Patent Application
20230028735
Embodiments of the present disclosure generally relate to the implantation of medical monitoring devices within patients, including implantable cardiac monitors (ICMs).
Subdermal implantable devices, such as ICMs, are devices that may be implanted under a patient's skin to continuously monitor the patient's cardiac activity. ICMs allow clinicians to monitor the patient's cardiac activity for an extended period of time, such as multiple years. The information recorded by ICM enables clinicians to determine if a patient complaining of symptoms has irregularities in their heart rhythm that cannot be confirmed in the clinic, particularly for transient and/or infrequent arrhythmias. For example, an ICM may be programmed to detect and record cardiac information and episodes such as atrial/ventricular tachycardia, atrial fibrillation, bradycardia, asystole, etc. The information can also aid the clinician in determining the best course of treatment for the patient. The ICM may be implanted in the patient's chest area near the sternum.
The implantation of monitoring devices, such as ICMs, is typically performed under local anesthetic using an implant tool kit, which includes an incision tool and a delivery tool.
A small incision is desired for patient comfort and ease of wound closure and healing post-implant. However, small incisions pose challenges for the implantation process. Using at least some known insertion systems, the incision may be difficult to keep open during the procedure to allow the implant device to pass from the delivery tool into the tissue pocket. Further, it may be difficult to maneuver the delivery tool into the tissue to correctly position the implant device at a required depth and position. For patients with taut tissue, additional force may be required to insert the implant device, while for patients with loose tissue, the implant device may move (e.g., migrate) after implant. Movement of the implant device within the pocket is undesirable as the change in position can diminish device functionality. For example, due to movement in the pocket, an ICM may be less capable of detecting cardiac signals and determining cardiac parameters, such as R-R intervals utilized in monitoring cardiac activity.
Moreover, in at least some known insertion systems, it may be difficult to push the implant device into the tissue, and this issue is exacerbated for larger implant devices. The increased force application may cause patient discomfort and delay healing. Finally, once the device is implanted, the physician may have difficulty closing the incision if the incision is damaged by the delivery tool.
A need remains for an implant delivery instrument that can safely, effectively, and accurately implant a device into a subdermal pocket in a patient for accurate patient monitoring.
In accordance with an embodiment, an implant delivery instrument is provided that includes a housing with a main body section that defines a passage therethrough from a front end of the main body section to a back end of the main body section. The passage is configured to receive an obturator through an opening at the back end, and is also configured to receive an implant device. Movement of the obturator through the passage is configured to push the implant device through a discharge opening at the front end and through an incision into a subdermal pocket of a patient. The housing includes a tab connected to and projecting from the front end of the main body section. The tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision, and the tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device.
Optionally, a thickness of the tab tapers along a length of the tab from a proximal end of the tab connected to the main body section to a distal end of the tab. Optionally, a width of the tab, along at least 90% of a length of the hub, is no greater than a width of the discharge opening. Optionally, the front end of the main body section includes a leading edge that defines a hard stop surface, and the tab is connected to the hard stop surface. The tab may be rigid and integrally connected to the hard stop surface.
Optionally, the main body section has a top side and a bottom side opposite the top side. The bottom side is configured to face towards skin of the patient as the implant device is pushed through the discharge opening into the subdermal pocket. The tab is disposed along a top edge of the discharge opening between the discharge opening and the top side of the main body section. The main body section of the housing may include at least one device support wall proximate to the front end. The at least one device support wall defines a ceiling of the passage to engage the implant device and inhibit tilting of the implant device in a direction away from the tab as the obturator pushes the implant device through the discharge opening.
Optionally, a lower surface of the tab is one of angled or curved so that a distal end of the tab is closer to a center of the passage than a proximal end of the tab connected to the main body section. The shaft of the obturator may define an elongated groove along an upper surface of the shaft. The lower surface of the tab may be configured to enter the groove. Optionally, the tab includes a narrow rib that projects from a base of the tab and defines the lower surface of the tab. The narrow rib enters the groove of the shaft and the base of the tab extends above the upper surface of the shaft without entering the groove. Optionally, the narrow rib and the groove are interlocking to prevent separation of the tab and the shaft.
Optionally, the main body section of the housing defines a receptacle cavity in communication with the passage. The receptacle cavity is exposed to an external environment through a cavity opening along a side of the main body section. The receptacle cavity is configured to receive the implant device through the cavity opening.
In an embodiment, an implant delivery instrument is provided that includes an obturator and a housing. The obturator includes an elongated shaft. The housing has a main body section that has a top side and a bottom side opposite the top side. The main body section defines a passage therethrough from a front end of the main body section to a back end of the main body section. The passage is configured to receive the obturator through an opening at the back end. The passage is also configured to receive an implant device. Movement of the obturator through the passage is configured to push the implant device through a discharge opening at the front end and through an incision into a subdermal pocket of the patient. The bottom side of the main body section is configured to face towards skin of the patient as the implant device is pushed into the subdermal pocket. The housing includes a tab connected to and projecting from the front end of the main body section. The tab connects to the front end at a location between the discharge opening and the top side of the main body section.
