MEDICAL DEVICES

TECHNICAL FIELD

Various embodiments disclosed herein generally relate to implantable medical devices. More specifically, this disclosure pertains to components engagable with implantable medical devices for retaining thereon one or more leads extending out from within the medical devices.

BACKGROUND

Cardiac rhythm management devices (cardiac pacemakers and implantable cardioverter-defibrillators) are commonly used to treat cardiac rhythm disturbances in patients. Recent surveys indicate that over 1.5 million pacemakers and implantable cardioverter-defibrillators (ICDs) are surgically installed on an annual basis. Cardiac device technology and implantation techniques are constantly being modified and improved in attempts to optimize device function and longevity after surgical installment. One challenge remains in the final steps of device implantation when it comes to proper positioning and wrapping of the leads behind the generator prior to packing of the device in the subcutaneous pocket and wound closure. Improper implantation and packing of the device leads in the pocket can increase the risk of lead erosion through the skin, lead fracture, sensing and pacing malfunctions, along with lead damage and dislodgement during future generator changes.

The basic components of a pacemaker or ICD include a housing in which are contained a generator and the atrial and/or ventricular leads attached to the generator. There are various approaches used to gain vascular access and to engage the atrial and/or ventricular leads with the myocardium, specifically one of the subclavian vein, the axillary vein, and the cephalic vein. Once the leads are positioned in the heart and fixed to the site of venous access, they are connected to the generator and subsequently wrapped behind or alternatively with the generator in a suitable manner to allow safe packing into a subcutaneous, surgically- constructed pocket incised into the patient's upper pectoral region prior to wound closure. These final steps of device implantation are challenging during surgical procedures because they require proper positioning and wrapping of the leads behind the generator prior to packing of the medical device in the subcutaneous pocket. The leads extending from cardiac rhythm management devices are generally provided in fixed lengths (e.g., 5 2cm, 58c m, 65 cm, 88 cm, among others). However, patients, their vasculature, and the sizes of their abdominal cavities are of variable lengths. Additionally, many patients require the installation of multiple leads, for example, up to three leads for cardiac resynchronization therapy (CRT). Often times, the lengths of the lead that is extravascular and in need of efficient packing in the pre-formed pocket, is quite long and can be difficult to pack safely behind the generator during a surgical procedure, particularly in cases when multiple leads are implanted and connected to the medical device. Improper implantation and packing of the device leads into the incised surgical pocket can increase the risk of lead erosion through the patient's skin, lead fractures, sensing and pacing malfunctions, along with lead damage and dislodgement during future surgeries to remove and replace generators. This is especially the case if the leads are not packed carefully behind the generator in the pocket especially since exposed leads lying free against the subcutaneous layer can easily erode through the skin increasing the risk of the occurrences of microbial infections in the surgical pocket. In addition, the leads can also be damaged during repeat generator changes as the pocket is being excised open surgically. Damaging an already implanted lead can be critical and life- threatening if a patient is pacemaker-dependent and relies on fully functional leads for pacing. Also, a damaged lead is not easy to extract and replace due to significant fibrosis around the lead that often occurs with time and the implantation of a new lead when one is damaged is not always possible due to vascular access limitations; there is frequently evidence of venous access stenosis over time at the site of previous lead insertion that makes it difficult to introduce an additional lead if necessary. Given the above concerns if the pacemaker leads are not safely packaged, it is often necessary to take a longer period of time in the operating room during generator changes trying to safely dissect to the implanted device while trying to avoid damaging the device leads that may located in the path of dissection. This prolonged operating room time also contributes to the financial burden of patient care as every extra minute of procedure time can be very costly to the health care system with an estimate of ~$180/min.

SUMMARY

The present disclosure pertains to resorbable lead retention devices for secure engagement to rearward-facing surfaces of implantable medical devices, for use as supports for winding thereonto and therearound one or more leads that extend out of the medical devices. The devices preferably comprise a resorbable polymer composition that slowly breakdowns over an extended period of time and are absorbed by a subject's body and optionally metabolized.

BRIEF DESCRIPTION OF THE FIGURES:

The drawings described herein are for illustrative purposes only of selected embodiments and are not intended to limit the scope of the present disclosure.

Fig. 1(A) is a perspective view of the rear-ward facing housing of a typical implantable cardiac rhythm management device with a single lead extending outward from a sidewall of the housing, while Fig. 1(B) shows the lead wound in a circular pattern against the rear-ward facing housing; Fig. 2(A) is a front view of an exemplary embodiment of a resorbable lead retention component of the present disclosure for engaging the rear-ward facing housing of a typical implantable cardiac rhythm management device, Fig. 2(B) is a rear view of the resorbable lead retention component, and Fig. 2(C) is a side view of the resorbable lead retention component; Fig. 3(A) is a perspective view of the resorbable lead retention component from Fig.

