressure is removed, the retaining hinge 131 moves back to its original position inside the tube.

[0095] The retaining hinge 131 may be shaped like a bell-shaped curved surface with a rounded top. Fig.17 A side view of the interior of an insertion tube 16 having a retaining hinge 131 is illustrated. The insertion tube 16 forms a hollow passage in which the IPM is placed for insertion into a patient. The distal end of the insertion tube 16 is cut at an angle perpendicular to the axis of the length of the insertion tube. The retaining hinge 131 is formed in an opening 140 of the insertion tube, which is formed by cutting and may have a curved shape. Fig.18A side view of a retaining hinge in an insertion tube opening is illustrated. A retaining hinge 131 is formed on the surface of the insertion tube 16, extending beyond the opposing surface 130 of the insertion tube 16, near the opening. Specifically, a U-shape or other shape is cut in the extended surface 130 of the insertion tube. Fig.19 A top view of an insertion tube 16 having a retaining hinge 131 in an opening 140 is shown. The retaining hinge 131 is formed on the extended surface 130 of the insertion tube, along the axis A of the length of the insertion tube 16 and in line with the notch 31. In one embodiment, the length of the U-shape can be about 0.220 to 0.230 mm and the width can be about 0.120 to 0.130 mm. However, other lengths and widths are also possible, particularly depending on the size of the insertion tube. For example, a longer or wider insertion tube can have a longer, wider or larger retaining hinge.

[0096] One end of hinge 131 is rounded and cut off from the insertion tube, while the other end remains attached to the insertion tube at joint 151 located at the proximal end of hinge 131, further from the port than the distal rounded end. Joint 151 allows hinge 131 to remain mobile relative to insertion tube 16.

[0097] Back to About Fig.18 As discussed above, the retaining hinge 131 may be bent from the joint 151 into the insertion tube 16 to form a curved surface, starting from the joint 151 and tilted 153a to the crest 150 inside the insertion tube. The hinge then tilts downward 153b from the crest 150 and ends at a rounded end of the U. The rounded end of the U is separate from the insertion tube and may move independently of the insertion tube to allow an IPM (not shown) to be inserted into or removed from the insertion tube 16. The free rounded end may extend above the inner surface of the insertion tube and may not contact the interior to allow movement. The size of the curved surface of the hinge may vary depending on the size of the insertion tube and the IPM. However, at a minimum, the free rounded end of the U-shaped hinge should not end at a position too high above the inner surface of the insertion tube that prevents the IPM from entering the tube.

[0098] The IPM can be inserted into the insertion tube through opening 140 by pressing the IPM against the bevel 153b at the distal end of the hinge closest to the opening. Pressure from the proximal end of the IPM (deepest in the insertion tube) presses the free end of the bevel downward and away from the interior of the insertion tube. As the IPM moves further into the insertion tube, the IPM passes through crest 150 and moves completely into the insertion tube. In one embodiment, the proximal end of the IPM contacts the shaft, as described above with respect to Figure 1 In another embodiment, the IPM may not contact the shaft until the IPM is ready to release and the insertion tube 16 begins to retract.

[0099] Once the distal end of the insertion tube passes the crest 150, the insertion tube is fully loaded and can be prevented from falling or accidentally releasing because the distal end cannot pass the crest 150 without applying pressure to the IPM. To remove the IPM, the insertion tube is inserted into the patient and once the desired position is reached, the insertion tube begins to be retracted. During the retraction of the insertion tube, pressure is applied to the proximal end of the IPM by the shaft, which can cause the distal end of the IPM to push past the proximal ramp 153a of the hinge and the crest 151 until the proximal end of the IPM passes over the crest and is released into the patient.

[0100] While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in form and details may be made therein without departing from the spirit and scope thereof.

Claims

1. An insertable physiological monitor syringe tool comprising: structure by which a monitor housed in said structure is rechargeable; and A hinge is retained which is cut from the surface of the structure and formed as a curved surface inside the structure.

2. The insertable physiological monitor syringe tool of claim 1, wherein the structure comprises an insertion tube having a hollow elongated shape.

3. The insertable physiological monitor syringe tool of claim 1, further comprising at least one of the following: an elongated handle having a groove formed therein along the longitudinal axis and including an opening at a distal end, wherein the structure is received in the groove; a fixed shaft proximally fixed to the proximal end of the elongated handle and extending through the insertion tube when the insertion tube is in the retracted position; as well as A tab is secured to the insertion tube, wherein the tab is configured to lock the insertion tube in an extended position.

4. An insertable physiological monitor syringe tool comprising: an elongated handle having a groove formed therein along the longitudinal axis and including an opening at a distal end; an insertion tube comprising a hollow elongated shape movably positioned within said elongated handle in said recess; a fixed shaft proximally fixed to the proximal end of the elongated handle and extending through the insertion tube when the insertion tube is in the retracted position; as well as A tab is secured to the insertion tube, wherein the tab is configured to lock the insertion tube in an extended position.

5. The insertable physiological monitor syringe tool of claim 4, further comprising: An implantable physiological monitor is placed within the insertion tube when the insertion tube is in the extended position.

6. The insertable physiological monitor syringe tool of claim 4, wherein a channel is formed in the proximal portion of the handle to allow movement of the projection.

7. The insertable physiological monitor syringe tool of claim 6, wherein the insertion tube is configured to retract into the handle via the groove when the projection moves in the channel toward the proximal end of the handle.

8. The insertable physiological monitor syringe tool of claim 4, wherein the insertion tube is made of plastic.

9. The insertable physiological monitor syringe tool of claim 4, wherein the proximal end of the insertion tube is sharpened.

10. The insertable physiological monitor syringe tool of claim 4, further comprising: One or more sets of guides are formed on the inner surface of the insertion tube and are shaped to surround at least a portion of the insertion tube in the groove.

11. The insertable physiological monitor syringe tool of claim 4, further comprising: A tip is formed on the distal end of the insertion tube.

12. The insertable physiological monitor syringe tool of claim 4, further comprising: A notch is formed on the proximal end of the insertion tube.

13. The insertable physiological monitor syringe tool of claim 12, wherein a button is secured to a recess of the insertion tube.

14. An insertable physiological monitor syringe tool system comprising: an elongated handle having a groove formed therein along the longitudinal axis; an insertion tube comprising a hollow elongated shape movably positioned within said elongated handle in said recess; a retaining hinge cut from the surface of the insertion tube and formed as a curved surface inside the structure; a fixed shaft proximally fixed to the proximal end of the elongated handle and extending through the insertion tube when the insertion tube is in the retracted position; a tab secured to the insertion tube, wherein the tab is capable of locking the insertion tube in an extended position; an insertable physiological monitor disposed within the insertion tube when the insertion tube is in the extended position; as well as A charging device, when located in the insertion tube, recharges the battery of the insertable physiological monitor.

15. The system of claim 14, further comprising: A cutting tool includes a handle and a blade secured to the distal end of the handle.

16. The system of claim 14, further comprising: A tunneling tool includes a handle and a rod secured to the distal end of the handle.

17. The system of claim 14, wherein the insertion tube is plastic.

18. The system of claim 14, further comprising: A tip is formed on the distal end of the insertion tube.

19. The insertable physiological monitor syringe tool of claim 14, further comprising: A notch is formed on the proximal end of the insertion tube.

20. The insertable physiological monitor syringe tool of claim 19, wherein a button is secured to a recess of the insertion tube.

Images