Optionally, the tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision. Optionally, the tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device. Optionally, a width of the tab, along at least 90% of a length of the hub, is no greater than a width of the discharge opening.
Optionally, the main body section of the housing includes at least one device support wall proximate to the front end. The at least one device support wall defines a ceiling of the passage to engage the implant device and inhibit tilting of the implant device in a direction away from the tab as the obturator pushes the implant device through the discharge opening.
In an embodiment, an implant delivery instrument is provided that includes an obturator and a housing. The obturator includes a shaft that defines an elongated groove along a surface of the shaft. The housing has a main body section that defines a passage therethrough from a front end of the main body section to a back end of the main body section. The passage is configured to receive the obturator through an opening at the back end. The passage is also configured to receive an implant device. Movement of the obturator through the passage is configured to push the implant device through a discharge opening at the front end and through an incision into a subdermal pocket of a patient. The housing includes a tab connected to the front end of the main body section at a location between the discharge opening and a first side of the main body section. The tab projects from the front end and is one of angled or curved so that a portion of the tab is received in the groove of the shaft of the obturator along a section of the shaft that projects out of the discharge opening.
Optionally, the tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision. The tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device. Optionally, a thickness of the tab tapers along a length of the tab from a proximal end of the tab connected to the main body section to a distal end of the tab. The distal end of the tab is received in the groove to provide a smooth transition from the obturator to the tab.
It will be readily understood that the components of the embodiments as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations in addition to the described example embodiments. Thus, the following more detailed description of the example embodiments, as represented in the figures, is not intended to limit the scope of the embodiments, as claimed, but is merely representative of example embodiments.
Reference throughout this specification to “one embodiment” or “an embodiment” (or the like) means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” or the like in various places throughout this specification are not necessarily all referring to the same embodiment.
Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a thorough understanding of embodiments. One skilled in the relevant art will recognize, however, that the various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obfuscation. The following description is intended only by way of example, and simply illustrates certain example embodiments.
The methods described herein may employ structures or aspects of various embodiments (e.g., systems and/or methods) discussed herein. In various method embodiments, certain operations may be omitted or added, certain operations may be combined, certain operations may be performed simultaneously and/or concurrently, certain operations may be split into multiple operations, certain operations may be performed in a different order, or certain operations or series of operations may be re-performed in an iterative fashion. It should be noted that, other methods may be used, in accordance with an embodiment herein. Further, wherein indicated, the methods may be fully or partially implemented by one or more processors of one or more devices or systems.
The terms “subdermal” and “subcutaneous” shall mean below the skin, but not intravenous (e.g., non-transvenous). For example, an implant device within a subcutaneous pocket is not located in a chamber of the heart, in a vein on the heart, or in the lateral or posterior branches of the coronary sinus. A subdermal or subcutaneous pocket is located below the skin but above the muscle.
According to at least one embodiment, an implant delivery instrument for implanting a monitoring device into a patient is provided that has a low profile housing. The low profile housing is designed to reduce damage to the incision site tissue relative to at least some known delivery tools used to implant a monitoring device into a patient. Relative to the known delivery tools, the low profile housing also reduces the insertion force necessary to insert an end of the housing into the incision during the implantation procedure, for ensuring that the device is accurately implanted to the correct depth and position within the subdermal pocket. The housing is designed with a tab or hub that holds the upper side of the incision open while the device is injected to avoid tissue snagging on the device. The implant delivery instrument described herein is able to implant devices into small incisions with the ability to maintain incision shape before and after the implantation. One or more embodiments herein describe the implant delivery instrument being used to implant ICMs into subdermal pockets, but the implant delivery instrument can also be used to inject other types of devices into a living body.
One or more technical effects of the implant delivery instrument described herein is improved patient comfort during the implantation procedure and faster patient recovery after the procedure, relative to at least some known delivery tools. For example, the comfort and recovery can be enhanced by reducing damage to the tissue of the patient during the insertion and maneuvering of the delivery tool in the incision, and avoiding efforts to fix an incorrectly positioned device during or after the implantation procedure. Another technical effect may include requiring less force to be applied to the delivery instrument during the implantation procedure than the at least some known delivery tools, such that the delivery instrument may be easier to use and manipulate to provide more accurate device implantation than the known delivery tools.