2, shown engaged with a typical implantable cardiac rhythm management device, while Fig. 3(B) is a side view of the component engaged with the device;

Fig. 4(A) is a perspective view of a lead extending outward from a sidewall of the housing of the device from Fig. 3, wound around the resorbable lead retention component, while Fig. 4(B) is a side view of lead wound around the component;

Fig. 5(A) is a side view of another exemplary embodiment of a resorbable lead retention component of the present disclosure for slidably engaging a key way provided within the rear-ward facing housing of a typical implantable cardiac rhythm management device shown in Fig. 5(B); Fig. 6(A) is a perspective view of another exemplary embodiment of a resorbable lead retention component of the present disclosure wherein the component comprises a suction cup for engaging a rear-ward facing housing of a typical implantable cardiac rhythm management device, while Fig. 6(B) is a side view of this exemplary embodiment;

Fig. 7(A) is a side view of another exemplary embodiment of a resorbable lead retention component of the present disclosure wherein the component comprises a slip-on resilient clip for engaging a rear-ward facing housing of a typical implantable cardiac rhythm management device, while Fig. 7(B) is a side view of this exemplary embodiment engaged with a cardiac rhythm management device;

Figs. 8(A), 8(B) are a side view and a front view respectively, of another exemplary embodiment of a resorbable lead retention component of the present disclosure engaged with a rear-ward facing housing of a typical implantable cardiac rhythm management device;

Fig. 9(A) is a perspective view of another exemplary embodiment of a resorbable lead retention component of the present disclosure wherein the component comprises an elongate bar for retaining a wound lead extending outward from a cardiac rhythm

management device, Fig. 9(B) is an exploded side view of the resorbable lead retention component shown adjacent to the rear- ward facing housing of a typical implantable cardiac rhythm management device, while Fig. 9(C) illustrates a variant of this exemplary embodiment;

Fig. 10(A) ) is an exploded side view of a variant of the resorbable lead retention component from Fig. 9(A) shown adjacent to the rear- ward facing housing of a typical implantable cardiac rhythm management device, Fig. 10(B) is a perspective view illustrating engagement of one of the resorbable lead retention component engaged with the rear-ward facing housing of a typical implantable cardiac rhythm management device, while Fig. 10(C) is a perspective view illustrating engagement of two of the resorbable lead retention components engaged with the rear-ward facing housing of a typical implantable cardiac rhythm management device;

Fig. 11(A) is a perspective view of a resilient fixation band for engaging a resorbable lead retention component shown in Fig. 11(B), while Fig., 11(C) shows the resorbable lead retention component secured against the typical implantable cardiac rhythm management device by the resilient fixation band; Fig. 12 is a perspective view of the resilient fixation band from Fig. 11(A) vertically engaged with a typical implantable cardiac rhythm management device for securing thereagainst a foot portion of a resorbable lead retention component of the present disclosure;

Fig. 13 is a perspective view of the resilient fixation band from Fig. 11(A)

horizontally engaged with a typical implantable cardiac rhythm management device for securing thereagainst a foot portion of a resorbable lead retention component of the present disclosure;

Figs. 14(A), 14(B) are a perspective view and a side view respectively, of the resilient fixation band from Fig. 11(A) securing a resorbable lead retention component of the present disclosure against a typical implantable cardiac rhythm management device by encircling the retention component and the device;

Figs. 15(A), 15(B) are a perspective view and a side view respectively, of another exemplary embodiment of a resilient fixation band having an inner projecting post;

Figs. 16(A) and 16(B) are a perspective view and a side view of the resilient fixation band from Figs. 15 engaged with an implantable cardiac rhythm management device and a lead extending from the device; and

Fig. 17) is a front view of another exemplary embodiment of a resilient fixation strap.

DETAILED DESCRIPTION

The present disclosure pertains to resorbable lead retention devices for secure engagement to rearward-facing surfaces of implantable medical devices, for use as supports for winding thereonto and therearound one or more leads that extend out of the medical devices. The devices preferably comprise a resorbable polymer composition that slowly breakdowns over an extended period of time and are absorbed by a subject's body and optionally metabolized.

The exemplary devices of the present disclosure are suitable for engagement with implantable medical devices exemplified by cardiac pacemakers, cardioverter-defibrillators, spinal cord stimulators, neurostimulation systems, intrathecal drug pumps for delivery of medicants into the spinal fluid, infusion pumps for delivery of chemotherapeutics and/or antispasmodics, insulin pumps, osmotic pumps, heparin pumps, and the like that have electrical leads or alternatively, cannula for receiving therethrough solutions, extending out from within the devices for egress at selected locations on patients' bodies.

Fig. 1(A) shows an exemplary cardiac pacemaker 10 with an electrical lead 12, while Fig. 1(B) shows the electrical lead 12 coiled against the rear-ward facing surface of the cardiac pacemaker 10. A surgeon would then install the cardiac pacemaker into a surgical pocket incised into a patient's chest cavity with the front-facing side of the pacemaker positioned to face outward towards the patient's skin surface and the rear-facing side positioned to face toward the abdominal cavity. Looping the leads into this position behind the device can be simply done by rotating the generator in one direction while the leads are attached to its header/connections. However, the wrapped/looped leads often become undone during insertion of the device into the pocket because the leads are not secured. The consequence is that the leads often migrate around within the pocket and to the front of the device, increasing the risk of damage to the leads due to their erosion through the patient's musculature and skin resulting in their fractures, sensing and pacing malfunctions. Furthermore, lead migration during the patient's healing process can result in dislodgement and partial or complete severing during future surgeries performed to remove and replace the device.

A first exemplary embodiment 15 of the resorbable lead retention devices of the present disclosure is shown in Figs. 2-4 and generally comprises an outer flat disk 16 to which is attached a post 17 with a flat end 18 that is engagable with the rear surface of an implantable medical device e.g., a cardiac pacemaker 20. An electrical lead 22 extending out from the cardiac pacemaker 20 can be wound around the post 17 and will be retained underneath the outer flat disk 16 during surgical installation of the cardiac pacemaker 20 and during the subsequent healing processes of the patient's body. The resorbable lead retention device by a suitable adhesive composition.

A second exemplary embodiment 30 of the resorbable lead retention devices of the present disclosure is shown in Fig. 5(A) and generally comprises an outer flat disk 32 to which is attached a post 33 to which is attached a second disk 34. The post 33 and second disk 34 of this lead retention device 30 are configured to slidingly engage a key way 42 provided within the rear surface of an implantable medical device 40 (Fig. 5(B)). It is suitable for the post 33 and second disk 34 of this lead retention device 30 to also frictionally engage the key way 42 so that the lead retention device 30 is retained by the key way 42 after it has been inserted thereinto. A lead (not shown) extending out from the medical device 40 can then be wound around the post 33 of the resorbable lead retention device 30 and is retained by the outer flat disk 32 during surgical installation of the medical device 40.

Another exemplary embodiment 45 of the resorbable lead retention devices of the present disclosure is shown in Figs. 6(A), 6(B) and generally comprises an outer flat disk 46 to which is attached a post 47 to which is attached a suction cup 48. This lead retention device 45 can be securely engaged with a the rear surface of an implantable medical device after which a lead extending out from the medical device can then be wound around the post 47 of the lead retention device 45 and is retained by the outer flat disk 46 during surgical installation of the medical device.

Another exemplary embodiment 50 of the resorbable lead retention devices of the present disclosure is shown in Figs. 7(A), 7(B) and generally comprises an outer flat disk 51 to which is attached a post 52 to which is attached a resilient clip 53 for engaging an end portion of an implantable medical device 55. The resilient clip 53 can securely engage a top end portion, a bottom end portion, or a bottom end portion such that the outer flat disk 51 extends outward from the rear-facing surface of the medical device 55. A lead (not shown) extending out from the medical device 55 can then be wound around the post 52 of the lead retention device 50 and is retained by the outer flat disk 51 during surgical installation of the medical device 55.

Another exemplary embodiment 57 of the resorbable lead retention devices of the present disclosure is shown in Fig. 8 and generally comprises an outer flat partial disk 58 to which is attached a post 59 to which is engagable to an implantable medical device 60 by the end surface (not shown) of the post 59. A lead (not shown) extending out from the medical device 55 can then be wound around the post 59 of the lead retention device 57 and is retained by the outer flat disk 48 during surgical installation of the medical device 60.