The housing 102 includes a main body section 109 and a tab 111. The main body section 109 extends from first end 110 thereof to a second end 112 thereof, which is opposite the first end 110. The first end 110 is designed to be held by an entity that manipulates the instrument 101, such as a medical professional or a robotic device. The first end 110 is the end that faces away from the patient during the implantation procedure, so the first end 110 is referred to herein as a back end 110. The second end 112 faces towards the patient, and optionally may contact patient tissue, during the implantation procedure. The second end 112 is referred to herein as a front end 112. The main body section 109 defines a passage 107 therethrough. The passage 107, shown in phantom in
The tab 111 is connected to the front end 112 of the main body section 109. The tab 111 projects beyond the front end 112. For example, the tab 111 extends in a forward or frontward direction from the main body section 109 based on the front/back orientation of the main body section 109. The tab 111 may extend coaxially with the passage 107 of the main body section 109. The tab 111 extends beyond the discharge opening 116.
The obturator 104 includes a shaft 118 and a handle 120. The handle 120 is at a back end 122 of the obturator 104. The shaft 118 is linearly elongated from the handle 120 to a front end 124 of the obturator 104 opposite the back end 122. The shaft 118 includes a distal tip 126 that is shaped and dimensioned to perform blunt dissection in subcutaneous tissue of the patient during the implantation procedure. For example, the distal tip 126 may be tapered, wedge-shaped, conical, or the like.
The main body section 109 may include a pair of wings 130 at the back end 110 that extend in opposite directions. The wings 130 are configured to be held between two fingers, while the user's thumb presses on the handle 120 of the obturator 104 to actuate the obturator 104 for injecting the implant device 108 into the subdermal pocket. The periphery of the main body section between the wings 130 and the front end 112 is contoured to facilitate manual gripping by the user.
The main body section 109 may define a receptacle cavity 128 in communication (e.g., fluid communication) with the passage 107. The receptacle cavity 128 is exposed to the external environment through a cavity opening 132 along a side 134 of the main body section 109. The receptacle cavity 128 is sized and shaped to receive the implant device 108 therein through the cavity opening 132. The housing 102 may include detents 155 within the receptacle cavity 128 that provide an interference fit on the implant device 108 to inhibit the implant device 108 from inadvertently falling out of the receptacle cavity 128. The receptacle cavity 128 may be located adjacent to (e.g., directly above) a portion of the passage 107, so the implant device 108 can drop from the receptacle cavity 128 into the passage 107 to inject the implant device 108. The receptacle cavity 128 has sufficient depth to hold the implant device 108 while the obturator 104 is located in the passage 107 next to (e.g., below) the implant device 108. The passage 107 includes inner dimensions that are similar to, but slightly larger than, the dimensions of the implant device 108 to enable the implant device 108 to move along the passage 107.
The implant device 108 in an embodiment is an ICM. ICMs are diagnostic tools that do not deliver pacing or shock therapies to the patient, nor do they require leads to be implanted in the patient's heart. ICMs are generally small (e.g., 1.1-1.5 cm3 in volume), and can be implanted using a small incision (e.g., 1 cm). Once inserted under the patient's skin, the ICM has a slim profile, mitigating patient concerns of comfort and aesthetics/body image. The ICM has a rectangular cross-section in the illustrated embodiment, with rounded corners and edges to avoid snagging on tissue. The ICM may have other form factors in alternative embodiments.
The ICM 108 may utilize QRS detection to determine R-R intervals utilized in connection with monitoring cardiac activity. In some ICMs, P-waves are captured from an EKG signal in order to provide evidence of sinus rhythm. An absence of P-waves is used to support a determination as to whether a patient is experiencing atrial fibrillation (AF). In subsequent analysis of the information collected by an ICM, when determining whether a patient is experiencing AF, it is desirable for clinicians to view P-wave activity in the stored data in order to facilitate diagnosis. The placement and stability of the ICM in the subdermal pocket is important for enabling the ICM to perform reliable, accurate monitoring of cardiac activity, such as for discerning the P-waves, considering that the ICM is spaced apart from the heart.
In the advanced position as shown in
Then, the obturator 104 is pulled back to the retracted state relative to the housing 102, as shown in
The instrument 101 is poised to deliver the implant device 108 into the subdermal pocket when the implant device 108 in the passage 107 and the housing 102 positioned with the tab 111 in the incision and the leading edge 142 in contact with the tissue surrounding the incision. The implant device 108 is implanted by pushing the handle 120 of the obturator 104 towards the wings 130. As the obturator 104 moves within the passage 107, the distal tip 126 pushes the implant device 108 through the discharge opening 116 and into the subdermal pocket. The instrument 101 functions similar to a syringe to inject the implant device 108 into the patient while the housing 102 is held in a desired orientation relative to the patient skin. After the implant device 108 is implanted, the user extracts the instrument 101 from the patient and closes the incision.