Yet another exemplary embodiment 65 of the resorbable lead retention devices of the present disclosure is shown in Figs. 9(A), 9(B) and generally comprises an outer elongate bar 66 to which is attached a post 67 to which is engagable to an implantable medical device 70 by the end surface (not shown) of the post 67. A lead (not shown) extending out from the medical device 70 can then be wound around the post 67 of the lead retention device 65 and is retained by the outer elongate bar 66 during surgical installation of the medical device 70. Fig. 9(C) shows a variant of the lead retention device 65 wherein a retainer lip 68 is provided at both ends of the elongate bar 66 for enhanced retention of leads after they are wound around the post 67.

Fig/s 10(A), 10(B), 10(C) illustrate a variant 75 of the resorbable lead retention device 65 shown in Figs. 9. The exemplary lead retention device 75 comprises an elongate bar 76 to which is attached a post 77 at one end of the bar 76. The lead retention device 75 is engagable with an implantable medical device 80 by the end surface of the post 80. It is optional to engage one lead retention device 75 with the medical device 80 with the post 77 positioned inboard on the rear-facing surface of the medical device 80 with the other end of the elongate bar 76 facing outbound to an edge of the medical device 80 as shown in Fig. 10(B). It is optional, if so desired, to engage two lead retention devices 75 with the medical device 80 with their posts 77 positioned inboard on the rear-facing surface of the medical device 80 with the other ends of the elongate bar 76s facing outbound in opposite directs to opposing edges of the medical device 80 as shown in Fig. 10(C).

A key element of the exemplary resorbable lead retention devices exemplified in Figs. 2-10 is that they comprise resorbable polymer compositions that slowly breakdown over extended periods of time and are absorbed by subjects' bodies and are optionally metabolized. Suitable resorbable polymers are exemplified by polylactic acid and polycaprolone. The rigidity and/or resilience and/or pliability of the lead retention devices can be adjusted by using various monomeric building blocks such as L-lactide, D-lactide, DL-lactide, glycolide and e-caprolactone. In particular, the rigidity and pliability of the devices can be adjusted as desired by the amount of e-caprolactone incorporated into a lactide-based polymer. The exemplary lead retention devices may be formed by processes exemplified by injection molding, compression molding, vacuum molding, thermoforming, and the like. The exemplary lead retention devices may also be formed by additive manufacturing processes exemplified by molten polymer deposition exemplified by fused deposition modeling and the like; binding of granular materials exemplified by selective laser sintering, selective heat sintering, and the like; photopolymerization of solubilised polymeric materials exemplified by digital light processing, stereolithography, and the like.

Another problem commonly associated with implanted medical devices is formation of fibrotic scar tissue unsecured migrating leads. Such scar tissue creates significant surgical and subsequent medical complications when the implanted device has to be removed for replacement or for adjustments or for other types of servicing. Accordingly, it is within the scope of the present disclosure to incorporate one or more antifibrotic agents into the resorbable polymer compositions. Altematively, the exemplary lead retention devices may be coated with one or more antifibrotic agents after the lead retention devices are formed. It is to be noted that the term "antifibrotic agent" as used herein means and agent that acts to inhibit and/or reduces the occurrence of fibrosis i.e., formation of excessive connective tissue on and/or about an implanted medical device and/or leads extending out of the implanted medical device between the medical device and its egress location on a patient's body, through one or more mechanisms including: inhibiting inflammation or the acute

inflammatory response, inhibiting migration or proliferation of connective tissue cells (such as fibroblasts, smooth muscle cells, vascular smooth muscle cells), reducing extracellular matrix (ECM) production or promoting ECM breakdown, and/or inhibiting tissue remodeling.

Suitable antifibrotic agents are exemplified by pirfenidone, colchicine, d- penicillamine, imatinib mesylate, cyclophosphamide, methotrexate, mycophenolate mofetil, proline analogs exemplified by cis-4-hydroxy-L-proline, 3,4-dehydro-DL-proline, (R)-(-)-2- thiazolidine-4-carboxylic acid, (S)-(-)-2-azetidinecarboxylic acid (ACA), 5-Lipoxygenase inhibitors and antagonists, chemokine receptor antagonists CCR (1, 3, 5), and cell cycle inhibitors exemplified by taxanes such as paclitaxel, docetaxel, and the like.

When used to coat the exemplary lead retention devices of the present disclosure, the antifibrotic agents are coated onto the devices at rates that will provide from about 0.01% to about 25% of the antifibrotic active ingredient per cm ² of the surface area of the devices. For example, about 0.01% w/w, about 0.05% w/w, about 0.1% w/w, about 0.2% w/w, about 0.3% w/w, about 0.4% w/w, about 0.5% w/w, about 0.75% w/w, about 1.0% w/w, about 1.25% w/w, about 1.5% w/w, about 1.75% w/w, about 2.0% w/w, about 2.25% w/w, about 2.5% w/w, about 2.75% w/w, about 3.0% w/w, about 3.25% w/w, about 3.5% w/w, about 3.75% w/w, about 4.0% w/w, about 4.25% w/w, about 4.5% w/w, about 4.75% w/w, about 5.0% w/w, about 5.25% w/w, about 5.5% w/w, about 5.75% w/w, about 6.0% w/w, about 7.0% w/w, about 8.0% w/w, about 9.0% w/w, about 10.0% w/w, about 15.0% w/w, about 20.0% w/w, about 25.0% w/w, and therebetween.

When incorporated into the resorbable polymer compositions which are then formed into the exemplary lead retention devices of the present disclosure, the antifibrotic agents are sequestered within and about the matrix formed by the resorbable polymer compositions. The antifibrotic agents are deposited at rates that will provide in the devices of the present disclosure, from about 0.01% to about 25% of the antifibrotic active ingredient by weight of the total weight of a resorbable lead retention device. For example, about 0.01% w/w, about 0.05% w/w, about 0.1% w/w, about 0.2% w/w, about 0.3% w/w, about 0.4% w/w, about 0.5% w/w, about 0.75% w/w, about 1.0% w/w, about 1.25% w/w, about 1.5% w/w, about 1.75% w/w, about 2.0% w/w, about 2.25% w/w, about 2.5% w/w, about 2.75% w/w, about 3.0% w/w, about 3.25% w/w, about 3.5% w/w, about 3.75% w/w, about 4.0% w/w, about 4.25% w/w, about 4.5% w/w, about 4.75% w/w, about 5.0% w/w, about 5.25% w/w, about 5.5% w/w, about 5.75% w/w, about 6.0% w/w, about 7.0% w/w, about 8.0% w/w, about 9.0% w/w, about 10.0% w/w, about 15.0% w/w, about 20.0% w/w, about 25.0% w/w, and therebetween.

Another problem commonly associated with implanted medical devices is occurrences of microbial infections around unsecured migrating leads. Accordingly, it is within the scope of the present disclosure to incorporate one or more antimicrobial agents into the resorbable polymer compositions. Alternatively, the exemplary lead retention devices may be coated with one or more antimicrobial agents after the lead retention devices are formed. It is to be noted that the term "antimicrobial" as used herein means antibiotic, antiseptic, disinfectant.

Suitable antimicrobial agents include aminoglycosides exemplified by tobramycine, gentamycin, neomycin, gentamicin, streptomycin, and the like; azoles exemplified by fluconazole, itraconazole, and the like; β-lactam antibiotics exemplified by penams, cephems, carbapenems, monobactams, β-lactamase inhibitors, and the like; cephalosporins exemplified by cefacetrile, cefadroxyl, cephalexin, cephazolin, cefproxil, cefbuperazone, and the like; chloramphenicol; clindamycin; fusidic acid; glycopeptides exemplified by vancomycin, teicoplanin, ramoplanin, and the like; macrolides exemplified by azithromycin,

clarithromycin, dirithromysin, erythromycin, spiramycin, tylosin, and the like; metronidazole; mupirocin; penicillins exemplified by benzylpenicillin, procaine benzylpenicillin, benzathine benzylpenicillin, phenoxymethylpenicillin, and the like; polyenes exemplified by

amphotericin B, nystatin, natamycin, and the like; quinolones exemplified by ciprofloxacin, ofloxacin, danofloxacin, and the like; rifamycins exemplified by rifampicin, rifabutin, rifapentine, rifaximin, and the like; sufonamides exemplified by sulfacetamine, sulfadoxine, and the like; tetracyclines exemplified by doxycycline, minocycline, tigecycline, and the like; and trimethoprim, among others.

When used to coat the exemplary lead retention devices of the present disclosure, the antimicrobial agents are coated onto the devices at rates that will provide from about 0.01% to about 25% of the antibiotic active ingredient per cm ² of the surface area of the devices. For example, about 0.01% w/w, about 0.05% w/w, about 0.1% w/w, about 0.2% w/w, about 0.3% w/w, about 0.4% w/w, about 0.5% w/w, about 0.75% w/w, about 1.0% w/w, about 1.25% w/w, about 1.5% w/w, about 1.75% w/w, about 2.0% w/w, about 2.25% w/w, about 2.5% w/w, about 2.75% w/w, about 3.0% w/w, about 3.25% w/w, about 3.5% w/w, about 3.75% w/w, about 4.0% w/w, about 4.25% w/w, about 4.5% w/w, about 4.75% w/w, about 5.0% w/w, about 5.25% w/w, about 5.5% w/w, about 5.75% w/w, about 6.0% w/w, about 7.0% w/w, about 8.0% w/w, about 9.0% w/w, about 10.0% w/w, about 15.0% w/w, about 20.0% w/w, about 25.0% w/w, and therebetween.