In the illustrated embodiment, the leading edge 142 is a planar surface that surrounds the tab 111 and the discharge opening 116 around an entire perimeter, such as along all four sides of the tab 111 and discharge opening 116 which have rectangular cross-sections. The leading edge 142 may be disposed on a flared segment 150 of the main body section 109, such as a flange. The surface of the leading edge 142 provides a hard stop to set and limit the depth that the instrument 101 extends into the patient through the incision.
In an embodiment, the tab 111 has a blunt dissection tip 152 at the distal end 140. The blunt dissection tip 152 is designed to maintain the incision in an open state to enable the implant device 108 (shown in
The tab 111 is designed to have a low profile to enable small incision sizes without undue stretching of the tissue at the incisions. At least one known delivery tool has a hub, rather than the tab 111, and the hub is a short tube that surrounds the entire perimeter of the obturator shaft and the implant device when extending from the housing. The tab 111 reduces the cross-sectional area of non-implanted matter that is inserted into the incision, relative to the tube-like hub. Unlike the tube-like hub, the tab 111 surrounds less than half of a perimeter of the discharge opening 116 (and less than half of the shaft 118 and implant device 108 that extend through the discharge opening 116).
In at least one embodiment, the tab 111 is a panel or wall that surrounds the discharge opening 116 along only one side thereof. It follows that the tab 111 surrounds the shaft 118 and the implant device 108, when extending through the discharge opening 116, only along one side as well. By extending only along one side, the tab 111 may reduce the cross-sectional area of the non-implanted matter inserted into the patient. To further limit the cross-sectional area, a width of the tab 111 may be no greater than a width of the discharge opening 116. The width of the discharge opening 116 extends along a width axis 190. The width axis 190 extends from a first gripping side 154 of the main body section 109 to a second gripping side 155 of the main body section 109. The discharge opening 116 has a height along a height axis 191. The shaft 118 projecting through the discharge opening 116 is oriented parallel to a longitudinal or length axis 192. The axes 190-192 are mutually perpendicular.
With additional reference to
In an embodiment, the tab 111 is located above the discharge opening 116 with respect to an orientation of the implant delivery instrument 101 during the implantation procedure. For example, the main body section 109 has a top side 134 and a bottom side 135 opposite the top side 134. The top side 134 may define the cavity opening 132.
With reference now back to
The tab 111 has a lower surface 172 opposite the upper surface 170. In an embodiment, the lower surface 172 is angled and/or curved towards the obturator 104. For example, the distal end 140 of the tab 111 is closer to a center 176 (e.g., centerline) of the passage 107 (shown in
With additional reference to
In an embodiment, the tab 111 includes a narrow rib 184 that projects from a base 186 of the tab 111. The rib 184 may represent or define the segment 183 of the lower surface 172 that enters the groove 180 of the shaft 118. The base 186 is wider than the rib 184. The base 186 extends above the upper surface 182 of the shaft 118 without entering the groove 180.
As shown in
With additional reference to
Unlike the embodiment shown in
Optionally, the tabs 111 shown in
A method may be performed to provide an implant delivery instrument. The method may include forming or obtaining a housing like the housing 102 shown and described with reference to
In an alternative embodiment, the implant device may be a leadless implantable medical device that include one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 9,216,285 “Leadless Implantable Medical Device Having Removable And Fixed Components” and U.S. Pat. No. 8,831,747 “Leadless Neurostimulation Device And Method Including The Same”, which are hereby incorporated by reference. Additionally or alternatively, the implant device may be a leadless cardiac monitor (ICM) that does not deliver electrical stimulation therapy (e.g., pacing or shock therapy). The ICM does not require leads to be implanted in the patient's heart. The ICM may include one or more structural and/or functional aspects of the device(s) described in U.S. patent application having Docket No. A15E1059, U.S. patent application Ser. No. 15/084,373, filed Mar. 29, 2016, entitled, “Method And System To Discriminate Rhythm Patterns In Cardiac Activity.”
All references, including publications, patent applications and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
As will be appreciated by one skilled in the art, various aspects may be embodied as a system, method, or instrument/product. Aspects are described herein with reference to the figures, which illustrate example methods, devices, and systems according to various example embodiments. Accordingly, while various arrangements are broadly contemplated, described and illustrated herein, it should be understood that they are provided merely in illustrative and non-restrictive fashion, and furthermore can be regarded as but mere examples of possible working environments in which one or more arrangements may function or operate.
It is to be understood that the subject matter described herein is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings hereof. The subject matter described herein is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings herein without departing from its scope. While the dimensions, types of materials and coatings described herein are intended to define various parameters, they are by no means limiting and are illustrative in nature. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the embodiments should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects or order of execution on their acts.
This application claims priority to U.S. Provisional Patent Application No. 63/223,652, filed Jul. 20, 2021 and titled Implant Delivery Instrument. The subject matter of the provisional application is expressly incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63223652 | Jul 2021 | US |