When incorporated into the resorbable polymer compositions which are then formed into the exemplary lead retention devices of the present disclosure, the antimicrobial agents are sequestered within and about the matrix formed by the resorbable polymer compositions. The antimicrobial agents are deposited at rates that will provide in the devices of the present disclosure, from about 0.01% to about 25% of the antibiotic active ingredient by weight of the total weight of a resorbable lead retention device. For example, about 0.01% w/w, about 0.05% w/w, about 0.1% w/w, about 0.2% w/w, about 0.3% w/w, about 0.4% w/w, about 0.5% w/w, about 0.75% w/w, about 1.0% w/w, about 1.25% w/w, about 1.5% w/w, about 1.75% w/w, about 2.0% w/w, about 2.25% w/w, about 2.5% w/w, about 2.75% w/w, about 3.0% w/w, about 3.25% w/w, about 3.5% w/w, about 3.75% w/w, about 4.0% w/w, about 4.25% w/w, about 4.5% w/w, about 4.75% w/w, about 5.0% w/w, about 5.25% w/w, about 5.5% w/w, about 5.75% w/w, about 6.0% w/w, about 7.0% w/w, about 8.0% w/w, about 9.0% w/w, about 10.0% w/w, about 15.0% w/w, about 20.0% w/w, about 25.0% w/w, and therebetween.

Another exemplary embodiment of the resorbable lead retention devices of the present disclosure is shown in Figs. 11-17 and generally comprises a resilient elastic band. As shown in Fig. 11(A) the elastic band 100 is provided with a plurality of spaced-apart fenestrations 102 around the circumference of the elastic band 100. An exemplary lead retention device

105 that can be secured to an implantable medical device is provided with an outer flat disk

106 to which is attached a post 107 having a foot component 108 at its end opposite the end engaged with the outer flat disk 106 (Fig. 11(B)). The foot component 108 is inserted into one of the fenestrations 102 in the elastic band 100 which is then slipped over an implantable medical device 110 (Fig. 11(C)), after which, a lead 112 extending out from the medical device 110 (shown in Figs. 12 and 13) is wrapped around the post 107 prior to surgical installation into a patient's body. As shown in Fig. 12, the elastic band engaged with the lead retention device 105 can be slipped over the top and bottom portions of the medical device 110. Alternatively, the elastic band 100 may be slipped over the side portions of the medical device 110 as shown in Fig. 13, and then the foot component 108 can be inserted between the medical device 110 and the elastic band 100 (without inserting the foot 108 into a fenestration provided on the band 100). Alternatively, as shown in Figs. 14(A), 14(B), the lead 112 can be wrapped around the post of the lead retention device 105 which is then positioned on the rearward facing surface of the medical device 110, and then secured in place by slipping the resilient band over the lead retention device 105 and the medical device 110. It is to be noted that the resilient elastic band 100 may comprise resorbable polymer compositions.

An exemplary variant 120 of the elastic band is shown in Figs. 15 and 16. This exemplary elastic band 120 is provided with an inward-depending post 122 around which a lead 127 extending out from an implantable medical device 125 is wrapped prior to slipping the elastic band 120 around the medical device 125 as shown in Figs. 16(A), 16(B).

Another exemplary variant 130 for securing to and retaining against an implantable medical device, an exemplary resorbable lead retention device of the present disclosure is shown in Fig. 17. This variant 130 comprises an elongate strap 132 with a plurality of fenestrations provided therealong, with one end of the strap 132 provided with plurality of staggered retaining elements 134 for insertion through a fenestration 135 and then pulling on the strap 132 to secure a retaining element against the fenestration to snugly secure a lead retention device against an implantable medical device. It is optional to provide a post on the strap for wrapping therearound one or more leads extending out of the medical device.

Those skilled in these arts will understand that each of the different embodiments and variants thereof disclosed herein are easily handled and manipulated by only one professional during performance of a surgical procedure to install an implantable medical device and to secure any leads or conduits extending outward therefrom in a preferred position on the rearward-facing surfaces of the medical device.